On February 8, 2024 Alligator Bioscience AB reported full year financial results for 2023 and for Q4 2023 and provides a business update (Press release, Alligator Bioscience, FEB 8, 2024, View Source [SID1234639933]).

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"Over the last 12 months our OPTIMIZE-1 trial evaluating our lead asset mitazalimab in pancreatic cancer has delivered two sets of highly encouraging interim data as well as faster-than-expected patient recruitment leading to an accelerated top-line readout, nine months earlier than planned. The top-line data has now provided further indication of the potential of mitazalimab combined with chemotherapy to confer significant clinical benefit to pancreatic cancer patients over the standard of care. The OPTIMIZE-1 Phase 2 results are a worthy validation of the capabilities of our drug development program. We now need to remain laser focused on our objective to deliver outstanding returns to our stakeholders and to maximize the chances of developing innovative therapies in an ever more challenging Biotech environment. Unfortunately, this initiative will affect our most important asset, our colleagues who have strived professionally and diligently to allow Alligator to deliver on our mission. We could not be more grateful for the efforts and commitment to advance mitazalimab and our other innovative options for those who suffer from hard-to-treat cancers, and we remain committed to supporting those colleagues impacted by this initiative."
Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
Mitazalimab

On October 11, the European Patent Office granted Alligator a new patent covering mitazalimab’s composition of matter until 2038, including a potential supplementary term. The patent expands protection for mitazalimab in Europe and brings the total number of patents in the mitazalimab intellectual property portfolio to 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia and more.
ATOR-4066

On November 3, Alligator presented a poster entitled "Combination treatment with ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, and anti-PD-1 reverses T cell exhaustion in vitro" at the 2023 SITC (Free SITC Whitepaper) (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) Annual Meeting held in San Diego.
ATOR-1017

On October 5, Alligator announced the publication of a scientific article entitled "ATOR-1017, an Fc-gamma receptor conditional 4-1BB agonist designed for optimal safety and efficacy, activates exhausted T cells in combination with anti-PD-1" in the journal Cancer Immunology, Immunotherapy.
Capital Markets Day

On December 1, Alligator hosted a Capital Markets Day in which members of the Company’s executive management team provided an overview of Alligator’s strategy, its proprietary and partnered assets and its technology platforms. The in-person event was held in Stockholm and live streamed online.
Significant events after the end of the period:
Mitazalimab

On January 29, Alligator announced positive top-line results from the OPTIMIZE-1 Phase 2 trial in pancreatic cancer, demonstrating that mitazalimab in combination with mFOLFIRINOX achieved a 40.4% Overall Response Rate (ORR), a median Duration of Response (DoR) of 12.5 months, and median Overall Survival (mOS) of 14.3 months, which compares favorably to the 11.1 months mOS demonstrated by FOLFIRINOX,[1] and more recently by NALIFIROX in the NAPOLI 3 Phase 3 trial.[2]
Results indicate that mitazalimab in combination with mFOLFIRINOX has the potential to deliver significant clinical benefit for pancreatic cancer patients over standard of care alone.
Alligator has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, the FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3-enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.
ATOR-4066

On January 16, Alligator announced that the United States Patent and Trademark Office (USPTO) had issued a new patent entitled "Novel peptides" which provides protection for ATOR-4066 regarding methods of treating cancer and/or a tumor using a bispecific antibody comprising the complementarity-determining regions (CDRs) of the ATOR-4066 molecule.
Company

Alligator plans to restructure and reduce the workforce with 20-25% to adjust the burn rate and secure its continued ability to invest in the development of mitazalimab and other key value drivers. When fully implemented, the restructuring is expected to reduce annual cost by approximately SEK 20 million.

Outlook into 2024
Alligator continues to advance its Phase 3-enabling activities for the further clinical evaluation of mitazalimab in pancreatic cancer. In addition, Alligator is intensifying its business development efforts to identify the right partner to bring mitazalimab to patients as fast as possible, leveraging its full commercial potential. With the OPTIMIZE-1 top-line data validating CD40 as a target, Alligator sees increased potential in its Neo-X-Prime bispecific antibody ATOR-4066, and will continue efforts to further strengthen its supporting preclinical data package and prepare it for clinical development. Alligator is also expecting the preliminary Phase 1 readout for ALG.APV-527, a bispecific antibody with a tumor-directed 4-1BB agonistic effect being co-developed with Aptevo Therapeutics, in the first half of 2024.

FINANCIAL SUMMARY FOR Q4 2023 and FULL YEAR 2023
The financial summaries for the quarterly periods ending December 31st, 2023 and December 31st, 2022 are presented below.

All amounts in MSEK,
unless specified October – December 2023 October – December 2022
Net Sales 11.7 20.1
Operating profit/loss -70.4 -52.6
Profit/loss for the period -69.8 -53.3
Earnings per share (SEK)
before and after dilution -0.11 -0.24
Cash Flow -7.1 -49.8
Cash & Cash Equivalents 66.1 97.3

The financial summaries for the full year periods ending December 31st, 2023 and December 31st, 2022 are presented below.

All amounts in MSEK,
unless specified January – December 2023 January – December 2022
Net Sales 58.1 35.7
Operating profit/loss -249.0 -192.8
Profit/loss for the period -248.6 -193.4
Earnings per share (SEK)
before and after dilution -0.55 -0.88
Cash Flow -30.2 -180.9
Cash & Cash Equivalents 66.1 97.3
The full report is attached as a PDF, and is also available on the company’s website.
Alligator will host a conference call on Friday, February 9, 2024, at 2 p.m. CET/ 8 a.m. EST for investors, analysts and media, where CEO Søren Bregenholt, CFO Marie Svensson, and CMO Dr. Sumeet Ambarkhane will present and comment on the Year-end report 2023, which will be followed by a Q&A session. The call will be held in English and can be accessed through Alligator’s channel on YouTube.

On February 7, 2024 Kyowa Hakko Kirin reported its Consolidated Financial Summary (IFRS) Fiscal 2023 (Press release, Kyowa Hakko Kirin, FEB 7, 2024, View Source [SID1234642359]).

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On March 7, 2024 AbbVie (NYSE: ABBV) reported that it will participate in the Barclays 26th Annual Global Healthcare Conference on Thursday, March 14, 2024. Robert A. Michael, president and chief operating officer, Scott T. Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, will present at 8:00 a.m. Central time (Press release, AbbVie, FEB 7, 2024, View Source [SID1234640941]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 7, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and that the U.S. Food and Drug Administration (FDA) placed all magrolimab studies in myelodysplastic syndromes (MDS) and AML, including related expanded access programs, on full clinical hold (Press release, Gilead Sciences, FEB 7, 2024, View Source [SID1234640175]). These decisions follow the recommendation of an independent Data Monitoring Committee which reviewed top-line data from a planned interim analysis of ENHANCE-3 for overall survival (OS). In that analysis, magrolimab in combination with azacitidine plus venetoclax demonstrated futility and an increased risk of death was observed, primarily driven by infections and respiratory failure.

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Based on these results, as well as data from two other clinical studies in higher-risk MDS (ENHANCE) and AML with TP53 mutations (ENHANCE-2) where the primary analyses also demonstrated futility with an increased risk of death in the magrolimab-treatment arm, Gilead will not pursue further development of magrolimab in hematologic cancers.

Patients in the ENHANCE-3 study will discontinue treatment with magrolimab and Gilead is communicating with investigators to determine appropriate next steps for patients in the study. Sub-analyses of ENHANCE-3 for efficacy and safety are ongoing and results will be shared with regulatory authorities and will be submitted for presentation at an upcoming medical meeting and/or publication in a peer-reviewed journal.

Gilead will share a top-line, integrated summary of all pivotal magrolimab trials (ENHANCE, ENHANCE-2 and ENHANCE-3) shortly, as well as more detailed results of each trial in upcoming medical conferences. In addition, Gilead is reviewing the safety of magrolimab across all ongoing solid tumor trials and will provide an update on this assessment as soon as possible.

"The complexity of treating blood cancer is highlighted in these results," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies."

About ENHANCE-3
ENHANCE-3 is a Phase 3 study evaluating the safety and efficacy of magrolimab versus placebo in combination with venetoclax plus azacitidine in newly diagnosed, previously untreated patients with AML who are ineligible for intensive chemotherapy. More information about ENHANCE-3 (NCT05079230) can be found at ClinicalTrials.gov.

On February 7, 2024 QSAM Biosciences Inc. (OTCQB: QSAM) ("QSAM or the "Company") reported that it has signed a definitive Agreement and Plan of Merger (the "Agreement") providing for the acquisition of the Company by Telix Pharmaceuticals Limited (ASX: TLX) ("Telix") (Press release, QSAM Biosciences, FEB 7, 2024, View Source [SID1234639942]).

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Pursuant to the Agreement, QSAM stockholders will receive (i) $33.1 million in Telix ordinary shares ("Telix Shares") or cash, less an adjustment amount equal to QSAM’s indebtedness and payables as of the merger closing (the "Closing Consideration"), and (ii) contingent value rights ("CVRs") to receive future payments of up to $90 million upon the achievement of four clinical and commercial milestones within ten years of closing.

Prior to closing the merger, QSAM will effect a reverse stock split of its common stock in a ratio between 1:1000 and 1:2000. Each whole share of QSAM common stock outstanding after the reverse split will receive Telix Shares. Any remaining fractional shares of QSAM common stock resulting from the reverse split will be exchanged for an equivalent value in cash on a per share basis based on the per share price of Telix Shares as of the signing date of the Agreement. All QSAM stockholders will receive one CVR for each QSAM common share held prior to the reverse split.

Telix Shares issued to QSAM stockholders will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), but will be issued pursuant an exemption to the registration requirements thereunder, and more specifically, Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D; and as a result, will be subject to resale restrictions under Rule 144 of the Securities Act.

QSAM stockholders representing greater than a majority of the total voting stock of the Company have already approved the merger. Closing, however, is subject to various conditions set forth in the Agreement including, among others, the filing of a definitive information statement pursuant to Regulation 14C of the Securities Exchange Act of 1934, as amended (the "Information Statement"). The merger cannot be closed until 20 days after the mailing of the Information Statement to QSAM stockholders.

Dr. C. Richard Piazza, QSAM’s Executive Chairman and co-Founder, stated, "The signing of our Merger Agreement with Telix marks a major milestone for QSAM and our shareholders. We are thrilled to advance this transaction to signing and expect to complete the transaction in the first half of 2024, subject to the timing of our Information Statement and the satisfaction of customary closing conditions. We believe strongly that Telix is the right partner to advance Samarium-153-DOTMP through clinical trials and give this important technology the best chance to improve the lives of patients suffering from bone cancer. We are equally excited for our shareholders, as we believe this is a great outcome for their investments."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "The acquisition of QSAM provides Telix with an additional near-term therapeutic pipeline asset, further differentiating our innovation position in radiopharmaceuticals and building depth in Telix’s key disease focus areas of urological and musculoskeletal oncology. Samarium is a highly optimal radionuclide for treating bone metastases, and the combination of Orphan Drug Designation and Rare Pediatric Disease Designation status with Telix’s demonstrated experience in pharmacy-based cold-kit distribution has strong potential for a rapid pathway to commercialisation of this asset."

Additional details about the Agreement, the CVRs and other material aspects of the merger and agreements and transactions contemplated by the merger will be provided in the Company’s Form 8-K to be filed subsequently with the SEC.