Arcellx to Participate in Upcoming Investor Conferences

On February 2, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the company’s participation in the following investor conferences (Press release, Arcellx, FEB 2, 2023, View Source [SID1234626797]).

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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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Guggenheim Oncology Conference 2023
Fireside chat on Thursday, February 9, 2023, at 11:20 a.m. ET

SVB Securities Global Biopharma Conference (Virtual)
Fireside chat on Thursday, February 16, 2023, at 3:00 p.m. ET
A live webcast of these discussions will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcasts will be archived and available for 30 days following the event.

ESSA Pharma to Participate in the Guggenheim Healthcare Talks 5th Annual Oncology Conference

On February 2, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company will participate in a fireside chat at the Guggenheim Healthcare Talks 5th Annual Oncology Conference in New York City on Thursday, February 9, 2023, at 9:00 a.m. Eastern Time (Press release, ESSA, FEB 2, 2023, View Source [SID1234626796]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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David R. Parkinson, President and Chief Executive Officer of ESSA Pharma; Peter Virsik, ESSA’s Chief Operating Officer; and David S. Wood, ESSA’s Chief Financial Officer, will host and participate in one-on-one meetings.

A live webcast of the presentation can be accessed in the Investors/Events & Presentations section of ESSA’s website at www.essapharma.com. An archived replay of the event will be available for 30 days.

Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab

On February 2, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for naxitamab (Press release, Y-mAbs Therapeutics, FEB 2, 2023, View Source [SID1234626793]). The decision follows a positive opinion from EMA’s Pediatric Committee ("PDCO"). Naxitamab is being developed by Y-mAbs for the treatment of patients with relapsed/refractory high-risk neuroblastoma, which is the indication targeted by the PIP, as well as osteosarcoma.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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A PIP outlines a pharmaceutical company’s strategy for investigation of the new medicinal product in the pediatric population and is a required submission as part of the regulatory process for the registration of new medicines in Europe. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved in the United States by the FDA under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information (View Source) for complete Boxed Warning and other important safety information.

Investor presentation

On February 2, 2023 Verrica Pharmaceuticals presenting its investor presentation (Filing, 8-K, Verrica Pharmaceuticals, FEB 2, 2023, View Source [SID1234626792]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Sesen Bio Files Investor Presentation in Connection with Pending Carisma Therapeutics Merger

On February 2, 2023 Sesen Bio, Inc. (NASDAQ: SESN) reported an investor presentation highlighting its value maximizing merger with Carisma Therapeutics Inc. ("Carisma") (Press release, Sesen Bio, FEB 2, 2023, View Source [SID1234626789]). The presentation can be found at www.SesenBioandCarisma.com.

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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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Highlights of the presentation include:

· The merger with Carisma delivers substantial and immediate value for Sesen Bio stockholders, which is meaningfully better than the alternative of dissolution and liquidation

o Expected special one-time cash dividend of approximately $70 million to be paid shortly after (and contingent upon) closing, $0.34 per share1.

o Additional potential cash upside via Contingent Value Right, including any potential proceeds from any sale of Sesen Bio’s legacy assets (including Vicineum) and from the potential $30 million milestone payment, $0.14 per share2, under the Roche Asset Purchase Agreement.

o Without the pending merger with Carisma, the most likely and feasible path for Sesen Bio would be a delisting from Nasdaq followed by a court-managed dissolution of the Company and a liquidation of assets.

o The Sesen Bio Board thoroughly considered dissolution and liquidation and determined there would be significant expense, delay and uncertainty.

o In a dissolution and liquidation scenario, only approximately 60%-90%3 of Sesen Bio’s cash balance, approximately $0.40-$0.60 per share, would be available for an initial distribution, which likely would not be available for six months or more after an additional stockholder vote. The full process could take up to three years in the Delaware court system to fully settle Sesen Bio’s potential future and unknown liabilities.

· Sesen Bio conducted a robust strategic review process to maximize stockholder value

o The Sesen Bio Board proactively initiated a comprehensive four-month review of strategic options, including evaluating merger, sale of assets, resumption of R&D and dissolution and liquidation of assets and wind-down of Sesen Bio.

o Conducted outreach to over 100 parties, resulting in 42 bids.

o Board negotiated with Carisma extensively, including additional due diligence activities with Key Opinion Leaders with expertise in solid tumors and cell therapy to analyze and understand Carisma’s pipeline and proprietary cell therapy platform.

1 Based on basic outstanding shares including unvested RSUs.

2 Amounts reflect potential payments in the future and have not been discounted. Does not include potential proceeds from the sale of Vicineum or the Company’s other legacy assets.

3 Based on precedent dissolution and liquidation processes and Company projections of potential liabilities and operating expenses.

· Sesen Bio stockholders stand to benefit from significant potential upside through ownership in combined company

o sesen Bio stockholders immediately benefit from owning 25.2% stake, $0.40 per share4, in the $357 million5 combined company with potential for significant long-term upside through Carisma’s proprietary CAR-M platform that could transform treatment for patients with cancer and other serious disorders.
o Combined company will be led by Carisma’s Board and management team, which has strong investor support, comprising of leaders within biotech, including AbbVie, Moderna, Wellington and TPG.
Sesen Bio urges stockholders to vote today "FOR" the value maximizing transaction with Carisma using the WHITE proxy card ahead of the March 2, 2023, Special Meeting of Stockholders.

Sesen Bio stockholders who need assistance voting or have questions regarding the Sesen Bio Special Meeting may contact Sesen Bio’s proxy solicitor, MacKenzie Partners, toll-free at 1-800-322-2885 or email at [email protected].

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.