On March 18, 2022 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, and Brookline Capital Acquisition Corp. (Nasdaq: BCAC, BCACU, BCACW), a special purpose acquisition company ("SPAC"), reported they have entered into a definitive business combination agreement (Press release, Apexigen, MAR 18, 2022, View Source [SID1234610334]). Upon closing of the transaction, Brookline Capital Acquisition Corp. will be renamed Apexigen, Inc. (the "Combined Company") and will be led by Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. The Combined Company expects to list its stock on Nasdaq under the ticker symbol "APGN".

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A group of healthcare investors and existing Apexigen stockholders has committed to participate in the transaction through a $15 million common stock and warrant PIPE at a purchase price of $10 for a unit consisting of one share and a half warrant for one share. Gross proceeds of the transaction available to the Combined Company at closing will be approximately $73 million (assuming no redemptions from Brookline Capital Acquisition Corp.’s trust account and before transaction expenses). In addition, Brookline Capital Acquisition Corp. and Lincoln Park have entered into a committed investment agreement under which the Combined Company would have the right to direct Lincoln Park to purchase up to an aggregate of $50 million of common stock of the Combined Company over a 24-month period (subject to certain requirements under the investment agreement), providing financing flexibility to the Combined Company.

"We’re tremendously pleased with the strong support from our investors and Lincoln Park, as well as from the experienced team at Brookline Capital Acquisition Corp. and their public life science investment banking affiliate, Brookline Capital Markets," said Dr. Yang. "This transaction brings Apexigen public and strengthens our balance sheet to advance the Phase 2 development of our lead program, sotigalimab, as well as to maximize the therapeutic potential of Apexigen’s APXiMAB antibody discovery platform and innovative pipeline of other antibody therapeutics. We remain encouraged by emerging data from ongoing Phase 2 clinical trials of sotigalimab, a potentially first-in-class and best-in-class CD40 agonist that may provide superior clinical benefit across multiple important cancer indications. Together with Brookline Capital Acquisition Corp., we look forward to driving sotigalimab through Phase 2 development and delivering on our shared vision to overcome outstanding challenges in oncology."

Dr. Samuel P. Wertheimer, Chairman and Chief Executive Officer of Brookline Capital Acquisition Corp., commented, "We are thrilled to partner with Apexigen to power the next generation of immuno-oncology therapeutics. Apexigen’s validated APXiMAB antibody discovery platform and expanding pipeline hold significant promise across multiple cancer indications with high unmet needs, as well as potential applications beyond oncology. We have great confidence in management’s ability to lead Apexigen through this next phase of growth as a publicly listed company, to reach new inflection points across its pipeline and to drive long-term value for stockholders."

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 that may 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 a multi-cellular immune response, 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. To maximize the therapeutic potential of sotigalimab, several Phase 2 trials are currently underway across multiple important cancer indications, lines of therapy and combination settings.
Phase 2 preliminary data from sotigalimab in combination with chemoradiation as a neoadjuvant therapy in esophageal/gastro-esophageal junction cancer is expected 1H22.
Phase 2 preliminary data from sotigalimab in combination with standard of care chemotherapy in sarcoma is expected by year-end 2022.
The company intends to consult with the FDA about a potential registrational path in post-anti-PD-(L)1 melanoma in mid-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. APX601 can deplete and inactivate TNFR2-expressing Tregs, reverse myeloid-mediated T cell suppression and directly kill TNFR2-expressing tumor cells. APX601 shows potent anti-tumor activity and is well-tolerated in preclinical models. Apexigen plans to develop APX601 for the treatment of multiple tumor indications of unmet medical need and continues to progress toward a mid-2022 IND application filing.
APX801: an NK cell engager designed to specifically activate natural killer cells leading to effective killing of tumor cells.
Partnered Programs: Apexigen’s pipeline includes five out-licensed product candidates that were discovered using the APXiMAB platform. One of these out-licensed products is commercially available and generating royalties for Apexigen. The other out-licensed product candidates are advancing in clinical development.

APXiMAB discovery platform: This platform has enabled Apexigen and its licensing partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies.

Summary of Transaction
The transaction values Apexigen at $205 million on a net-equity basis, net of exercise proceeds for Apexigen’s pre-closing options and warrants. As a result of the transaction, gross proceeds available to the Combined Company at closing will be approximately $73 million funded by approximately $58 million in cash held in Brookline Capital Acquisition Corp.’s trust account (assuming no stockholders exercise their redemption rights at closing and before transaction expenses) and $15 million from a fully committed PIPE that involves the sale of units consisting of one share and half a warrant for one share at a purchase price of $10.00 per unit. The PIPE includes participation from healthcare institutional and individual investors. This does not include proceeds from Lincoln Park’s $50 million committed equity line.

In addition, Brookline Capital Acquisition Corp. and Lincoln Park have entered into a committed investment agreement and related registration rights agreement under which the Combined Company will have the right to direct Lincoln Park to purchase up to an aggregate of $50 million of common stock of the Combined Company over a 24-month period under certain conditions and restrictions as outlined in Brookline’s Form 8-K. Sales of shares of common stock to Lincoln Park would be subject to the filing and effectiveness of a registration statement with the Securities and Exchange Commission (the "SEC"), which would not occur until after closing the business combination between Apexigen and Brookline. Lincoln Park has agreed not to cause or engage in any manner in any direct or indirect short selling or hedging of shares of common stock of the Combined Company.

The Boards of Directors of Brookline Capital Acquisition Corp. and Apexigen have unanimously approved the merger and related agreements and transactions. Following the Merger, the Combined Company’s board of directors shall consist of seven members, of which Apexigen will select six and Brookline Capital Acquisition Corp. will select one. Completion of the merger is subject to approval of Brookline Capital Acquisition Corp. and Apexigen stockholders and other customary closing conditions, including the filing of a definitive proxy statement with the SEC. The parties currently expect to complete the transactions in July 2022.

Brookline Capital Markets is acting as capital markets advisor to Brookline Capital Acquisition Corp. Wedbush PacGrow is acting as exclusive strategic financial advisor to Apexigen.

DLA Piper LLP (US) is serving as legal advisor to Brookline Capital Acquisition Corp. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal advisor to Apexigen.

For more information, please visit www.brooklinecapitalacquisitioncorp.com.

Conference Call Information
Apexigen and Brookline Capital Acquisition Corp. will host a conference call today, Friday, March 18, 2022, at 8:30 a.m. Eastern Time, to discuss the proposed transaction. To access the conference call, please dial 1-877-407-9716 (domestic) or 1-201-493-6779 (international) at least 10 minutes prior to the start time and reference conference ID: 13727957. A live or archived webcast of the conference call can be accessed here or in the News & Events section of the Apexigen website at View Source

On March 18, 2022 EpiVax reported the 1st Annual Tregitope Summit will be held on Monday, May 16th 2022 at the The Westin Boston Seaport District (Press release, EpiVax, MAR 18, 2022, View Source [SID1234610333]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Registration is now open!

Organizing Theme: Activation of Regulatory T Cells for Induction of Immune Tolerance

Interest in therapeutics specifically for inducing and activating Tregs by various approaches including administration of Tregitopes, is growing, and we see the need for an annual meeting for academic and industry researchers to share ideas, create new collaborations and continue to expand this growing therapeutic area.

Session 1: Treg cells as therapeutics
Chair: Dr. David Scott, Uniformed Services University Health System

Session 2: Protein Therapeutics (including Tregitopes) and antigen specific approaches to Address Tolerance: Therapeutics designed to Stimulate Tregs
Chair: Dr. Amy Rosenberg, EpiVax

We encourage you to attend this unique forum. Registration link here: https://bit.ly/EpiVaxTregitopeSummit

Attending Hanson Wade’s Treg Directed Therapies? We’ve planned the Tregitope Summit for the Monday before for ease of attendance!

On March 18, 2022 Lynk Pharmaceuticals Co., Ltd. (Lynk Pharmaceuticals) and Simcere (2096.HK) reported a strategic partnership to develop and commercialize a highly selective JAK1 inhibitor LNK01001 in China (Press release, Lynk Pharmaceuticals, MAR 18, 2022, View Source [SID1234610332]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Lynk Pharmaceuticals is responsible for the development of the product. Simcere will obtain the exclusive rights to market LNK01001 for the indications of rheumatoid arthritis and ankylosing spondylitis in China, after completing the payment of all commercialization rights and interests.

JAK1 belongs to an important subgroup of the cytosolic tyrosine kinase Janus kinase (JAKs) family that is closely related to the pathogenesis of various autoimmune diseases. 6 head-to-head clinical studies have demonstrated the huge clinical potential of selective JAK1 inhibitor as an emerging new treatment of rheumatoid arthritis, with significant advantages over methotrexate and several biological agents. Published data of JAK1 inhibitor as treatment of ankylosing spondylitis have shown sufficient superiority of JAK1 inhibitor in a head-to-head study over Humira, the TNFα targeting blockbuster. Selective JAK1 inhibitors are thus considered to be the next superstar of therapies.

LNK01001 is a highly selective JAK1 inhibitor with therapeutic potential for various autoimmune diseases. Clinical trials in Chinese and western patient groups are being carried out, including phase II studies in China in three indications of rheumatoid arthritis, ankylosing spondylitis, and atopic dermatitis. Previously, LNK01001 has completed Phase I clinical studies in healthy subjects in China and Australia. The results of preclinical data show that LNK01001 has higher selectivity and potentially better safety than other marketed JAK inhibitors. It is expected to provide patients with newer, safer and more effective treatment options.

"We are very pleased to have reached the commercialization cooperation of LNK01001 with Simcere in China. It marks a big step forward towards commercialization for Lynk through Simcere’s marketing strength." Said Dr. Zhao-Kui (ZK) Wan, founder & CEO of Lynk Pharmaceuticals, "Simcere is an innovation and R&D-driven company that ranks among top Chinese pharmaceutical enterprises. Its proven commercialization excellence, combining with our R & D capability, will likely to create more benefit for the patients sooner."

Mr. Jinsheng Ren, Chairman and CEO of Simcere said: "Autoimmune disease therapeutic are one of Simcere’s three strategic focuses. We are very pleased to have reached this cooperation with Lynk Pharmaceuticals. We will work closely with our partner with all efforts, and accelerate the development and commercialization process of LNK01001, to bring safer and more effective treatments to patients."

On March 18, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022 (Press release, Calliditas Therapeutics, MAR 18, 2022, View Source [SID1234610330]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Everest received Breakthrough Therapy Designation (BTD) from the China Center for Drug Evaluation, National Medical Products Administration (CDE,NMPA) in December, 2020 and have completed enrollment of the 60 Chinese patients required to complement the submission of the global data set from the NefIgArd trial. Everest plans to conduct an interim analysis of the Chinese patients and this is expected to lead to a regulatory submission in China in 2H of 2022.

"We are excited about the possibility of a significantly earlier potential approval in China, and are happy to support our partner Everest in their endeavors to bring the first approved medicine for IgA nephropathy to Chinese patients," said CEO Renée Aguiar-Lucander.

As previously reported, in 2019 Calliditas entered into a license agreement to develop and commercialize NEFECON in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN). In March 2022, Calliditas expanded this partnership to include South Korea.

On March 18, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, Decibel Therapeutics, MAR 18, 2022, View Source [SID1234610323]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In 2021, Decibel made significant progress across our pipeline and towards our goal to bring transformative treatments to patients with hearing and balance disorders. We are on track to meet a number of important milestones in 2022, including the initiation of the first clinical trial of our lead gene therapy candidate, DB-OTO, designed to treat congenital hearing loss resulting from an otoferlin deficiency," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "Among the milestones expected in 2022, we look forward to reporting the results of the interim analysis of our Phase 1b clinical trial of DB-020 in patients receiving cisplatin chemotherapy. We were also pleased that our gene therapy research and development collaboration with Regeneron was extended, that we expanded our preclinical gene therapy pipeline, and that we augmented our excellent Board of Directors."

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration and/or a Clinical Trial Application (CTA) in Europe for DB-OTO in 2022. Decibel also anticipates initiating a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022.
Presented New Preclinical Data at the 45th Annual Association for Research in Otolaryngology Conference (ARO) for DB-OTO and AAV.104 Programs: In February 2022, Decibel presented preclinical DB-OTO data as well as preclinical data highlighting the identification of proprietary, cell-selective promoters for three of its gene therapy pipeline programs at ARO. New DB-OTO data further characterized expression of otoferlin over time following DB-OTO administration in mice and non-human primates consistent with the expression previously reported in mice that achieved stable functional recovery. Decibel also shared functional recovery and tolerability data associated with DB-OTO dosing over a 10-fold dose range in mice. Decibel also presented data on how the Company deploys its platform to develop novel, proprietary, cell-selective promoters and the potential advantages that cell-selective expression may confer to its gene therapy preclinical programs.
Announced AAV.104 Gene Therapy Program for Restoration of Hearing in Patients with Congenital Hearing Impairment Due to Recessive Mutations in the Stereocilin (STRC) Gene: In November 2021, Decibel announced the target for its discovery stage program, AAV.104, which aims to restore hearing to individuals with an STRC deficiency, the second most common cause of autosomal recessive, non-syndromic, congenital hearing loss. The AAV.104 program is designed to express STRC selectively in outer hair cells, thus providing STRC specifically in its natural cellular location, a strategy that we believe has the potential to restore expression of the protein and hearing.
Product Candidate Selection for AAV.103 Program Anticipated in 2022: Decibel intends to select a product candidate for its AAV.103 program to restore hearing to individuals with a gap junction beta-2 (GJB2) deficiency, the most common cause of autosomal recessive, non-syndromic, congenital hearing loss.
Gene Therapies for Hair Cell Regeneration

Plans to Announce AAV.201 Program Target(s): Decibel continues to advance gene therapy programs for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy (BVP). Decibel plans to announce the program target(s) for its AAV.201 program in 2022. Our AAV.201 program is an AAV-based gene therapy that utilizes a proprietary supporting cell-selective promoter to express ATOH1 in combination with an additional factor. Our AAV.201 program aims to restore balance by promoting regeneration of Type I and Type II hair cells in the vestibular system.
Otoprotection Therapeutic

Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss Expected in the First Half of 2022: Decibel expects to report the results of an interim analysis from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss, a serious and debilitating condition for which there are no approved therapies, in the first half of 2022. Cisplatin, a commonly used chemotherapy agent, is known to cause hearing loss, tinnitus and speech recognition difficulty. DB-020 comprises a proprietary formulation of sodium thiosulfate that has been optimized for delivery to the ear. DB-020 is designed to protect hearing without interfering with cisplatin’s anti-cancer activity by locally disabling cisplatin in the cochlea.
Research Highlights:

Publication of Foundational Study of Noise-related Inner Ear Damage: In September 2021, Cell Reports published findings from a study of noise-related inner ear damage by the University of Maryland School of Medicine in collaboration with Decibel and the Karolinska Institute. The study’s aim was to generate an atlas of gene expression changes across inner ear cell types following noise damage. The study represents the first such comprehensive analysis and provides a foundational dataset that can be mined for future studies of the inner ear.
Corporate Highlights:

Strengthened Board of Directors with Key Appointments: In December 2021, Decibel announced the appointments of Alison Finger, MBA, and Saraswathy Nochur, Ph.D. to its Board of Directors. Previously, in June 2021, William (Bill) H. Carson, M.D., was appointed as Chairman of the Board of Directors.
Extended Research Term Under Strategic Collaboration with Regeneron to Discover and Develop Gene Therapies for Hearing Loss: In November 2021, Decibel announced that Regeneron extended the research term of its collaboration to discover and develop gene therapies for hearing loss. The research term was extended to November 15, 2023, and Regeneron is obligated to pay Decibel the associated extension fee of $10 million in the fourth quarter of 2022. Through the collaboration, Regeneron provides Decibel with broad access to its proprietary suite of technologies to support Decibel’s goal of discovering new medicines for congenital, monogenic hearing loss. Decibel retains worldwide development and commercialization rights to the product candidates being developed in the collaboration and is obligated to pay Regeneron tiered royalties based on net sales.
Fourth Quarter and Full Year 2021 Financial Results:

Cash Position: As of December 31, 2021, cash, cash equivalents and available-for-sale securities were $162.3 million, compared to $54.3 million as of December 31, 2020. The increase in cash, cash equivalents and available-for-sale securities was primarily due to net proceeds of $125.0 million from the company’s IPO in February 2021 and net proceeds of $27.4 million from the second closing of our Series D fundraising in February 2021 offset by operating expenses.
Research and Development Expenses: Research and development expenses were $8.0 million for the fourth quarter of 2021, compared to $7.9 million for the same period in 2020. Research and development expenses were $29.8 million for the full year 2021, compared to $25.3 million for the full year 2020. The increase in research and development expenses for the full year 2021 was primarily due to higher development costs related to manufacturing activities and IND-enabling studies for DB-OTO.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the fourth quarter of 2021, compared to $5.1 million for the same period in 2020. General and administrative expenses were $20.4 million for the full year 2021, compared to $14.2 million for the full year 2020. The increase in general and administrative expenses for the full year 2021 was primarily attributable to higher costs associated with operating as a public company, including D&O insurance and accounting and legal fees, as well as higher wages due to increased headcount.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.