On March 3, 2023 Plus Therapeutics, Inc. (the "Company") reported that it has entered into a Subscription and Investment Representation Agreement (the "Subscription Agreement") with Richard J. Hawkins, its Chairman of the board of directors of the Company, who is an accredited investor (the "Purchaser"), pursuant to which the Company agreed to issue and sell one (1) share of the Company’s Series F Preferred Stock, par value $0.001 per share (the "Preferred Stock"), to the Purchaser for $1,000 in cash (Filing, 8-K, Cytori Therapeutics, MAR 3, 2023, View Source [SID1234628136]). The sale closed on March 3, 2023. Additional information regarding the rights, preferences, privileges and restrictions applicable to the Preferred Stock is set forth under Item 5.03 of this Current Report on Form 8-K and is incorporated herein by reference.

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The Subscription Agreement contains customary representations and warranties and certain indemnification rights and obligations of the parties.

The foregoing summary of the Subscription Agreement does not purport to be complete and is subject to, and qualified in its entirety by, such document, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 3.02. Unregistered Sales of Equity Securities.

The disclosure required by this Item is included in Item 1.01 of this Current Report on Form 8-K and is incorporated herein by reference. Based in part upon the representations of the Purchaser in the Subscription Agreement, the offering and sale of the Preferred Stock was exempt from registration under Rule 506 of Regulation D under Section 4(a)(2) of the Securities Act of 1933, as amended.

Item 3.03. Material Modifications to Rights of Security Holders.

The disclosure required by this Item is included in Item 5.03 of this Current Report on Form 8-K and is incorporated herein by reference.

Item 5.03. Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

On March 3, 2023, the Company filed a certificate of designation (the "Certificate of Designation") with the Secretary of State of the State of Delaware, effective as of the time of filing, designating the rights, preferences, privileges and restrictions of the Preferred Stock. The Certificate of Designation provides that the Preferred Stock will have 50,000,000 votes per share of Preferred Stock and will vote together with the Company’s common stock, $0.001 par value (the "Common Stock") as a single class exclusively with respect to any proposal to amend the Company’s Amended and Restated Certificate of Incorporation (as may be amended and/or restated from time to time, the "Amended Certificate") to effect a reverse stock split of the Common Stock ( "Reverse Stock Split"). The Preferred Stock will be voted, without action by the holder, on any such proposal in the same proportion as shares of Common Stock are voted on such proposal. The Preferred Stock otherwise has no voting rights except as otherwise required by the General Corporation Law of the State of Delaware.

The Preferred Stock is not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Preferred Stock has no rights with respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Preferred Stock will not be entitled to receive dividends of any kind.

The outstanding share of Preferred Stock shall be redeemed in whole, but not in part, at any time: (i) if such redemption is approved by the board of directors in its sole discretion or (ii) automatically and effective upon the approval by the Company’s stockholders of a Reverse Stock Split. Upon such redemption, the holder of the Preferred Stock will receive consideration of $1,000 in cash.

The foregoing summary of the Certificate of Designation does not purport to be complete and is subject to, and qualified in its entirety by reference to the Certificate of Designation, a copy of which is attached hereto as Exhibit 3.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

On March 3, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3 RINGSIDE study evaluating investigational new drug AL102 in desmoid tumors conducted a prespecified periodic review of data from the study and recommended that the study continue without modifications (Press release, Ayala Pharmaceuticals, MAR 3, 2023, View Source [SID1234628135]).

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"We thank the IDMC members for their work and guidance and are pleased with their recommendation to continue RINGSIDE with no changes," said Ken Berlin, President and CEO of Ayala. "This recommendation was made based on the analysis of recently updated data from the Phase 2 segment of RINGSIDE. We have commenced enrollment in the Phase 3 segment of RINGSIDE on a worldwide basis. In addition, patients from Phase 2 have the opportunity to continue treatment in the open label extension in Phase 3. We believe that once-daily AL102 has best-in-class potential and are excited about its potential use in desmoid tumors. If approved, we believe it will be a valuable addition to the future therapeutic armamentarium in this underserved indication."

Andres Gutierrez, M.D. Ph.D., EVP and Chief Medical Officer of Ayala, stated, "The IDMC is looking forward to reviewing the long term-safety profile of AL102 from the open label extension of Phase 2 and has also agreed to the proposed plans for analysis and reporting of results in the ongoing Phase 3 segment of the study. We plan to present these recently updated data from the Phase 2 segment of RINGSIDE at an upcoming medical meeting in 2023."

Phase 3 of RINGSIDE is a double-blind, placebo-controlled, clinical trial enrolling up to 156 patients with progressive disease, comparing AL102 at 1.2 mg once-daily to placebo. The primary endpoint for Phase 3 is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), tumor volume reduction, and patient-reported Quality of Life (QOL) measures. For more information on the RINGSIDE Phase 2/3 study of AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors

Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall, or other parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to surgical morbidity and a high rate of recurrence post-surgery. There are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

On March 3, 2023 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ), reported that it will host a business update conference call and webcast on Tuesday, March 14, 2023, at 8:30 AM EST (Press release, Lucid Diagnostics, MAR 3, 2023, View Source [SID1234628134]). During the call, Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer, will provide a business update, including an overview of the Company’s operations and growth strategy. In addition, Dennis McGrath, Lucid’s Chief Financial Officer, will discuss the Company’s fourth-quarter 2022 financial results.

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The webcast will be available at the investor relations section of the Company’s website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 877-550-1858 and international listeners should dial 1-848-488-9160. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update Conference Call" to join.

Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at luciddx.com.

On March 3, 2023 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, reported that it will host a business update conference call and webcast on Wednesday, March 15, 2023, at 8:30 AM EST (Press release, PAVmed, MAR 3, 2023, View Source [SID1234628133]). During the call, Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer, will provide a business update including an overview of the Company’s operations and growth strategy. In addition, Dennis McGrath, PAVmed’s President and Chief Financial Officer, will discuss the Company’s fourth-quarter 2022 financial results.

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The webcast will be available at the investor relations section of the Company’s website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 877-550-1858 and international listeners should dial 1-848-488-9160. All listeners should provide the operator with the conference call name "PAVmed, Inc. Business Update Conference Call" to join.

Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at pavmed.com.

On March 3, 2023 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported the completion of an end of Phase 1 (EOP1) meeting with the US Food and Drug Administration ("US FDA") (Press release, Aptorum, MAR 3, 2023, View Source [SID1234628132]). SACT-1 is a repurposed small molecule drug formulated in oral suspension targeting neuroblastoma in pediatric patients and has also received orphan drug designation previously from the US FDA.

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The EOP1 meeting was focused on gaining alignment with the US FDA regarding the clinical and regulatory pathway for SACT-1 for the treatment of neuroblastoma in pediatric patients aged 2-18. The FDA generally agreed with the chemistry-manufacturing-control (CMC) strategy and our proposed clinical development plan for Phase 1/2 trials.

Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: "We are pleased to announce the completion of End of Phase 1 Meeting with US FDA and this represents another key milestone for the company and one of the targeted strategic goals for the year of 2023. With additional supportive information from US FDA on the clinical development of SACT-1, this supports the continued focus of Aptorum Group to embark on the exciting Phase 1/2 clinical trials for SACT-1, subject to further FDA’s clearance of the final clinical protocol."

About SACT-1

SACT-1 is an oral suspension based repurposed small molecule drug formulated in oral suspension to target neuroblastoma. SACT-1’s mechanism has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in high-risk or relapsed neuroblastoma patients where an amplification of MYCN is usually observed). SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy. SACT-1 has been observed to be potentially applicable to neuroblastoma and other cancers in the preclinical studies.