On July 28, 2022 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, reported its cash position as of June 30, 2022, and its revenues for the first half of 2022 (Press release, Inventiva Pharma, JUL 28, 2022, View Source [SID1234617078]).

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Cash Position

As of June 30, 2022, Inventiva’s cash position was €87.2 million compared to €80.5 million as of March 31, 2022 and €95.4 million as of December 31, 2021.

Net cash used in operating activities amounted to €26.1 million in the first half of 2022 compared to €19.8 million for the same period in 2021. R&D expenses for the first half of 2022, mainly driven by the development of lanifibranor in NASH, were up 53% compared to the first half of 2021. This significant increase in R&D expenses was driven by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH and, to a lesser extent, with the Legend Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes . In January 2022, the Company received a €4 million milestone payment from AbbVie following the inclusion of the first patient in the ongoing Phase IIb clinical trial with cedirogant (previously ABBV-157) in adult patients with moderate to severe chronic plaque psoriasis, and the 2021 R&D tax credit ("CIR") for €3.6 million was received in May 2022.

Net cash generated from investing activities for the first half of 2022 amounted to €0.8 million, compared to -€1.2 million for the same period in 2021.

Net cash from financing activities for the first half of 2022 amounted to €13.96 million compared to no net cash generated from financing activities over the first half of 2021. This increase is mainly driven by the equity raised through the Company’s At-The-Market Program for approximately €9.3 million (gross proceeds) on June 15, 2022, and three loan agreements with French banks for a total amount of
€5.3 million. One of the loans has been contracted as part of a state-guaranteed PGE loan facility ("Prêt Garanti par l’Etat") with Bpifrance and the two others from a stimulus economic plan ("Prêts Participatifs Relance") granted by Crédit Agricole Champagne-Bourgogne and Société Générale.

Over the first half of 2022, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.2 million versus €1.5 million for the first half of 2021, due to the strengthening of USD versus Euro.

Furthermore, the Company also finalized the documentation requirement under the credit facility for up to $50 million with the European Investment Bank (the "EIB") announced on May 16, 2022, by signing a warrant agreement with the EIB on July 1, 2022. The Company plans to use the proceeds from the EIB facility, when received, towards its clinical studies and preclinical pipeline, including to help fund a portion of its NATiV3 Phase III clinical trial of lanifibranor in patients with NASH3.

Considering its current R&D and clinical development programs and excluding any proceeds from the EIB credit facility and any potential additional financial resources, the Company estimates that its existing cash, cash equivalents and short-term deposits should allow the Company to fund its operations through the end of the second quarter 20234.

Revenues

The Company’s revenues for the first half of 2022 amounted to €0.1 million, as compared to €0.2 million for the same period in 2021.

Next key milestones expected

Strategy update on the potential development of odiparcil – anticipated by end of 2022
Publication of the results of the investigator-initiated study with lanifibranor in patients with NAFLD and T2D – previously planned for second half of 2022 is now expected in the first quarter of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for first half of 2023
Study completion of phase IIb trial of cedirogant in patient with psoriasis conducted by AbbVie – planned for first half of 2023
Topline results of Phase IIa LEGEND of lanifibranor in combination with empagliflozin in patients with NASH and T2D– planned for second half of 2023
Upcoming investor conference participation

H.C. Wainwright 24th Annual Global Investment Conference – September 12-14, New York City
KBC Life Sciences Conferences – September 15-16, Virtual
Lyon Pôle Bourse- September 28, Lyon
HealthTech Innovation Days – October 12-14, Paris
Portzamparc BNP Paribas Biotech & Santé – October 4, Virtual
Jefferies 2022 London Healthcare Conference – November 15-17, London
Upcoming scientific conference participation

Paris Nash Meeting – September 8-9, Paris
91èmes Journées Scientifiques de l’AFEF – October 5-8, Dijon
AASLD – The Liver Meeting – November 4-8, Washington, DC
6th Obesity and NASH Drug Development Summit – November 29 through December 1st, Boston
Next financial results publication

Financial results for the first half of 2022: Wednesday, September 21, 2022 (after U.S. market close)

On July 28, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo to treat patients with solid and hematologic malignancies, reported that new data at the 2022 iPSC Manufacturing Summit held in Boston, Mass. on the development of a precision genome engineered induced pluripotent stem cells (iPSCs) to incorporate a synthetic cytokine receptor, permitting more efficient differentiation and expansion of cells into functional, persistent cytotoxic cell types that is further compatible with efficient scale-up production (Press release, Umoja Biopharma, JUL 28, 2022, View Source [SID1234617094]).

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"Our newest data highlights a new way to efficiently differentiate and expand high-quality iPSCs in quantities necessary for treating more patients with potentially life-changing cell therapies," said lead author of the study and principal scientist at Umoja, Teisha Rowland, Ph.D. "Previously, scientists were limited with culturing these cells on plates, but with the new ShRED system we show that it is possible to grow cells in suspension, which is expected to translate to large-scale manufacturing. Importantly, we also showed that CAR-NK cells made using this new technique are highly functional therapeutic cells. This further validates employing our RACR technology platform to overcome critical limitations facing the cell therapy industry."

On Thursday July 28th, Principal Scientist Teisha Rowland, Ph.D., gave a presentation titled "Engineering iPSCs with Synthetic Receptors to Drive Differentiation Compatible with Scale-Up." The presentation demonstrated progress on Umoja’s iPSC platform and the development of a synthetic receptor enabled differentiation (ShRED) protocol that employs a rapamycin activated cytokine receptor (RACR) to drive differentiation and expansion of iPSCs in a controlled and consistent manner, without the addition of expensive growth factors and cytokines. Activating RACR with a rapamycin analog (rapalog) during hematopoietic progenitor (HP) generation was shown to increase HP yield controls in conventional cell culture format. Additional improvement of cell culture conditions further enhanced RACR-driven yields.

Furthermore, resultant iPSC-derived cytotoxic innate lymphocytes (RACR-iCILs) displayed improved innate cytotoxicity and serial killing in several tumor models. CAR-RACR-iCILs (cells engineered with chimeric antigen receptors) displayed potent and specific CAR-driven and innate tumor killing. Furthermore, RACR engineered NK cells demonstrated enhanced tumor control in a mouse breast cancer model. In addition, RACR-iCIL cells can be produced with high yields when grown in suspension, eliminating requirements for 2D culture that limit scale up manufacture of iPSC derived cell therapy products.

"We are continuing to advance our "off-the-shelf" iPSC therapy platform that aims to overcome major challenges in allogeneic cell therapy, including eliminating the need for toxic lymphodepletion and reducing manufacturing complexity and cost," said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. "We are excited to share this new data on the development of our ShRED platform for the differentiation and expansion of iPSC-derived cells which is expected to yield a more consistent and potent product. The continued progress across our four complimentary platforms truly exemplifies Umoja’s commitment and determination towards developing curative treatments that can be delivered to any patient, with any tumor, at any time."

About RACR
CAR T cells generated by the body with VivoVec can be expanded and sustained with the rapamycin activated cytokine receptor (RACR) system, an engineered signaling system designed to improve chimeric antigen receptor (CAR) T cell persistence and produce durable anti-tumor responses. The RACR/CAR payload is integrated into the genomic DNA of a patient’s T cells. Rapamycin activates the RACR system resulting in preferential expansion and survival of cancer-fighting T cells. The RACR technology enables a patient’s cells to expand in a manner that resembles a natural immune response that does not require lymphodepletion, promoting durable T cell engraftment. RACR/CAR technology can also be used to enhance ex vivo manufacturing in support of more traditional autologous or allogeneic cell therapy manufacturing processes. To learn more about Umoja’s RACR platform please visit View Source

On July 28, 2022 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that the company will release its financial results for the second quarter ended June 30, 2022, including a corporate update, on Thursday, August 4, 2022, before the opening of the U.S. financial markets (Press release, Immunic, JUL 28, 2022, View Source [SID1234617110]). A webcast will follow at 8:00 am ET.

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To participate in the webcast, please register in advance at: View Source or on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

On July 28, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report second quarter 2022 financial results and provide a corporate update on Thursday, August 4, 2022 (Press release, Jounce Therapeutics, JUL 28, 2022, View Source [SID1234617062]). Jounce Therapeutics’ management team will host a webcast and live conference call at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please register here and please be advised to do so at least 10 minutes prior to joining the call. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On July 28, 2022 Labcorp (NYSE: LH) (the "Company"), a leading global life sciences company, reported that its Board of Directors has authorized the Company to pursue a spin-off of the Company’s wholly owned Clinical Development business to Labcorp shareholders through a tax-free transaction (Press release, LabCorp, JUL 28, 2022, View Source [SID1234617079]). The planned spin-off will result in two independent, publicly traded companies, each poised for strong, sustainable growth:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Labcorp: A leading global laboratory business comprising the Company’s routine and esoteric labs, central labs and early development research labs, all of which are leaders with deep scientific expertise, vast health data and insights, and an extensive, advanced global laboratory network.
The Clinical Development Business: A leading, global Contract Research Organization (CRO) providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations.
Following the decision by the Board last year to initiate a dividend and accelerate the Company’s share repurchase program, Labcorp’s management team and Board continued to evaluate all avenues to further enhance stakeholder value. The planned spin-off is expected to provide each company with:

Strengthened strategic flexibility and operational focus to pursue specific market opportunities and better meet customer needs.
Focused capital structures and capital allocation strategies to drive innovation and growth.
A more targeted investment opportunity for different investor bases.
"Spinning off the Clinical Development business will benefit customers and shareholders by creating two standalone businesses that are poised to accelerate growth and focus resources on distinct strategic priorities, customer needs and value creation," said Adam Schechter, chairman and CEO of Labcorp. "Our shareholders will be able to participate in the upside potential of two market-leading businesses in the global healthcare sector, each of which will be well-capitalized and positioned to generate sustainable growth with strong free cash flows and attractive returns. Our customers will continue to have access to our full range of capabilities with the same quality and seamless delivery of services they have come to expect from our teams. Today is a testament to our long history of growth through innovation and track record of delivering on our mission to improve health and improve lives."

Labcorp: A Compelling Value Proposition with a Strong Growth Platform Serving All Healthcare Sectors and Customers

Labcorp will remain a global leader advancing healthcare through science, innovation and technology with deep scientific expertise, vast health data and insights, and an extensive, advanced global laboratory network. Together, its lab-based businesses will create a cohesive, global provider of laboratory-focused services with complementary resources operating at scale and a diverse customer base. Following the planned spin-off, the business will be positioned to:

Invest in R&D and innovation to develop and launch diagnostic advancements globally in key areas including oncology, Alzheimer’s, autoimmune and liver disease through organic and inorganic opportunities.
Bring together its global health and patient data and provide insights to enable customers to advance innovation.
Utilize its worldwide laboratory network to serve a broad, growing and global customer base including pharmaceutical and biotechnology companies, physicians, health systems, consumers, and other start-ups and labs who require lab services or diagnostic testing.
Launch innovative tests globally, providing patients, physicians, health systems and pharmaceutical companies with access to Labcorp’s advanced science, technology and diagnostic capabilities.
Over the last four quarters ending June 30, 2022, Labcorp’s routine and esoteric labs, central lab and early development research lab businesses delivered total revenue of $12.7 billion, or $10.5 billion excluding COVID-19 Testing revenues. These businesses combined grew 5.5% on a CAGR basis from second quarter 2019 to second quarter 2022 excluding COVID-19 Testing revenues. Going forward, Labcorp will continue to have an attractive growth profile and is expected to deliver mid-single digit annual revenue growth. In addition, Labcorp remains committed to its capital allocation strategy and maintaining its investment grade credit rating.

Adam Schechter will continue to lead Labcorp as chairman and CEO following the completion of the planned spin-off. Labcorp will continue to be headquartered in Burlington, North Carolina.

The Clinical Development Business: Leading Global CRO Focused on Supporting Biotechnology and Pharmaceutical Customers and Accelerating Innovation

The Clinical Development business will continue to be a leading global provider of Phase I-IV clinical trial, market access and technology solutions to both large and emerging pharmaceutical and biotechnology organizations. Following the planned spin-off, the business will be positioned to:

Capitalize on growth opportunities across Phases I-IV clinical trials and extend its leadership in oncology, cell and gene therapy, rare disease, and other emerging therapeutic areas.
Increase agility with large pharmaceutical and biotechnology clients to better serve customers and advance life-saving therapies.
Retain access to Labcorp’s vast health and clinical data set through an arrangement which will enable it to provide enhanced trial execution and a differentiated value proposition.
Continue to invest in capabilities, technologies, diverse talent and innovation to enhance trial execution and better serve all of its customers.
Implement a capital structure that is tailored to support its growth strategy and enhance stakeholder value.
Over the last four quarters ending June 30, 2022, the Clinical Development business delivered total revenue of $3.0 billion. This business grew 8.0% on a CAGR basis from second quarter 2019 to second quarter 2022. Going forward, the Clinical Development business is expected to deliver high-single-digit revenue growth.

Transaction Details

Labcorp currently expects to effect the planned spin-off through a dividend of the Clinical Development business’ shares to Labcorp’s shareholders. Following the spin-off, Labcorp expects to continue to be publicly traded on the New York Stock Exchange and expects the Clinical Development business to be publicly listed. The spin-off is intended to qualify as a tax-free transaction for U.S. federal income tax purposes.

The Board of Directors, executive leadership, and company name of the Clinical Development business will be determined and announced in the future as plans for the spin-off continue to progress.

Labcorp anticipates that, consistent with any applicable legal and tax requirements, there will be ongoing transitional and commercial arrangements to provide for a seamless delivery of services to the customers and other stakeholders of the Labcorp and the Clinical Development businesses.

Labcorp is targeting completion of the planned spin-off in the second half of 2023. The spin-off will be subject to the satisfaction of certain customary conditions, including, among others, the receipt of final approval by Labcorp’s Board of Directors, the receipt of appropriate assurances regarding the tax-free nature of the separation and effectiveness of any required filings with the Securities and Exchange Commission. Labcorp notes that there can be no assurances regarding the ultimate timing of the transaction or that the spin-off will be completed.

Advisors

Barclays, Evercore and Goldman Sachs & Co. LLC are serving as Labcorp’s financial advisor, and Jones Day and Hogan Lovells are serving as legal counsel.

Conference Call and Webcast

Labcorp will discuss the spin-off announcement on its second quarter 2022 earnings conference call, which will be held today at 9:00 a.m. ET. The online webcast of the call, along with the accompanying slide presentation, will be available at View Source

The conference call may also be accessed by dialing 800-715-9871 (646-307-1963 for international callers). The conference ID is 4124787. A telephone replay of the call will be available through August 11, 2022, and can be heard by dialing 800-770-2030 (609-800-9909 for international callers). The conference ID for the replay is 4124787.