10-Q – Quarterly report [Sections 13 or 15(d)]

Merck & Co has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Carisma Therapeutics to Present at Upcoming Healthcare Industry Conferences in May 2023

On May 5, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the company will present at several healthcare industry conferences in May 2023 (Press release, Carisma Therapeutics, MAY 5, 2023, View Source [SID1234631104]). These conferences include:

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American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting 2023

Carisma is giving an oral presentation during the meeting:
Chris Sloas, Ph.D., Senior Scientist, Carisma Therapeutics will give a presentation titled "Engineered Microenvironment Converters (EM-Cs): Macrophages Expressing Synthetic Cytokine Receptors Rebalance Pro-/Anti-Inflammatory Signals in Disease Microenvironments"
Friday, May 19, 2023 at 5:15 pm PST
Carisma will also present two abstracts during the meeting:
Pre-clinical development of CT-1119, a mesothelin-targeting chimeric antigen receptor macrophage poster
A Phase 1, First in Human (FIH) Study of Autologous Anti-HER2 Chimeric Antigen Receptor Macrophage (CAR-M) in Participants(pt) with HER2 Overexpressing Solid Tumors Trials in Progress Poster
Michael Klichinsky, Pharm.D., Ph.D., Co-Founder & Chief Scientific Officer will give a presentation titled "Beyond T-cells: CAR-Macs, CAR-NKs."
Tuesday, May 16, 2023 at 10:45 am PST
Tuesday, May 16 to Saturday, May 20, 2023
Los Angeles, California

PEGS Boston Summit

Nicholas Minutolo, Ph.D., Head of Protein Engineering, will give a presentation titled "Advances in CAR-M Cellular Immunotherapy" during the meeting.
Wednesday, May 17, 2023 at 3:05 pm EDT
Boston, Massachusetts
Myeloid Network Seminar Series

Michael Klichinsky, Pharm.D., Ph.D., Co-Founder & Chief Scientific Officer, will give a presentation titled "Genetically engineering macrophages: CAR-M and Beyond."
Thursday, May 11, 2023 at 11:00 am EDT
Virtual
A replay of webcasts, when available, will be posted and archived at Carisma’s Investor Events webpage for a limited time following the event.

Oncolytics Biotech® Reports First Quarter 2023 Financial Results and Operational Highlights

On May 5, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the first quarter ended March 31, 2023 (Press release, Oncolytics Biotech, MAY 5, 2023, View Source [SID1234631103]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Our core programs in breast and pancreatic cancer are moving towards registrational studies with compelling clinical data and important milestones expected this year," said Dr. Matt Coffey, President and Chief Executive Officer. "The first of these milestones will come later this month when we report data from BRACELET-1, a randomized phase 2 trial expected to inform the design of a subsequent pivotal registrational study in HR+/HER2- metastatic breast cancer. Stakeholders across the breast cancer community have demonstrated a keen interest in this readout, which will add to a dataset that already includes statistically significant phase 2 results showing pelareorep’s ability to drive a robust overall survival benefit in this indication. Notably, the BRACELET-1 abstract was selected for an oral presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting, providing a highly prestigious venue to discuss the results with potential partners and the clinical community."

Dr. Coffey continued, "Looking into the second half of 2023, we expect to report updated results from GOBLET’s first-line pancreatic cancer cohort and provide guidance on the optimal registration paths for our breast and pancreatic cancer programs. With these programs both targeting large markets with significant clinical unmet needs and supported by robust clinical proof-of-concept data, we believe confirming their paths towards approval will represent important value-creating events and substantially de-risk and maintain pelareorep’s development pathway."

First Quarter and Subsequent Highlights

Breast Cancer Program

BRACELET-1 data to be shared in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting

BRACELET-1 is designed to confirm and expand upon Oncolytics’ prior positive clinical results for pelareorep in HR+/HER2- metastatic breast cancer and inform the design of a subsequent registrational study. These prior data include phase 1 results demonstrating pelareorep’s single-agent activity, as well as randomized phase 2 data that showed a statistically significant near doubling of median overall survival in patients treated with pelareorep combined with paclitaxel compared to those treated with paclitaxel monotherapy. Additionally, data from early-stage HR+/HER2- breast cancer patients demonstrated pelareorep’s ability to stimulate anti-tumor immunity, remodel tumor microenvironments, and potentially improve patient prognosis by decreasing the risk of cancer recurrence score.

BRACELET-1 includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with avelumab in HR+/HER2- metastatic breast cancer. The trial was designed to enroll a total of 48 patients and is not powered to detect statistical significance. An abstract corresponding to the upcoming oral presentation will be published by ASCO (Free ASCO Whitepaper) on May 25, 2023, at 5:00 p.m. ET. The oral presentation will take place on June 3, 2023, during a session being held from 2:15 p.m. – 3:45 p.m. ET.

Additional Immunotherapeutic Opportunity

Upcoming ASCO (Free ASCO Whitepaper) poster on preclinical pelareorep-chimeric antigen receptor (CAR) T cell therapy combination program

The poster, titled "Efficacy of function-enhanced, re-activatable, dual-specific CAR T cells pre-loaded with oncolytic virus for immunotherapy of high-grade glioma," will be presented in Poster Hall A from 2:15 p.m. – 5:15 p.m. ET on June 3, 2023. The corresponding abstract will be published prior to the ASCO (Free ASCO Whitepaper) meeting, on May 25, 2023, at 5:00 p.m. ET.

The data to be presented at the ASCO (Free ASCO Whitepaper) meeting follow preclinical results published in Science Translational Medicine (STM), which showed pelareorep synergistically enhancing the efficacy of CAR T cell therapy in murine solid tumor models (link to PR, link to the paper). Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies, one of which has generated results with a potential partner’s own CAR T constructs that are in-line with those published in the STM publication.

Key Opinion Leader Webinar

Oncolytics will host a key opinion leader (KOL) webinar on June 5, 2023 at 8 a.m. ET, where KOLs and the Oncolytics management team will discuss recent data from the BRACELET-1 study. A live question and answer session will follow the formal presentation.

To register for the webinar, please click here.

Financial Highlights

As of March 31, 2023, the Company reported $29.7 million in cash, cash equivalents, and marketable securities.
The net loss for the first quarter of 2023 was $6.4 million, compared to a net loss of $6.8 million for the first quarter of 2022. The basic and diluted loss per share was $0.10 in the first quarter of 2023, compared to a basic and diluted loss per share of $0.12 in the first quarter of 2022.
Net cash used in operating activities for the three months ended March 31, 2023 was $7.8 million, compared to $6.3 million for the three months ended March 31, 2022. The change reflected higher net operating activities and non-cash working capital changes.
General and administrative expenses for the first quarter of 2023 were $3.2 million, compared to $2.6 million for the first quarter of 2022. The increase was mainly due to increased investor relations activities, partly offset by lower share-based compensation expense.
Research and development expenses for the first quarter of 2023 were $3.5 million, compared to $3.7 million for the first quarter of 2022. The decrease was primarily due to lower BRACELET-1 study costs and share-based compensation expense, partly offset by increased manufacturing expenses associated with a process development production run and higher personnel-related expenses.
2023 Anticipated Milestones and Catalysts

Overall response rate and progression-free survival data from phase 2 BRACELET-1 metastatic breast cancer study: Q2 2023
Preclinical data from the combination of pelareorep and CAR T cell therapy: Q2 2023
Updated data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) from the GOBLET study: H2 2023
Update on the metastatic colorectal and anal cancer cohorts from the GOBLET study: H2 2023
Guidance for the registration paths for HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC: H2 2023
Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, May 5, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 3550-3191. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 503-191#.

Ultragenyx to Present at Bank of America’s 2023 Health Care Conference

On May 5, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s chief executive officer and president, will present at Bank of America’s 2023 Health Care Conference on Wednesday, May 10, 2023, at 9:20 a.m. PT (Press release, Ultragenyx Pharmaceutical, MAY 5, 2023, View Source [SID1234631102]).

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The live and archived webcast of the panel will be accessible from the company’s website at View Source

Twist Bioscience Reports Fiscal Second Quarter 2023 Financial Results

On May 5, 2023 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 second quarter of fiscal 2023 ended March 31, 2023 (Press release, Twist Bioscience, MAY 5, 2023, View Source [SID1234631101]).

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"We reported a strong quarter overall, breaking the $60 million revenue threshold for the first time and exceeding our guidance," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "NGS, in particular, had an excellent quarter and we announced our Biopharma Solutions integrated offering, which brings together in vivo, in vitro and in silico approaches to antibody discovery. In January, we shipped the first products from the Factory of the Future and are now manufacturing the vast majority of our genes, gene fragments and oligo pools in our Wilsonville facility."

Twist also announced decisive and proactive actions aimed at accelerating its path to profitability while simultaneously extending the company’s runway. These actions will focus resources on the support of key commercial and development opportunities that have the potential to deliver significant return on investment. As part of these initiatives, Twist conducted a comprehensive review of the business and is resizing many teams throughout the organization and reducing its workforce by approximately 270 employees, or about 25%. For example, manufacturing for the majority of synthetic biology products has transitioned to the Factory of the Future, thereby reducing overall fixed costs and removing duplication between the South San Francisco and Wilsonville sites. NGS panels will continue to be made in South San Francisco. Additionally, Twist plans to maintain its global commercial presence to drive topline growth while streamlining teams including R&D across the business to focus on programs where Twist believes it has a clear competitive advantage and sees the greatest potential for long-term profitable growth and value creation. The biopharma team has been resized to focus on revenue-generating partnerships and Twist will moderate its investment in DNA data storage while maintaining its competitive lead.

Dr. Leproust continued, "As we grow the company and pursue the many commercial opportunities we see ahead, we remain laser focused on achieving adjusted EBITDA breakeven for the core and biopharma businesses while maintaining optionality for the potential we see in data storage. Following a strategic and holistic analysis of the business, we prioritized and reengineered our cost base, and with these substantive changes, we believe we are operating from a position of strength, operating as a leaner organization focused on disruptive market opportunities for profitable and scalable growth."

FISCAL 2023 SECOND QUARTER FINANCIAL RESULTS

•Orders: Total orders received for the second quarter of fiscal 2023 were $64.2 million compared to $55 million for the same period of fiscal 2022.
•Revenue: Total revenues for the second quarter of fiscal 2023 were $60.2 million compared to $48.1 million for the same period of fiscal 2022.
•Cost of Revenues: Cost of revenues for the second quarter of fiscal 2023 was $41.7 million compared to $29.7 million for the same period of fiscal 2022.
•Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2023 were $27.4 million compared to $31.2 million for the same period of fiscal 2022.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses were $54.0 million for both the second quarter of fiscal 2023 and the same period of fiscal 2022.
•Net Loss: Net loss attributable to common stockholders for the second quarter of fiscal 2023 was $59.2 million, or $1.04 per share, compared to $60.7 million, or $1.13 per share, for the same period of fiscal 2022.
•Cash Position: As of March 31, 2023, the company had $387.7 million in cash, cash equivalents and investments.

Recent Highlights:

•Shipped products to 2,100 customers in the second quarter of fiscal 2023, versus approximately 2,000 customers in the second quarter of fiscal 2022.
•Shipped approximately 152,000 genes during the second quarter of fiscal 2023, compared with approximately 124,000 genes during the second quarter of fiscal 2022.
•Launched T Cell Receptor (TCR) and Chimeric Antigen Receptor (CAR) libraries to enable identification of next-generation cell therapies.
•Partnered with Aster Insights to develop and launch a next-generation oncology panel for cancer research.
•Announced technology early access of the Twist enhanced Whole Genome Sequencing (eWGS) solution focused on non-human genomic applications, to enable researchers to obtain simultaneous low-pass whole genome data together with deep coverage of selected regions, in a high-throughput and cost-effective workflow.
•Launched an updated Twist 96-Plex Library Prep Kit designed to enable cost-effective low-pass whole genome sequencing.
•Added controls for SARS Omicron sublineage BQ.1.
•Launched the Twist Biopharma Solutions integrated offering of antibody discovery services combining synthetic libraries and AI machine learning with an in vivo immunization approach gained through the acquisition of Abveris, also known as Twist Boston.

•Announced a third agreement with Astellas by which Astellas will license a suite of Twist VHH antibody libraries.
•Published data in BioRxiv on the successful discovery of alpaca-derived VHH antibodies using a disruptive, function-forward in vivo discovery workflow on the Beacon optofluidic platform.
•Continued to work toward demonstration of end-to-end Gb Century Archive DNA data storage solution by the end of calendar 2023 and launch of the Tb Century Archive solution in early calendar 2025.

Updated Fiscal 2023 and 2024 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2023 and 2024, including the third and fourth quarter of fiscal 2023, in alignment with today’s announcement of the company’s decisive and strategic actions. Additionally, in light of these developments, Twist withdraws all of its prior financial guidance for fiscal year 2024 and provides the more limited financial guidance with respect to fiscal year 2024 below. 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 2023, Twist provided the following updated financial guidance:

•Revenue guidance is expected to be approximately $235 million to $238 million, compared to previous guidance of $261 million to $269 million
◦SynBio revenue is expected to be $96 million to $98 million, compared to previous guidance of $104 million to $106 million
◦NGS revenue is expected to be $113 million to $114 million, compared to previous guidance of $120 million to $123 million
◦Biopharma revenue is expected to be $26 million, compared to previous guidance of $37 million to $40 million
•Gross margin for fiscal 2023 is expected to be 35-36%, compared to previous guidance of approximately 39-40% for fiscal 2023
•Operating expenses including R&D and SG&A are expected to be approximately $313 million to $319 million for the year, a decrease compared to previous guidance of $330 million primarily driven by a decrease in expected stock-based compensation expense
◦R&D expense is expected to be approximately $112 million to $114 million, compared to previous guidance of $130 million
◦SG&A expense is expected to be $197 million to $200 million, compared to previous guidance of $204 million
◦Mark to market of contingent consideration and indemnity holdbacks is projected to be a credit of $5 million, compared to previous guidance of $4 million
◦Separation costs are expected to be approximately $9 million to $11 million

•Operating loss is expected to be approximately $230 million to $234 million, a decrease compared to the $260 million projection given in November 2022, and includes the following:
◦Stock-based compensation is expected to be approximately $43 million, compared to previous guidance of $50 million
◦Depreciation and amortization are expected to be approximately $29 million, with no change from previous guidance
◦Operating expenses for DNA data storage is expected to be approximately $40 million, a decrease from previous guidance of $46 million
◦Capital expenditure is expected to be approximately $40 million, compared to previous guidance of $50 million
◦FY23 Year End Cash is projected to be $320 million, compared to previous guidance of $300 million

For the third quarter of fiscal year 2023, Twist provided the following financial guidance:

•Revenue is expected to be approximately $60 million to $61 million
•Gross margin is expected to be approximately 30%

For the fourth quarter of fiscal 2023, Twist provided the following financial guidance:

•Revenue is expected to be approximately $62 million to $63 million
•Gross margin is expected to be approximately 36%

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

•Twist expects to exit fiscal 2024 with adjusted EBITDA breakeven for its core (SynBio, NGS) and Biopharma businesses in the fourth quarter
•Operating expenses for DNA data storage are expected to be $40 million, a decrease compared to previous guidance of $57 million
•Fiscal year end cash is projected to be $220 million, compared to previous guidance of $170 million

This foregoing updated financial guidance for the full fiscal year 2024 replaces all prior outlook and guidance provided by Twist with respect to fiscal year 2024.

Non-GAAP Information

Adjusted EBITDA is a non-GAAP financial measure defined as net earnings or loss adjusted to exclude interest income (expense), benefit from (provision for) income taxes, depreciation and amortization, and stock-based compensation expense. Since Twist has a single reporting and operating segment, to provide adjusted EBITDA for the SynBio and NGS businesses and the Biopharma business, on a supplemental basis to provide greater insight into Twist’s businesses to investors, Twist disaggregates its consolidated results of operations, including but not limited to revenues, gross profit and operating and other expenses, and allocates portions thereof to each business. Similarly, on a supplemental basis, Twist disaggregates consolidated stock-based compensation expense and other adjustments and allocates portions thereof to each

business. Such disaggregated supplemental information is not prepared in conformity Accounting Standards Codification 280 and thus also constitutes non-GAAP financial information. A reconciliation of these non-GAAP financial guidance measures to a corresponding GAAP financial guidance measure is not available on a forward-looking basis because the Company does not provide guidance on GAAP net loss and is not able to present the various reconciling cash and non-cash items between GAAP net loss and adjusted EBITDA without unreasonable effort. In particular, stock-based compensation expense is impacted by the Company’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which is difficult to predict and is subject to change. The actual amount of these expenses during fiscal 2024 will have a significant impact on Twist’s future GAAP financial results.

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 8:00 a.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The conference call will be webcast live through the Investor Relations section under the "Company" tab at www.twistbioscience.com. Those parties interested in participating via telephone must register on the Company’s Investor Relations website or by clicking here. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that can be used to access the call. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The webcast replay will be available for two weeks.