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 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 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.

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"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.

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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.

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"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.