On May 10, 2023 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business and financial update for the first quarter of 2023 (Press release, ERYtech Pharma, MAY 10, 2023, View Source [SID1234631374]).

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"In February this year, we were pleased to announce our strategic plans with Pherecydes, with the intent to build a global leader in phage therapy and address the huge medical need caused by antimicrobial resistance. We are now progressing through the preparation steps for this merger, and, as our teams have started intensive interactions in that respect, we already see a remarkable match of our respective capabilities and prospects for fruitful synergies.", said Gil Beyen, Chief Executive Officer of ERYTECH. "The Management and Board of ERYTECH are convinced that the strategic choice of combining with Pherecydes and creating a champion in AMR is of the best interest of ERYTECH and its stakeholders, and will be pleased to propose this ambitious strategic move for approval to the Company’s shareholders at the next General Assembly Meeting in June. For the sake of transparency, we inform the market that ERYTECH was recently contacted by a new shareholder, Akkadian Partners, who shared with us its opposition to ERYTECH’s merger project with the objective to conduct alternative acquisition projects through ERYTECH. After due consideration by Management and the Board of directors of ERYTECH, these alternative ideas were deemed not to be in the best interest of ERYTECH and its stakeholders and certainly not of sufficient robustness and value to distract the Company from its strategic direction."

Business Highlights

▪Combination with Pherecydes announced and merger process on track for proposed closing in June

On February 15, 2023, the Company announced the strategic combination with Pherecydes, a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections, with the ambition to create a global leader in extended phage therapy and accelerate the development of a portfolio of phage candidates targeting pathogenic bacteria. This transaction is the result of the extensive strategic review process announced by ERYTECH on several occasions since November 2021.

The combination will draw on the complementary expertise and resources of the two companies to accelerate the development of a French phage therapy industry, aimed at combating antibiotic resistance, a globally recognized health issue, and at extending this technology to other therapeutic areas with significant unmet medical needs.

ERYTECH and PHERECYDES intend to merge their operations and relocate all teams to ERYTECH’s premises in Lyon, where they will benefit from presence in a major European hub for infectious diseases.

The proposed transaction is structured as a merger of PHERECYDES into ERYTECH, pursuant to which the shareholders of PHERECYDES would receive newly issued ERYTECH ordinary shares in consideration of the contribution of the assets and liabilities of PHERECYDES. The fairness of the exchange ratio will be reviewed by a court-appointed independent appraiser (commissaire à la fusion). His report will be made publicly available prior to the extraordinary shareholders meeting of ERYTECH and PHERECYDES, together with the required exemption document in relation to the merger in accordance with applicable laws.

The extraordinary general meetings of ERYTECH and PHERECYDES shareholders will be called upon to vote on the proposed merger, currently expected to be convened on June 23, 2023. The proposed transaction is expected to close shortly after the approval by the shareholders.

This project is supported by the Boards of Directors and major shareholders of ERYTECH and PHERECYDES.

▪Akkadian Partners

On April 17, 2023, Akkadian Partners, an entity domiciled in Luxembourg and acting on behalf of the Akkadian Partners Fund, declared that on April 13, 2023, they crossed the threshold of 5% of the share capital of ERYTECH Pharma and held 5.06% of the share capital and 4.83% of the voting rights of the company.

On May 1st, 2023, Akkadian Partners informed the Board of ERYTECH that they intended to oppose the project of merging with Pherecydes and take de facto control of ERYTECH with a view to pursue alternative acquisition projects with ERYTECH’s cash.

In that context, the Management and Board of ERYTECH have reviewed and assessed the ideas of acquisitions projects mentioned by Akkadian, with the assistance of external financial and legal advisers. After due consideration, ERYTECH determined that these ideas, were not in the best interest of ERYTECH and its stakeholders, and remote from ERYTECH’s strategy and identity, with significant uncertainty and risks associated with these projects.

It is worth noting that Akkadian indicated that they are committed to increase their stake in ERYTECH up to 15% of the share capital in the short term and around 25% in the mid-term (i.e., below the 30% threshold triggering the obligation to file a mandatory tender offer on ERYTECH). Although Akkadian does not seem to intend to acquire a controlling stake in ERYTECH, it requested the appointment of 4 directors (and the resignation of 5 incumbent directors) which would represent the majority of ERYTECH’s Board. Such attempt to gain de facto control of ERYTECH without filing a tender offer on ERYTECH and without offering liquidity to minority shareholders is hostile and will be strongly rejected. Note that ERYTECH is not aware of any further acquisitions of ERYTECH shares completed by Akkadian.

ERYTECH, while confirming its strategic decision to merge with Pherecydes, will oppose any financial predation project which would not be in the best interest of the company and its stakeholders.

Update on Q1 2023 Financial Results and Cash position

▪As of March 31, 2023, ERYTECH had cash and cash equivalents totaling €30.5 million (approximately $33.7 million), compared with €38.8 million as of December 31, 2022. The €8.3 million net decrease in cash position during the first quarter of 2023 was the result of a €7.5 million net cash utilization in operating activities and investing activities, including a one-off €1.2 million expense for restructuring and pre-merger activities, and €0.6 million used in financing activities, with the start of the scheduled repayment of the 2020, €10 million government-guaranteed ‘Covid-19’ loan. The variation of the U.S. dollar against the euro led to a €0.2 million negative currency exchange impact.

▪At the current stage of transition activities in view of the proposed merger with Pherecydes, the Company confirms its earlier guidance that its current cash position can fund its current activities and planned operating expenses to the second half of 2024.

▪Given the ongoing preparation of the announced business combination with Pherecydes, which includes the preparation of proforma accounts and the review with market regulators, the Company will not provide interim quarterly P&L information for Q1 2023.

2023 Financial Calendar*

•Shareholders’ Meeting: June 23, 2023, at 9.30am CEST – Paris

•Business Update and Financial Highlights for the Second Quarter & First Half of 2023: September 11, 2023 (after U.S. market close), followed by a conference call & webcast on September 12, 2023 (2:30pm CET/8:30am ET)

•Business Update and Financial Highlights for the Third Quarter of 2023: November 6, 2023 (after U.S. market close), followed by a conference call & webcast on November 7, 2023 (2:30pm CET/8:30am ET)

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.