On July 28, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported its cash position as of June 30, 2022, and its revenues for the second quarter of 2022 (Press release, MaaT Pharma, JUL 28, 2022, View Source [SID1234617082]).

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"The second quarter of 2022 saw further progress in our pipeline and the achievement of a crucial milestone for MaaT Pharma. The announcement of data showing a satisfactory safety profile and robust engraftment for MaaT033, our second drug candidate, opens an attractive market opportunity to expand the development to a wider patient population as we focus on preventing complications in patients receiving allo-HSCT[2] and in haematological malignancies overall," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

Second quarter operational and clinical highlights

Clinical development

In June 2022, the Company confirmed positive results from its Phase 1b study evaluating MaaT033, the Company’s second drug candidate, in blood cancer patients; the clinical trial was completed early due to promising interim results.
MaaT Pharma also indicated that preparations are on track for the upcoming Phase 2/3 trial to evaluate MaaT033’s efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation; based on current plans, this study is expected to start in Q4 2022.
In Europe, MaaT013, the Company’s leading drug candidate, is currently being evaluated in two clinical trials launched in Q1 2022, which are moving forward according to the Company’s expected timelines:
Phase 3 open label, single arm trial for drug candidate MaaT013 in the treatment of acute Graft-versus-Host Disease: in addition to France, Germany, and Spain where the trial is ongoing, the Company has received regulatory approvals to start the clinical trial in Austria and Belgium. An interim review of preliminary data is expected in the first half of 2023.
Phase 2a trial, sponsored by AP-HP[3], evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with melanoma, is ongoing.
In the US, interactions with the U.S. Food and Drug Administration (FDA) are ongoing regarding MaaT013, for which US development is currently on clinical hold.
Operational highlights

On May 31, 2022, MaaT Pharma held its annual general meeting. For further information, please visit: View Source
On June 7, 2022, the Company hosted its first virtual R&D Day conference, attended by 150 participants. The replay is accessible here: View Source
"Over the first half of 2022 we are proud to have delivered to our shareholders the operational and clinical milestones set out at the time of our IPO. Our cash position remains solid, providing us with a cash runway through Q3 2023 by which time we expect to have interim data from our Phase 3 trial of MaaT013, and the first patient treated with MaaT033 in a Phase 2/3," stated Siân Crouzet, CFO and COO of MaaT Pharma.

Cash position1

As of June 30, 2022, total cash and cash equivalents were EUR 38.4 million, as compared to EUR 41.1 million as of March 31, 2022, and EUR 43.3 million as of December 31, 2021. The net change in cash over the first half of 2022 was EUR 4.9 million, including EUR 2.7 million in bank loans from BNP Paribas and Caisse d’Epargne Rhone Alpes (CERA) received over the course of the second quarter of 2022. Additional draws down, up to 4.4 million euros, are expected to be made by the end of 2022 from existing facilities signed with CIC and Bpifrance. The Company believes it has sufficient cash to cover needs of the development programs up until the end of the third quarter of 2023.

Revenues in Q2 20221

MaaT Pharma reported revenues[4] from its compassionate access program of EUR 0.2 million for the quarter ended June 30, 2022, compared with EUR 0.3 million for the first quarter of 2022. Total revenues for the first half of 2022 amount to EUR 0.5 million compared with EUR 0.4 million for the first half of 2021. In 2021, revenues were invoiced as of February 2021 whereas in 2022 the Company benefits from a full 6 months of revenues.

Upcoming financial communication and investor conference participation

September 12-14, 2022 – C. Wainwright 24th Annual Global Investment Conference
September 15-16, 2022 – KBC Securities Life Sciences Conference
September 28, 2022 – 5th edition – Forum LPB Valeurs Régionales
September 29, 2022 – Half-year Results 2022*
October 6-7, 2022 – Investor Access Event
*Indicative calendar that may be subject to change.

[1] Unaudited data
[2] Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment of liquid tumors which affect approximately 22,000 patients every year in the 7 major markets
[3] AP-HP: Assistance Publique – Hôpitaux de Paris
[4] Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM).

On July 28, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) ("Lexicon") reported the pricing of its previously announced underwritten public offering of 16,843,600 shares of its common stock, par value $0.001 (the "Common Stock"). The shares of Common Stock are being offered at a public offering price of $2.50 per share (Press release, Lexicon Pharmaceuticals, JUL 28, 2022, View Source [SID1234617081]). All of the shares are being offered by Lexicon. The gross proceeds from the public offering are expected to be approximately $42.1 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Lexicon has granted the underwriters a 30-day option to purchase up to an additional 2,526,540 shares of Common Stock (the "Option Shares") at the public offering price, less underwriting discounts and commissions. The public offering is expected to close on or about August 1, 2022, subject to the satisfaction of customary closing conditions.

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Lexicon currently intends to use the net proceeds that it will receive from the public offering and the concurrent private placement, together with its existing cash and cash equivalents and short-term investments, for (i) funding pre-commercial and commercial launch activities for sotagliflozin in heart failure; (ii) funding continued development of sotagliflozin in heart failure and LX9211 in neuropathic pain; and (iii) working capital and other general corporate purposes.

Citigroup and Piper Sandler are acting as joint book-running managers for the public offering.

In addition to the shares being sold in the underwritten public offering, Lexicon has agreed to sell 17,156,400 shares of its Common Stock to raise gross proceeds of approximately $42.9 million in a concurrent private placement at $2.50 per share to one or more affiliates (the "Private Placement Purchasers") of Invus, L.P., Lexicon’s largest stockholder. The Private Placement Purchasers will have the option to purchase, on a pro rata basis, up to an additional 2,573,460 shares of Common Stock at the public offering price of $2.50 per share to the extent the underwriters exercise their option to purchase the Option Shares. The sale of these shares of Common Stock will not be registered under the Securities Act of 1933, as amended (the "Securities Act"). The concurrent private placement is also scheduled to close on August 1, 2022, subject to the satisfaction of customary closing conditions. The closing of the underwritten public offering is not conditioned on the closing of the concurrent private placement.

A shelf registration statement on Form S-3 relating to the underwritten public offering was filed with the U.S. Securities and Exchange Commission ("SEC") on August 6, 2021 and declared effective by the SEC on September 14, 2021. The shares of Common Stock proposed to be issued in the concurrent private placement have not been registered under the Securities Act, or the securities laws of any state or other jurisdiction in the United States, and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, in the United States except pursuant to registration under the Securities Act, or an applicable exemption from the registration requirements of the Securities Act and, in each case, in compliance with other applicable securities laws. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and accompanying prospectus may also be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attn: Prospectus Department, by telephone at 1-800-747-3924, or by email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale is not permitted.

On July 28, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported that it will participate in the Jefferies Industrials Conference being held in New York, NY (Press release, Leidos, JUL 28, 2022, View Source [SID1234617080]).

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Roger Krone, Chief Executive Officer, will engage in a question and answer "fireside chat" on Tuesday, Aug. 9, 2022, at 3:30 p.m. ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source . A replay of the webcast will be available following the presentation at the same link listed above for 90 days afterward.

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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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.

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)