On July 31, 2024 Clinical stage drug development company Syntara Limited (ASX: SNT) reported that it has completed full recruitment in its Phase 2 trial evaluating SNT-5055, in combination with ruxolitinib, treating the bone marrow cancer myelofibrosis (Press release, Syntara, JUL 31, 2024, View Source;v=70bc033a22188bdfefb8a0b8ad3c24897ef2837d [SID1234645175]).

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After commencement of the open-label study in December 2023, Syntara has reached the milestone with the 15ᵗʰ patient dosed yesterday and has already exceeded the minimum threshold of one month treatment for 12 patients proposed in FDA discussions for safety evaluation.

The trial is being conducted across 19 clinical trial sites in the USA, Australia, South Korea and Taiwan. SNT-5505 is a pan-LOX inhibitor and the lead asset in Syntara’s proprietary clinical pipeline.

Syntara expects to report interim results from the trial in late 2024, in conjunction with the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In line with the excellent safety profile observed in earlier phase 1 and phase 2 studies, no drug related dropouts nor any serious adverse reactions have been observed to date.

The reassuring safety profile, alongside the interim data, is expected to allow Syntara to engage with and discuss pivotal study design with the FDA in Q1 2025, with the full 12month data set to be available in Q3 2025.

Syntara CEO Gary Phillips said:

"I’d like to thank the haematology clinics, investigators and the Syntara clinical team for achieving this significant milestone in such a timely fashion. We now look forward to presenting our interim data later in the year and building a solid foundation for the next stage of discussions with the FDA and potential strategic partners."

Syntara commenced the combination trial after it found encouraging efficacy and an excellent safety profile in a Phase 2 monotherapy trial of the drug, as presented at ASH (Free ASH Whitepaper) in December 2023. An effective pan-LOX inhibitor, such as SNT-5505, for myelofibrosis has disease modifying potential for patients and would unlock a market conservatively estimated to be more than $1 billion per annum.

SNT-5505 is a pan-LOX inhibitor that has also demonstrated compelling pre-clinical data when used in combination with standard of care in other haematological malignancies such as myelodysplastic syndrome and solid tumours like those found in hepatocellular carcinoma and pancreatic cancer.

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 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported to have dosed the first patient with MT-303 in a Phase 1 study for hepatocellular carcinoma (HCC) (Press release, Myeloid Therapeutics, JUL 31, 2024, View Source [SID1234645216]). MT-303 is Myeloid’s second in vivo mRNA CAR program to enter the clinic from its pipeline of in vivo immune cell programming therapies. Dosing with MT-303 represents a significant milestone to bring advanced novel therapies to people with liver cancer.

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Dr. Matthew Maurer, Chief Medical Officer of Myeloid, commented, "We are thrilled to have swiftly advanced MT-303 into the clinic as the first in vivo CAR therapy applicable to the majority of liver cancers, and other cancers expressing GPC3. MT-303 can be administered like any other off-the-shelf intravenous therapy, without the need for pretreatment conditioning, and offers the potential to trigger a coordinated immune response against the cancer, reinforced and maintained with ongoing repeat dosing."

GPC3 is a target of significant global interest given its high expression in HCC and limited expression in normal tissues. Unlike autologous cell therapies, Myeloid’s approach focuses on in vivo programming of immune cells with off-the-shelf mRNA-encoded CAR technology that expresses selectively within myeloid cells. MT-303 arms myeloid cells with a proprietary chimeric antigen receptor that enables these cells to kill hepatocellular carcinoma and to engage an adaptive immune response against the tumor. This coordinated immune response is essential to foster a sustained immune surveillance and defense against tumor recurrence.

Dr. Timothy Humphries, Linear Clinical Research, lead principal investigator on the MT-303 trial added, "Hepatocellular carcinoma is a highly lethal cancer with limited effective therapies. I am elated to bring the option and potential of MT-303, the first in vivo CAR therapy for this disease, to my patients with the hope of providing tolerable and durable clinical benefit."

"The Myeloid team continues to push forward and revolutionize cancer treatment with the world’s first clinical-stage in vivo mRNA CAR therapies," said Daniel Getts, Ph.D., CEO of Myeloid. "With multiple clinical trials ongoing that evaluate our therapeutic candidates, including MT-302, our novel TROP2-targeting mRNA CAR in dose escalation studies, and adding MT-303, we have a proven ability to translate cutting-edge mRNA CAR technology into clinical candidates. We are excited by the transformative potential of our in vivo immune cell programming for liver cancer patients."

Dr. Getts continued, "Strategically, these clinical programs provide insights as we continue to expand our development portfolio to other targets, to other immune cell types, and to novel receptor combinations for our in vivo CAR approaches."

Myeloid’s in vivo programming candidates are designed with proprietary insights to deliver personalized therapy, providing benefits to patients while reducing time and costs through the elimination of ex vivo handling of patient cells and complex neoantigen sequencing. The Myeloid platform integrates validated antibody/antigen binding with novel combinations of myeloid signaling domains, coded within a simple mRNA that can be delivered repeatedly using lipid nanoparticles (LNPs). The platform’s versatility provides a range of signaling domains and immune cell types useful for combination approaches.

About Liver Cancer

With limited treatment options, and over 850,000 new cases diagnosed globally each year, liver cancer has become the third leading cause of cancer death. After initial treatment success with small molecule therapies, the development of new treatment approaches in the field of liver cancer has been limited. Today, patients with liver cancer who are refractory to first line treatment are left with few treatment options, creating a substantial unmet medical need. Myeloid sees an opportunity to make a significant contribution to address this need, by providing a new CAR for these patients who are living with liver cancer. The CARs are capable of providing a coordinated and durable immune response to counter advanced disease. The CARs are combinable and will expand the treatment options for physicians.

About the Phase 1 Study of MT-303

The MT-303 Phase 1 study (NCT06478693) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adults with advanced or metastatic hepatocellular carcinoma that overexpresses GPC3. This study will also define the recommended Phase 2 dose (RP2D) of MT-303.

About MT-303

MT-303 represents the first candidate in a new therapeutic modality targeting hepatocellular carcinoma (HCC). This clinical candidate is a first-in-class, GPC3-FcA-LNP, with a strong preclinical profile supporting its advance into this first-in-human trial. GPC3 is overexpressed in most human hepatocellular carcinomas, with limited expression in corresponding normal tissues. Increased GPC3 expression has been linked to tumor growth.

Treatment with MT-303 as a monotherapy demonstrates activity in a GPC3/HCC preclinical model, confirming the tumor-fighting potency of programmed myeloid cells even in the model’s absence of T cells. MT-303 has demonstrated strong expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-303 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells.

MT-303 represents Myeloid’s second in vivo CAR clinical program, building on the company’s innovative approach to cancer treatment through immune cell programming.

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.