On May 16, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the first quarter 2024 (Press release, AIM ImmunoTech, MAY 16, 2024, View Source [SID1234643384]). As previously announced, the Company will host a conference call and webcast today, Thursday, May 16, 2024, at 8:30 AM ET (details below).

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"AIM is making fundamental progress across our clinical development programs and continues to be encouraged by Ampligen’s potential. We recently reported encouraging top-line data across our pipeline. We also recently completed cGMP manufacturing of 9,000 vials of Ampligen. Both of these successes are extremely important as we seek commercial partners. We remain focused on the continued execution of our operational, clinical and regulatory initiatives and seek to generate – through such progress – a basis for increased stockholder value," commented AIM Chief Executive Officer Thomas K. Equels.

Recent Highlights

Completed cGMP manufacturing of clinical vials of Ampligen
Announced first dose level is generally well-tolerated in Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer
Announced appointment of Charles Lapp, MD as a Consulting Medical Officer for AIM’s ME/CFS and Long COVID programs
Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer:
In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate of 45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. Objective Response Rate includes complete response and partial response to treatment. There was a total Clinical Benefit Rate of 55% when including patients who experienced stable disease. Researchers also reported a median Progression-Free Survival of 7.8 months.
Released multiple CEO Corner segments highlighting Company news and clinical programs
Expected Upcoming Pipeline Milestones

Q2 2024

Final dataset for Post-COVID Conditions (AMP-518)
2024

Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First Subject Dosed
Publications of data in scientific journals
Summary of Financial Highlights for First Quarter 2024

As of March 31, 2024, AIM reported cash, cash equivalents and marketable securities of $10.9 million.
Research and development expenses for the three months ended March 31, 2024, were $2.0 million, compared to $2.1 million for the same period in 2023.
General and administrative expenses were $3.8 million for the three months ended March 31, 2024, compared to $2.3 million for the same period 2023.
The net loss from operations for the three months March 31, 2024, was $5.8 million, or $0.12 per share, compared to $3.7 million, or $0.08 per share, for the three months ended March 31, 2023.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q1 2024 operational and financial results today, May 16, 2024 at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On May 16, 2024, Nuvalent, Inc. reported that the U.S. Food and Drug Administration granted breakthrough therapy designation to NVL-655 for the treatment of patients with locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors (Press release, Nuvalent, MAY 16, 2024, View Source [SID1234643401]).

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On May 16, 2024 Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, reported it will introduce its new preclinical drug candidate, NTX-472, at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago from May 31 to June 4 (Press release, Nutcracker Therapeutics, MAY 16, 2024, View Source [SID1234643418]).

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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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NTX-472 uses engineered mRNA-encoded proteins to simultaneously engage CD20, CD19, and CD47. Nutcracker Therapeutics is currently developing the candidate for the treatment of B cell lymphoma.

Additionally, Dr. Nicole Fay, director of pharmacology and product lead for NTX-250 (the company’s lead candidate), will be presenting and participating in a panel discussion at the 10th Sachs Oncology Innovation Forum (OIF) on May 31, which runs concurrently with the ASCO (Free ASCO Whitepaper) annual meeting.

Poster Presentation at ASCO (Free ASCO Whitepaper) 2024

Title: Development of NTX-472, a formulated mRNA therapy targeting CD20, CD19, and CD47, for treatment of B-cell lymphoma
Abstract Number: 2537
Session Title: Developmental Therapeutics — Immunotherapy
Session Location: Hall A
Session Date and Time: June 1, 9:00 a.m. – 12:00 p.m. CDT

Lead Author: Adrienne Sallets

Abstract titles are available on the ASCO (Free ASCO Whitepaper) conference website. More information about the conference can be found on ASCO (Free ASCO Whitepaper)’s website.

Sachs OIF Activities

Location:
Waldorf Astoria Chicago Hotel
11 E Walton St, Chicago, IL 60611

Panel Discussion: New Methods of Therapeutic Delivery for Oncology
Date and Time: May 31, 2:40 p.m. CDT
Speaker: Nicole Fay

Corporate Presentation
Presentation Track: A, Room Faulkner
Date and Time: May 31, 11:50 a.m. CDT
Speaker: Nicole Fay

More details about the event can be found on the OIF website, along with the full agenda.

On May 16, 2024 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2024 as well as recent company highlights (Press release, Akari Therapeutics, MAY 16, 2024, View Source [SID1234643385]).

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"My first few weeks as Interim CEO of Akari have been filled with non-stop activity and optimism," said Samir R. Patel, MD, Akari Interim President and CEO. "We continue to work towards completion of the merger with Peak Bio, advance PAS-nomacopan in geographic atrophy, and explore value creation through business opportunities with nomacopan, a phase 3 ready compound. In addition, we continue to be incredibly optimistic about the potential opportunities afforded by Peak’s ADC platform technology."

Recent Company Highlights

Entered into a definitive agreement with Peak Bio Inc. (Peak Bio) to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX. The merger is expected to close in the third quarter of 2024.
Announced portfolio prioritization plan for combined go-forward company which will focus on Peak’s antibody drug conjugate (ADC) platform technology and Akari’s PAS-nomacopan Geographic Atrophy (GA) program. As a result of this prioritization, the Company’s HSCT-TMA program was suspended.
Announced key leadership changes, including the appointment of experienced life sciences entrepreneur Samir R. Patel, M.D. as interim CEO, following the departure of Rachelle Jacques.
Commenced implementation of a reduction-in-force of approximately 67% of the Company’s total workforce as part of an operational restructuring plan, which included the elimination of certain senior management positions, to reduce operating costs while supporting the Company’s long-term strategic plan.
In May 2024, issued unsecured convertible, short-term promissory notes to Samir R. Patel, M.D, the Company’s President and Chief Executive Officer, and Ray Prudo, M.D., the Company’s Chairman of the Board, each in the amount of $500,000 to provide operating capital.
First Quarter 2024 Financial Results

As of March 31, 2024, the Company had cash of approximately $1.3 million.

Research and development expenses were approximately $2.3 million for the three months ended March 31, 2024, as compared to approximately $1.7 million for the same period in 2023.

General and administrative expenses were approximately $3.7 million for the three months ended March 31, 2024, as compared to approximately $2.9 million for the same period in 2023.

Total other income, net was approximately $0.4 million for the three months ended March 31, 2024, as compared to approximately $5.6 million for the same period in 2023, of which $0.6 million and $5.6 million was the result of net non-cash gains related to the company’s liability-classified warrants issued in connection with the company’s September 2022 private placement transaction.

Net loss was approximately $5.6 million for the three months ended March 31, 2024, as compared to net income of approximately $1.0 million for the same period in 2023. Excluding the non-cash gains of approximately $0.6 million and $5.6 million for the three months ended March 31, 2024 and 2023, respectively, related to the company’s liability-classified warrants, net loss was $6.2 million and $4.6 million, respectively.

Readers are referred to, and encouraged to read in its entirety, the company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, as filed with the Securities and Exchange Commission on March 15, 2024, which includes further detail on the Company’s business plans, operations, financial condition, and results of operations.

About the Merger

On March 5, 2024, Akari and Peak Bio announced a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX, under the Chairmanship of Hoyoung Huh, MD, PhD. Under the terms of the agreement, Peak stockholders will receive a number of Akari ordinary shares (represented by American Depositary Shares) for each share of Peak stock they own, as determined on the basis of the exchange ratio described in the agreement. The exchange is expected to result in implied equity ownership in the combined company of approximately 50% for Akari shareholders and approximately 50% for Peak stockholders on a fully diluted basis, subject to adjustment under certain circumstances, including based on each party’s relative level of net cash at the closing of the proposed transaction. The transaction is expected to close by the third quarter of this year subject to the satisfaction of customary closing conditions, including approval by the shareholders of both companies.

On May 16, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that members of the Company’s senior management team will participate in the following investor conferences in May and June 2024 (Press release, Zai Laboratory, MAY 16, 2024, View Source [SID1234643419]):

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J.P. Morgan 20th Annual Global China Summit
Panel Discussion: Thursday, May 23, 2024, 10:00 a.m. HKT
Location: Shanghai, China

Jefferies Global Healthcare Conference
Fireside Chat: Wednesday, June 5, 2024, 3:30 p.m. ET in Track 2
Location: New York, New York

Goldman Sachs 45th Annual Global Healthcare Conference
Presentation: Wednesday, June 12, 2024, 1:20 p.m. ET
Location: Miami Beach, Florida