Sesen Bio and Carisma Therapeutics Announce Increased Special Cash Dividend and Stockholder Support for Pending Merger

On February 14, 2023 Sesen Bio, Inc. (Nasdaq: SESN) and Carisma Therapeutics Inc. (Carisma), a privately-held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the companies have reached a voting and support agreement (the "Support Agreement") with Bradley L. Radoff and Michael Torok (together with their respective affiliates, the "Investor Group") (Press release, Sesen Bio, FEB 14, 2023, View Source [SID1234627211]). The Investor Group, which beneficially owns approximately 8.7% of Sesen Bio’s outstanding common stock, has committed to vote its shares in support of the pending merger.

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In connection with the Support Agreement, Sesen Bio and Carisma have further amended the previously amended merger agreement announced on December 29, 2022, which has been unanimously approved by the Boards of Directors of both companies:

Increased the one-time special cash dividend expected to be paid to Sesen Bio stockholders to $75 million, $0.36 per share1. This represents an increase from the expected special cash dividend of approximately $70 million, approximately $0.34 per share, under the first amendment to the merger agreement, and an increase from the up to $25 million special cash dividend under the terms of the original merger agreement;

Extended the period of time for payments under the Contingent Value Right ("CVR") related to any potential proceeds from the sale of Vicineum and Sesen Bio’s other legacy assets to March 31, 2027, from December 31, 2023, under the previous terms. Under the CVR, Sesen Bio stockholders remain entitled to any proceeds from the potential milestone payment under the Roche Asset Purchase Agreement; and

Michael Torok will join the Carisma Board of Directors upon closing of the merger as the only Sesen Bio representative.

Dr. Jay Duker, Chair of the Sesen Bio Board of Directors, said, "We appreciate Mr. Radoff’s and Mr. Torok’s constructive engagement. Our discussions with our stockholders over the last several weeks have enabled valuable changes to the merger agreement that benefit all stockholders, including the significantly increased expected special cash dividend of $75 million and an enhanced CVR. We are confident that the merger with Carisma maximizes value for all Sesen Bio stockholders, and we are pleased Mr. Radoff and Mr. Torok will support the pending transaction. We look forward to expeditiously closing the merger by the end of the quarter."

1 Based on basic outstanding shares including unvested RSUs.

Steven Kelly, President and Chief Executive Officer of Carisma, added, "We are excited to reach this agreement with Sesen Bio and Messrs. Radoff and Torok. The merger provides significant funding for Carisma’s R&D pipeline to advance our revolutionary proprietary cell therapy platform. We are confident the combined company will be well positioned to create significant value for stockholders."

Mr. Torok, on behalf of the Investor Group, said, "We are pleased that our extensive engagement with Sesen Bio and its representatives has helped unlock additional value for Sesen Bio’s stockholders. We believe the amended merger terms represent the most value maximizing path for stockholders. We are excited about the long-term value potential of the Carisma platform, and I look forward to joining the Carisma Board."

Carisma’s previously announced approximately $30 million financing remains committed and is expected to close concurrently with the pending merger.

The issuance of the special cash dividend and CVR remain contingent on the closing of the pending transaction, which is expected to occur in the first quarter of 2023, subject to approval by Sesen Bio stockholders and other customary closing conditions.

Following completion of the incremental financing from Carisma’s key investors and subsequent completion of the merger, Sesen Bio stockholders are expected to own 24.2% of the pro forma company consistent with the exchange ratio formula set forth in the original merger agreement, dated September 20, 2022.

The Sesen Bio Board unanimously recommends that stockholders vote "FOR" each of the proposals listed on the WHITE proxy card enclosed with the previously mailed definitive proxy statement / prospectus. As previously disclosed, the special meeting of stockholders will be held exclusively via live webcast on March 2, 2023, at 10:00 a.m. Eastern Time. Sesen Bio stockholders of record as of January 17, 2023, will be entitled to vote at the meeting.

The complete Support Agreement, which includes other customary provisions, will be filed as an exhibit to a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel. Evercore is serving as lead financial advisor to Carisma for the transaction and BofA Securities, Inc. is also serving as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore are serving as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel. Olshan Frome Wolosky LLP is serving as legal counsel to the Investor Group.

Sensei Biotherapeutics to Present New Preclinical Data for SNS-101, a Conditionally Active VISTA-blocking Antibody, at the Keystone Symposia on Next Generation Antibody Therapeutics

On February 14, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported its new preclinical data on SNS-101, a conditionally active, pH-selective VISTA-blocking antibody, at Next Generation Antibody Therapeutics: From Discovery to Patient, organized by Keystone Symposia, being held February 19-22, 2023 in Banff, Alberta, Canada (Press release, Sensei Biotherapeutics, FEB 14, 2023, View Source [SID1234627210]). The presentation will be made by Sensei’s Chief Scientific Officer, Dr. Edward van der Horst.

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Presentation Details:

Title: SNS-101, a conditionally active anti-VISTA antibody, potentiates anti-tumor effects of PD-1 blockade and displays favorable pharmacokinetic and cytokine release characteristics
Presenter: Edward van der Horst, Ph.D., Chief Scientific Officer
Session: Conditional Targeting with Multi-Specific Engagers
Date and time: Monday, February 20, 2023 between 9:00-11:15 a.m. MST

Material from the presentation will also be presented in a poster at the conference, as detailed:
Poster Number: 2027
Session: Poster Session 2
Date and time: Tuesday, February 21, 2023 at 7:30 p.m. MST

SVB Global Biopharma Conference Presentation

On February 14, 2023 Prelude Therapeutics presents its corporate presentation (Presentation, Prelude Therapeutics, FEB 14, 2023, View Source [SID1234627207]).

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Perrigo to Release Fourth Quarter and Fiscal Year 2022 Financial Results on February 27, 2023, Conduct Virtual Investor Day on February 28, 2023

On February 14, 2023 Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, reported that it plans to issue its fourth quarter and fiscal year 2022 financial results after the U.S. equity markets close on February 27, 2023 (Press release, Perrigo Company, FEB 14, 2023, View Source,-2023,-Conduct-Virtual-Investor-Day-on-February-28,-2023 [SID1234627206]). As a reminder, the Company plans to host its Virtual Investor Day on February 28, 2023, beginning at 8:00 AM EST. All interested parties are invited to access the event at View Source and are encouraged to register in advance.

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Inventiva reports preliminary financial results for Full-Year 2022

On February 14, 2023 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 certain preliminary financial results as of and for the year ended December 31, 2022 (Press release, Inventiva Pharma, FEB 14, 2023, View Source [SID1234627203]).

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Preliminary Financial Results1

Cash and cash equivalents, short-term deposits, R&D Expenses, Net cash used in operating activities, Net cash generated from investing activities and Net cash generated from financing activities.

As of December 31, 2022, the Company had €86.7 million of cash and cash equivalents and €1.0 million of short-term deposits1, compared to €61.2 million and €11.4 million, respectively as of September 30, 2022, and €86.6 million and €8.8 million, respectively, as of December 31, 2021.

Cash and cash equivalents at year end included the €12.8 million upfront payment (including €1.3 million of withholding taxes, amounting to net proceeds of €11.5 million) received on November 4, 2022 from Chia Tai Tianqing Pharmaceutical Group, Co., LTD ("CTTQ"), a subsidiary of Sino Biopharm, in connection with the previously announced licensing and collaboration agreement dated September 21, 2022.

Cash and cash equivalents at year end also included the €25.0 million tranche of the previously announced unsecured loan agreement executed with the European Investment Bank ("EIB") on May 16, 2022, which the Company received on December 8, 2022, the €9.3 million gross proceeds (€8.8 million net proceeds) raised through the Company’s At-The-Market ("ATM") Program on June 15, 2022, and the proceeds of three previously announced loan agreements with a syndicate of French banks for a total amount of €5.3 million. One of the loans was contracted as part of a French state-guaranteed loan facility with Bpifrance, and the two other loans were obtained as part of a French state stimulus economic plan granted by Crédit Agricole Champagne-Bourgogne and Société Générale.

Research and development ("R&D") expenses for the fourth quarter of 2022 increased generally in line with the increase recorded during the first three quarters of 2022, and amounted to €60.5 million for the full year 2022, compared to €48.5 million in 2021. This increase was driven mostly by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH, including a full twelve months of operation for the U.S. affiliate and, to a lesser extent, with the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes ("T2D").

Net cash used in operating activities amounted to (€44.9) million for the full year 2022, compared to (€47.7) million in 2021. Net cash used in operating expenses in 2022 was driven primarily by R&D expenses, partially offset by the upfront payment received from CTTQ.

Net cash generated from (used in) investing activities amounted to €8.9 million for the full year 2022 compared to (€1.8) million net cash used for the same period in 2021. The variance is mainly due to the change in short term deposits between both periods.

Net cash generated from financing activities amounted to €37.3 million for the full year 2022 compared to €25.4 million for 2021. Net cash generated from financing activities in 2022 has been driven by the proceeds of the first tranche of €25 million from the EIB loan, proceeds of €9.3 million from the sale of securities through the Company’s ATM program and proceeds of €5.3 million from three French state partially guaranteed loans, as described above.

For the full year 2022, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million versus a positive effect of €4.8 million for 2021, due to the strengthening of USD versus Euro.

Considering its current R&D and clinical development programs, the Company estimates that its existing cash, cash equivalents and short-term deposits should allow the Company to fund its operations through the fourth quarter of 20232. This cash runway estimate does not include the conditional second tranche of €25.0 million of the EIB loan agreement3.

Revenues

The Company’s revenues for the full year 2022 amounted to €12.2 million, as compared to €4.2 million for 2021. The revenues recorded in 2022 were driven mostly by the Company’s development agreement with CTTQ, executed on September 21, 2022, and revenues recorded in 2021 primarily consisted of a €4.0 million milestone payment for a milestone that was recorded following the launch by AbbVie of the Phase IIb clinical trial with cedirogant. As previously disclosed, this trial of cedirogant has since been discontinued by AbbVie and the partnership with AbbVie has been terminated.

Next key milestones expected

Publication of the topline results of the investigator-initiated study with lanifibranor in patients with Non-Alcoholic Fatty Liver Disease ("NAFLD") and T2D – planned for the first quarter of 2023
Publication of the topline results of the LEGEND Phase IIa combination trial of lanifibranor in combination with empagliflozin in patients with NASH and T2D – planned for the second half of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – targeted for the second half of 2023
Upcoming investor conference participation

Cowen 43rd Annual Health Care Conference – March 6-8 – Boston, MA
Guggenheim Health Altitudes Summit 2023 – March 13-16 – Telluride, Colorado
Evercore ISI NASH Renaissance – March 30 – Virtual
Kempen Life Sciences Conference – April 25-26 – Amsterdam
Upcoming scientific conference participation

Global NASH – March 2-3 – London
AEEH – March 15-17 _ Madrid
Liver Connect conference – March 23-26 – Huntington Beach , CA
AASLD Emerging topic: NASH Cirrhosis from mechanisms to management – March 25-26- Los Angeles, CA
Next financial results publication

Full-Year 2022 financial results: Wednesday, March 29, 2023 (after U.S. market close)