On July 31, 2024 Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported second quarter 2024 financial results and corporate highlights (Press release, Biomea Fusion, JUL 31, 2024, View Source [SID1234645199]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Q2 2024 was another busy quarter for the company. The company’s top priority is working with FDA to resolve the clinical hold for BMF-219 in diabetes. We have made great progress with the second program, BMF-500 and our third program will be announced following the 60th European Association for the Study of Diabetes (EASD). Topline readout from the Phase 2b of COVALENT-111 with approximately 195 patients is on track for Q4 2024, and the topline readout from the Phase 2a of COVALENT-112 with approximately 20 patients is on track for Q4 2024," stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board.

DIABETES

COVALENT-111 (BMF-219 for Type 2 Diabetes) & COVALENT-112 (BMF-219 for Type 1 Diabetes)

On June 6, 2024, company announced it received notice from FDA that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. In its communication, FDA noted deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed dose escalation phase of COVALENT-111.
Initial data reported from the first two type 1 diabetes patients dosed with BMF-219 in COVALENT-112 demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219. BMF-219 has been generally well tolerated by both patients.
Anticipated Milestones:

Topline Week 26 data readout of Phase 2b with approximately 195 patients of COVALENT-111 expected for Q4 2024.
Topline data readout of Phase 2a of COVALENT-112 with approximately 20 patients expected for Q4 2024.
OBESITY

Third Program (Oral, Small Molecule, GLP-1R Agonist)

Anticipated Milestones:

Announce a third development candidate, a potent, selective, GLP-1 receptor agonist, expected in Q3 2024.
ONCOLOGY

COVALENT-101 (BMF-219 for Liquid Tumors)

Anticipated Milestones:

Complete dose escalation portion of COVALENT-101 expected by year end 2024.
(Two cohorts, CLL and DLBCL of COVALENT-101 have been discontinued due to insufficient enrollment.)
COVALENT-102 (BMF-219 for Solid Tumors)

Anticipated Milestones:

Complete dose escalation portion of COVALENT-102 expected by year end 2024.
COVALENT-103 (BMF-500 for Acute Leukemias)

Anticipated Milestones:

Complete dose escalation portion of COVALENT-103 expected by year end 2024.
FUSION SYSTEM DISCOVERY PLATFORM

Continued the development of the Biomea FUSION Platform technology.
SECOND QUARTER 2024 FINANCIAL RESULTS

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2024, the Company had cash, cash equivalents and restricted cash of $113.7 million, compared to $177.2 million as of December 31, 2023.
Net Income/Loss: The Company reported a net loss attributable to common stockholders of $37.3 million for the three months ended June 30, 2024, which included $4.8 million of stock-based compensation, compared to a net loss of $24.9 million for the same period in 2023, which included $3.4 million of stock-based compensation. Net loss attributable to common stockholders was $76.3 million for the six months ended June 30, 2024, which included $9.9 million of stock-based compensation, compared to a net loss of $53.9 million for the same period in 2023, which included $6.7 million of stock-based compensation.

Research and Development (R&D) Expenses: R&D expenses were $31.8 million for the three months ended June 30, 2024, compared to $21.9 million for the same period in 2023. The increase of $9.9 million was primarily due to an increase of $7.2 million related to clinical and $1.6 million related to pre-clinical development cost for the Company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs of $1.8 million. R&D expenses were $65.6 million for the six months ended June 30, 2024, compared to $46.3 million for the same period in 2023. The increase of $19.3 million was primarily due to an increase of $11.8 million related to clinical and $2.5 million related to pre-clinical development cost for the Company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs of $4.9 million.

General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the three months ended June 30, 2024, compared to $5.7 million for the same period in 2023. The increase of $1.4 million was primarily due to increased personnel-related expenses, including stock-based compensation. G&A expenses were $14.4 million for the six months ended June 30, 2024, compared to $11.4 million for the same period in 2023. The increase of $3.0 million was primarily due to an increase of $2.1 million from personnel-related expenses, including stock-based compensation and $1.3 million related to general external consultants and legal related expenses.

On July 31, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported topline data from its Phase 2 ASPEN-06 clinical trial (Press release, ALX Oncology, JUL 31, 2024, View Source [SID1234645197]). The trial demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The topline results from the ASPEN-06 clinical trial confirm the robust response that evorpacept can deliver, generating a clinically meaningful impact on key measures of anti-cancer activity for patients with gastric cancers and continuing to surpass benchmarks in the field," said Jason Lettmann, chief executive officer at ALX Oncology. "Additionally, they provide valuable insight beyond the interim data previously reported, offering a more conclusive look at the impact of evorpacept and identifying the most responsive patient population. Importantly, the level of clinical benefit seen in this trial provides support for developing evorpacept in combination with anti-cancer antibodies in additional tumor types and drives ALX’s development strategy."

ASPEN-06 is a randomized, multi-center, international trial evaluating evorpacept, ALX Oncology’s investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated proprietary Fc domain, in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (collectively, TRP) against TRP alone for the treatment of patients with HER2-positive gastric/GEJ cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Patients in the trial (N=127) were generally well-balanced across arms based on pre-specified stratification factors including line of therapy, prior ENHERTU (fam-trastuzumab deruxtecan-nxki) use, Asia region, tumor location (GC or GEJ), HER2 expression level (IHC3+ or IHC2+/ISH+) and HER2-positive biopsy (fresh or archival).

The trial’s primary endpoint is overall response rate (ORR). Key secondary endpoints are safety, median duration of response (mDOR), progression-free survival (PFS) and overall survival (OS).

Key Phase 2 ASPEN-06 Clinical Trial Topline Results:

In the full intent-to-treat population (N=127), the addition of evorpacept to TRP demonstrated an ORR of 40.3% compared to the TRP control ORR of 26.6%
In patients with fresh HER2-positive biopsies (n=48), evorpacept plus TRP demonstrated an ORR of 54.8% compared to 23.1% for the TRP control
Median duration of response (DOR) in the evorpacept arm was 15.7 months [95% CI: 11.0; NE] compared to the TRP control of 7.6 months [95% CI: 6.3; NE] in the full intent-to-treat population
Secondary endpoints of PFS and OS were immature at the time of analysis
Evorpacept in combination with TRP was generally well tolerated and consistent with TRP control
"By meeting our clinically meaningful and pre-specified threshold of greater than 10% difference in response between the evorpacept treatment and control arms, these new data validate the mechanism of action and potential clinical utility of evorpacept for patients. Notably, this is now the first CD47 blocker to demonstrate clinical benefit and a well-tolerated safety profile in a randomized trial," said Sophia Randolph, M.D., Ph.D., chief medical officer at ALX Oncology. "ASPEN-06 also provides valuable insights into responding patient populations and the importance of HER2 target expression that will inform our clinical program. These data represent a significant advancement for immuno-oncology."

The ASPEN-06 full data set will be submitted for presentation at an upcoming medical conference.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to evorpacept for the second-line treatment of patients with HER2-positive gastric or GEJ carcinoma. Additionally, both the FDA and European Commission have granted Orphan Drug Designation for this indication.

Conference Call and Webcast on July 31 at 4:30 PM EDT
The Company will host a conference call and webcast today at 4:30 PM EDT. To access the live conference call, please dial (800) 715-9871 (U.S./Canada) or +44.800.260.6466 (internationally) at least 10 minutes prior to the start time and refer to conference ID 9637001. The link to the live webcast of the conference call will be posted in the News & Events section (see "Events") of the Company’s website at www.alxoncology.com. An archived replay will be accessible for 90 days following the event.

About the ASPEN-06 Phase 2 Clinical Trial
ASPEN-06 is a randomized Phase 2 (open-label) / Phase 3 (double-blinded), multi-center, international trial of patients with second- or third-line metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy (NCT05002127). HER2 status was determined by an FDA-approved test in the most recent gastric/GEJ cancer tissue sample. The primary analysis of the full intent-to-treat population included all randomized patients whose HER2 status was based on a tissue sample obtained at any time. An additional primary analysis was conducted on patients who had a recent HER2-positive tissue sample after prior anti-HER2 therapy ("fresh biopsy"). While trastuzumab is currently approved in combination with cisplatin and capecitabine/5-FU for HER2-positive gastric/GEJ cancers, it is not approved in combination with standard-of-care CYRAMZA + paclitaxel. The Phase 2 portion of the ASPEN-06 trial enrolled 127 patients. To determine the activity of evorpacept + trastuzumab + CYRAMZA + paclitaxel, in the Phase 2 portion of ASPEN-06, patients were randomized to receive either a four-drug combination regimen (evorpacept + trastuzumab + CYRAMZA + paclitaxel) or a three-drug combination regimen (trastuzumab + CYRAMZA + paclitaxel). This design enabled the assessment of evorpacept’s contribution to the standard of care plus trastuzumab and to global standard of care, CYRAMZA + paclitaxel.

On July 31, 2024 Oxford Vacmedix (OVM), developing therapeutic cancer vaccines, reported the grant of a prestigious non-dilutive Investor Partnership Award from Innovate UK, the UK’s innovation agency, to support the clinical development of OVM-200 (Press release, Oxford Vacmedix, JUL 31, 2024, View Source;utm_medium=rss&utm_campaign=innovate-uk-grant-for-ovm-200 [SID1234645194]). The application was supported by Proven Connect, with additional funding from Prostate Cancer Research when the award is made. The award demonstrates the confidence that Innovate UK have in OVM’s Recombinant Overlapping Peptide (ROP) technology and in the early clinical results with OVM-200.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OVM-200 is OVM’s lead cancer vaccine, developed using the novel ROP techonogy pioneered by Professor Shisong Jiang at the University of Oxford. It targets survivin which is over expressed in many solid tumours, and is being trialled in the UK in five leading hospitals, to treat ovarian cancer, prostate cancer and non-small cell lung cancer. Phase 1a, the first part of a Phase 1 trial, was completed in 2023 and demonstrated both safety and a very strong immune response as well as allowing the selection of the optimal dose regime of OVM-200 for use to treat late stage cancer. Phase 1b using the dose selected is ongoing.

The Innovate UK Investor Partnership Award is for $900,000 (approx. £740,000) and is dependent on aligned investor funding of at least $1.8m (approx. £1.5m). The Proven Connect funding from Prostate Cancer Research will be in addition to the award from Innovate UK. OVM is currently seeking Series B investment of up to $15m to take OVM-200 into Phase 2 in combination and to accelerate other pipeline projects.

William Finch, CEO of Oxford Vacmedix said;

"We are delighted to have this non-dilutive Investor Partnership Award from Innovate UK and with the ongoing support from Proven Connect. The award shows the confidence that the UK’s innovation agency have both in our ROP technology and in the early clinical results for OVM-200. Continuing the clinical development for OVM-200 will bring hope to many patients and has the potential to meet real clinical need. We are confident of securing investment in our Series B fund and look forward to any additional contacts with potential investors."

On July 31, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has concluded a license agreement with F. Hoffmann-La Roche Ltd (hereafter "Roche") [Head Office: Basel, Switzerland. Thomas Schinecker] for inavolisib, a PI3K alpha inhibitor, currently in development for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation in combination with palbociclib and fulvestrant (Press release, Chugai, JUL 31, 2024, View Source;category= [SID1234645178]). Under the license agreement between Roche and Chugai, Chugai obtained exclusive rights for the development and marketing of inavolisib in Japan. Roche will receive an upfront fee and milestone payments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"PIK3CA mutations are detected in approximately 40%1 of patients with hormone receptor (HR)-positive breast cancer. Patients with PIK3CA mutated HR-positive, HER2 negative advanced BC have a poorer prognosis and thus there remains a significant unmet need for this patient group. Inavolisib, which has shown positive data in global clinical trials, is expected to be a new treatment option for patients with breast cancer. Chugai will work closely with Roche to conduct domestic development in order to bring inavolisib to patients with breast cancer as soon as possible," said Chugai’s President and CEO, Dr. Osamu Okuda.

Inavolisib was discovered by Genentech, a member of the Roche Group, and is currently under development for two global Phase III clinical studies in patients with locally advanced or metastatic HR-positive/HER2-negative breast cancer with PIK3CA mutations (INAVO120 and INAVO121) and one global Phase III clinical study in patients with PIK3CA mutated HER2-positive breast cancer (INAVO122). The INAVO120 study demonstrated that the inavolisib-based regimen (in combination with palbociclib and fulvestrant) more than doubled progression-free survival, reducing the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001) in the first-line setting. The inavolisib-based regimen has also been shown to be well tolerated with a manageable safety profile.
Based on the positive results of the INAVO120 study, inavolisib has been granted Breakthrough Therapy Designation for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutations in the first-line setting as well as Priority Review by the U.S. Food and Drug Administration (FDA) for the new drug application with a PDUFA date of November 27, 2024

Chugai will continue to effectively utilize the research and development resources of the Roche Group to find innovative new drugs so as to satisfy unmet medical needs.

About inavolisib
Inavolisib is an investigational, oral targeted treatment that could provide well-tolerated, durable disease control and potentially improved outcomes for people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. Inavolisib has been designed to help minimize the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.

About the INAVO120 study
The INAVO120 study is a global Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of inavolisib in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

The study included 325 patients. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.

The INAVO120 study met its primary endpoint, extending PFS by 7.7 months compared to the control group, demonstrating the superiority of the combination of inavolisib, palbociclib and fulvestrant (hazard ratio, 0.43 [95% CI = 0.32, 0.59]; p<0.0001)2. Regarding safety, the incidence of hyperglycemia, diarrhea, stomatitis, nausea, and skin rash was higher in the inavolisib group compared to the control group, but most of these events were Grade 1-2 (incidence of Grade 3-4 events was hyperglycemia: 5.6%, stomatitis: 5.6%, diarrhea: 3.7%, nausea: 0.6%, and skin rash: 0%), confirming that the inavolisib was well tolerated and the safety profile was manageable.

About Hormone Receptor-Positive Breast Cancer
HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70%3 of cases. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options. The PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.

On July 31, 2024 Imugene Limited (ASX:IMU), a clinical-stage immuno‐ oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 June 2024 (Press release, Imugene, JUL 31, 2024, View Source [SID1234645177]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CLINICAL TRIAL UPDATES

Azer-cel continues to enrol in the Phase 1b study. Azer-Cel (azercabtagene zapreleucel) is an off-the-shelf (allogeneic) cell therapy which targets CD19 to treat blood cancers.

The Phase 1b allogeneic (allo) CAR T study is an ongoing multi-centre clinical trial in patients who suffer from a difficult to treat sub-set of non-Hodgkin’s lymphoma (NHL) called Diffuse-Large Bcell lymphoma (DLBCL) that have relapsed after autologous CAR T therapy. These DLBCL patients have limited therapeutic options and are an unmet medical need.

Following completion of the Phase 1b study there is potential to start a registrational Phase 2/3 study in 2025 and become the first approved allogeneic CAR T cell therapy for cancer. VAXINIA Bile Tract Cancer trial opened, and the VAXINIA MAST trial higher dose cohort opened for enrolment.

Imugene launched its Phase 1 bile tract cancer (cholangiocarcinoma) trial, which aims to enrol 10 patients. In the Phase 1 MAST trial, one patient with bile tract cancer who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA, achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, and the patient has been in the trial for over 630 days. A second patient with bile tract cancer (cholangiocarcinoma), who has also progressed on prior drug therapies, achieved stable disease, meaning their cancer neither increased nor decreased and no new tumours appeared for more than four months upon receiving IV administered VAXINIA.

The results seen in these patients provided the rationale for Imugene to open a VAXINIA trial in this specific patient population. The FDA granted Fast Track Designation to the VAXINIA program in November 2023, accelerating the development and potential approval process due to the urgent need for new treatments. The MAST trial, which began by administering low doses to patients with advanced solid tumours, has progressed through several dose escalation cohorts without safety concerns.

This bile tract cancer trial not only supports the ongoing evaluation of VAXINIA’s efficacy, but also emphasizes its role in addressing the significant challenges associated with treating bile tract cancer, an aggressive form cancer with limited effective treatments for patients. Subsequent to the end of the quarter, Imugene announced that the first patient had been dosed at St. Vincent’s Hospital in Melbourne.

Additionally, it was confirmed that the fifth cohort of both arms of the Phase 1 MAST monotherapy dose escalation trial have now cleared, with the sixth high dose cohort of each arm having opened.

Imugene Phase 1 onCARlytics trial doses first patient in Intravenous (IV) combination arm in the OASIS trial.

Late in the quarter, the first patient was dosed in the intravenous (IV) combination arm of the Company’s Phase 1 onCARlytics clinical trial. The trial, known as OASIS, is pioneering in its combination of a CD19-expressing oncolytic virus with a CD19-targeting drug called BLINCYTO (blinatumomab). CD19 is used in blood cancers, but solid cancers like breast, lung, gastric, bile tract, and colon, etc. don’t have a common target on their cell surface; the goal of onCARlytics is to present a target for CD19 therapies. The CD19-expressing CF33 oncolytic virus marks or paints the tumour target with CD19 on the cell surface, followed by treatment with a CD19 targeting therapy. The trial aims to recruit 40-45 patients with advanced solid tumours and is currently being conducted at three sites in the US, with the potential to expand to 10 sites.

The first patient, who has bile tract cancer, was dosed at City of Hope in California. The primary objective of the trial is to evaluate the safety and efficacy of onCARlytics when administered either intratumorally (IT) or intravenously (IV), alone or in combination with blinatumomab, a CD19-targeting bispecific monoclonal antibody.

Preliminary early combination data are expected in the fourth quarter of 2024, subject to patient enrolment rates. If successful, onCARlytics could significantly expand the market for CD19-targeting therapies. CD19 therapies are currently only approved in blood cancers, which only make up 10 percent of cancers, while solid cancers make up 90 percent of the cancer market. If successful onCARlytics could make CD19 targeted therapies an option to treat patients with solid cancers. This could potentially impact a market which is estimated to be valued at approximately US$532 billion by 2032.

CORPORATE UPDATES:

Imugene and Kincell Bio Announce Strategic Manufacturing and Process Development Partnership for azer-cel. In April, Imugene and Kincell Bio established a strategic partnership focused on manufacturing and process development. Under this agreement, Kincell Bio acquired Imugene’s manufacturing facility in North Carolina. Additionally, this strategic shift ensures continued clinical supply of azer-cel, Imugene’s advanced allogeneic CAR T cell therapy while Imugene retains all rights to azer-cel.

VAXINIA selected for Oral and Poster Presentations at 2024 Cholangiocarcinoma Foundation Annual Conference.

Imugene presented its VAXINIA technology at the 2024 Cholangiocarcinoma Foundation Annual Conference in April in Salt Lake City, Utah. In both an oral and a poster presentation, the company discussed the effectiveness and safety of VAXINIA as a treatment for gastrointestinal malignancies, including bile tract cancer (cholangiocarcinoma), highlighting its potential as a monotherapy treatment in a field where early detection and treatment options are limited. This conference provides a platform for healthcare professionals and researchers to exchange insights on advancing the treatment and understanding of bile tract cancer.

Presentation at Bell Potter Emerging Leaders Conference.

Imugene CEO & Managing Director Leslie Chong presented at the Bell Potter Emerging Leaders Conference in May 2024. A copy of the presentation can be viewed here.

FINANCIALS

At the end of the June quarter Imugene has A$93.1 million in cash or equivalents (Excluding R&D tax rebate of ~$11 million expected imminently), providing a runway to support its clinical pipeline and operations into late 2025. Net cash used in operating activities for the quarter amounted to A$19 million, with direct research and development costs accounting for 57% of total costs. In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in items 6.1 of the Appendix 4C include payments for remuneration of director fees to executive and non-executive directors in the normal course of business at commercial rates, excluding reimbursements of out-ofpocket expenses. Options granted to directors that are included in Imugene’s Remuneration Report under share-based payments, are non-cash amounts and represent valuations using the Black-Scholes methodology. Share-based payments relating to option grants to directors are therefore not included in item 6.1 of the Appendix 4C.