On July 13, 2023 Alligator Bioscience AB reported financial results for H1 2023 and Q2 2023 and provides a business update (Press release, Alligator Bioscience, JUL 13, 2023, View Source [SID1234633214]).

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"This quarter Alligator has been strongly pushing ahead with the encouraging clinical development of our lead asset mitazalimab while continuing to lay the groundwork for our forthcoming discussions with regulators in the US and Europe on the optimal path to market. The latest interim analysis from OPTIMIZE-1 demonstrated yet again the potential superior clinical benefit of mitazalimab in combination with chemotherapy in pancreatic cancer compared to the standard of care. The compelling clinical case we are building for mitazalimab was further recognized this quarter with the award of Orphan Drug Designation by the FDA, as well as our presentation of additional data from OPTIMIZE-1 at this year’s prestigious ASCO (Free ASCO Whitepaper) annual meeting. Patient recruitment for the ongoing OPTIMIZE-1 Phase 2 study is now complete and we are eagerly looking forward to the accelerated top-line results at the beginning of next year. We are also extremely pleased to have successfully concluded our preferential rights issue, which will allow us to achieve our next mitazalimab milestones as we continue to build a pancreatic cancer program with the potential to deliver significant value for our company, shareholders and patients."Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
Mitazalimab

On June 27, Alligator hosted a Key Opinion Leader (KOL) webcast entitled "Improving Efficacy and Prolonging Survival in Pancreatic Cancer – A Look into Mitazalimab Interim Data from the OPTIMIZE-1 Phase 2 Study" featuring Dr. Zev Wainberg, Professor of Medicine at University of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal (GI) Oncology Program.

On June 26, Alligator announced the results of the second interim efficacy analysis from the OPTIMIZE-1 Phase 2 study evaluating mitazalimab in combination with mFOLFIRINOX in 1st line pancreatic cancer. The continued follow-up on the futility analysis cohort (23 patients) showed a deepening of tumor responses and an increase in the Objective Response Rate to 57% (from 52%). The interim ORR of 44% in the full OPTIMIZE-1 cohort (57 patients) confirms the benefit of mitazalimab added to mFOLFIRINOX. The median Duration of Response of 8.7 months compares favorably with 5.9[1] months reported with FOLFIRINOX in a similar patient population.

On June 5, Alligator presented an abstract at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, entitled "Efficacy and Safety of mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): an interim analysis of the OPTIMIZE phase 1b/2 study".
On May 18, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to mitazalimab for the treatment of pancreatic cancer, qualifying Alligator for various incentives, including potentially seven years of market exclusivity after regulatory approval in the US.

On April 27, Alligator and Amphera announced the successful dosing of the last patient in the REACTIVE-2 Phase 1 study evaluating mitazalimab in combination with MesoPher in patients with metastatic pancreatic cancer.
On April 12, Alligator announced the completion of patient enrolment in the OPTIMIZE-1 Phase 2 study ahead of schedule and confirmed that top-line data are expected early Q1 2024.

On April 3, Alligator announced that the FDA had cleared the company’s Investigational New Drug (IND) application, allowing Alligator to initiate the OPTIMIZE-2 Phase 2 study to evaluate the safety and efficacy of mitazalimab in combination with a PD-1 inhibitor in urothelial carcinoma. Alligator expects OPTIMIZE-2 to begin in H1 2024.
Preferential Rights Issue

On May 17, Alligator announced it will receive SEK 181 million in gross proceeds from the Preferential Rights Issue approved at the Extraordinary General Meeting held on April 24, in accordance with the proposal by the Board of Directors.
Exercise of development option by Orion

On May 11, Alligator announced that its partner Orion had exercised an option to develop bispecific antibodies under their initial research collaboration and license agreement entered into in 2021. This option exercise triggers the payment of an undisclosed milestone to Alligator.
ATOR-4066

On April 17, Alligator Principal Scientist Anette Sundstedt presented a poster entitled "ATOR-4066, a Neo-X-PrimeTM bispecific antibody targeting CD40 and CEA, activates myeloid cells in primary human tumors in vitro and induces anti-tumor immunity in vivo" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, Florida.
FINANCIAL SUMMARY FOR Q2 2023 and H1 2023
The financial summaries for the quarterly periods ending June 30th, 2023 and June 30th, 2022 are presented below.

All amounts in MSEK,
unless specified April – June 2023 April – June 2022
Net Sales 17.4 5.2
Operating profit/loss -63.7 -45.9
Profit/loss for the period -63.7 -45.7
Earnings per share (SEK)
before and after dilution -0.19 -0.21
Cash Flow 115.6 -41.7
Cash & Cash Equivalents 160.6 192.9

The financial summaries for the half-yearly periods ending June 30th, 2023 and June 30th, 2022 are presented below.

All amounts in MSEK,
unless specified January – June 2023 January – June 2022
Net Sales 27 10.5
Operating profit/loss -125.9 -88.9
Profit/loss for the period -126.3 -88.8
Earnings per share (SEK)
before and after dilution -0.46 -0.40
Cash Flow 63.4 -85.5
Cash & Cash Equivalents 160.6 192.9
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a conference call today at 4 p.m. CEST/ 10 a.m. ET for investors, analysts and media, where CEO Søren Bregenholt, CFO Marie Svensson, and CMO Sumeet Ambarkhane will present and comment on the Q2 interim report, which will be followed by a Q&A session. The call will be held in English.

The livestream call can be accessed through Alligator’s channels on LinkedIn or YouTube.