On May 10, 2023 Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported the pricing of a public offering of an aggregate of 1,800,876 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 warrants to purchase up to 1,800,876 shares of common stock and Series A-2 warrants to purchase 1,800,876 shares of common stock, at a combined public offering price of $3.887 per share (or pre-funded warrant in lieu thereof) and accompanying warrants (Press release, Ensysce Biosciences, MAY 10, 2023, View Source [SID1234631349]). The Series A-1 warrants will have an exercise price of $3.637 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-2 warrants will have an exercise price of $3.637 per share, will be exercisable immediately upon issuance and will expire eighteen months from the date of issuance. The closing of the offering is expected to occur on or about May 12, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $7 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for the further clinical development of their product candidates and for working capital and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-271480), which was declared effective by the Securities and Exchange Commission (the "SEC") on May 9, 2023. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus will be filed with the SEC and may be obtained, when available, on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

In connection with the offering, the Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 210,085 shares of the Company’s common stock that were previously issued in September 2021 through December 2022 at exercise prices ranging from $16.80 to $187.20 per share, such that effective upon the closing of the offering the amended warrants will have a reduced exercise price of $3.637 per share, at an additional offering price of $0.125 per amended warrant.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 10, 2023 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a clinical stage oncology company, reported financial results for the first quarter ended March 31, 2023 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAY 10, 2023, View Source [SID1234631348]).

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"We have made encouraging progress enrolling patients in the CYT-0851 Phase 1 combination trial with capecitabine and gemcitabine, while maintaining our strong financial discipline," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We look forward to sharing preliminary data on the Phase 1 combination cohorts with CYT-0851 in mid-year."

Recent Updates to the CYT-0851 Clinical Program

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Enrollment in the Phase 1 trial with CYT-0851 in combination with capecitabine in advanced ovarian cancer continues at the 400mg dose of CYT-0851, which was determined to be the recommended Phase 2 dose in the capecitabine combination. Preliminary data on the combination with capecitabine are expected to be disclosed in mid-2023.
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Enrollment in the Phase 1 dose escalation cohorts of CYT-0851 in combination with gemcitabine in solid tumors continues. A maximum tolerated dose and/or recommended Phase 2 dose of CYT-0851 in combination with gemcitabine is expected to be determined and preliminary results to be disclosed in mid-2023.
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A poster of preliminary results of monotherapy and combination data with CYT-0851 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) during the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology poster session on June 3, 2023 at 8:00am.
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Poster title: Phase 1 results of CYT-0851, a monocarboxylate transporter (MCT) inhibitor, in combination with capecitabine (cape) or gemcitabine (gem) in advanced solid tumors. Abstract: 3099, Poster Bd #: 297
Recent Business Updates

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Cyteir is pursuing out-licensing of its preclinical DNA polymerase theta (POLθ or POLQ) inhibitor program.

First Quarter 2023 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of March 31, 2023 were $137.2 million, which are expected to fund planned operations into 2026.

Research and development (R&D) expenses: R&D expenses were $9.3 million for the first quarter of 2023 versus $10.1 million for the same period in 2022. The year-over-year decrease in R&D spending was due primarily to a decrease in costs related to our MCT inhibitor program, which includes research activities and ongoing clinical trial costs, partially offset by an increase in personnel severance-related costs.

General and administrative (G&A) expenses: G&A expenses were $4.1 million for the first quarter of 2023 compared to $4.0 million for the same period in 2022. The year-over-year increase in G&A expenses was primarily due to an increase in personnel severance-related costs, partially offset by a decrease in insurance and state taxes.

Net loss: Net loss was $12.5 million, or $0.35 per share, in the first quarter of 2023 compared to $14.1 million, or $0.40 per share, for the same period in 2022.

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.