On August 2, 2024 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the third quarter of fiscal 2024 ended June 30, 2024 (Press release, Twist Bioscience, AUG 2, 2024, View Source [SID1234645306]).

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"We once again surpassed our revenue guidance, ending the quarter with $81.5 million in revenue, and exceeded our targets for both cash burn and gross margin," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We saw strength in NGS as well as growth driven by our SynBio product line with sequential growth for our Express Genes portfolio. Recently, we leveraged the Express workflow and infrastructure to introduce new products, including our Express Antibodies, CHO and HEK293, as well as Multiplexed Gene Fragments, with direct synthesis of up to 500 base pairs in length."

Dr. Leproust continued, "We continue to employ disciplined execution and commercial prowess to expand our portfolio of products and services as we progress on our path to profitability and move toward an adjusted EBITDA loss of $20 million in the fiscal fourth quarter of 2024. We are encouraged by the continued increase in margin with approximately 900 basis point increase over the same period last year to 43.3% and we are moving toward a gross margin over 50% by the end of fiscal 2025."

See "Non-GAAP Information" below for a discussion of the measure adjusted EBITDA.

FISCAL 2024 THIRD QUARTER FINANCIAL RESULTS

•Orders: Total orders received for the third quarter of fiscal 2024 grew to $85.3M compared to $63.8M for the same period of fiscal 2023.
•Revenue: Total revenues for the third quarter of fiscal 2024 grew to $81.5 million compared to $63.7 million for the same period of fiscal 2023.
◦SynBio revenue grew to $33.0 million for the third quarter of fiscal 2024 compared to $25.9 million for the same period of fiscal 2023.
◦NGS revenue grew to $43.4 million for the third quarter of fiscal 2024 compared to $33.2 million for the same period of fiscal 2023.
◦Biopharma revenue was $5.1 million for the third quarter of fiscal 2024 compared to $4.6 million in the same period of fiscal 2023.
•Cost of Revenues: Cost of revenues for the third quarter of fiscal 2024 was $46.2 million compared to $41.8 million for the same period of fiscal 2023.
•Gross Margin: Gross margin for the third quarter of fiscal 2024 increased to 43.3% compared to 34.4% for the same period of fiscal 2023.
•Research and Development Expenses: Research and development expenses for the third quarter of fiscal 2024 were $22.5 million compared to $24.5 million for the same period of fiscal 2023.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of fiscal 2024 were $56.8 million compared to $46.1 million for the same period of fiscal 2023.
•Net Loss: Net loss attributable to common stockholders for the third quarter of fiscal 2024 was $85.6 million, or $1.47 per share, compared to $57.4 million, or $1.01 per share, for the same period of fiscal 2023. On a non-GAAP basis and excluding approximately $45.0 million for an impairment related to Biopharma assets, net loss attributable to common stockholders for the third quarter of fiscal 2024 was $40.6 million.
•Adjusted EBITDA: Adjusted EBITDA for the third quarter of fiscal 2024 was $(22.0) million compared to $(29.6) million for the same period of fiscal 2023. See the table included in this release for a reconciliation between our adjusted EBITDA and net loss attributable to common stockholders, the most directly comparable GAAP financial measure.
•Cash Position: As of June 30, 2024, the company had $289.4 million in cash, cash equivalents and short-term investments, a reduction of approximately $4 million from the March 31, 2024 balance of approximately $293 million.

Recent Highlights:

•Shipped products to approximately 2,300 customers in the third quarter of fiscal 2024, compared to approximately 2,200 customers in the third quarter of fiscal 2023.
•Shipped approximately 212,000 genes during the third quarter of fiscal 2024, compared with approximately 171,000 genes during the third quarter of fiscal 2023.
•Launched Twist Multiplexed Gene Fragments, pools of directly synthesized dsDNA up to 500bp in length with no limit on sequence number, to enable high throughput screening applications.
•Added Cloned Oligo Pools up to 300 nucleotides with no limit to pool size, to Twist’s ecommerce platform.

•Expanded high-throughput antibody portfolio with the launch of Twist Express Antibodies, CHO, complementing Twist’s HEK293 antibody offering.
•Announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405, the first antibody discovered using Twist synthetic antibody libraries to be evaluated in patients.
•Published preclinical data detailing the discovery of TB206-001, a first-in-class antibody that could enhance cancer immunotherapy by targeting adenosine A2A receptor and alleviating the suppressive tumor microenvironment.
•Launched a synthetic RNA control for H5N1, one of the causes of Highly Pathogenic Avian Influenza (HPAI).
•Joined the U.S. AI Safety Consortium, a group established by the Department of Commerce’s National Institute of Standards and Technology to support the development and deployment of trustworthy and safe AI.

Updated Fiscal 2024 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2024, including the fourth quarter of fiscal 2024. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2024, Twist provided the following updated financial guidance:

•Total revenue is expected to be approximately $310 million to $311 million compared to previous guidance of $300 million to $304 million, indicating year over year growth of approximately 27%, and includes the following:
◦SynBio revenue is expected to be approximately $121 million compared to the previous estimate of $118 million to $120 million, indicating year over year growth of 23%
◦NGS revenue is expected to be in the range of $169 million to $170 million compared to the previous estimate of $162 million to $164 million, indicating year over year growth of 36% to 37%
◦Biopharma revenue is expected to be approximately $20 million, no change to prior estimates and indicating year over year decrease of approximately 13%
•Gross margin is expected to be approximately 42.0% for fiscal 2024, the high end of the previous guidance range of 41.5% to 42%
•Loss from operations before taxes of approximately $227 million to $230 million, inclusive of the approximately $45 million impairment charge; on a non-GAAP basis excluding the impairment charge, loss from operations is expected to be in the range of $182 million to $185 million, a slight decrease from our previous guidance of $183 to $188 million
◦Capital expenditure of approximately $13 million, a decrease of $2 million compared to prior guidance of $15 million
◦Ending cash, cash equivalents and short-term investments at September 30, 2024 of more than $255 million, an increase of $10 million over previous guidance of more than $245 million.

For the fourth quarter of fiscal year 2024, Twist provided the following financial guidance:

•Total revenue of approximately $82 million to $83 million compared to the previous estimate of $77 million to $80 million
•Gross margin of approximately 44% compared to the previous estimate of 43-44%
•Adjusted EBITDA loss of $20 million

On August 2, 2024 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended June 30, 2024 and provides a business update (Press release, INmune Bio, AUG 2, 2024, View Source [SID1234645302]).

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Q2 2024 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro):

● The Phase 2 randomized, blinded clinical trial for patients with Early Alzheimer’s Disease is on schedule to reach its final enrollment before the end of Q3 followed by top-line data approximately six months from the last patient enrolled.

● Announced completion of blinded interim analysis of the ongoing Phase II Alzheimer’s Disease trial, confirming that the trial is appropriately powered to assess its primary and secondary cognitive endpoints, the Early Mild Alzheimer’s Cognitive Composite (EMACC) and CDR. The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality.

● New Phase 1b analysis of proteomic data presented at AAIC shows XPro’s significant effects on a broad range of synaptic proteins and pathways. The analysis revealed that a 12-week treatment with XPro resulted in a significant change in synaptic proteins, which are essential for communication between neurons. The formation and elimination of synapses is executed by cells of the innate immune system such as astrocytes. When these cells are in a dysregulated inflammatory/immune state, synapse formation is reduced and synapse elimination is increased, resulting in loss of communication between neurons which, in the case of AD, results in cognitive impairment. Restoring synapses requires a normally functioning innate immune system.

● The Company successfully completed extended stability validation for XPro at continuous storage in solution at 2C-8C. The 24 and 30-month stability test samples passed all chemistry and potency assays allowing the Company to make a conservative claim of 24-month stability and positioning it to meet the dosing demands envisioned in the Phase III trial.

● Shared the progress of two early patients in the Phase 1b AD trial in Australia who have continued to receive XPro treatment under an open-label program administered by their treating physician. The video testimonials underscore XPro’s unique attributes that may halt progression of cognitive impairment versus existing treatments that slow the pace of, but do not stop the progression of, cognitive decline.

INKmune Platform:

● Announced a new formulation of INKmune that supports single bag administration at the highest trial dose, and expansion of bioreactor capacity in preparation of scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA that also includes additional validation data supporting an alternative critical reagent used in INKmune manufacturing, improving supply chain redundancy.

● Completed the first cohort in the Phase I/II open label trial (the "CarePC" trial) of INKmune in metastatic castration-resistant prostate cancer (mCRPC). Following review by the Safety Review Committee (SRC), approval was granted to proceed with the second dose level (cohort 2) and two patients have been enrolled. Data from this open-label trial is expected to be released intermittently as it becomes available.

● Patient enrollment in CarePC remains robust and on schedule. The first patient of the middle dose cohort will complete treatment this month and the 2nd patient of the middle dose cohort is about to be screened. The safety of INKmune remains excellent and all patients in the CarePC trial have been treated as an out-patient. Data from the trial is expected to be released later this year.

● The most recent pre-clinical data and early clinical results with INKmune have been published in the peer-reviewed Journal for ImmunoTherapy of Cancer this month. The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmune priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from cancer patients are equally as potent as those generated from healthy volunteers, further supporting INKmune’s in vivo treatment methodology. The research also provides new insights into the metabolic and physiological mechanisms underlying NK cell memory, paving the way for innovative treatments in both hematological malignancies and solid tumors.

Corporate:

● The Company is presenting at BTIG’s Virtual Biotechnology Conference 2024 on Tuesday, August 6, 2024 at 8AM ET and will host one-on-one meetings August 5/6. This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. To join the conference, email.

● Joined the broad-market Russell 3000 Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective as of Monday, July 1st, 2024.

● The Company successfully raised a combined $14.5 million of equity capital before placement agent fees and expenses in two separate transactions in late April. Of note, in the first $4.8 million offering, management and members of the Board of Directors purchased approximately 20% of the offering. Excluding shares and warrants acquired by insiders, both offerings were priced at-the-market.

● Received a research and development rebates from Australia in July of approximately $2.5 million USD.

Upcoming Events and Milestones:

● Full enrollment in the Phase II XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected before the end of Q3 followed by top-line data approximately six months from the last patient enrolled.

● Initiate a Phase II trial of XPro in patients with Treatment-Resistant Depression 2H 2024.

● Expect to complete enrollment in the Phase I portion of INKmune in metastatic castration-resistant prostate cancer trial in Q4 2024. The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available.

Financial Results for the First Quarter Ended June 30, 2024:

● Net loss attributable to common stockholders for the quarter ended June 30, 2024 was approximately $9.7 million, compared to approximately $6.5 million during the quarter ended June 30, 2023.

● Research and development expenses totaled approximately $7.1 million for the quarter ended June 30, 2024, compared to approximately $4.1 million during the quarter ended June 30, 2023.

● General and administrative expenses were approximately $2.8 million for the quarter ended June 30, 2024, compared to approximately $2.3 million during the quarter ended June 30, 2023.

● Other income (expense), net was approximately $0.1 million for the quarter ended June 30, 2024, compared to approximately ($0.1) million during the quarter ended June 30, 2023.

● As of June 30, 2024, the Company had cash and cash equivalents of approximately $31.1 million.

● As of August 1, 2024, the Company had approximately 19.8 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.

Date: August 1, 2024
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448
Participant Dial-in (international): 1-203-518-9708
Conference ID: INMUNE

A live audio webcast of the call can be accessed by clicking here or using this link:
View Source;tp_key=8a15b560a4

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through August 8, 2024, by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11156467.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

On August 2, 2024 Agenus reported that in May 2021, Agenus entered into a License, Development and Commercialization Agreement with Bristol Myers Squibb ("BMS" and the "BMS License Agreement") pursuant to which it granted BMS an exclusive license to develop, manufacture and commercialize our proprietary TIGIT bispecific antibody program AGEN1777 (Filing, 8-K, Agenus, AUG 2, 2024, View Source [SID1234645300]). Pursuant to the BMS License Agreement, we received a non-refundable upfront cash payment of $200 million. In addition to this $200 million upfront cash payment, BMS has made subsequent milestone payments of $20 million in December 2021, triggered by dosing of a first patient in a Phase 1 study, and $25 million in January 2024, triggered by dosing of a first patient in a Phase 2 study.

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On July 30, 2024, we received notice from BMS that, as part of a broader strategic realignment of their development pipeline which involves other licensed products, it is returning AGEN1777 back to Agenus and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.

When AGEN1777 was initially licensed to BMS, it had no clinical data. Since then, significant safety data has been generated in early clinical trials with indications of clinical activity. We intend to explore further development and/or relicensing of this molecule, including potential combinations with our portfolio of synergistic immuno-oncology agents.

Under the terms of the BMS License Agreement, BMS has granted us, effective as of January 26, 2025 an exclusive, royalty-free and fully paid-up, worldwide, and sublicensable license to BMS’ know-how and patent rights that arose from activities performed under the BMS License Agreement to develop and manufacture AGEN1777. Additionally, BMS will assign to us all regulatory registrations, applications, authorizations, and approvals that BMS holds in connection with AGEN1777. We will not incur any early termination penalties as a result of the termination. Agenus will have the right to continue development or enter a subsequent license in the future.

The foregoing summary of the material terms of the BMS License Agreement is qualified in its entirety by the complete terms and conditions of the BMS License Agreement, filed with the Securities and Exchange Commission on June 30, 2021 as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q.

On August 2, 2024 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported that it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio plasma focus Dx – the industry’s first and only kitted, pan-solid tumor liquid biopsy test (Press release, LabCorp, AUG 2, 2024, View Source [SID1234645296]).

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PGDx elio plasma focus Dx builds on the success of PGDx elio tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable.

"The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. "This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients."

PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay targets guideline-recommended biomarkers to enable more accurate clinical assessments and is coupled with automated bioinformatics to deliver accelerated results. This solution enhances oncologists’ ability to make timely treatment decisions in conjunction with other laboratory and clinical findings while also promoting sample and data ownership.

PGDx elio plasma focus Dx is part of Labcorp’s comprehensive precision oncology portfolio of testing solutions. For more information, visit View Source

On August 2, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter, Chugai) reported that Chugai Pharma Taiwan Ltd. (hereafter, CPT), a wholly-owned subsidiary of Chugai, obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Chugai’s Alecensa (alectinib) as an adjuvant treatment following tumor resection (tumors ≥ 4 cm or node positive) for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), on August 1, 2024 (Press release, Chugai, AUG 2, 2024, View Source [SID1234645275]). CPT is responsible for the development, regulatory submission, import, and sales of Chugai-originated products in Taiwan.

"We are very pleased that Alecensa has been approved in Taiwan as adjuvant therapy for early-stage ALK-positive NSCLC. The results of the ALINA study, which demonstrated a 76% reduction in the risk of recurrence or death, have generated significant anticipation in clinical settings. We believe this approval will have a positive impact on lung cancer treatment in Taiwan. We remain committed to delivering this medication to patients awaiting treatment as swiftly as possible," said Takashi Okamoto, President of CPT.

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The approval is based on results from the ALINA study, a global Phase 3 study of Alecensa as an adjuvant therapy in people with completely resected IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.

[Reference information]
Chugai’s Alecensa Reduces the Risk of Disease Recurrence or Death by 76% in People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer (Press release on October 20, 2023)
View Source

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study included 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival. Secondary outcome measures include overall survival and percentage of patients with adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, for people with NSCLC whose tumors are identified as ALK-positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.

Alecensa was approved by the U.S. Food and Drug Administration (FDA) in April 2024 as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test, and in June 2024 by the European Commission, as a monotherapy for adjuvant treatment following tumor resection for adult patients with ALK-positive NSCLC at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).

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