On August 14, 2023 Kaiyue Life reported the completion of Pre-A round of financing in August 2023 (Press release, KeYe Life Technologies, AUG 14, 2023, View Source;article_id=88 [SID1234644608]). This round of funds will be mainly used for platform construction and to advance the core pipeline to IND in China and the United States and other pipeline development.

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Founder Dr. Zhang Yandong said: "I am very grateful for the continued efforts of the company’s strong and professional founding team and the strong support and trust of investors. The success of this round of financing is a full recognition of the company’s operational capabilities and the development potential of its technology platform."

The head of a well-known family fund said: "We are very pleased to participate in the Pre-A round of investment in Kaiyue Life.

On August 14, 2023 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported financial results for the three and six months ended June 30, 2023 and provides a business update (Press release, Biocept, AUG 14, 2023, View Source [SID1234634441]).

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"Biocept’s primary focus is establishing our proprietary cerebrospinal fluid assay CNSide as standard of care. We continue to diligently work towards submission to the National Comprehensive Cancer Network (NCCN) for consideration to include CNSide in their standard-of-care guidelines. We believe securing this status will broaden physician adoption and support reimbursement that reflects our test’s value in clinical decision-making," said Antonino Morales, Biocept President and CEO. "Our ongoing FORESEE clinical trial is powered to generate data in support of this goal by assessing CNSide’s impact on physicians’ treatment decisions. I’m exceptionally pleased that patient enrollment in FORESEE has passed the midpoint, with four clinical sites open around the country for patient recruitment and several additional medical centers expected to join in the coming weeks.

"We plan to provide further evidence of CNSide’s clinical utility through publication in peer-reviewed medical journals. We have submitted a manuscript with a description of our assay and its features, validation from pilot studies and compelling case studies showing actual use in patient management. Four additional manuscripts are being prepared in collaboration with leading neuro-oncologists for submission to scientific journals, including several documenting their clinical experiences with CNSide in their practices," Mr. Morales continued.

"We right sized our business to align with our primary focus, which is helping to extend our cash runway. Progressing towards standard of care, completing the FORESEE clinical trial, and reducing expenses are key to Biocept becoming a self-sustaining business," Mr. Morales added.

Earlier today Biocept announced that Priya U. Kumthekar, MD, a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist at Northwestern University, and David Piccioni, MD, PhD, Director of Neuro-Oncology at University of California, San Diego, discussed the use of CNSide in presentations at the 2023 SNO/ASCO CNS Cancer Conference, which was held last week.

Biocept intends to host a business update call later in August to present a progress report on the FORESEE trial and discuss other recent developments. Details of the call will be announced in a press release.

Second Quarter Financial Results

Net revenues for the second quarter of 2023 were $0.6 million, compared with $5.8 million for the second quarter of 2022, with the decline due to lower RT-PCR COVID-19 testing volume. As previously reported, the Company ceased providing COVID-19 testing services in February 2023. The number of commercial accessions delivered for the second quarters of 2023 and 2022 were 322 and 77,779, respectively.

Cost of revenues for the second quarter of 2023 was $2.6 million, compared with $8.0 million for the second quarter of 2022, with the decrease primarily due to the cessation of COVID-19 testing services and reduced headcount.

Research and development (R&D) expenses for the second quarter of 2023 were $0.4 million, compared with $1.7 million for the second quarter of 2022, with the decrease primarily due to a reduction in headcount and lower purchases of materials and supplies.

General and administrative (G&A) expenses for the second quarter of 2023 were $3.5 million, compared with $4.3 million for the second quarter of 2022. The decrease was primarily due to lower headcount and consulting fees.

Sales and marketing expenses for the second quarter of 2023 were $0.3 million, compared with $1.7 million for the second quarter of 2022, with the decrease primarily due to a reduction in headcount, and lower consulting, promotion and outside service-related expenses.

Non-cash change in the fair value of warrant liability for the second quarter of 2023 was $2.4 million. There was no comparable item for the second quarter of 2022.

Net loss attributable to common stockholders for the second quarter of 2023 was $3.6 million, or $3.50 per share, compared with a net loss attributable to common stockholders for the second quarter of 2022 of $10.0 million, or $17.82 per share.

Six Month Financial Results

Net revenues for the first half of 2023 were $1.3 million, compared with $25.8 million for the first half of 2022.

Operating expenses for the first half of 2023 were $14.5 million, and included cost of revenues of $5.6 million, R&D expenses of $1.4 million, G&A expenses of $6.5 million and sales and marketing expenses of $1.0 million.

Net loss attributable to common stockholders for the first half of 2023 was $10.8 million, or $13.25 per share, compared with net loss attributable to common stockholders for the first half of 2022 of $12.3 million, or $21.78 per share.

Biocept reported cash of $6.6 million as of June 30, 2023, compared with $12.9 million as of December 31, 2022. In May 2023, the Company received net cash proceeds of approximately $3.6 million from an underwritten public offering, after deducting underwriting discounts and other expenses payable by the Company.

About the FORESEE Clinical Trial

The multi-center, prospective FORESEE clinical trial is a longitudinal therapy response monitoring study in subjects with leptomeningeal metastases (LM) using CNSide (CSF Tumor Cells) compared to standard of care (CSF cytology, clinical evaluation, and imaging). The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring the response of LM to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The trial is enrolling up to 40 patients with breast or non-small cell lung cancer (NSCLC) who have suspected or confirmed LM. Standard of care methods to diagnose or assess the treatment response of LM have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide is a Laboratory Developed Test (LDT) that is used commercially at the physician’s discretion in Biocept’s CLIA-certified, CAP-accredited laboratory.

On August 14, 2023 Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, reported a business update and provided financial results for the quarter ended June 30, 2023 (Press release, Gamida Cell, AUG 14, 2023, View Source [SID1234634410]).

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"Since the approval of Omisirge in April, Gamida Cell has made excellent progress on the launch," said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. "We have rapidly confirmed significant payer coverage and are seeing high interest from transplant centers, exceeding our plans. This is a testament to the unmet needs that Omisirge has the potential to address for patients, as well as the exceptional work of our experienced cell therapy team. We continue to progress our discussions in our efforts to secure a strategic deal to fully resource our Omisirge commercial efforts. We are optimistic that between our progress on the Omisirge launch and our discussions with potential partners, we can accelerate efforts to expand patient access to Omisirge."

The U.S. Food and Drug Administration (FDA) approved Omisirge in April 2023 for use in adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation. The Omisirge launch is ahead of expectations in terms of both transplant center onboarding and market access, with 12 transplant centers already onboarded, eight more in the onboarding process, and active engagement with virtually all of the top 70 transplant centers. The company has also confirmed coverage with payers that cover more than 85% of commercial lives, as well as confirmed coverage and reimbursement with Medicare from the Centers for Medicare and Medicaid Services (CMS). All documents are in place for coverage under the Department of Veterans Affairs, Department of Defense and Medicaid.

"We are very encouraged by the strong interest we have received from transplant centers to date, including centers that did not participate in our clinical studies," said Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell. "The enthusiasm for Omisirge is consistent with expectations from the market research we conducted both pre- and post-approval, supporting our assertion that Omisirge has the potential to capture approximately 20% peak market share. We anticipate this peak share will include patients who might have been otherwise transplanted with a different donor source, as well as patients who historically would not have been able to find an appropriate donor. We have onboarded more centers at this point in our launch than we initially anticipated and are ahead of our expectations in terms of payer coverage. We look forward to engaging with and onboarding additional transplant centers in the coming months to provide more access to Omisirge for patients."

Second Quarter Highlights and Recent Developments

Omisirge

Commercial progress:
The company is seeing strong demand from transplant centers and is ahead of its goal of onboarding 10-15 transplant centers in 2023. As of the morning of August 14, 2023, 12 transplant centers have been onboarded and eight additional transplant centers are in the onboarding process.
Patients are enrolled in the company’s Gamida Cell Assist program, which means that their transplanter has the intent to utilize Omisirge as the patient’s donor source.
The company has confirmed coverage with payers who cover more than 85% of commercial lives and is in ongoing discussions with additional commercial payers.
CMS coverage and reimbursement has been confirmed for patients covered by Medicare. All required documentation is in place for patients who are covered under Medicaid, Department of Defense and Veterans Affairs.
The company is ready to reliably deliver Omisirge within 30 days from the start of manufacturing.
Publication: The company announced the publication of a prospective sub-study of the Phase 3 clinical trial for Omisirge titled "Immune Reconstitution Profiling Suggests Antiviral Protection After Transplantation with Omidubicel: A Phase 3 Substudy." The publication is available online on the Transplantation and Cellular Therapy journal website.
Corporate Developments

Strategic review: The company continues to work with Moelis & Company LLC to engage and advance discussions with multiple parties as part of its efforts to explore alternatives to support a fully resourced launch.
Terry Coelho, MBA, appointed Chief Financial Officer: In May 2023, Gamida Cell announced the appointment of Terry Coelho as Chief Financial Officer. Ms. Coelho, a seasoned finance executive with more than 35 years of experience across all areas of finance and business development at emerging growth companies and established global companies, is positioned to support Gamida Cell’s transition into a commercial-phase company and its pursuit of a strategic partnership.
Jeremy Blank appointed to Board of Directors: In August 2023, the company’s Board of Directors appointed Jeremy Blank, Chief Investment Officer of Community Fund, to the Board, where he will serve on the Transactions Committee. "Having closely followed Gamida Cell for over a decade, it is a privilege to join the Board of Directors," said Mr. Blank. "I have high confidence in Gamida’s team and technology and our firm invested in both of Gamida’s most recent equity offerings. I look forward to supporting Gamida’s strategic process which is a great opportunity to create shareholder value." Mr. Blank will provide a valuable perspective to the Board as it aids the company in executing its corporate strategy. From 2005 to 2020, Mr. Blank also served as a partner at York Capital Management, a $15 billion global investment fund. Before that, he was a Vice President and credit analyst at Morgan Stanley. Mr. Blank currently serves as a Director on the boards of Insightec Ltd. and Advanced Emissions Solutions, Inc. (NASDAQ: ADES). Community Fund is a significant shareholder in Gamida Cell.
Strengthened balance sheet: The company ended the second quarter with $54.1 million in cash as a result of the net proceeds of $29.8 million from both the April equity offering and the at-the-market offering (ATM), thereby extending cash runway into the second quarter of 2024. Additionally, the company reduced its outstanding principal balance in the quarter by $9.0 million, from $94.0 million to $85.0 million.
Investor Day: Gamida Cell hosted an Investor Day on June 29, 2023. The event was attended by over 180 participants, both in-person and virtual, and included an update on the commercial launch of Omisirge as well as discussions with industry thought leaders. Steven Devine, M.D., Chief Medical Officer at the National Marrow Donor Program (NMDP)/Be The Match, discussed the unmet needs and barriers to care in stem cell transplant, and explained how Omisirge can help address some of these issues. Usama Gergis, M.D., MBA, Professor of Oncology & Director of Transplant and Cellular Therapy, Sidney Kimmel Cancer Center, Thomas Jefferson University, discussed the implications of a health outcomes economics research model developed in partnership with Gamida Cell that showed that a 20% peak market share of Omisirge may increase transplant access for eligible patients, particularly those from racially and ethnically diverse groups that are currently underserved.
GDA-201

Phase 1 study: Gamida Cell’s GDA-201, an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies, is being evaluated in an ongoing Phase 1 study for treatment of non-Hodgkin lymphoma. The study is continuing to enroll patients at six sites in the U.S. Data are expected in the first quarter of 2024.
Data presented at International Society for Cell and Gene Therapy (ISCT) 2023 Annual Meeting: GDA-201 data presented at ISCT on June 2, 2023 demonstrated the robustness of cryopreserved GDA-201 and continued to support signs of strong lymphoid homing and decreased exhaustion of GDA-201 cells.
New data on nicotinamide (NAM) mechanism of action: Data published in Science Translational Medicine in the July 19 edition demonstrated that culturing NK cells with NAM, which the company uses to enhance and expand cells, and IL-15 increases metabolic fitness, energy charge and glucose flux within NK cells, providing a pathway for resistance to oxidative stress and increased potency compared to NK cells cultured with IL-15 but without NAM. Through preventing degradation of the protein FOXO1, the presence of NAM was found to increase levels of CD62L, an important lymph node homing marker. This expression cascade provides evidence for the strong lymph node homing, direct killing and antibody dependent cell-mediated cytotoxicity capabilities of NK cells cultured with NAM. The publication also includes outcome data from the Phase 1 dose escalation clinical trial for Gamida Cell’s NK cell therapy candidate GDA-201 in patients with non-Hodgkin lymphoma as well as translational data from biopsy specimens.
Second Quarter 2023 Financial Results

Research and development expenses were $8.7 million in the second quarter of 2023, compared to $10.6 million in the same quarter in 2022. The decrease of $1.9 million was primarily due to a $1.6 million reduction associated with the discontinuation of development of our engineered NK cell therapy pipeline, and $0.7 million in lower Omisirge Phase 3 spend, including a decrease in payments for manufacturing services, partially offset by a decrease of $0.4 million in IIA (Israeli Innovation Authority) income.

Commercial expenses were $3.9 million in the second quarter of 2023, compared to $3.2 million in the second quarter of 2022. The increase of $0.7 million was attributable to an increase in launch readiness activities.
General and administrative expenses were $6.3 million in the second quarter of 2023, compared to $4.3 million in the same period in 2022. The increase of $2.0 million was associated with higher professional services expenses, in part due to the April 2023 follow on offering and business development activities.

Financial expenses, net, were $12.9 million in the second quarter of 2023, compared to $0.5 million in the same period of 2022. The increase of $12.4 million was primarily due to non-cash expenses totaling approximately $10.4 million, including the fair value impact on our warrants liability of $4.9 million, the fair value impact on the 2022 convertible note of $4.3 million, and a decrease in capitalization of finance costs to fixed assets of $0.6 million. In addition, the increase was due to higher cash expenses of $2.0 million, including $1.7 million in issuance costs from our April 2023 underwritten public offering and an increase of $1.0 million in interest expenses associated with the 2022 convertible notes, partially offset by increased interest income of $0.5 million.
Net loss was $31.7 million in the second quarter of 2023, compared to a net loss of $18.6 million in the second quarter of 2022, driven primarily by the increase in financial expenses of $12.4 million.
Cash Position: As of June 30, 2023, Gamida Cell had total cash and cash equivalents of $54.1 million compared to $64.7 million as of December 31, 2022. The decrease of $10.4 million is due primarily to net cash used in operating activities of $44.3 million partially offset by $34.7 million in net cash proceeds from the issuance of shares and warrants from our underwritten public offering and the issuance of shares via the ATM facility. Subsequent to the quarter close and through August 9th, the company raised an additional $14.0 million in net proceeds via the ATM facility. The company expects its current cash and cash equivalents, including the funds raised subsequent to the close of the second quarter, to support its ongoing operating activities into the second quarter of 2024, based on Gamida Cell’s current operational plans and excluding commercialization activities beyond the initial launch of Omisirge, as well as any additional financing activities that may be undertaken.
Debt Position: As of June 30, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $15.0 million, from $25.0 million as of December 31, 2022, to $10.0 million at the end of the second quarter. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75.0 million.
Conference Call Information

Gamida Cell will host a conference call today, August 14, at 8:30 a.m. ET to discuss these financial results and company updates. To access the conference call by phone, please register here and be advised to do so at least 10 minutes prior to joining the call. A live conference call webcast can be accessed here and also in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A webcast replay will be available approximately two hours after the event for approximately 30 days.

On August 14, 2023 Foundation Medicine Inc., reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for Janssen Biotech, Inc. (Janssen’s) AKEEGA (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) (Press release, Foundation Medicine, AUG 14, 2023, View Source [SID1234634409]).

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Prostate cancer is one of the most common cancers in men.1 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,2 occurring in approximately 10-15% of diagnoses.3,4 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.

Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 30 companion diagnostic indications. Foundation Medicine is the global leader in companion diagnostic approvals. The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.

"With such a rapidly evolving therapeutic landscape in prostate cancer, high-quality companion diagnostics are important tools to support oncologists in the development of personalized treatment plans for each unique patient," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "This companion diagnostic specifically will help enable broader access to an important new therapy option in BRCA1/2+ mCRPC. We look forward to ongoing collaboration with Janssen to help bring more treatment options to patients facing a cancer diagnosis."

"BRCA1- or BRCA2-mutated metastatic castration-resistant prostate cancer has had a devastating impact on so many men and their families," said Shelby Moneer, VP Patient Programs and Education, ZERO Prostate Cancer. "We are so encouraged to see continued progress in advancing treatment options and diagnostics for this devastating condition."

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

On August 14, 2023 Biocept, Inc. (Nasdaq: BIOC) ("Biocept" or the "Company"), a leading provider of molecular diagnostic assays, products and services, reported that its CNSide cerebrospinal fluid assay was featured in two oral presentations at the 2023 SNO/ASCO CNS Cancer Conference on Saturday, August 12 (Press release, Biocept, AUG 14, 2023, View Source [SID1234634408]). The abstracts were presented by Priya U. Kumthekar, MD, a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist at Northwestern University, and David Piccioni, MD, PhD, Director of Neuro-Oncology at University of California, San Diego. The conference, sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), was held August 10-12 in San Francisco.

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"While patients with leptomeningeal metastasis (LM) have limited treatment options, select patients may benefit from targeted therapies," said Dr. Kumthekar. "Using CNSide in patients with solid tumors and LM to detect HER2 amplification could provide valuable information in treatment decision making." Dr. Kumthekar is the principal investigator at Northwestern University of Biocept’s ongoing FORESEE clinical trial, which is evaluating the performance of CNSide in monitoring the response of LM to treatment and assessing the impact of CNSide on treatment decisions made by physicians.

"Patients with leptomeningeal carcinomatosis (LMC) have limited survival and early detection by traditional CSF cytology is poor," said Dr. Piccioni. "From this study, we concluded that using CNSide was superior in detecting LMC, and its ability for molecular profiling on captured CSF tumor cells (CSF-TCs) could improve earlier detection and treatment outcomes."

A summary of the abstracts is as follows:

"The HER2 Flip: HER2 Amplification of Tumor Cells in the Cerebrospinal Fluid (CSF-TCs) of Patients with Leptomeningeal Metastasis having solid tumors; implications for treating the LM tumor with anti-HER2 therapy."

Results of this study indicated that HER2 amplification in the CSF can be detected in a substantial fraction of CSF-TCs from patients with LM having breast, upper GI and non-small cell lung cancer, and other solid tumors, and that an increased HER2 positivity in LM may imply HER2 as a driver for developing LM. The results suggest that prospective studies are needed to determine if evaluation of HER2 amplification in the CSF of patients with LM having solid tumors should be routinely considered, as it may offer viable treatment options otherwise not considered.
"Circulating tumor cell analysis from the cerebrospinal fluid informs early diagnosis, treatment and prognosis in leptomeningeal carcinomatosis (LMC)."

This study compared traditional CSF cytology and circulating tumor cell (CTC) analysis using CNSide to evaluate patients for presence of LMC. The results suggested that CTC provided superior sensitivity in detecting LMC compared with traditional cytology, and allowed for earlier detection and consequently earlier treatment. Molecular analysis of CTCs also allowed for identification of therapeutic targets specific to the CSF, which provides more information for treatment decision making and potentially improves survival versus historical controls.
The abstracts from both presentations are available on the Biocept website here.