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Clarity successfully completes $203 million institutional placement

On July 28, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the successful completion of a $203 million placement to institutional investors ("Placement") (Press release, Clarity Pharmaceuticals, JUL 28, 2025, View Source [SID1234654571]).

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The offer price per new fully paid ordinary share issued under the Placement ("New Share") was $4.20 ("Offer Price"), representing a 2.2% premium to Clarity’s last closing price and an 18.0% premium to the 15-day VWAP. Following the completion of the Placement, the Company will have a pro-forma cash balance of approximately $288 million1, which will help fund Clarity in connection with the below-mentioned expected catalysts and milestones, including the specified clinical trial programs.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The last eight months have been an incredibly tumultuous period for global markets generally, driven by the US political environment. When these times occur, pre-revenue biotechnology companies can be affected significantly more than other businesses due to their need to raise capital in order to get products to market. In addition to the global financial turmoil, there has been some unfortunate news from local biotechnology companies, putting significant pressure on the Australian biotechnology market. Being a successful pre-revenue biotechnology company listed on the ASX also presents additional considerations. For Clarity in particular, the inclusion of the Company in a number of indices over this period, such as the ASX200 and ASX300, has significantly raised the profile of the Company to certain investor groups, including index funds. These factors, amongst other variables, have contributed to the volatility in Clarity’s share price and an increasing number of short positions in our Company, reaching approximately 10% of our current total number of shares on issue.

"However, during this period of volatility our team has not lost sight of our purpose: to better the lives of people living with cancer. This drive has resulted in the achievement of many substantial milestones across our entire business, including outstanding clinical trial data, validation of new products in pre-clinical development, roll-out of enhanced supply and manufacturing in preparation for potential commercialisation and a number of important regulatory objectives.

"The coalescing of strong company fundamentals with ASX investor dynamics provided Clarity with an opportunity to capitalise with a fast, well-executed and sizeable placement to a small number of institutional investors who are close to the Company. The Placement has received phenomenal support, evidenced by the raising of over $200 million at not only a premium to the last closing share price, but a substantial premium to the share price observed for almost the entirety of CY2025. This places Clarity in a strong position, with an enviable Balance Sheet, where we can work to complete a number of high value-driving clinical trials, including our pivotal Phase 3 trials, as we progress our products towards potential commercialisation. The completion of the institutional Placement, coupled with significant short- and medium-term deliverables, such as the read-outs of the Co-PSMA trial and the Phase 3 trials, respectively, as well as longer-term activities, such as the further development of our therapy programs, are expected to underpin short-, medium- and longer-term shareholder value growth as we work towards our ultimate goal of better treating people with cancer."

Bell Potter Securities Limited acted as Sole Lead Manager. Lander & Rogers acted as Clarity’s Australian legal adviser.

UPCOMING EXPECTED CATALYSTS AND MILESTONES
Clinical Development
64Cu-SAR-bisPSMA diagnostic program in prostate cancer

Co-PSMA investigator-initiated trial (head-to-head, biochemical recurrence [BCR]): Readout Q3/4 CY2025
AMPLIFY trial (Phase 3, BCR): Enrolment complete Q4 CY2025
CLARIFY trial (Phase 3, pre-prostatectomy): Enrolment complete H1 CY2026
New Drug Application (NDA) planning and submission activities in anticipation of positive trial results
64/67Cu‑SAR‑bisPSMA theranostic program in prostate cancer

SECuRE (Phase 2, Cohort Expansion): Anticipated enrolment complete by Q1 CY2026
⁶⁴Cu‑SAR‑Bombesin diagnostic program in prostate cancer

Ongoing data review following positive Phase II SABRE topline trial data (June 2025) for prostate-specific membrane antigen (PSMA)-negative prostate cancer
Continued planning for the next trial and possible alternative indications with 64Cu-SAR-Bombesin
64Cu-SARTATE diagnostic program in neuroendocrine tumours (NETs)

Phase 3 trial planning following positive DISCO topline trial data (June 2025): Anticipated End-of-Phase (EOP) meeting with the US Food and Drug Administration (FDA) H2 CY2025
Pipeline Advancements

Pre-clinical development of the theranostic 64/67Cu-SAR-trastuzumab product in breast cancer and the diagnostic 64Cu-SAR-bisFAP product: Complete H1 CY2026
First-in-human trials for both products: Initiate clinical programs H2 CY2026
Continued Strategic Manufacturing Expansion of 64Cu-SAR-bisPSMA

Initial NDA and US commercial supply readiness
Additional agreements established for copper-64 and drug product manufacturing capacity in preparation for proposed commercial launch of 64Cu-SAR-bisPSMA globally: CY2025/6
Global Commercial Team Buildout for 64Cu-SAR-bisPSMA Launch

Hiring of key roles for proposed product launch of 64Cu-SAR-bisPSMA, including Sales, Marketing and Market Access.

Celyad Oncology announces €1 Million Private Placement

On July 28, 2025 Celyad Oncology (Euronext: CYAD) (the "Company" or "Celyad") reported that it has entered into a subscription agreement for a private placement financing (Press release, Celyad, JUL 28, 2025, View Source [SID1234654570]).

Under the terms of the agreement, CFIP CLYD (UK) Limited ("Fortress") will subscribe to a capital increase for an aggregate amount of €1 million in exchange for 3,333,333 newly issued ordinary shares of Celyad. The shares will be issued at a subscription price of EUR 0.30 per share, which represents a 15% discount to the volume-weighted average price (VWAP) of Celyad’s shares on Euronext Brussels over the ten (10) trading days preceding the date of signing. Fortress’s subscription commitment is subject to customary conditions precedent. The closing is expected to take place on or around August 5, 2025. CFIP CLYD (UK) Limited is an affiliate of Fortress Investment Group.

The private placement is being conducted within the limits of the Company’s authorized capital as approved by the Extraordinary Shareholders’ Meeting of 14 November 2023, with cancellation of the preferential subscription rights of the existing shareholders in favor of Fortress. Following and subject to the issue of the shares to Fortress, Fortress is expected to hold approximately 58.51% of the Company’s shares.

The net proceeds of the placement will be used to support the working capital of the Company for general corporate purposes. The Company believes that following the close of the private placement, its cash runway will be extended from mid Q3 2025 to mid Q4 2025 which will give additional time for the Company to evaluate its strategic options to strengthen its balance sheet.

As Fortress qualifies as a related party of the Company, the board of directors applied Article 7:97 of the Belgian Code of Companies and Associations (the "BCCA"), which requires, among other things, the intervention of a committee of independent directors to give an opinion to the board of directors. The conclusions of the committee’s opinion is as follows: "The Committee has assessed the envisaged Transaction in light of the criteria included in article 7:97 of the BCCA and concluded, in view of the Company’s financial situation and cash flow requirements, after considering and examining alternative funding options and taking into account the interest of all stakeholders, that the expected advantages of the Transaction outweigh the expected disadvantages thereof, which leads to the conclusion that the Transaction is to the advantage and in the interest of the Company. The Transaction is in line with the Company’s strategic policy and is not manifestly unreasonable and the Committee affirms its positive advice in relation to the Transaction". The directors previously appointed by Fortress did not participate in the deliberations or votes.

In light of the Company’s limited cash runway, the board of directors believes that the envisaged capital increase is in the best interests of the Company and its stakeholders because, if completed, the capital increase will give additional time for the Company to evaluate its strategic options to strengthen its balance sheet. In accordance with article 7:97 of the BCCA, the Company’s auditor has issued a report on the accounting and financial information contained in the committee’s opinion and the board minutes approving the related party transaction. The auditor’s conclusion in this respect is as follows: "Based on our assessment, nothing has come to our attention that causes us to believe that the accounting and financial information included in the advice of the committee of independent directors dated July 23, 2025 and in the minutes of the Board of Directors dated July 23, 2025, justifying the proposed transaction, is not fair and sufficient, in all material respects, with regard to the information available to us within the scope of our mission."

Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

On July 28, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor (Press release, Celcuity, JUL 28, 2025, View Source [SID1234654569]).

In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The mPFS, as assessed by blinded independent central review ("BICR"), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.

The gedatolisib doublet also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

The topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer:

· The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.

· The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of therapy.

· Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA wild-type ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.

Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial said: "Patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease has progressed while on, or after, treatment with a CDK4/6 inhibitor typically derive limited benefit from subsequent endocrine-based therapy. The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control."

Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase 1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis.

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity said: "The topline data from VIKTORIA-1 demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with CDK4/6 inhibitors. The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm shifting results. We are also very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event."

Brian Sullivan, Chairman, Chief Executive Officer and co-founder of Celcuity said, "The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population. We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer."

Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call on Monday, July 28, 2025, at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website following the live event.

Notes

HR+/HER2- Breast cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Survival rates are low with 30% of patients anticipated to live beyond five years after diagnosis.2 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

VIKTORIA-1

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is enrolling subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) are randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.

BullFrog AI to Present at BTIG Annual Virtual Biotechnology Conference

On July 28, 2025 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence ("AI") and machine learning to enable the successful development of pharmaceuticals and biologics, reported that Vin Singh, CEO, will participate in a fireside chat and one-on-one meetings at BTIG’s Annual Virtual Biotechnology Conference, being held Tuesday, July 29 through Wednesday, July 30 (Press release, Bullfrog AI, JUL 28, 2025, View Source [SID1234654568]).

Fireside Presentation Details

Date: Wednesday, July 30, 2025

Time: 11:20 a.m. ET

To request access to the presentation, contact: [email protected]. Registered attendees can request one-on-one meetings with BullFrog AI management via your BTIG banking representative.

If you are unable to attend the conference and would like to schedule a meeting with BullFrog AI management, please contact [email protected].

AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

On July 28, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the "DURIPANC" study) (See: ClinicalTrials.gov NCT05927142) (Press release, AIM ImmunoTech, JUL 28, 2025, View Source [SID1234654567]).

The DURIPANC study – which is a joint collaboration with AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands – is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling.

Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: "Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes."

See: DURIPANC, Mid-Year Interim Clinical Progress Update.

Pancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:

No significant toxicity, an encouraging safety profile for a post-chemo setting;
~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and
OS >6 months in the majority (64%) of eligible patients-better than expected in this setting.
AIM ImmunoTech CEO Thomas K. Equels stated: "Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide."

AIM’S Pancreatic Cancer Profile

The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Since 2017, more than 50 pancreatic cancer patients received treatment with Ampligen as an immuno-oncology mono-therapy under a Dutch government-approved Compassionate Use/Early Access Program at Erasmus MC. Prof. van Eijck was the lead investigator and the EAP has produced a number of detailed analyses in both abstracts and peer-reviewed medical research publications:

Rintatolimod (Ampligen) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program
Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow?
Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses
Based on these strong results suggesting Ampligen’s potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor.

In order to protect what has the potential to be a valuable long-term benefit for stockholders, AIM has developed an intellectual property plan specific to pancreatic cancer that includes a recently issued U.S. patent for Ampligen as an oncology treatment in combination with an anti-PD-L1, extending protection to August 9, 2039, as well as orphan drug designations in pancreatic cancer in both the United States and the European Union granting years of market exclusivity to AIM for Ampligen post-commercial approval.