On September 4, 2023 Celyad Oncology (Euronext: CYAD) (the "Company" or "Celyad Oncology"), reported its financial results and recent business developments for the first half year, ended June 30, 2023 (Press release, Celyad, SEP 4, 2023, View Source [SID1234634860]).

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"Celyad Oncology is now fully focused on maximizing the potential of its proprietary technology platforms and intellectual property, enabling the Company to be at the forefront of developing next-generation CAR T-cell therapies. We are eager to see the impact of our research efforts on the future of CAR T-cell treatments, with the goal to broaden the range of cancer indications and tackle the main limitations of current CAR T-cell therapies" commented Georges Rawadi, Celyad Oncology’s Chief Executive Officer.

First Half 2023 and recent corporate highlights:

Georges Rawadi was appointed Chief Executive Officer of the Company as from April 27, 2023. Georges Rawadi is a seasoned executive with over 20 years of experience in pharma/biotech, as research director, business developer, CEO, and board member. He also has insightful knowledge of both the company and the CAR-T space as he spent four years at Celyad Oncology (2014-2018) as Vice-President Business Development & Intellectual Property ("BD & IP"). Georges Rawadi has a genuine passion for seeking and creating new business opportunities.
On May 5th, 2023, the Company announced voluntary delisting of its American Depositary Shares representing ordinary shares ("ADSs") from the Nasdaq Global Market. Delisting was effective as of July 20, 2023. The Company continues to be listed on Euronext Brussels and Euronext Paris.
On August 24, 2023, the Company announced that it has obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million in 2 tranches:
A first tranche of 2.0 million was disbursed in the context of authorized capital as of September 4, 2023; and
A second tranche to be subscribed by Fortress is subject to the approval by the extraordinary shareholders’ meeting. Following this private placement, the Company believes that its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the end of the fourth quarter of 2024.
First Half 2023 and recent operational highlights:

Short hairpin ribonucleic acid (shRNA) non-gene edited technology – During this first half of 2023, we have collected and presented data validating our shRNA multiplexing approach:
We developed a micro-RNA (miRNA)-based multiplex shRNA platform designed for easy, efficient, and tunable downregulation of up to four target genes simultaneously;
We showed that the downregulation of each target gene could be fine-tuned, from a moderate downregulation up to a functional knock-out, without the need of gene editing thereby avoiding associated potential safety issues;
The plug-and-play design of our platform is designed to allow swapping of each target sequence without affecting the performance of the technology and streamlining of the generation of engineered adoptive T-cell therapies;
To demonstrate the effectiveness of our approach, we have been able to simultaneous knock-down in CAR T-cells several genes involved in different cellular processes such as alloreactivity (CD3ζ), cell persistence (β2M, CIITA), T-cell exhaustion (PD-1, LAG-3), or ligand-induced apoptosis (CD95);
Data were presented at the World Oncology Cell Therapy Congress in Boston, US (April 25-26, 2023) and at the CAR-TCR Summit in Boston, US (August 29 – September 1).
NKG2D-based CAR T-cells and multi-specific CAR T-cell platform – During this first half of 2023, we have published data validating our NKG2D-based CAR T-cell approach and presented data from our multi-specific CAR T-cell platform:
Results from 16 patients treated in the dose-escalation segment of the hematological arm of the Phase I THINK trial were published in The Lancet Haematology Journal (Lancet Haematol. 2023 Mar;10(3):e191-e202) and provided proof-of-concept for targeting NKG2D ligands (NKG2DL) with CAR T-cell therapy;
We have developed different CD19/NKG2DL multi-specific CAR T-cells, utilizing both tandem and dual NKG2D-based CARs that encompass the extracellular domain of the natural NKG2D receptor fused to an anti-CD19 scFv, or co-expressed with an anti-CD19 CAR, respectively;
The majority of our CD19/NKG2DL multi-specific CAR T-cell candidates were able to secrete cytokines, proliferate, and eliminate acute lymphoblastic leukemia tumor cells lacking the CD19 antigen in vitro. Interestingly, some of these multi-specific CAR T-cells displayed a better in vitro functionality against wild-type leukemia tumor cells expressing the CD19 antigen as compared to CD19-specific single targeting CAR T-cells, highlighting the potential of our approach against both CD19 positive and CD19 negative cancer cells;
First in vivo data suggest that our CD19/NKG2DL multi-specific CAR T-cell candidates have an enhanced anti-tumor efficacy against heterogeneous lymphoma tumors as compared to currently existing treatment options;
We are currently developing several NKG2D-based multi-specific CAR T-cells for the treatment of diverse solid cancers where there is a high heterogeneity in antigen expression;
Data were presented at the Immuno-Oncology Summit Europe 2023 held in London, UK (June 20-22, 2023).
Upcoming anticipated milestones

More data and evidence in the context of the multi-specific CAR platform and shRNA multiplexing approach in H2 2023, with the aim of a clinical evaluation of assets and initiation of clinical trials either by the Company and/or through strategic partnerships afterwards;
Relocation, in H2 2023, into a new research facility which fits better its current needs after the strategic shift. The Company will remain headquartered at the Axis Parc, Mont-Saint-Guibert, Belgium but with its new business location at Dumont 9.
Upcoming Conferences

The Company will take part in the 4th International Conference on Lymphocyte Engineering (ICLE) in Munich (September 12-14) and the annual congress of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in San Diego (November 1-5), as well at several business conferences in the second half of 2023.
First Half 2023 Financial Results

Key financial figures for the first half of 2023, compared with the first half of 2022 and full year 2022, are summarized below:

The Company’s license and collaboration agreements generated no revenue in the first half of 2023 similar to the first half of 2022.

The Research and Development (R&D) expenses have decreased primarily due to the Company’s decision to discontinue some of preclinical programs and manufacturing and clinical study activities after the Company’s decision to adopt and implement a new business strategy. Furthermore, there has been a decrease of employee expenses and related travel costs which is mainly related to headcount reduction through 2022, to support the Group’s reorganization around preclinical and clinical programs, as well as a decrease of the expenses associated with share-based payments (non-cash expenses) related to the warrant plan offered to the Company’s employees, managers and directors.

General and Administrative (G&A) expenses were €3.7 million in 2023 as compared to €6.2 million in 2022. This decrease is primarily related to lower insurances costs, the decrease of employee expenses due to headcount reduction and management changes through 2022 to support the Company’s reorganization and the decrease of the expenses associated with the share-based payments (non-cash expenses) related to the warrants plan offered to the Company’s employees, managers and directors.

As of June 30, 2023, there was no change in fair value of the contingent consideration and other financial liabilities as Management has determined that there have been no event (such as a firm sublicense or collaboration contract) that increases the probability of the projected future cash outflow due to Celdara Medical, LLC and Dartmouth College, indicating that the probability is remote, similar to December 31, 2022.

Regarding the other income/other expenses, the Company recorded €2.1 million in net other income for the first half of 2023 compared to a net other income of €1.6 million for the first half of 2022. The net other income for the first half of 2023 is primarily due to the gain on the sale of certain fixed assets to Cellistic for €1.1 million and grant income from the Walloon Region of €0.8 million.

Net loss was €3.7 million, or €(0.17) per share, for the first half of 2023 compared to a net loss of €14.1 million, or €(0.62) per share, for the same period of 2022.

Net cash used in operations, was €8.3 million for the first half of 2023 compared to €16.3 million for the first half of 2022. The decrease of €8.0 million is primarily driven by the sale of the manufacturing activities in 2022 combined with global decrease on preclinical and clinical activities, insurance costs, headcount, management changes costs and associated impact on the change in working capital.

As of June 30, 2023, the Company had cash and cash equivalents of €5.0 million. No capital increase has occurred in the first half of 2023.

As of June 30, 2023, the total number of basic shares outstanding were 22.6 million similar to December 31, 2022.

Conference Call and Webcast Details

A conference call will be held on Tuesday 5th of September at 1:00 p.m. CET / 7:00 a.m. EDT discuss half year 2023 financial results and provide an update on the Company’s recent changes and upcoming milestones.

Participants may access the conference call by dialing +1-877-407-9716 or +1-201-493-6779 (United States, International), +32 (0) 800-73-904 (Belgium Fixed) or +32 (0) 800-73-566 (Belgium Mobile). Participants may ask for instant telephone access to the event via the "Call me" link or attend the conference live webcast.

Archived recording will be available in the "Events" section of the Celyad website after the event.

Financial Calendar 2023

November 9th, 2023 Third Quarter 2023 Business Update
The financial calendar is communicated on an indicative basis and may be subject to change.

On September 4, 2023 AstraZeneca reported that Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy (Press release, AstraZeneca, SEP 4, 2023, View Source [SID1234634856]).

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The approval by the National Medical Products Administration (NMPA) was based on positive results from two clinical trials, including the ASCEND Phase III trial of Calquence versus investigator’s choice of idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) for patients with relapsed or refractory (R/R) CLL and an open-label, single-arm Phase I/II trial in China for patients with R/R CLL.1,2

CLL is the most prevalent type of adult leukaemia across the globe and represents approximately 6.4% of B-cell non-Hodgkin lymphoma patients in China.3

Professor Li Jianyong, Director of Haematology, People’s Hospital of Jiangsu Province, and Leader of China CLL Working Group, said: "Many people living with chronic lymphocytic leukaemia experience relapse and need additional treatment options to help manage their disease. I’m delighted that with this approval patients now have access to an established treatment that has already demonstrated effectiveness in many patients across the globe."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Today’s approval is another step towards our goal of making Calquence available to as many patients as possible and offering physicians a treatment option with a well-established efficacy and tolerability profile. Patients with chronic lymphocytic leukaemia are often older and dealing with significant comorbidities, and tolerability is a critical factor in their treatment."

In the ASCEND Phase III trial, 88% of patients with R/R CLL treated with Calquence were alive and free from disease progression after 12 months compared with 68% of patients treated with IdR/BR.1 Longer-term follow-up data showed 62% of patients treated with Calquence were alive and had not progressed at 42 months versus 19% of patients treated with IdR/BR.

Additionally, results from a Phase I/II trial in Chinese adults with R/R CLL showed Calquence achieved an overall response rate (ORR) of 83.3%. At a median follow-up of 20.2 months, median progression-free survival (PFS) was not reached and the 12-month and 18-month PFS rates were 90.7% and 78.8%, respectively. The safety and tolerability of Calquence in these trials were consistent with that observed in previous clinical trials.1,2

Calquence is approved for the treatment of CLL and SLL in the US and Japan and is approved for the treatment of CLL in the EU and in several other countries worldwide in the treatment-naïve and R/R settings. Calquence is also approved in the US, China and several other countries for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is not currently approved for the treatment of MCL in Japan or the EU.

Notes

CLL
CLL is the most prevalent type of leukaemia in adults, with over 100,000 new cases globally in 2019.4 Although some people with CLL may not experience any symptoms at diagnosis, others may experience symptoms, such as weakness, fatigue, weight loss, chills, fever, night sweats, swollen lymph nodes and abdominal pain.5 In CLL, there is an accumulation of abnormal lymphocytes within the bone marrow and in blood and lymph nodes. As the number of abnormal cells increases, there is less room within the marrow for the production of normal white blood cells, red blood cells and platelets. This could result in anaemia, infection and bleeding.6 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

ASCEND
ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in patients with relapsed or refractory CLL.1

In the trial, 310 patients were randomised (1:1) into two treatment arms.1 Patients in the first arm received Calquence monotherapy (100mg twice-daily until disease progression or unacceptable toxicity).1 Patients in the second arm received physician’s choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3-kinase inhibitor, or rituximab in combination with bendamustine, a chemotherapy.1

The primary endpoint at the interim analysis was PFS assessed by an independent review committee (IRC), and key secondary endpoints included investigator-assessed PFS, IRC and investigator-assessed ORR and duration of response, as well as overall survival (OS), patient-reported outcomes and time to next treatment.1

ASCEND is the first randomised Phase III trial to directly compare a BTK inhibitor as monotherapy to these combinations in relapsed or refractory CLL.1

Phase I/II trial in Chinese patients
The Phase I/II trial is an open-label, multicentre clinical trial evaluating pharmacokinetics, tolerability, safety and clinical efficacy of Calquence in adult Chinese patients with CLL who have received at least one prior therapy and other B-cell malignancies.2 In Phase I, patients with relapsed or refractory B-cell malignancies received a single dose of Calquence 100mg orally followed by a two-day washout period and subsequent treatment with Calquence 100mg orally twice daily in 28-day cycles, until progressive disease (PD) or treatment discontinuation (TD) for any other reason.2 In Phase II, patients with relapsed or refractory CLL (n=60) received Calquence 100mg orally twice daily until PD or TD for any other reason.2 The primary efficacy endpoint was ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 classification assessed by Blinded Independent Central Review (BICR).2 Secondary endpoints were investigator-assessed ORR, BICR- and investigator-assessed time to response, duration of response and PFS, OS, safety including adverse events and Calquence plasma concentration.2

Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.7 In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

Calquence has been used to treat 50,000 patients worldwide and is approved for the treatment of CLL and SLL in the US, approved for CLL in the EU and many other countries worldwide and approved in Japan for relapsed or refractory CLL and SLL.

As part of an extensive clinical development programme, AstraZeneca is currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for the treatment of multiple B-cell blood cancers, including CLL, MCL, diffuse large B-cell lymphoma, Waldenström’s macroglobulinaemia, marginal zone lymphoma and other haematologic malignancies.

On September 4, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has cleared cohort 1 of the intratumoral (IT) arm of the combination study where VAXINIA is administered in combination with Pembrolizumab (Press release, Imugene, SEP 4, 2023, View Source [SID1234634855]).

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As a result, Imugene is now recruiting for cohort 2 of each of the arms (IT and intravenous/IV) in the combination study, in addition to cohort 4 of each of the arms of the monotherapy dose escalation.Imugene MD & CEO Leslie Chong said: "We’ve now seen a very significant number of patients dosed with VAXINIA as part of the MAST study, with those patients suffering as a result of a variety of tumour types. It’s exciting that we’re getting so close to finding out the impact that this treatment is having for these patients in need."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

On September 1, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the following statement about the closure of COBRA, a minimum residual disease (MRD) study (Press release, Guardant Health, SEP 1, 2023, View Source [SID1234634848]).

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The COBRA study was designed to evaluate the effectiveness of using MRD testing to improve clinical outcomes in patients with stage II colon cancer after curative-intent surgery with a planned final readout in 2026.

"Our MRD test has great potential to help patients and their doctors stay ahead of cancer, and we remain confident about its promise to vastly improve patient care and its continued prospects for broad access and reimbursement," said Craig Eagle, MD, Guardant Health chief medical officer.

"We agree with the decision, based on the recent planned interim analysis, to close the COBRA study to new enrollees," said Dr. Eagle. "The field has progressed rapidly since the study was designed over four years ago, and since the study was initiated we have made tremendous progress with multiple upgrades of our MRD test. Additionally, we have many ongoing studies that will demonstrate the effectiveness of our current MRD tests in colorectal cancer and other settings."

On September 1, 2023 Medivir AB (NASDAQ Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that it will host a key opinion leader webcast on the current and future HCC (primary liver cancer) treatment landscape, including how treatment challenges and needs in HCC differs from most other cancers (Press release, Medivir, SEP 1, 2023, View Source [SID1234634847]). The webcast will take place on September 8, 2023 at 13:00 CET/07:00 EST.

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The webcast will feature presentations by Dr. Jeff Evans, Beatson West of Scotland Cancer Center, Glasgow, UK, who will discuss the current treatment landscape and unmet medical need in treating patients with HCC. He will be joined by Dr. Maria Reig, Liver Cancer Unit, Hospital Clínic BCLC group, Villarroel, Barcelona, Spain, who will discuss how HCC is different from many other tumor types and its unique treatment challenges. Both Drs are investigators in the phase 1b/2a study with fostrox in combination with Lenvima and will also share their perspectives from the ongoing study. They will be joined by Dr Pia Baumann, Medivir’s CMO who will provide an update on the ongoing study and fostrox development plans.

All three will be available to answer questions following the formal presentations.

The webcast will be streamed via a link on the website: www.medivir.com/investors/presentations The presentation will be available on Medivir´s website after the webcast.

– "The promising observations we have seen so far in the ongoing phase 1b/2a study of fostrox in combination with Lenvima mean that we are further intensifying our plans for the next phase of clinical development of fostrox. When doing so, it is critical that this is done in close collaboration with external experts to ensure that the specific needs of the disease and changes in treatment landscape are central components of future plans. We are pleased that Drs Evans and Reig, members of our Scientific Advisory Council, are able to provide their expertise on these important topics in this webcast," says Dr. Pia Baumann, CMO at Medivir.

Dr. Jeff Evans is a Professor of Translational Cancer Research in the School of Cancer Sciences, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow, UK. He is the Lead of the Glasgow Experimental Cancer Medicine Centre (ECMC) and National Clinical Lead of the NHS Scotland Cancer Research Network. He is an investigator in the fostrox clinical development program.

Dr. Maria Reig is the Head of the BCLC and Liver Oncology Unit at Hospital Clinic of Barcelona in Spain. Her expertise and area of interest is the development of prognostic models for patients with liver cancer and evaluation of treatment options with special emphasis in systemic therapy as well as new research about immune modulation and cancer emergence after antiviral treatment. She is an investigator in the fostrox clinical program.

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox
Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.