On March 21, 2024 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and fourth-quarter and full-year 2023 financial results (Press release, Kronos Bio, MAR 21, 2024, View Source [SID1234641341]).

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"In 2023, we made great progress across our portfolio and business. We demonstrated that KB-0742 has a safety profile that is clearly differentiated from all other CDK9 inhibitors, and we believe our extended dosing schedule will show increased efficacy signals while maintaining a favorable safety profile," said Nobert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We also announced our second development candidate, KB-9558, which is designed to target the KAT domain of p300 and downregulate IRF4 transcription in multiple myeloma. We are looking forward to completing the IND-enabling studies in 2024 and expect to dose our first patients in the first half of 2025."

Clinical Program and Recent Company Updates

KB-0742
•At the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, the Company reported target engagement, tumor regressions, and an acceptable safety profile for KB-0742 dosed at 60mg three-days-on, four-days-off in heavily pre-treated patients with transcriptionally addicted solid tumors. Out of fourteen "all-comer" patients, two patients with myxoid liposarcoma exhibited tumor regressions: one (7th line) had a partial response (per RECIST v1.1) lasting 113 days and the second achieved a 26% reduction in tumor diameters with stable disease. KB-0742 also cleared the 80mg three-days-on, four-days-off schedule in dose escalation and is currently enrolling patients in the KB-0742 60mg four-days-on, three-days-off dose escalation cohort of the Phase 1/2 trial.
•At a medical conference in mid-2024, the Company intends to share an update on the clinical data to date from patients with transcriptionally addicted tumors who were dosed with 60mg three-days-on, four-days-off, and from "all-comer" patients in the dose-escalation cohort who received 80mg three-days-on, four-days-off.
•In the third quarter of 2024, the Company expects to clear the 80mg four-days-on, three-days-off dose escalation cohort, and begin enrolling patients in an expansion cohort including one or more of the following: non-small cell lung cancer, small cell lung cancer, ovarian cancer, and triple negative breast cancer.

Exhibit 99.1
•The Company expects to announce topline data from the expansion cohort at the 80mg four-days-on, three-days-off dose in the first half of 2025.

KB-9558
•In December 2023, the Company announced the nomination of KB-9558, a p300 KAT inhibitor, as a development candidate.
•KB-9558 is the second development candidate to emerge from Kronos Bio’s product engine, where the Company identified that inhibition of the lysine acetyltransferase (KAT) domain on p300 inhibits expression of interferon regulatory factor 4 (IRF4) and thus collapses the transcription regulatory network that is required for the survival of multiple myeloma cells.
•The Company plans to present data on KB-9558 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, being held from April 5-10, 2024 in San Diego, California, including how targeting p300’s enzymatic KAT domain can selectively downregulate IRF4.
•Pending completion of IND-enabling studies in 2024, the Company intends to initiate a first-in-human trial in relapsed or refractory multiple myeloma in the first half of 2025.

Lanraplenib
•In December 2023, after a review of data from the Phase 1b portion of its Phase 1b/2 trial of lanraplenib in combination with gilteritinib in FLT3-mutated relapsed/refractory acute myeloid leukemia (AML), the Company decided not to proceed to Phase 2.

Company Update
•Kronos Bio extended its expected cash runway by a year, into the second half of 2026, through restructurings and resource optimization.

Fourth-Quarter and Full-Year 2023 Financial Highlights

▪Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $175.0 million in cash, cash equivalents and investments as of December 31, 2023, the Company anticipates sufficient resources to fund its planned operations into the second half of 2026.

▪R&D Expenses: Research and development expenses were $18.7 million for the fourth quarter of 2023, which includes non-cash stock-based compensation expense of $2.5 million. For the full year of 2023, research and development expenses were $86.4 million, which includes non-cash stock-based compensation expense of $12.0 million.

▪G&A Expenses: General and administrative expenses were $10.9 million for the fourth quarter of 2023, which includes non-cash stock-based compensation expense of $2.7 million. For the full year of 2023, general and administrative expenses were $41.7 million, which includes non-cash stock-based compensation expense of $13.0 million.

▪Net Loss: Net loss for the fourth quarter of 2023 was $25.3 million, or $0.43 per share, including non-cash stock-based compensation expense of $5.2 million. Net loss for the full-year 2023 was $112.7 million, or $1.95 per share, including non-cash stock-based compensation expense of $25.0 million.

On March 21, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives, reported financial results for the full year ended December 31, 2023 and provided a corporate update (Press release, Kineta, MAR 21, 2024, View Source;utm_medium=rss&utm_campaign=kineta-reports-full-year-2023-financial-results-and-provides-corporate-update [SID1234641340]).

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In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. The Company announced the restructuring as a result of certain investors indicating that they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. In connection with the restructuring, the Company announced that it is exploring strategic alternatives to maximize stockholder value.

"2023 was a productive year for Kineta where we initiated the Phase 1/2 VISTA-101 trial of KVA12123 as monotherapy and in combination with pembrolizumab in cancer patients, and saw promising results, underscoring the potential of KVA12123 as a next-generation immunotherapy. We truly appreciate the efforts of the healthcare professionals, the patients and their caregivers, and the Kineta employees involved in this trial. We look forward to sharing the clinical update in the second quarter and we will continue to explore strategic alternatives that will allow us to continue to pursue our mission of developing transformative immunotherapies for patients with cancer," said Craig Philips, President of Kineta.

RECENT CORPORATE HIGHLIGHTS

Phase 1/2 VISTA-101 Trial of KVA12123 in Patients with Solid Cancer Tumors

Efficacy

Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors.
Monotherapy Dose Escalation (3-300 mg KVA12123 Q2W)
Of 21 patients enrolled, 12 received at least one baseline and one follow up scan.
Best overall response (BOR) in nine of 12 patients is currently stable disease among patients with at least one follow-up scan with a mean duration of 15 weeks.
One patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced a stable disease lasting 28 weeks.
Nine participants remain on-treatment.
Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W).
Of nine patients enrolled, three received at least one baseline and one follow-up scan.
BOR in 2 of 3 patients with at least one follow up scan is:
Stable disease in one CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions.
Partial response in one patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions.
Eight patients remain on treatment.
Biomarkers

Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines.
Dose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells.
Safety

No dose limiting toxicities (DLTs) observed in any patient at any dose level.
No evidence of cytokine release syndrome in any patient at any dose level.
Conference Presentations

Co-organized the 3rd Annual VISTA Symposium, with Hummingbird Bioscience and Dartmouth Giesel School of Medicine, to be held virtually on March 27, 2024.
Presented clinical and preclinical data on VISTA blocking KVA12123 at the Keystone Symposia of Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance.
Presented new preclinical data on KVA12123 in acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Blood Cancer Discovery Symposium.
ANTICIPATED FUTURE MILESTONES

Additional KVA12123 monotherapy safety and efficacy data in Q2 2024.
Initial KVA12123 and pembrolizumab combination therapy data in Q2 2024.
EXPLORATION OF STRATEGIC ALTERNATIVES

In February 2024, the Company announced that it is pursuing strategic alternatives to maximize shareholder value due to certain investors indicating they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. As a result, the Company has suspended new patient enrollment into the Phase 1/2 VISTA-101 trial and will not be recruiting patients into either the sixth cohort in the monotherapy arm or the third cohort in the combination therapy arm. Patients currently enrolled in the trial will be permitted to continue to participate. In connection with the restructuring, the Company implemented a workforce reduction of the Company’s workforce of approximately 64% of the Company’s then-current employee base.
2023 FINANCIAL HIGHLIGHTS

Cash position: As of December 31, 2023, cash was $5.8 million, compared to $13.1 million as of December 31, 2022. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes, partially offset by $8.6 million net proceeds received from institutional and individual investors and $5.0 million in cash received from the Merck milestone payment in July 2023. As of December 31, 2023, we had $5.8 million in cash, and there is substantial doubt about our ability to continue as a going concern. Based on our current operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the filing date of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which we expect to file on March 21, 2024.
Revenues: Total revenues were $5.4 million for the year ended December 31, 2023 and $2.0 million for the year ended December 31, 2022. Revenues in 2023 were primarily due to our achievement of a development milestone under the Merck Exclusive License and Research Collaboration Agreement, which triggered a $5.0 million milestone payment. Revenues in 2022 were due to research and development services from the Genentech Option and License Agreement, which was terminated in December 2022, and also due to services provided under a grant that was concluded in December 2022.
Research and development (R&D) expense: R&D expenses were $9.0 million for the year ended December 31, 2023 and $15.9 million for the year ended December 31, 2022. The decreases in R&D expenses were primarily due to lower activities for KVA12123 manufacturing and clinical study start up as the Company began enrolling the first patient in the study, which occurred in April 2023.
General and administrative expense: General and administrative expenses were $12.1 million for the year ended December 31, 2023 and $8.7 million for the year ended December 31, 2022. The increase was primarily due to increases in personnel costs of $2.3 million and insurance and other company expenses of $1.1 million. Personnel costs increased due to higher salaries and benefits of $1.2 million from increased headcount to support public company responsibilities and higher stock-based compensation of $1.0 million, which increased due to options granted during 2023. Insurance and other company expenses increased primarily due to public company directors and officers insurance premiums of $601,000 and board fees of $270,000.
Net loss: Net loss was $14.1 million, or $1.28 per basic and diluted share, for the year ended December 31, 2023 compared to a net loss of $63.4 million, or $12.87 per basic and diluted share, for the year ended December 31, 2022.

On March 21, 2024 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its fourth quarter and full year 2023 financial results and provided a corporate update (Press release, Instil Bio, MAR 21, 2024, View Source [SID1234641339]).

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Recent Highlights:

Announced entering into a strategic collaboration to develop an autologous folate receptor α (FRα)-CoStAR enhanced TIL for a potential investigator-initiated trial (IIT) in non-small cell lung cancer in China

Announced a strategic update to the ITIL-306 program, including closure of Instil’s UK manufacturing and cessation of ITIL-306 clinical trial activities

Exploring opportunities to in-license/acquire and develop novel therapeutic candidates in diseases with significant unmet medical need

Cash runway expected beyond 2026
Fourth Quarter and Full Year 2023 Financial and Operating Results:

As of December 31, 2023, Instil had $175.0 million in total cash, cash equivalents, restricted cash, marketable securities and long-term investments, which consisted of $9.2 million in cash and cash equivalents, $1.5 million in restricted cash, $141.2 million in marketable securities and $23.2 million in long-term investments, compared to $260.9 million in total cash, cash equivalents and marketable securities, which consisted of $43.7 million in cash and cash equivalents and $217.2 million in marketable securities, as of December 31, 2022. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of December 31, 2023 will enable it to fund its operating plan beyond 2026.

Research and development expenses were $2.0 million and $39.6 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $20.7 million and $141.1 million for the fourth quarter and full year ended December 31, 2022, respectively.

General and administrative expenses were $10.9 million and $47.6 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $12.9 million and $62.2 million for the fourth quarter and full year ended December 31, 2022, respectively.

Restructuring and impairment charges were $0.2 million and $72.0 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $23.2 million for the fourth quarter and full year ended December 31, 2022.

Net loss per share, basic and diluted were $1.99 and $24.00 for the fourth quarter and full year ended December 31, 2023, respectively, compared to $8.29 and $34.46 for the fourth quarter and full year ended December 31, 2022. Non-GAAP net loss per share, basic and diluted were $1.26 and $10.14 for the fourth quarter and full year ended December 31, 2023, respectively, compared to $3.70 and $26.18 for the fourth quarter and full year ended December 31, 2022.

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding restructuring and impairment charges and non-cash stock-based compensation expense. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

On March 21, 2024 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update (Press release, Bolt Biotherapeutics, MAR 21, 2024, View Source [SID1234641338]).

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"We made substantial progress advancing our two proprietary clinical-stage development programs in 2023," said Randall Schatzman, Ph.D., Chief Executive Officer. "We have now administered BDC-1001, which we have renamed trastuzumab imbotolimod, to patients in all five of the Phase 2 cohorts. BDC-3042 also continues to advance, and has now entered the fourth dose escalation cohort without a dose-limiting toxicity. Both clinical programs are on track and we look forward to providing updates later this year."

Recent Highlights and Anticipated Milestones

•
Trastuzumab imbotolimod (BDC-1001) Phase 2 program continues to advance. Trastuzumab imbotolimod is a BoltbodyTM ISAC that is currently in Phase 2 clinical development across five distinct cohorts treating patients with HER2-positive cancer. The first three cohorts evaluate monotherapy trastuzumab imbotolimod in colorectal, endometrial, and gastroesophageal cancer, and the fourth and fifth cohorts evaluate trastuzumab imbotolimod with or without pertuzumab for the treatment of HER-2 positive metastatic breast cancer. All cohorts utilize a Simon two-stage design. Roche is providing pertuzumab in support of the trial. The most recent update on trastuzumab imbotolimod was presented at the ESMO (Free ESMO Whitepaper) 2023 Congress in October 2023, noting a 29% objective response rate (ORR) comprising 1 complete response (CR) and 3 partial responses (PRs) in evaluable patients with HER2-positive tumors at the recommended Phase 2 dose (RP2D). BDC-1001 was well tolerated. The most common treatment-related treatment-emergent adverse events (TEAE) was Grade 1 or 2 infusion-related reactions, which were seen in 30% of patients in the study.
•
BDC-3042 Phase 1 dose escalation study continues to advance. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This dose-escalation Phase 1 clinical study will initially evaluate BDC-3042 as monotherapy in patients with a variety of solid tumors, and will then evaluate the combination of BDC-3042 with a PD-1 inhibitor. Bolt has completed the first three dosing cohorts without observing any dose-limiting toxicities and the trial is enrolling well.

•
Cash, cash equivalents, and marketable securities were $128.6 million as of December 31, 2023. Cash on hand is expected to fund multiple clinical milestones in 2024 and operations through late 2025.

Fourth Quarter and Full Year 2023 Financial Results

•
Collaboration Revenue – Collaboration revenue was $2.1 million for the quarter and $7.9 million for the full year ended December 31, 2023, compared to $1.4 million and $5.7 million for the same quarter and year in 2022. Revenue in the comparative periods was generated from the services performed under our R&D collaborations as we fulfill our performance obligations.

•
Research and Development (R&D) Expenses – R&D expenses were $16.3 million for the quarter and $61.5 million for the full year ended December 31, 2023, compared to $16.8 million and $73.1 million for the same quarter and year ended 2022. The decrease in R&D expenses was due to lower manufacturing expenses related to the timing of batch production, offset by higher clinical expenses related to the advancement of trastuzumab imbotolimod clinical trial into Phase 2.

•
General and Administrative (G&A) Expenses – G&A expenses were $5.5 million for the quarter and $22.5 million for the full year ended December 31, 2023, compared to $5.6 million and $22.9 million for the same quarter and year in 2022.

•
Loss from Operations – Loss from operations was $19.8 million for the quarter and $76.2 million for the full year ended December 31, 2023, compared to $21.0 million and $90.3 million for the same quarter and year in 2022. This is in part a reflection of proactive cost-containment measures taken in June 2022.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On March 21, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the dosing of the first participant with the first of two cycles of 12GBq of 67Cu-SAR-bisPSMA in cohort 4, the final cohort in the dose escalation phase of the SECuRE trial (Press release, Clarity Pharmaceuticals, MAR 21, 2024, View Source [SID1234641334]).

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The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with Prostate-Specific Membrane Antigen (PSMA)-expressing mCRPC using 64Cu/67Cu SAR-bisPSMA. 64Cu SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation trial with a cohort expansion involving up to 44 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

Cohort 4 explores the anti-cancer effects of multiple therapy cycles of 67Cu-SAR-bisPSMA at the highest dose of 12GBq on the SECuRE trial participants. The fourth cohort is the last cohort of the dose escalation phase before moving into the Phase II stage of the trial with dose expansion in 14 participants, pending safety evaluation.

Cohort 4 is designed as a "3+3" cohort, where the first 3 participants will receive 2 therapy cycles followed by an SRC meeting before commencing recruitment of the final 3 participants. Based on the safety profile observed in the first 3 cohorts of the SECuRE trial, a change to the dosing schedule of cohort 4 from "2 doses" to "up to 4 doses" has been approved by the SRC. The amendment to the protocol is currently underway, which will be submitted to the US Food and Drug Administration (FDA) and respective Institutional Review Boards for implementation. This will allow patients who are benefiting from 67Cu-SAR-bisPSMA to receive 2 additional doses under the SECuRE trial in cohort 4 (up to 4 doses in total).

Participants treated in the SECuRE trial to date have received multiple lines of therapy prior to their recruitment into the study, including androgen deprivation therapy (ADT), androgen receptor pathway inhibition (ARPI) therapy, investigational agents, chemotherapy and other radioligand therapies such as alpha and beta-emitters (225Ac and 177Lu-based therapies, respectively). Most trial participants had received chemotherapy (67%, 10/15) and the median number of lines of therapy prior to receiving 67Cu-SAR-bisPSMA was 4. The median prostate-specific antigen (PSA) at study entry was 117.1 ng/ml (range 0.11-1,494.2).

The first 3 cohorts in the dose escalation phase of the trial were successfully completed with no DLTs reported in any of the participants dosed. No adverse events (AEs) related to 64Cu-SAR-bisPSMA were observed. Most AEs related to 67Cu-SAR-bisPSMA were low grade (grade 1 or 2). The most common AE reported was mild dry mouth (grade 1, 4/15 participants, 27%). The most common grade 3 AE was anaemia, reported in 2/15 participants (13%).

Preliminary data shows that despite having high levels of PSA and having received multiple treatments, 60% (9/15) of participants across all cohorts (including the lowest dose cohort of 67Cu-SAR-bisPSMA at 4GBq) showed reductions in PSA levels of greater than 35% from a single therapy cycle of 67Cu-SAR-bisPSMA. PSA reductions of greater than 80% were seen in 27% of all trial participants. In cohorts 2 and 3 (8 and 12GBq, respectively), PSA reductions of greater than 35% were observed in almost 80% (78%, 7/9) of participants and PSA was reduced by over 80% in 44% (4/9) of participants so far.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Treating the first participant in cohort 4 just a week after announcing the safety review from cohort 3 and opening cohort 4 is remarkable. With all available slots now allocated in the first part of cohort 4, we look forward to completing this final cohort in the dose escalation stage of the trial and moving to dose expansion, where we plan to enrol 14 patients. This high pace of recruitment into the SECuRE trial reflects the high unmet need in the prostate cancer therapy space as well as clinicians’ excitement about our SAR-bisPSMA product.

"Results from the first 3 cohorts and the data from 2 patients who received additional doses of 67Cu-SAR-bisPSMA under the US Expanded Access Program (EAP) are outstanding. These 2 patients from the EAP received 1 or 3 additional doses of 67Cu-SAR-bisPSMA at 8GBq or 4GBq, respectively2,3. They had failed multiple lines of therapy prior to being treated with 67Cu-SAR-bisPSMA and have had dramatic responses (94% reduction in PSA levels in one patient, and reduction to undetectable PSA levels in another) with only a few mild or moderate side effects from the treatment and excellent quality of life. This demonstrates great efficacy and a favourable safety profile of our product with the multi-dosing treatment. We look forward to replicating those results in cohort 4 and in the dose expansion phase of the trial at the higher dose of 12GBq. The data to date continues to reinforce our strong belief that we have a best-in-class radiopharmaceutical therapy, with dramatic responses obtained in patients that had failed multiple treatments, including other radiopharmaceutical therapies, as well as all other standard of care therapies and products in development. Coupled with the favourable safety profile, we believe we are well on our way to fulfilling our promise of improving treatment outcomes for people with cancer."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) Technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR Technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide4. The American Cancer Institute estimates in 2024 there will be 299,310 new cases of prostate cancer in the US and around 35,250 deaths from the disease.