On August 1, 2024 Galapagos NV (Euronext & NASDAQ: GLPG) reported its half-year 2024 financial results and provided a second quarter and post-period update and the outlook for the remainder of 2024 (Press release, Galapagos, AUG 1, 2024, View Source [SID1234645301]). The results are further detailed in the H1 2024 financial report available on the financial reports section of the corporate website.

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"We are very pleased with the progress we have made in delivering on our Forward, Faster strategy," said Dr. Paul Stoffels1, Galapagos’ CEO and Chairman of the Board of Directors. "We are on track with key regulatory milestones, having submitted the IND for our Phase 1/2 study of GLPG5101 in the U.S., and the CTA for the Phase 2 study of GLPG5201 in Europe, with plans for an upcoming IND filing in the U.S. for GLPG5201. With these submissions, Galapagos is pioneering innovative approaches in cell therapy with the potential to administer fresh, fit CAR-T cells within a vein-to-vein time of just seven days – critical for patients with rapidly advancing cancers. Our innovation strategy, powered by our unique technology platforms and value-enriching collaborations has significantly expanded our pipeline. With over 15 ongoing preclinical programs in oncology and immunology, our ambition to initiate at least one first-in-human study in 2025 and introduce at least two new clinical candidates annually starting in 2026, positions us strongly for sustained value creation."

Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’.

Thad Huston, Galapagos’ CFO and COO, added: "Strengthened by our newest collaboration with Blood Centers of America to expand our cell therapy manufacturing network across the U.S, we are gearing up for our pivotal CAR-T studies and commercial readiness. We continue to evaluate business development opportunities and were happy to announce a clinical collaboration with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy, uza-cel. This aligns well with our strategy to advance novel cell therapies and enables us to expand our portfolio to include treatments for solid tumors. We reaffirm our 2024 outlook, with key pipeline catalysts on track and cash burn guidance, excluding business development, in the range of €280-320 million."

HALF-YEAR 2024 AND POST-PERIOD BUSINESS UPDATE

Regulatory, clinical, and manufacturing progress with CD19 CAR-T candidates, GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) and GLPG5201 in chronic lymphocytic leukemia (R/R CLL) & Richter transformation (RT), and submitted protocol amendment for BCMA CAR-T candidate, GLPG5301, in relapsed/refractory multiple myeloma (R/R MM).

•
Submitted Investigational New Drug (IND) application for ATALANTA-1 Phase 1/2 study of GLPG5101 to the U.S. Food and Drug Administration (FDA). Clinical Trial Application (CTA) for Phase 2 dose expansion study of GLPG5201 submitted to the European Medicines Agency (EMA) and IND for EUPLAGIA-1 Phase 1/2 study on track for filing in Q4 2024.

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Presented additional encouraging safety, efficacy and translational Phase 1/2 data for GLPG5101 and GLPG5201 at scientific conferences2,3,4 demonstrating feasibility of Galapagos’ innovative cell therapy manufacturing platform to address unmet needs of high-risk patients with median seven-day vein-to-vein delivery of fresh, fit CAR-T cells.

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Temporarily paused patient enrolment in the Phase 1/2 PAPILIO-1 study of GLPG5301 in R/R MM and submitted a protocol amendment to the EMA following one observed case of Parkinsonism. We anticipate resuming recruitment in the coming months.

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Established strategic collaboration with Blood Centers of America, significantly advancing Galapagos’ U.S. expansion strategy. This collaboration complements our existing collaborations with Landmark Bio and Thermo Fisher Scientific, and supports upcoming pivotal studies and potential future commercial manufacturing of cell therapies near cancer treatment centers, aiming to deliver more and faster access to potentially life-saving treatments across the U.S.

Continued to execute on innovation strategy with license agreements and research collaborations in small molecules and cell therapies in solid tumor indications.

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Signed clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos’ cell therapy manufacturing platform. Adaptimmune to receive initial payments totaling $100 million, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales.

2
EHA 2024, 13-16 June, Madrid, Spain. Kersten MJ, et al.

3
EBMT-EHA 2024, 15-17 February, Valencia, Spain. Blum S, et al.; Tovar N, et al.; Kersten MJ, et al.

4
EBMT 2024, 14–17 April, Glasgow, UK. Hoefsmit E, et al.; Ortiz-Maldonado V, et al.; Kersten MJ, et al.
•
Expanded the strategic collaboration and licensing agreement with BridGene Biosciences, which was announced early 2024, to include the discovery of a highly selective oral SMARCA2 small molecule proteolysis targeting chimera (PROTAC5) in precision oncology. This combines Galapagos’ expertise in selective ATPase small molecules with BridGene’s PROTAC discovery engine. The collaboration intends to advance the molecule into a preclinical candidate, with Galapagos holding exclusive global rights for further development and commercialization of the product candidates developed under the agreement. Under the terms of the agreement, BridGene is eligible to potentially receive up to $159 million in total payments plus tiered royalties on net sales.

Progressed proprietary R&D pipeline of >20 clinical and preclinical small molecule and cell therapy programs in oncology and immunology.

•
Focused on biologically validated targets to develop potential best-in-class therapeutics in areas of high unmet medical needs.

•
Accelerating early-stage preclinical pipeline in oncology and immunology with the goal to initiate at least four IND/CTA enabling studies and at least one first-in-human study in 2025.

•
From 2026 onwards, aiming to fuel the clinical pipeline with at least two new clinical candidates annually across cell therapies and small molecules and various indications.

At the Annual and Extraordinary Shareholders’ Meetings held on 30 April 2024, all proposed resolutions were approved.

•
Approved resolutions include the revised 2024 Remuneration Policy and 2023 Remuneration Report.

FINANCIAL PERFORMANCE

First half-year 2024 key figures (consolidated)

(€ millions, except basic & diluted earnings per share)

Six months ended
30 June % Change
2024 2023
Supply revenues

19.1 — 
Collaboration revenues

121.2 118.6 +2 %

Total net revenues

140.3 118.6 +18 %

Cost of sales

(19.1 ) — 
R&D expenses

(145.2 ) (108.7 ) +34 %
G&Aii and S&Miii expenses

(63.9 ) (57.9 ) +10 %
Other operating income

16.6 20.3 -18 %

Operating loss

(71.3 ) (27.7 )

Fair value adjustments and net exchange differences

49.5 0.2
Net other financial result

48.9 32.9
Income taxes

1.1 (12.7 )

Net profit/loss (-) from continuing operations

28.2 (7.3 )

Net profit from discontinued operations, net of tax

71.0 35.6

Net profit of the period

99.2 28.3

Basic and diluted earnings per share (€)

1.51 0.43

Current financial investments, cash & cash equivalents

3,430.4 3,901.5 (*)

(*)
Including €26.6 million of net accrued interest income

5
A proteolysis-targeting chimera (PROTAC) is a hetero-bifunctional molecule containing two small molecule-binding ligands joined together by a linker.

DETAILS OF THE FINANCIAL RESULTS OF THE FIRST HALF YEAR OF 2024

As a consequence of the transfer of our Jyseleca business to Alfasigma, the results related to Jyseleca for the first half-year of 2024 are presented separately from the results of our continuing operations in the line ‘Net profit from discontinued operations, net of tax’ in our consolidated income statement. The comparative first half-year of 2023 has been restated accordingly for the presentation of the results related to the Jyseleca business.

Results from our continuing operations

Total operating loss from continuing operations for the six months ended 30 June 2024 was €71.3 million, compared to an operating loss of €27.7 million for the six months ended 30 June 2023.

•
Total net revenues for the six months ended 30 June 2024 amounted to €140.3 million, compared to €118.6 million for the six months ended 30 June 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €115.1 million for the first six months of both 2024 and 2023. Our deferred income balance at 30 June 2024 includes €1.2 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration.

•
Cost of sales for the six months ended 30 June 2024 amounted to €19.1 million and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.

•
R&D expenses in the first six months of 2024 amounted to €145.2 million, compared to €108.7 million for the first six months of 2023. This increase was primarily explained by higher costs for cell therapy and small molecule programs in oncology.

•
G&A and S&M expenses amounted to €63.9 million in the first six months of 2024, compared to €57.9 million in the first six months of 2023. This was predominantly due to an increase in S&M expenses due to investments in strategic marketing for oncology.

•
Other operating income amounted to €16.6 million in the first six months of 2024, compared to €20.3 million for the same period last year. This decrease is mainly driven by lower grants and R&D incentives.

Net financial income in the first six months of 2024 amounted to €98.4 million, compared to net financial income of €33.1 million for the first six months of 2023.

•
Fair value adjustments and net currency exchange gains in the first six months of 2024 amounted to €49.5 million, compared to fair value adjustments and net currency exchange differences of €0.2 million for the first six months of 2023, and were primarily attributable to €18.2 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €31.2 million of positive changes in fair value of current financial investments.

•
Net other financial income in the first six months of 2024 amounted to €48.9 million, compared to net other financial income of €32.9 million for the first six months of 2023, and was primarily attributable to €49.4 million of interest income, which increased significantly due to the increase in interest rates.

Net profit from continuing operations for the first six months of 2024 was €28.2 million, compared to a net loss from continuing operations of €7.3 million for the first six months of 2023.

Results from discontinued operations

(€ millions) 

Six months ended
30 June % Change
2024 2023
Product net sales

11.3 54.3 -79 %
Collaboration revenues

26.0 155.9 -83 %

Total net revenues

37.3 210.2 -82 %

Cost of sales

(2.0 ) (7.8 ) -74 %
R&D expenses

(11.3 ) (103.1 ) -89 %
G&A and S&M expenses

(10.3 ) (63.7 ) -84 %
Other operating income

54.6 3.4

Operating profit

68.3 39.0 +75 %

Net financial result

2.8 (2.5 )
Income taxes

(0.1 ) (0.9 )

Net profit from discontinued operations

71.0 35.6

Total operating profit from discontinued operations amounted to €68.3 million in the first six months of 2024, compared to an operating profit of €39.0 million in the same period last year.

•
Product net sales of Jyseleca in Europe were €11.3 million for the first six months of 2024 consisting of sales to customers in January 2024. Product net sales to customers for the first six months of 2023 amounted to €54.3 million. As from 1 February 2024, all economics linked to the sales of Jyseleca in Europe are for the account of Alfasigma.

•
Collaboration revenues for the development of filgotinib with Gilead amounted to €26.0 million for the first six months of 2024, compared to €155.9 million for the same period last year. The sale of the Jyseleca business to Alfasigma on 31 January 2024 led to the full recognition by us in revenue of the remaining deferred income related to filgotinib.

•
Cost of sales related to Jyseleca net sales were €2.0 million for the first six months of 2024. Cost of sales related to Jyseleca net sales for the first six months of 2023 amounted to €7.8 million.

•
R&D expenses for the development of filgotinib for the first six months of 2024 amounted to €11.3 million, compared to €103.1 million in the first six months of 2023. As from 1 February 2024, all filgotinib development expenses still incurred during the transition period are recharged to Alfasigma.

•
G&A and S&M expenses related to the Jyseleca business amounted to €10.3 million in the first six months of 2024, compared to €63.7 million in the first six months of 2023. As from 1 February 2024, all remaining G&A and S&M expenses relating to Jyseleca are recharged to Alfasigma.

•
Other operating income for the first six months of 2024 amounted to €54.6 million (€3.4 million for the same period last year) and comprised €52.3 million related to the gain on the sale of the Jyseleca business to Alfasigma. This result as of 30 June 2024 of the transaction is considering the following elements:

•
€50.0 million of upfront payment received at closing of the transaction of which €40.0 million was paid into an escrow account. This amount will be kept in escrow for a period of one year after the closing date of 31 January 2024. We gave customary representations and warranties which are capped and limited in time (at 30 June 2024, this €40.0 million is presented as "Escrow account" in our statement of financial position).

•
€9.8 million of cash received from Alfasigma related to the closing of the transaction as well as €0.9 million of accrued negative adjustment for the settlement of net cash and working capital.

•
€47.0 million of fair value on 31 January 2024 of the future earn-outs payable by Alfasigma to us (the fair value of these future earn-outs at 30 June 2024 is presented on the lines "Non-current contingent consideration receivable" and "Trade and other receivables"). As from 1 February 2024, we are entitled to receive royalties on net sales of Jyseleca in Europe from Alfasigma.

•
€40.0 million of liability towards Alfasigma on 31 January 2024 for R&D cost contributions of which €10.0 million was paid in the first half-year of 2024 (at 30 June 2024, €30.0 million of liabilities for R&D cost contribution is presented in our statement of financial position on the line "Trade and other liabilities").

Net profit from discontinued operations related to Jyseleca amounted to €71.0 million for the first six months of 2024, compared to a net profit amounting to €35.6 million for the first six months of 2023.

Cash, cash equivalents and current financial investments totaled €3,430.4 million as of 30 June 2024, as compared to €3,684.5 million as of 31 December 2023. Total net decrease in cash and cash equivalents and current financial investments amounted to €254.1 million during the first six months of 2024, compared to a net decrease of €192.5 million during the first six months of 2023. This net decrease was composed of (i) €250.0 million of operational cash burn including €78.6 million cash impact of business development activities, (ii) €36.9 million for the acquisition of financial assets held at fair value through other comprehensive income, (iii) €31.2 million of net cash in related to the sale of the Jyseleca business to Alfasigma of which €40.0 million has been transferred to an escrow account, offset by (iv) €41.6 million of positive exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income.

OUTLOOK 2024

Financial outlook

The cash burn guidance for full year 2024, not including business development, is confirmed in the range of €280 million to €320 million. Our cash burn guidance for 2024 including business development to date is €370 million to €410 million.

Advancing current pipeline and strengthening capabilities

We continue to strengthen our capabilities in cell therapy and small molecules internally and through strategic business development and are advancing multiple clinical and preclinical candidates across various indications and modalities. Before year-end, we anticipate:
•
Progress in patient recruitment in ongoing Phase 1/2 studies with CD19 CAR-T candidates, GLPG5101 and GLPG5201.
•
Presentation of additional safety, efficacy, translational and durability data from ongoing Phase 1/2 studies with CD19 CAR-T candidates, GLPG5101 in R/R NHL and GLPG5201 in R/R CLL with or without RT.
•
Submission of IND to the FDA for Phase 1/2 EUPLAGIA-1 study of GLPG5201.
•
Resume study enrollment of Phase 1/2 PAPILIO-1 study of GLPG5301 in R/R MM in the coming months.
•
Further upscaling of cell therapy manufacturing network in the U.S. and Europe for the manufacturing of fresh cell therapies with a median vein-to-vein time of seven days.
•
Progress in patient recruitment in ongoing dermatomyositis (DM) and systemic lupus erythematosus (SLE) Phase 2 studies with TYK2 inhibitor, GLPG3667.
•
Acceleration of the pipeline through strategic partnerships, early-stage research collaborations, licensing or acquisitions in areas of high unmet medical needs.

CONFERENCE CALL AND WEBCAST PRESENTATION

We will host a conference call and webcast presentation on 2 August 2024, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received after registration, or by selecting the "call me" feature.

The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

On July 30, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2024 (Press release, Amplia Therapeutics, JUL 31, 2024, View Source [SID1234645176]).

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Key Highlights from the Quarter

• Updated data and analysis from the Phase 1b ACCENT trial in pancreatic cancer presented at the prestigious annual meetings of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
• Recruitment in the ACCENT Phase 2a trial has progressed well and in early June we reported 24 of 26 patients had been recruited.
• The inaugural meeting of the Company’s Clinical Advisory Board was held.

Operations Update

Clinical Development

The strategic priority for the company over the last quarter has been timely execution of the Phase 2a portion of the ACCENT trial in pancreatic cancer. The ACCENT clinical trial explores the safety, tolerability, and most importantly, efficacy of the Company’s best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy drugs gemcitabine and Abraxane, in newly diagnosed patients with advanced pancreatic cancer.

The Company reported dosing the first patient in the Phase 2a ACCENT trial in January this year using the dose identified from the Phase 1b trial. In March 2024, the Company reported that 11 patients had been dosed in the Phase 2a trial at that time, and in June we reported that 24 patients of the 26 required had been recruited to the trial.

The Phase 2a stage of the ACCENT trial is open at six sites in Australia-in Melbourne, Sydney and Brisbane-and at five hospitals in the Republic of Korea, in and around the capital Seoul. Korea was chosen as a second country in which to conduct the trial given the excellent medical and clinical trial facilities and capabilities in the country.

The Phase 2a trial is being conducted using Simon’s Two-Stage Design, a commonly used method for Phase 2 clinical trials. The trial design was chosen as it can result in efficient determination of whether a new drug has sufficient promise to warrant further development. In the ACCENT trial, the first stage consists of efficacy assessment in a group of 26 patients where a confirmed complete or partial response in six (6) patients in considered sufficiently promising to warrant continuation of the trial. In the second stage of the trial an additional 24 patients will be enrolled, giving a total of 50 patients. The decision about the drug’s efficacy is made based on the combined results of both stages.

It is important to note that the formal term ‘confirmed partial response’ means that there is at least a 30% reduction in the overall size of tumour lesions, sustained over a two-month period, with no new tumour lesions. Given that the ACCENT trial is focused on patients with advanced pancreatic cancer, a >30% reduction in tumour size represents a significant therapeutic response in this aggressive disease. In the Phase 1b stage of the ACCENT trial completed in October last year, we reported that six out of the fourteen patients on the trial recorded a partial response.

In April we presented a poster with updated analysis of data from the ACCENT Phase 1b trial at the world’s foremost scientific meeting in cancer research, the annual meeting of the AACR (Free AACR Whitepaper). In addition to the excellent response rate observed for the fourteen patients on the trial, significantly higher than predicted from historical studies of gemcitabine and Abraxane treatment alone, we also presented data showing there was a clear dose-dependence in response, where four of the six partial responses observed were from the highest dosing cohort. This, combined with other data, strongly suggests that the responses observed are related to effects from the drug narmafotinib. This data was subsequently published in the abstracts for the annual ASCO (Free ASCO Whitepaper) meeting in May. During the conference, the inaugural meeting of the Company’s Clinical Advisory Board was also held to discuss the ACCENT trial progress, as well as strategy and plans for additional trials of narmafotinib in pancreatic cancer. The CAB consists of five world-class clinical oncologists, with expertise in pancreatic cancer from Australia, the US and Canada.

Financial update

Amplia finished the June 2024 quarter with cash of $4.8 million (March 2024: $3.4million). During the quarter, the Company had net operating cash outflows of $2.5 million in relation to operating activities (March 2024: $2.0 million outflow).

Operating cashflows included:

• Outflows of $0.7 million for staff and administration/corporate costs; and

• Outflows of $1.8 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the Phase 1b/2a clinical trial for narmafotinib (AMP945).

During the quarter the Company undertook a two for five, fully underwritten pro-rata nonrenounceable Entitlement offer and raised $4.27m (before costs) receiving significant support from new and existing institutional investors and the Company’s Directors.

Payments to Related Entities

In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $112,500 and relate to paymentsto the CEO/Managing Director in line with employment contracts and payments to the Non-Executive Directors.

Outlook and future activities

The Company will continue to focus on timely execution of the Phase 2a portion of the ACCENT trial. Additional clinical opportunities for narmafotinib, including a potential clinical trial in ovarian cancer, are also being actively explored.

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]).

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"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 Creatv Bio, a Division of Creatv MicroTech, Inc. (Creatv) reported that its Cancer Associated Macrophage-Like (CAML) liquid biopsy biomarker has been included as part of the pivotal Phase 3 trial of BriaCell Therapeutics Corporation’s lead clinical candidate, Bria-IMT in combination with an immune checkpoint inhibitor in metastatic breast cancer (Press release, CREATV MICROTECH, JUL 31, 2024, View Source [SID1234645217]).

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This study is expected to enroll a total of 404 patients in two arms – Bria-IMT in combination with an immune checkpoint inhibitor versus treatment of physicians’ choice in late-stage metastatic breast cancer patients, with no approved alternative therapies available (listed on ClinicalTrials.gov as NCT06072612). Bria-IMT was awarded Fast Track status by the U.S. Food and Drug Administration (FDA).

Blood samples are being provided to Creatv to analyze for the presence of circulating tumor cells (CTCs), CAML subtyping, and to monitor PD-L1 upregulation in patients. The samples are being taken at baseline and at a designated time following the initial patient treatment.

Creatv previously demonstrated that CAMLs can accurately (i) predict a cancer’s aggressiveness as well as multi-organ metastasis, (ii) provide a universal companion diagnostics tool using blood instead of tissue from patients, (iii) predict treatment response within approximately 30 days of receiving a new therapy in any solid tumor type, (iv) detect minimal residual disease, and (v) cancer recurrence.

"The use of biomarkers like CAMLs holds great promise in helping clinicians determine whether a patient is responding to a specific therapy in a timely manner," remarked Dr. Cha-Mei Tang, President and CEO of Creatv Bio. "We are looking forward to participating in this important trial with BriaCell and are confident that as a result, this biomarker will provide clinicians with a valuable tool to guide their treatment choices for cancer patients."

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]).

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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.