Apexigen Completes Business Combination to Become a Publicly Listed Immuno-oncology Company

August 1, 2022 at 8:00 AM EDT

-Common stock of Apexigen to commence trading on the Nasdaq Capital Market today under the ticker symbol “APGN”-

-Clinical pipeline includes multiple Phase 2 studies of sotigalimab, a CD40 agonist antibody with first-in-class and best-in-class potential-

-Gross proceeds from the transaction totaled $19.0 million, combining funds held in Brookline Capital Acquisition Corp.’s trust account and a concurrent PIPE financing-

SAN CARLOS, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, today announced the closing of its previously announced business combination with Brookline Capital Acquisition Corp. (“BCAC”), a special purpose acquisition company. Gross proceeds from this transaction totaled $19.0 million, which included funds held in BCAC’s trust account and a concurrent private placement investment in public equity (“PIPE”) financing. The combined, publicly traded company will operate under the name Apexigen, and its common stock will commence trading on the Nasdaq Capital Market on August 1, 2022, under the ticker symbol “APGN.” Apexigen’s management team will continue leading the combined company.

“Today marks an important turning point for Apexigen as we become a publicly listed biopharmaceutical company, poised to provide innovative solutions to overcome outstanding challenges in oncology,” said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. “This successful transaction propels our business forward, unlocks value for our stockholders, and enhances our ability to meet the needs of patients. Emerging data across our broad Phase 2 development program suggest there is significant opportunity for lead candidate sotigalimab, a potentially first-in-class and best-in-class CD40 agonist, to provide meaningful clinical benefit across multiple solid tumor indications. Sotigalimab’s encouraging and favorable safety profile may allow for combination with numerous other therapies, including PD-1 and other checkpoint inhibitors, chemotherapy, radiation therapy, cell therapies, and cancer vaccines. We believe sotigalimab has the potential to become a backbone of combination therapy to treat patients with cancer. With the opportunity for multiple potential approval pathways, we believe we are well-positioned to achieve value-creating milestones, including presentation of emerging data from ongoing Phase 2 trials. Given the broad therapeutic potential for sotigalimab, we will pursue opportunities for strategic partnerships to maximize the value of this important program.”

Apexigen Overview

Apexigen Wholly Owned Pipeline: Apexigen’s wholly owned pipeline is focused on innovative antibody-based therapeutics for oncology, with an emphasis on new immuno-oncology agents designed to harness the patient’s immune system to combat and eradicate cancer. The company’s pipeline of immuno-oncology therapeutic candidates is led by sotigalimab, which is currently in Phase 2 clinical development, and also includes multiple preclinical programs.

  • Sotigalimab: a potentially first-in-class and best-in-class CD40 agonist antibody, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and safety. Activation of CD40 initiates and amplifies multiple immune responses, engaging components of both the innate and adaptive arms of the immune system to work in concert against cancer. As such, CD40 activation could play a fundamental role in tumor-specific immune activation with prospective applicability for the treatment of multiple solid tumors. Given the breadth of potential of sotigalimab and the clinical signals observed, several Phase 2 trials are currently underway across multiple important cancer indications, lines of therapy and combination settings to maximize the therapeutic potential of sotigalimab.

    • The company has identified multiple regulatory approval pathways for sotigalimab. Building on encouraging data from the company’s Phase 2 trial of sotigalimab in combination with nivolumab to treat patients with PD-1 blockade refractory melanoma, in July 2022, the company received support from the FDA in connection with a Type C meeting. The purpose of the meeting was to discuss a potential randomized registration-enabling clinical trial of sotigalimab in combination with a PD-1 inhibitor to treat patients with PD-1 blockade refractory melanoma.

    • Recent published data from the multi-center Phase 2 PRINCE trial sponsored by the Parker Institute for Cancer Immunotherapy and Cancer Research Institute further support the advancement of sotigalimab in front-line metastatic pancreatic cancer in combination with standard-of-care chemotherapy. In June 2022, these data were published in Nature Medicine and featured in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Results demonstrated that novel circulating lymphocyte and tumor tissue biomarkers may be predictive of greater overall survival than patients without these biomarkers. Enhanced clinical benefit for sotigalimab/chemo correlated with several markers including baseline of elevated CD4 helper T-cell subpopulations in circulation and enhanced infiltration of activated antigen-presenting cells and certain oncogenes such as E2F in the tumors.

    • FDA has granted orphan drug designation to sotigalimab for the treatment of pancreatic cancer and sarcoma.

    • Updated Phase 2 data from sotigalimab in combination with chemoradiation as a neoadjuvant therapy in esophageal/gastro-esophageal junction cancer will be presented at the 2022 European Society for Medical Oncologists (ESMO) Congress in September 2022.

  • APX601: an anti-TNFR2 antagonist antibody designed to reverse immune suppression in the tumor microenvironment and unleash immune-mediated tumor killing activity through a unique mechanism of action. In preclinical models, APX601 depletes and inactivates TNFR2-expressing Tregs, reverses myeloid-mediated T cell suppression and directly kills TNFR2-expressing tumor cells. APX601 shows potent anti-tumor activity in tumor models. APX601 is IND-ready and Apexigen plans to advance APX601 into a Phase 1/2 clinical trial for the treatment of multiple tumor indications of unmet medical need when the company secures adequate financing.

  • APX801: an NK cell engager designed to specifically activate natural killer cells leading to effective killing of tumor cells currently at the pre-clinical stage.

Out-licensed Programs: Apexigen’s APXiMAB™ discovery platform has enabled the discovery of multiple protein therapeutic product candidates against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. In addition to the product candidates that the company wholly owns, several product candidates discovered through the use of the APXiMAB platform are in clinical development by the company’s licensees. The most advanced of these programs is Novartis’ Beovu® (brolucizumab-dbll) product, which received FDA approval in 2019 and is marketed in over 70 countries. Two of the company’s licensees are developing other programs in later-stage development: Simcere’s BD0801 is in Phase 3 clinical development in ovarian cancer and Mabwell’s 9MW0211 is in an adaptive, pivotal Phase 2/3 clinical trial in wet age-related macular degeneration.

Summary of Transactions

On March 17, 2022, Apexigen entered into a business combination agreement with BCAC. In addition, BCAC and Lincoln Park entered into a committed investment agreement and related registration rights agreement under which Apexigen will have the right to direct Lincoln Park to purchase up to an aggregate of $50 million of common stock over a 24-month period following the business combination, subject to certain conditions and restrictions.

As a result of the transaction, Apexigen received gross proceeds of $19.0 million prior to transaction expenses, which includes $4.5 million from BCAC’s trust account and $14.5 million of the expected $15.0 million from PIPE investors led by existing Apexigen stockholders. The company expects to receive the remaining $0.5 million once a final investor satisfies applicable regulatory requirements. The proceeds from the business combination and PIPE transactions do not include potential proceeds from Lincoln Park’s $50.0 million committed equity line. Please refer to the definitive proxy statement/prospectus filed with the U.S. Securities and Exchange Commission (“SEC”) by Apexigen for additional information regarding the transaction.

上一篇 下一篇