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 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 15, 2024 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 116.8 million in the first quarter of 2024 (Q1 2023: NOK 105.9 million), and EBITDA of NOK 7.9 million (NOK -1.2 million) following positive operational developments and cost control (Press release, PhotoCure, MAY 15, 2024, View Source [SID1234648643]). The Company reiterates its business and financial guidance for 2024 with 40 to 70 new and upgraded Saphira blue light tower installations during the year, product revenue growth of 6% to 9% in constant currency, and positive EBITDA excluding business development expenses.

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"Photocure delivered positive results in the first quarter of 2024 with Hexvix/Cysview revenue growth of 10% year-over-year and EBITDA of NOK 7.9 million. Both our North American and European business segments had positive contributions in the quarter as we continue to grow revenues and contain expenses," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 118.0 million in the first quarter of 2024 (NOK 106.2 million) and EBITDA* of NOK 7.9 million (NOK -1.2 million), driven by a combination of unit volume and price increases and a benefit from foreign exchange. Hexvix/Cysview revenues ended at NOK 116.8 million in the quarter (Q1 2023: NOK 105.9 million). EBIT was NOK 0.7 million (NOK -7.7 million) and the cash balance at the end of the period was NOK 258.3 million.

At the end of Q1 2024, the installed base of rigid BLC systems in the U.S. was 364, up 14% since Q1 2023. This includes 6 mobile towers owned by ForTec Medical. In the U.S., 27 flexible BLC towers remain active.

"ForTec has decided to pursue a mobile BLC strategy, expanding on a pilot program that began in 2021. In addition to the 6 Saphira towers that it currently owns, ForTec intends to expand its portfolio of equipment and launch a mobile BLC program throughout the U.S. later this year. A national roll-out by ForTec’s sales force would significantly increase the number of field-based account managers selling BLC with Cysview, and would also open the market to hospitals that currently do not have access to BLC equipment, particularly those in ForTec’s vast customer network," Schneider adds.

Photocure reiterates its business and financial guidance for 2024: The company anticipates new and upgraded Saphira blue light tower installations in the U.S. in the range of 40 to 70, consolidated product revenue growth of 6% to 9% in constant currency, and positive EBITDA excluding business development expenses.

"Our first quarter results underscore that 2024 is off to a strong start as we remain focused on maximizing the growth and profitability of our Hexvix/Cysview franchise. We expect momentum to continue with the strong Saphira placements in the U.S., increasing penetration in Europe leveraging the recent image quality upgrades, the anticipated commercial expansion of Fortec’s mobile tower strategy, and building upon the growing awareness of the benefits of blue light cystoscopy in light of the many new bladder cancer treatments coming to the market," Schneider says, and concludes:

"Additionally, there are several initiatives and events that have potential to create a step change in the future growth of our business including potential reclassification of BLC equipment in the U.S., which is anticipated to open the market to multiple tower manufacturers, our plan to reintroduce a new flexible BLC solution globally through a partnership, and the anticipated market approvals of Asieris’s candidates; Cevira and Hexvix in China. Given the many initiatives and activities in progress, we believe that 2024 is setting up to be an exciting year for the Company."

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2024 financial report on page 23.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20240515_13/

The presentation is scheduled to conclude at 14:45 CEST.

On May 15, 2024 CrossBridge Bio, Inc. (CrossBridge), a pioneering pre-clinical stage biotechnology company dedicated to advancing antibody-drug conjugate (ADC) therapeutics for unmet needs through stable dual linker payload technology that aims to significantly improve safety as well as potency/durability while addressing tumor resistance and heterogeneity, proudly announces the receipt of a substantial competitive non-dilutive grant from the Cancer Prevention and Research Institute of Texas (CPRIT) (Press release, CrossBridge Bio, MAY 15, 2024, View Source [SID1234647683]). This grant marks a significant milestone in CrossBridge’s mission to propel its innovative dual-payload ADC platform and potential best-in-class TROP2 program, CBB-120, to IND-enabling studies.

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CrossBridge’s cutting-edge ADC platform is at the forefront of cancer treatment innovation, utilizing site-specific antibody-branched linker conjugation, a stable tripeptide linker, and the ability to conjugate dual payloads via click chemistry. With the non-dilutive grant, CrossBridge is ready to accelerate the pre-clinical development of CBB-120 as a potential differentiated therapeutic for triple-negative breast cancers, hormone-positive Her2-negative breast cancers, and various other TROP2+ cancers with unmet needs, where our dual payloads will be most effective.

"The data we will generate with this grant will support de-risking our next-generation ADC platform and provide another potential option for cancer patients. We are thankful for the review committee and CPRIT for funding CBB-120." CEO and Co-Founder, Michael Torres, Ph.D.

We sincerely thank the Cancer Prevention and Research Institute of Texas (CPRIT) for their support. The $2.6 million seed award highlights CrossBridge’s unwavering commitment to advancing ADC therapeutics and providing transformative treatments to patients with challenging cancers. This funding will boost our pre-clinical efforts and strengthen our position as a trailblazer in ADC innovation.

On May 15, 2024 Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company developing N-myristoyltransferase (NMT) inhibitors as targeted therapies for the treatment of hematologic cancers and solid tumors, reported that it will be attending the Biotechnology Innovation Organization (BIO) International Convention taking place June 3-6, 2024, at the San Diego Convention Center, in San Diego, California, USA (Press release, Pacylex Pharmaceuticals, MAY 15, 2024, View Source [SID1234645049]). The BIO Convention is the premier life sciences networking conference in the world, bringing together leaders, innovators and investors from the pharmaceutical, biotech and medical device industries.

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Pacylex’s Chief Executive Officer, Dr. Michael Weickert, will be attending the conference and participating in the BIO One-on-One Partnering system. He will be available to review Pacylex’s recent clinical progress with zelenirstat currently being dosed in patients in two Phase 2a studies, in refractory and relapsed B-cell non-Hodgkin’s lymphoma and in advanced refractory colorectal cancer patients, at 4 clinical sites in Canada. He will also share new data describing how zelenirstat works in different cancers by inhibiting the myristoylation required for assembly, translocation, and/or function of validated targets like B-cell receptor, EGFR, and VEGFR. Zelenirstat also blocks Complex I formation in mitochondria of cancer cells which shuts down oxidative phosphorylation, especially critical for metastasis and cancer stem cells.

"We are learning from laboratory and clinical studies that inhibiting myristoylation appears to be an efficient way to turn off many cancer-critical processes with one switch", said Dr. Michael Weickert, CEO of Pacylex. "That may explain why Phase 1 zelenirstat patients with heavily pretreated and refractory ovarian, appendiceal, and colorectal cancer had 6 to 15 months of stable disease when treated with our recommended phase 2 dose. "

Registered attendees can discuss investment and licensing opportunities with Dr. Weickert by scheduling a meeting using the BIO One-on-One Partnering system. If there are no compatible time slots available, please contact Dr. Weickert directly to schedule a meeting.