On May 10, 2023 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the first quarter of 2023 (Press release, ChromaDex, MAY 10, 2023, View Source [SID1234631347]).

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First Quarter 2023 and Recent Highlights

Total net sales were $22.6 million, up 31% from the prior year quarter, with $17.6 million from Tru Niagen.
Strong gross margin of 59.9% and a $2.8 million reduction in operating expenses, reflecting financial discipline.
Selling and marketing expense as a percentage of net sales was 34.9% versus 47.7%, an improvement of 1,280 basis points from the prior year quarter, while investing in a strategic brand building event.
General and administrative expense decreased $2.5 million from the prior year quarter.
Net loss was $1.9 million or $(0.03) per share, an improvement of $0.08 per share from the prior year quarter.
Adjusted EBITDA, a non-GAAP measure, was a loss of only $0.1 million, a $4.4 million improvement from the prior year quarter.
"In the first quarter of fiscal 2023, we achieved $22.6 million in revenue and generated $2.8 million in positive operating cash flows," said ChromaDex Chief Executive Officer, Rob Fried. "We raised the conservative end of our 2023 revenue outlook to 12.5% growth and, importantly, are seeing significant opportunities for future growth that are not reflected in this outlook."

Results of operations for the three months ended March 31, 2023 compared to the prior year quarter

ChromaDex reported a net sales increase of 31%, or $5.3 million, to $22.6 million. The increase in net sales was largely driven by growth in sales of Tru Niagen and growth in Niagen ingredient sales.

Gross marginpercentagedeclined 110 basis points to 59.9%. The decline in gross margin percentage is largely attributable to a shift in business mix as well as modest cost inflation, partially offset by overall scale.

Operating expensedecreased 15%, or $2.8 million, to $15.5 million driven by a $2.5 million reduction in general and administrative expense due to lower legal fees, share-based compensation and severance and restructuring costs.

Net loss was $1.9 million, or $0.03 loss per share, compared to a net loss of $7.7 million or $0.11 loss per share for the first quarter of 2022. Adjusted EBITDA, a non-GAAP measure, approached break-even with a loss of only $0.1 million, a $4.4 million improvement from Q1 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net loss, the most directly comparable GAAP measure.

Net cash inflow from operating activities was $2.8 million compared to a cash outflow of $7.2 million in the prior year quarter, largely due to improvements in net loss of $5.8 million paired with changes in working capital.

2023 Full Year Outlook

Looking forward, for the full year, the Company expects at least 12.5% revenue growth year-over-year. The conservative end of the Company’s outlook reflects prevailing macroeconomic uncertainty and only considers recurring, steady revenue growth from the e-commerce business and established partnerships, as well as upside from new partnerships realized in the first quarter. However, potential upside lies within new partnerships, channels, and products. The Company projects that gross margin will remain stable year over year as cost savings initiatives are expected to largely offset continued inflationary pressures. Moreover, further optimization, coupled with new and focused customer acquisition strategies are expected to result in reduced selling and marketing expense as a percentage of net sales. The Company plans to increase investments in research and development to drive innovation and expects a reduction in general and administrative expense of $1 to $2 million year over year.

Investor Conference Call

A live webcast will be held Wednesday, May 10, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s first-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on May 10, 2023 through 11:59 p.m. Eastern time on May 17, 2023. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

On May 10, 2023 Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities reported the launch of two new RNAscope in situ Hybridization Probes Kappa and Lambda as analyte specific reagents (ASRs) for the detection of immunoglobulin kappa and lambda light chains mRNA in B-cells (Press release, Bio-Techne, MAY 10, 2023, View Source [SID1234631346]).

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Detection of B-cell clonality is useful for identification of monoclonal B-cell populations which are often associated with a malignancy. Immunoglobulin kappa and lambda chains are important biomarkers for the assessment of B-cell clonality. Flow cytometry is the current gold standard for assessing kappa and lambda light chains, but it may not be effective for certain B-cell lymphomas that lack surface immunoglobulin expression. In such cases, formalin-fixed, paraffin-embedded (FFPE) tissues are required, but methods such as immunohistochemistry (IHC) may not be sensitive enough to detect light chain expression in B-cells. RNAscope ISH Probes Kappa and Lambda are designed to detect immunoglobulin kappa and lambda light chains mRNA. RNAscope probes are visualized with the highly sensitive RNAscope ISH detection reagents, which are compatible with FFPE tissue.

ASRs are critical building blocks for Laboratory Developed Tests (LDTs) and play a key role in ensuring the accuracy and reliability of test results. By using ASRs, CLIA labs can develop customized tests that are tailored to the specific needs of their patient population, while maintaining high standards of analytical and clinical performance. This allows for greater flexibility and innovation in the development of new tests, while ensuring that they meet the regulatory requirements for accuracy and reliability.

"We are excited to expand our ASR probe menu with the launch of RNAscope ISH Probes Kappa and Lambda, as these are important oncology biomarkers," said Kim Kelderman, President, Diagnostics and Genomics. "We are committed to enabling our customers with Bio-Techne’s innovative spatial biology solutions to serve patients and improve lives."

ACD, a Bio-Techne Brand, is proud to be certified to ISO 13485:2016 standard. ASR probes are manufactured in compliance with GMP requirements to ensure product quality.

On May 10, 2023 Bayer and Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics by utilizing proprietary bicyclic peptides technology (Bicycle), reported that they have entered into a strategic collaboration agreement to discover, develop, manufacture, and commercialize Bicycle radioconjugates for multiple agreed upon oncology targets (Press release, Bicycle Therapeutics, MAY 10, 2023, View Source [SID1234631345]).

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Bicyclic peptides are peptides consisting of 9-20 amino acids that can be synthetically manufactured and bind to targets with high affinity and selectivity, affording high tumor penetration and fast excretion from healthy organs. They are chemically synthesizable, featuring a low molecular weight and tunable pharmacokinetics, with a large surface-area for molecular interactions that allows protein-protein interactions to be targeted. The two companies will jointly use Bicycle’s peptide technology to develop bicyclic peptides for several undisclosed oncology targets. Targeted radiotherapies are an innovative class of cancer therapies. Due to their unique mode of action, they have the potential to unlock a broad opportunity space and serve patients in high-unmet medical need indications.

"At Bayer, we enter strategic collaborations to expand our access to innovation," said Christian Rommel, Ph.D., Global Head of Research and Development and Member of the Executive Committee, Pharmaceuticals Division, Bayer. "With Bicycle’s proprietary peptide-based technology, we continue to strengthen our oncology development pipeline by adding next-generation targeted radiotherapeutics to address high unmet medical needs of cancer patients."

"Bayer is a pioneer in the radiopharmaceuticals space and provides new and additional validation of our unique technology," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We believe our bicyclic peptide platform, coupled with Bayer’s scale and expertise in developing radiopharmaceuticals, has the potential to deliver improved clinical outcomes for patients with cancer. We look forward to collaborating with Bayer to bring forth new potential first-in-class radiopharmaceutical treatments based on Bicycles."

Under the terms of the agreement, Bayer and Bicycle will collaborate on the development of bicyclic peptides for multiple oncology targets. Bicycle will utilize its proprietary phage platform to discover and develop bicyclic peptides and Bayer will be responsible for, and fully fund, all further preclinical and clinical development, manufacturing, and commercialization activities. Bicycle will receive a $45 million upfront payment and with potential development and commercial-based milestone fees, payments to Bicycle could total up to $1.7 billion. Bicycle will also be eligible to receive mid-single to double-digit tiered royalties on Bicycle-based medicines commercialized by Bayer. The closing of the transaction is subject to clearance of the transaction under the U.K. National Security and Investment Act 2021.

On May 10, 2023 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported first quarter 2023 financial results and provided an update on its BEACON clinical trial and pipeline progress (Press release, Beam Therapeutics, MAY 10, 2023, View Source [SID1234631344]).

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"As we work through the sentinel cohort process with our investigators, we are encouraged by the overall momentum of the BEACON trial, with multiple new sites activated, a growing number of patients on the wait list for future enrollment, and continuing progress preparing for internal GMP manufacturing in our North Carolina facility," said John Evans, chief executive officer of Beam. "In parallel to BEACON, we are preparing to initiate our second clinical trial this year, evaluating BEAM-201 in patients with a devastating form of blood cancer, while advancing our in vivo programs, BEAM-301 and BEAM-302, all of which remain on track. As leaders in the field of base editing, we have spent the last several years building a deep platform and pipeline and securing meaningful funding to support this ambitious set of goals. We plan to continue to follow the science, maintain a disciplined investment strategy, and preserve optionality in our portfolio, so that we can maximize our potential to create medicines that provide life-long cures for patients in need."

Hematology Program Updates

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Beam continues to advance its BEACON Phase 1/2 clinical trial evaluating BEAM-101 as a treatment for sickle cell disease (SCD), with five sites now active and a wait list for enrollment.
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In the sentinel cohort, which is designed to include three patients treated on a sequential basis, the first patient enrolled in the BEACON trial in late 2022 has been withdrawn from the study by the investigator due to personal, non-medical reasons prior to treatment with BEAM-101.
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Two additional patients have been enrolled in the sentinel cohort and are undergoing the screening procedures required to enable mobilization and ultimately treatment with BEAM-101.
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Beam expects to fully enroll the sentinel cohort in 2023.
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Enrollment of additional patients for the expansion cohort, which can occur in parallel with the sentinel cohort, is also anticipated to begin this year.
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The company continues to anticipate reporting initial data on multiple patients from the BEACON trial in 2024.

Immunology/Oncology Program Updates

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Beam is advancing BEAM-201, a multiplex-edited allogeneic CAR-T product candidate, for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL). The company expects to begin enrollment and dose the first patient in its Phase 1/2 clinical trial of BEAM-201 by mid-2023.
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Beam also continues to invest in and advance its next-generation allogeneic strategies designed to improve cell persistence and expand the utility and accessibility of cell therapies in cancer and other diseases. The company plans to share updates on these efforts in 2023.
Genetic Disease (in vivo) Program Updates

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Beam is advancing two in vivo base editing product candidates, BEAM-301 and BEAM-302, leveraging lipid nanoparticles (LNPs) for delivery to the liver. The company expects to:
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Submit a regulatory application for authorization to initiate clinical trials for BEAM-301 for the treatment of glycogen storage disease 1a (GSD1a) by late 2023 or early 2024; and
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Submit a regulatory application for authorization to initiate clinical trials for BEAM-302 for the treatment of alpha-1 antitrypsin deficiency (AATD) in early 2024.
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In 2023, Beam plans to continue advancement of multiple additional in vivo liver editing programs, including both its wholly owned and collaboration programs, through lead optimization, and advance its LNP delivery technologies for delivery of base editing medicines to the liver and other tissues.
Manufacturing Updates

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Beam expects to initiate current good manufacturing practice compliant operations at its North Carolina manufacturing facility in late 2023.
Leadership Addition

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In March 2023, Beam appointed Gopi Shanker, Ph.D., as chief scientific officer. Dr. Shanker is a scientific leader with more than 20 years of drug development experience as well as deep expertise in novel genetic medicine modalities.
Upcoming Presentations at ASGCT (Free ASGCT Whitepaper)

Beam plans to present new in vivo data from its Engineered Stem Cell Antibody Paired Evasion (ESCAPE) platform, which it continues to advance in an effort to enable utility of its base editing investigational medicines in as many patients as possible, and from its base editing program for the treatment of Stargardt disease at the American Society of Cell and Gene Therapy 26th Annual meeting. The meeting is being held May 16-20, 2023, in Los Angeles.

Details of the presentations are as follows:

Title: Paired HSC Epitope Engineering of CD117 (Ckit) for Antibody-Mediated Autologous Hematopoietic Stem Cell Therapy Conditioning for the Potential Treatment of Hemoglobinopathies

Date & Time: Friday, May 19, 2023 12:00 pm – 2:00 pm PT

Session Title: Friday Poster Session

Title: (308) In Vivo Genetic Eye Disease Correction Using Split AAV-Mediated Adenine Base Editing

Date & Time: Friday May 19, 2023, 4:30 pm – 4:45 pm PT

Session Title: Gene Targeting and Gene Correction: Hemoglobin, Muscle, and Eye

First Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of March 31, 2023, as compared to $1.1 billion as of December 31, 2022.
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Research & Development (R&D) Expenses: R&D expenses were $99.6 million for the first quarter of 2023, compared to $65.4 million for the first quarter of 2022.
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General & Administrative (G&A) Expenses: G&A expenses were $23.5 million for the first quarter of 2023, compared to $19.2 million for the first quarter of 2022.
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Net Loss: Net loss was $96.5 million for the first quarter of 2023, or $1.33 per share, compared to $69.2 million for the first quarter of 2022, or $1.01 per share.
Cash Runway

Beam expects that its cash, cash equivalents and marketable securities as of March 31, 2023, will enable the company to fund its anticipated operating expenses and capital expenditure requirements at least into 2025. This expectation includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, BEAM-201, BEAM-301 and BEAM-302 described above, as well as continued investments in platform advancements and manufacturing capabilities.

On May 10, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported its financial results for the first quarter ended March 31, 2023 and provided an overview of recent developments (Press release, Atreca, MAY 10, 2023, View Source [SID1234631343]).

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"In the first quarter of 2023 we continued to advance both ATRC-101 and our preclinical programs. The additional data from the ongoing Phase 1b study of ATRC-101 that we reported in March will help inform our anticipated go / no-go decision for Phase 2 development, which remains on-track for later this year," said John Orwin, Chief Executive Officer of Atreca. "We continue to invest strategically in our platform, which has supported an acceleration of our discovery and early-stage development efforts. We are making great progress in advancing both the APN-497444 and APN-346958 programs and continue to anticipate nominating clinical candidates for both programs later this year."

Recent Developments and Highlights

In March 2023, Atreca reported additional data from the ongoing Phase 1b study of ATRC-101 monotherapy and in combination with pembrolizumab in patients with select solid tumor cancers, with ATRC-101 continuing to be well tolerated and clinical activity observed in multiple tumor types with a correlation observed between target expression and progression free survival. Atreca is enrolling additional patients at a dose level of 30mg/kg in both the Q3W monotherapy and combination therapy arms and expects to report additional data and provide details on its potential Phase 2 development plans by the end of 2023. To-date, 81 total participants have been enrolled across all cohorts in the study.
Data from the Phase 1b study of ATRC-101 will be presented during an oral abstract session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The oral abstract session will be held on June 4, 2023, from 9:45am – 12:45pm CDT.
First Quarter and 2023 Financial Results

As of March 31, 2023, cash and cash equivalents and investments totaled $56.4 million.
Research and development expenses for the three months ended March 31, 2023, were $13.5 million, including non-cash stock-based compensation expense of $1.4 million.
General and administrative expenses for the three months ended March 31, 2023, were $8.1 million, including non-cash stock-based compensation expense of $1.8 million.
Atreca reported a net loss of $21.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.54, for the quarter ended March 31, 2023.