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.

On July 31, 2024 Celularity Inc. (Nasdaq: CELU) ("Celularity") a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, reported its 2023 full-year reported combined net sales of its advanced biomaterial product and biobanking businesses and announced first half 2024 expected combined net sales (Press release, Celularity, JUL 31, 2024, View Source [SID1234645200]). As used here, "net sales" refers to direct-customer and distributor product sales of advanced biomaterial products and biobanking services, respectively, and does not include any revenue from other sources such as fees or revenue earned under research collaboration agreements.

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As reported on its Form 10-K for the year ended December 31, 2023, Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $22.8 million for the full year 2023, consisting of advanced biomaterial product net sales of $17.3 million and biobanking net sales of $5.4 million. Reported full year 2023 combined net sales of $22.8 million represents an increase of 26.7% over full year 2022 reported combined net sales and is slightly above the high end of the expected full year 2023 combined net sales range of $22.06 million to $22.76 million announced in January.

Full-year 2023 reported combined net sales is inclusive of the fourth quarter 2023, in which Celularity reported combined net sales of its advanced biomaterial product and biobanking businesses of $12.1 million, consisting of advanced biomaterial product net sales of $10.7 million and biobanking net sales of $1.4 million. Reported fourth quarter combined net sales of $12.1 million are also at the high end of the expected net sales range of $11.4 million to $12.1 million announced in January.

Celularity also updated its expected net sales of its biomaterial products and biobanking businesses for the first quarter 2024 and the second quarter 2024, respectively. For the first quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $14.8 million compared to the guidance range of $10.25 million to $11.5 million announced in February, consisting of expected net sales for its advanced biomaterial product business of $13.5 million and expected net sales for its biobanking business of $1.3 million. For the second quarter 2024, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses of $11.0 to $13.0 million, consisting of expected advanced biomaterial product net sales of $10.0 to $11.5 million and expected biobanking net sales of $1.0 to $1.5 million. For the first half of 2024 combined, Celularity expects combined net sales of its advanced biomaterial product and biobanking businesses between $25.8 and $27.8 million.

"At this midpoint of 2024, we believe Celularity is on a positive revenue trajectory, building on the very strong net sales growth we reported for 2023," said Robert J. Hariri, M.D., Ph.D., Chairman, CEO and founder of Celularity. "The significant increase in our net sales reflects the growing demand for our advanced biomaterial products and biobanking services. While we are encouraged by our progress, we recognize the financial challenges impacting the industry."

Dr. Hariri continued, "As we navigate the second half of 2024, we are committed to expanding our market presence, enhancing our product offerings, and implementing further strategic measures to improve our financial stability. Our team’s relentless dedication to innovation and operational excellence has enabled us to exceed our financial targets, yet we must remain vigilant in managing our resources effectively. We believe that by maintaining a balanced approach, we can continue to drive long-term value for our shareholders while navigating the complexities of our financial landscape."

Celularity’s advanced biomaterial product portfolio consists of four commercial-stage products and three development pipeline product candidates. Celularity’s commercial-stage products are off-the-shelf placental-derived allogeneic allografts and connective tissue matrices marketed primarily under its own brands in the U.S. for use in soft tissue repair and reconstructive procedures, including acute and chronic non-healing wounds and burns:

Biovance, a human amniotic membrane allograft designed to cover or offer protection from the surrounding environment in soft tissue repair and reconstructive procedure.
Biovance3L, a tri-layer human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites and to support the treatment of ocular surface disease and ocular surgical applications.
Interfyl, a decellularized human placental connective tissue matrix designed for use to replace or supplement damaged or inadequate integumental tissue.
CentaFlex, a decellularized human placental matrix allograft derived from human umbilical cord designed for use as a surgical covering, wrap, or barrier to protect and support the repair of damaged tissues.
Celularity’s advanced biomaterial product developmental pipeline includes human placental tissue derived medical devices that are intended to treat aging-associated and other degenerative diseases and disorders characterized by the progressive loss of function and/or structure of the affected tissues, including:

Celularity Tendon Wrap, a scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use in the management and protection of tendon injuries.
Celularity Bone Void Filler, a moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that Celularity is developing for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects.
Celularity Placental Matrix, a resorbable device composed of extracellular matrix derived from decellularized human placental tissue that Celularity is developing for use as a passive temporary wound covering.

On July 31, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate virtually at the 9th Annual Needham Virtual MedTech & Diagnostics 1×1 Conference on Tuesday, August 13, 2024 (Press release, Personalis, JUL 31, 2024, View Source;1-Conference [SID1234645218]).

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