On March 3, 2023 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, its financial results for the year ended December 31, 2022 and provides a business update (Press release, INmune Bio, MAR 3, 2023, View Source [SID1234628138]).

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Q4 2022 and 2022 Corporate Highlights:

DN-TNF Platform Highlights (XPro and INB03):

· Consolidating the Mild Cognitive Impairment (MCI) Phase 2 trial into the Mild Alzheimer’s Disease Phase 2 study which will become a single Phase 2 AD trial. The combined trials should improve our ability to demonstrate a clinical benefit in patients receiving XPro, accelerate enrollment, and reduce costs. Including patients with MCI in the Phase 2 AD trial does not significantly increase the trial size and should shorten the time to last patient enrolled. Patients that complete the six-month Phase 2 AD study are eligible to enroll into a 12-month Open Label Extension trial (OLE). The OLE study is a 12-month study where long-term safety and efficacy of XPro treatment in patients with early AD are evaluated. Topline readout of Phase 2 AD trial is expected in 2H 2024.

· Phase 2 AD Trial open in Canada following receipt of No Objection Letter from Health Canada in November.

· Received research and development rebates from Australia and the United Kingdom in early 2023 that totaled approximately $6.4 million USD. The Company will reinvest the cash rebate in increasing recruitment and enrollment in Australia where we expect to continue to receive future rebates associated with research and development spend, in Canada to expand the Phase 2 AD program and in other foreign jurisdictions to allow the enrollment of early AD patients into the ongoing Phase 2 AD trial.

· Announced pre-clinical data that support a pioneering approach to treating Duchenne Muscular Dystrophy (DMD) targeting soluble TNF (sTNF) using a Dominant-Negative TNF (DN-TNF) biologic significantly decreased muscle damage and inflammation and promote muscle growth in the mouse mdx model of DMD. The company formed a wholly owned subsidiary, DN02, Inc., which will hold all the intellectual property to facilitate partnering and business development activities for DMD without impacting the Company’s CNS programs. There are currently no approved drugs that promote muscle regeneration in DMD patients.

· FDA review of Chemistry Manufacturing and Controls (CMC) associated with a clinical hold on XPro AD trial in the U.S. is ongoing. The Company continues to have dialog with the FDA to address the FDA’s clinical hold questions. We plan to open US Phase 2 trials sites for XPro in AD when the current hold is lifted. The Company continues to enroll patients in AUS and CAN and is working to open additional international regulatory venues. We will inform investors when each new country opens. We expect the US will open in plenty of time to include Phase 2 patients, however there are no negative consequences to the development program if all or most of the Phase 2 patients are enrolled outside of the US.

· The polysarcosine (pSar) DN-TNF program converts XPro from a single drug into a DN-TNF drug platform. Polysarcosine is a novel half-life extender that effectively replaces the PEG half-life extender used in XPro. The pSar program is an essential part of INmune Bio’s business development efforts. XPro has been designated for the CNS programs, including AD, TRD, ALS and other neurological diseases. The pSar program provides at least 3 new DN-TNF biologics that are eligible for composition-of-matter IP and have unique biologic characteristics that allow partnering DN-TNF opportunities beyond CNS, such as oncology, DMD and other diseases. Each drug is a novel DN-TNF compound that will require a unique development program. DMD and oncology are the first two pSar programs that are targeted for partnering.

· MUC4 expressing cancers include breast cancer, HER2+ breast cancer, triple negative breast cancer, gastric and pancreatic cancer which are candidates for DN-TNF therapy. In pre-clinical models, INB03 DN-TNF reduces MUC4 expression to decrease resistance to immunotherapy. A pSar DN-TNF compound with new composition-of-matter IP is in animal testing and if positive, this unique DN-TNF drug will be moved into a strategic partnering program in oncology. Data on combination of DN-TNF with trastuzumab-deruxtecan (Enhertu) was presented at SABCS in November 2022. Additional data will be presented at AACR (Free AACR Whitepaper) in April 2023

INKmune Platform:

· IND to be filed this month for the use of INKmune to treat patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. Excluding skin cancer, prostate cancer is the most common cancer in men. "Despite advances in the treatment of men with metastatic castration-resistant prostate cancer, the lethal form of the disease, median survival remains short and novel treatment approaches are urgently needed," said Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer who will be Principal Investigator (PI) of the INKmune trial. "Current treatment paradigms, including chemotherapy, second generation androgen receptor signaling inhibitors, and others have largely been maximized for therapeutic benefit. Although immunotherapy has shown activity and promise in other solid tumors, immunotherapeutic approaches for prostate cancer such as checkpoint inhibitors have been unsuccessful to date. Given the promise of immunotherapy, establishing the efficacy of an ‘off-the-shelf" immuno-therapeutic approach for mCRPC would be practice changing and could profoundly impact the care and quality of life for mCRPC patients. Harnessing the innate anti-tumor activity of NK cells represents a golden opportunity to advance immunotherapy to effectively and safely treat mCRPC. Now is the time to pursue such an approach." The Phase I/II design will enroll patients at several medical centers in the US.

· Additional sites have opened to support the ongoing phase I trial in high risk MDS/AML. A second site in the UK, The Royal Hallamshire Hospital at Sheffield University Medical School enrolled a patient this week with treatment scheduled for March 9th. A third site in Europe, Attikon University Hospital in Athens, Greece, will open shortly.

· The first four patients treated with INKmune were presented at the American Society for Hematology in December. INKmune treatment was associated with the rapid and sustained generation of cancer killing memory-like NK cells in the blood of 3 of 4 patients treated. The INKmune primed NK cells developed the ability to kill NK-resistant tumor cells in-vitro which was absent before treatment. INKmune also initiated increases in important systemic cytokines TNF-a, IL-15, MIP1-a, MIP1-b and IL2Ra which are associated with increased NK cell function and survival.

· The ASH (Free ASH Whitepaper) 2023 presentation included bioinformatics data showing that INKmune primed NK cells, in contrast to IL-15 primed NK cells, upregulates 30 mitochondrial survival proteins and more than 40 nutrient receptors on the NK cell; increasing survival potential in the TME. These data, when combined with the therapeutic persistence data presented in the INKmume treated patients and data on the function of INKmune primed NK cells presented at the Innate Killer Symposia 2022 supports the use of INKmune therapy to treat patients with solid tumors.

· The Company announced positive pre-clinical data in prostate cancer, renal cell carcinoma, ovarian cancer and nasopharyngeal cancer tumor cell lines resistant to natural killer killing. These pre-clinical studies are essential steps in bridging INKmune from the bench to the bedside and guide the INKmune solid tumor development program.

Upcoming Events and Milestones:

· Top-line results for the Phase 2 XPro trial for treatment of neuroinflammation as a cause of Alzheimer’s Disease is expected in 2H 2024.

· We will initiate a Phase 2 trial of XPro in patients with Treatment Resistant Depression that is partially funded by a $2.9 million NIH grant upon resolution of the FDA manufacturing review.

· Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML in 2023.

· Initiation of a Phase I/II program in a prostate cancer upon the acceptance of the IND by the FDA.

Financial Results for the Year Ended December 31, 2022:

Net loss attributable to common stockholders for the year ended December 31, 2022 was approximately $27.3 million, compared to approximately $ 30.3 million for the year ended December 31, 2021.

Research and development expense totaled approximately $17.1 million for the year ended December 31, 2022 to approximately $20.5 million during the year ended December 31, 2021.

General and administrative expense was approximately $9.3 million for the year ended December 31, 2022 compared to approximately $8.8 million during the year ended December 31, 2021.

Other expense was approximately $1.3 million for the year ended December 31, 2022 compared to approximately $1.2 million during the year ended December 31, 2021.

As of December 31, 2022, the Company had cash and cash equivalents of approximately $52.2 million.

As of March 2, 2023, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter Conference Call when reaching an operator.

Date: March 2, 2023
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13735978

A live audio webcast of the call can be accessed using this link or clicking here:
View Source;tp_key=9a74893972

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 9 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13735978

About Metastatic Castration-Resistant Prostate Cancer (mCPRC

Prostate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men globally, with an incidence of 1.4 million and 375,000 deaths in 2020. In the United States, it is estimated that there were 268,490 new cases and 34,500 deaths in 2022. Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. In patients with mCRPC, the prostate cancer grows and spreads to other parts of the body, despite the use of androgen deprivation therapy (ADT) to block the action of male sex hormones. Approximately 10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at least 84% of these patients presenting with metastases at the time of CRPC diagnosis. Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

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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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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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.