Global Polymerase Chain Reaction (PCR) for qPCR, dPCR, Singleplex & Multiplex Markets, 2023-2024 and 2027: Disruption Looms, Syndromic Diagnostics Looks Unstoppable, The Instrumentation Curve – ResearchAndMarkets.com

Global Polymerase Chain Reaction (PCR) for qPCR, dPCR, Singleplex & Multiplex Markets, 2023-2024 and 2027: Disruption Looms, Syndromic Diagnostics Looks Unstoppable, The Instrumentation Curve – ResearchAndMarkets.com




Global Polymerase Chain Reaction (PCR) for qPCR, dPCR, Singleplex & Multiplex Markets, 2023-2024 and 2027: Disruption Looms, Syndromic Diagnostics Looks Unstoppable, The Instrumentation Curve – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “PCR Markets. Forecasts for qPCR, dPCR, Singleplex & Multiplex Markets and by Application, Product and Place. With Executive and Consultant Guides, Including Customized Forecasting and Analysis. 2023 to 2027” report has been added to ResearchAndMarkets.com’s offering.


The report forecasts the market size over five years with the only analysis available that breaks out Singleplex and Multiplex testing markets.

COVID-19 Diagnostics is driving PCR into a dominant technology role and spurring the growth of new PCR based technologies. Will thermal cycling become obsolete? Are singleplex tests going to be obsolete? Will routine respiratory screening become a reality? Will diagnostics move into the Physician’s Office or even the Home? Will digital PCR become the new lab standard?

PCR has proved itself in the market. And the new generation of PCR, digital PCR promises to keep that success going. Driven even faster by the huge demand for pandemic diagnostics. New levels of sensitivity have implications for Liquid Biopsy and Cancer Screening markets.

Lowering costs, improving outcomes and even helping in the battle against Anti Microbial Resistance. Learn about this market including the issues and outlooks. The two key trends of Point of Care Testing and Molecular Diagnostics are merging with spectacular success.

Make investment decisions and valuations with confidence using the latest data.

Key Topics Covered:

1 Market Guides

1.1 Situation Analysis

1.2 Guide for Executives and Marketing Staff

1.3 Guide for Investment Analysts and Management Consultants

2 Introduction and Market Definition

2.1 What are PCR Technologies?

2.2 PCR and Syndromic Testing

2.3 Market Definition

2.3.1 Market Size

2.3.2 Currency

2.3.3 Years

2.4 Methodology

2.4.1 Methodology

2.4.2 Sources

2.4.3 Authors

2.5 Perspective: Healthcare and the IVD Industry

2.5.1 Global Healthcare Spending

2.5.2 Spending on Diagnostics

2.5.3 Important Role of Insurance for Diagnostics

3 PCR – Guide to PCR Technologies

3.1 Concepts

3.1.1 Method

3.2 Applications

3.2.1 Finding Specific DNA

3.2.2 Measuring DNA

3.2.3 Medical and Diagnostic Applications

3.2.3.1 Carrier, prenatal and tissue typing

3.2.3.2 Cancer Diagnosis and Management

3.2.3.3 Infectious Disease – New Levels of Accuracy and Sensitivity

3.2.3.4 Forensic Applications

3.2.3.5 Science and Research

3.3 PCR – Advantages and Disadvantages

3.4 Different Types of PCR

3.4.1 Simple Changes

3.4.1.1 Multiplex-PCR

3.4.1.2 VNTR PCR

3.4.1.3 Asymmetric PCR

3.4.1.4 Long PCR

3.4.1.5 Nested PCR

3.4.1.6 Quantitative PCR

3.4.1.7 Hot-start PCR

3.4.1.8 Touchdown PCR

3.4.1.9 Assembly PCR

3.4.1.10 Colony PCR

3.4.1.11 Suicide PCR

3.4.1.12 Cold PCR

3.4.2 Digital PCR

3.4.2.1 Droplet Digital PCR

3.4.2.2 Comparison between dPCR and Real-Time PCR (qPCR)

3.4.2.3 Digital PCR in Use

3.4.2.4 Digital PCR Commercial History

3.4.3 Isothermal PCR

4 Industry Overview

4.1 Players in a Dynamic Market

4.1.1 Academic Research Lab

4.1.2 Diagnostic Test Developer

4.1.3 Instrumentation Supplier

4.1.4 Chemical/Reagent Supplier

4.1.5 Pathology Supplier

4.1.6 Independent Clinical Laboratory

4.1.7 Public National/regional Laboratory

4.1.8 Hospital Laboratory

4.1.9 Physicians Office Lab (POLS)

4.1.10 Audit Body

4.1.11 Certification Body

5 Market Trends

5.1 Factors Driving Growth

5.1.1 A New Standard

5.1.2 Down the Curve We Go

5.1.3 Multiplexing

5.1.4 Syndromic Diagnostics Looks Unstoppable

5.1.5 The Genetic Blizzard

5.2 Factors Limiting Growth

5.2.1 The Cost Curve

5.2.2 The Other Guys

5.2.3 Systemic Roadblocks

5.3 Diagnostic Technology Development

5.3.1 The Instrumentation Curve

5.3.2 Shifting Role of Diagnostics

5.3.3 Diagnostics Moves Out of the Hospital

5.3.4 Disruption Looms

5.3.5 The Next Five Years

6 PCR Recent Developments

6.1 Recent Developments – Importance and How to Use This Section

6.1.1 Importance of These Developments

6.1.2 How to Use This Section

6.2 Multiplex Meningitis/Encephalitis Panel Market Expanding

6.3 Sensible Dx to Launch 10-Minute POC PCR System

6.4 ReadyGo Dx Plans to Make MDx Testing Easy

6.5 Transformative Biotech Acquires Summit Biolabs’ PCR Tech

6.6 Visby Medical POC STI Multiplex Test Cleared

6.7 Sherlock Biosciences Buys Sense Biodetection

6.8 Agilent, Qiagen Nab FDA Approvals for Lung Cancer Treatment CDx

6.9 HealthTrackRx Investing in Rapid Turnaround Times

6.10 LEX Dx Developing Ultra-Fast Low-Cost PCR

6.11 Next-Gen Dx Technologies Face Uncertain Future

6.12 Rover Dx Developing All-Optical Rapid POC qPCR Platform

6.13 ProtonDx Plans Rapid Molecular Dx Instrument

6.14 Innova Medical Group Licenses MDx Tech

6.15 MicroGEM to Grow Market for 30-Minute RT-PCR System

6.16 Precipio Receives CE-IVD Mark for Cancer Panels

6.17 Siemens Healthineers to Develop Next-Gen MDx Platform

6.18 New York State Approves Enzo Biochem HPV Molecular Test

6.19 Grip Molecular Developing Biosensor Panel to Detect Respiratory Infections

6.20 Co-Diagnostics Seeks EUA for At-Home PCR Diagnostic System

6.21 Chelex-Based Protocol to Reduce Cost, Time for PCR Testing

6.22 Finnish Firms to Form Point-of-Care Testing Firm

6.23 Visby Medical Scales Up Handheld PCR Test for STIs

6.24 DnaNudge Raises $60M

6.25 Roche Reports Diagnostics Revenue Up 51 Percent

6.26 BforCure Preparing Multiple ID Panels for PoC qPCR Platform

6.27 Enzo Biochem, CLX Health Partner for C19 Testing for Travel

6.28 Bio Molecular Systems Gets Approval for Portable PCR Cycler

6.29 Roche Acquires GenMark

6.30 Handheld qPCR Devices Close to Commercialization

6.31 Nuclein Closes $14M in Funding

6.32 WuXi Diagnostics Closes $150M Series B Financing Round

6.33 Visby Medical to develop rapid Flu-COVID PCR test

6.34 Thermo Fisher to acquire Mesa Biotech

6.35 Scope Fluidics Secures €6.2M Supporting Rapid MDx

6.36 SARS- Testing Demand to Continue ‘Through 2022, and Beyond’

6.37 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection

6.38 Fluidigm Saliva Test for SARS-CoV-2 Uses Extraction-free RT-PCR

6.39 Visby Medical Gonorrhea Test Wins $19M AMR Diagnostic Competition

7 Profiles of Key PCR Companies

  • Abacus Diagnostica
  • Abbott Laboratories
  • Accelerate Diagnostics
  • Ador Diagnostics
  • ADT Biotech
  • Agilent/Dako
  • Akonni Biosystems
  • Alveo Technologies
  • Amoy Diagnostics Co., Ltd.
  • Anatolia Geneworks
  • Applied BioCode
  • Applied DNA Sciences
  • Aurora Biomed
  • Aus Diagnostics
  • AVIVA Systems Biology
  • Beckman Coulter Diagnostics
  • Becton, Dickinson and Company
  • Binx Health
  • Biocartis
  • bioMerieux Diagnostics
  • Bioneer Corporation
  • Bio-Rad Laboratories, Inc
  • Bosch Healthcare Solutions GmbH
  • Bruker
  • Caris Molecular Diagnostics
  • Cepheid (Danaher)
  • Credo Diagnostics Biomedical
  • CTK Biotech
  • Cue Health
  • Curetis N.V./Curetis GmbH
  • Diagenode Diagnostics
  • Diasorin S.p.A
  • Eiken Chemical
  • Enzo Biochem
  • Eurofins Scientific
  • Fluxergy
  • Fujirebio
  • Genetic Signatures
  • GenMark Dx (Roche)
  • Greiner Bio-One
  • Hibergene Diagnostics
  • Hologic
  • Immunexpress
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • LightDeck Diagnostics
  • Luminex Corp (DiaSorin)
  • LumiraDx
  • Maxim Biomedical
  • Meridian Bioscience
  • Mesa Biotech (Thermo Fisher)
  • Millipore Sigma
  • Minute Molecular
  • Mobidiag (Hologic)
  • Molbio Diagnostics
  • Nanomix
  • NGeneBio
  • Novacyt
  • Operon
  • Panagene
  • Perkin Elmer
  • Precipio
  • Primerdesign (Novacyt)
  • Promega
  • Prominex
  • Qiagen
  • QuantuMDx
  • QuidelOrtho
  • Randox Toxicology
  • Roche Molecular Diagnostics
  • Saw Diagnostics
  • Scope Fluidics
  • SD Biosensor
  • Seegene
  • Siemens Healthineers
  • SkylineDx
  • Sona Nanotech
  • SpeeDx
  • Standard BioTools
  • Stilla Technologies
  • T2 Biosystems
  • Thermo Fisher Scientific Inc.
  • Vela Diagnostics
  • Veramarx
  • Veredus Laboratories
  • Vircell
  • Visby Medical
  • XCR Diagnostics
  • YD Diagnostics
  • Zhejiang Orient Gene Biotech

For more information about this report visit https://www.researchandmarkets.com/r/oktkh1

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Molecular Diagnostics for Cancer Markets with Executive & Consultant Guides – Forecasts to 2027 by Cancer Type, Product, and Place – ResearchAndMarkets.com

Molecular Diagnostics for Cancer Markets with Executive & Consultant Guides – Forecasts to 2027 by Cancer Type, Product, and Place – ResearchAndMarkets.com




Molecular Diagnostics for Cancer Markets with Executive & Consultant Guides – Forecasts to 2027 by Cancer Type, Product, and Place – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Molecular Diagnostics for Cancer: Markets Forecasts by Cancer Type, Product, and Place with Executive & Consultant Guides and Customization. 2023 to 2027” report has been added to ResearchAndMarkets.com’s offering.


Exciting technical developments especially in companion diagnostics, hold the promise of a dynamic, growing and evolving world market where single laboratories serve a global patient base.

The report provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help understand test pricing in detail. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions.

Assistance in providing specific growth and market size estimates for new technology tests is normally provided without additional charges. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities’ growth. Again, assistance in using the information is normally provided without additional charges.

After a pandemic interruption the market for Cancer Molecular Diagnostics is back on the growth path. And growth is accelerating in every segment. We include a special segment Cancer Companion Diagnostics, a new segment of the market that is reshaping the industry. Over 120 companies are profiled. A range of dynamic trends are pushing market growth and company valuations.

Key Market Trends

  • Personalized medicine
  • Pharmacogenomics
  • Liquid biopsy
  • Minimal residual disease testing
  • Emergence of new economies with large markets
  • Physician diagnostics being displaced by new intelligent diagnostic tests

Key Topics Covered:

1 Market Guides

1.1 Cancer MDx – Strategic Situation Analysis

1.2 Guide for Executives, Marketing, and Business Development Staff

1.3 Guide for Management Consultants and Investment Advisors

2 Introduction and Market Definition

2.1 What are Molecular Diagnostics?

2.2 The Diagnostics Revolution

2.3 Market Definition

2.3.1 Revenue Market Size

2.4 Methodology

2.4.1 Methodology

2.4.2 Sources

2.4.3 Authors

2.5 Perspective: Healthcare and the IVD Industry

2.5.1 Global Healthcare Spending

2.5.2 Spending on Diagnostics

2.5.3 Important Role of Insurance for Diagnostics

3 Market Overview

3.1 Market Segments

3.1.1 Traditional Market Segmentation

3.1.2 Laboratory Focus and Segmentation

3.2 Industry Structure

3.2.1 Hospital Testing Share

3.2.2 Economies of Scale

3.2.3 Physician Office Labs

3.2.4 Physicians and POCT

4 Market Trends

4.1 Factors Driving Growth

4.1.1 New Diagnostics Create New Markets

4.1.2 New Roles for Diagnostics

4.1.3 The Aging Effect

4.1.4 Expanding the Pharmaceutical Toolbox

4.1.5 Regulatory Retreat

4.2 Factors Limiting Growth

4.2.1 Falling Prices

4.2.2 Lower Costs

4.2.3 Wellness has a Downside

4.3 Instrumentation, Automation and Diagnostic Trends

4.3.1 Traditional Automation and Centralization

4.3.2 The New Automation, Decentralization and Point Of Care

4.3.3 Instruments Key to Market Share

4.3.4 Bioinformatics Plays a Role

4.3.5 PCR Takes Command

4.3.6 Next Generation Sequencing Fuels a Revolution

4.3.7 NGS Impact on Pricing

4.3.8 Whole Genome Sequencing, A Brave New World

4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment

4.3.10 Shifting Role of Diagnostics

4.3.11 Multiplexing and Foundation One

4.3.12 Pharmacogenomics Technology

4.3.13 Gene Editing and Gene Therapy

5 Molecular Diagnostics Recent Developments

5.1 Recent Developments – Importance and How to Use This Section

5.1.1 Importance of These Developments

5.1.2 How to Use This Section

5.2 Grail Cancer Test Faces New Clinical Questions

5.3 Freenome Acquires Cancer Dx Firm Oncimmune

5.4 Quest Diagnostics to Acquire Liquid Biopsy Firm Haystack Oncology

5.5 Ultima Genomics, Genome Insight Partner on WGS for Cancer Patients

5.6 Digital Pathology Meets Cancer Sequencing

5.7 Exact Sciences Preps Expanded Oncology Portfolio

5.8 Qiagen Details Oncology Plans for Digital PCR Platform

5.9 Sema4 Exiting Reproductive Health Screening

5.10 Thermo Fisher Introduces Cancer Profiling Assay

5.11 Genomic Test IDs Cysts Likely to Progress to Cancer

5.12 Naveris to Commercialize Virus-Related Cancer Tests

5.13 Larger Liquid Biopsy Panels Loom

5.14 Halo Diagnostics to Offer Genomic Profiling Tests

5.15 BillionToOne Raises $125M

5.16 Local Cancer Genomic Profiling Options Grow

5.17 German MDx Firm Mainz Biomed Raises $10M in IPO

5.18 Guardant Health Q3 Revenues Up 27 Percent

5.19 BforCure Raises $2.3M to Adapt Rapid PCR Platform for Cancer Detection

5.20 Nucleix to Invest in Early-Stage Lung Cancer Dx

5.21 Labcorp, GeneCentric Partnering on Development of RNA-Based Cancer Diagnostics

5.22 Grail Gets Approval for Galleri Multicancer Test

5.23 Finnish Firms to Form Point-of-Care Testing Firm

5.24 Datar Cancer Genetics Expands to Dx and Screening

5.25 HTG Molecular Diagnostics: HTG Transcriptome Panel

5.26 PacBio’s Omniome Acquisition Shortens Path to Clinical

5.27 Invitae to Acquire Genosity for $200M

5.28 Bio-Techne Obtains CE Mark for Exosomal Liquid Biopsy Prostate Test

5.29 Agilent Technologies to Acquire Liquid Biopsy Firm Resolution Bioscience

5.30 Natera Revenues Grow 35 Percent

5.31 AnchorDx Closes $40M Financing Round

5.32 Exact Sciences Strategy for End-to-End Cancer Testing

5.33 Genomics England: Whole Genome Sequencing for Cancer Patients to Launch

6 Profiles of Key MDx Companies

6.1 10x Genomics, Inc.

6.2 Abbott Laboratories

6.3 AccuraGen Inc.

6.4 Adaptive Biotechnologies

6.5 Aethlon Medical

6.6 Agilent/Dako

6.7 Anchor Dx

6.8 ANGLE plc

6.9 ARUP Laboratories

6.10 AVIVA Systems Biology

6.11 Baylor Miraca Genetics Laboratories

6.12 Beckman Coulter Diagnostics

6.13 Becton, Dickinson and Company

6.14 BGI Genomics Co. Ltd

6.15 BillionToOne

6.16 Bioarray Genetics

6.17 Biocartis

6.18 Biocept, Inc.

6.19 Biodesix Inc.

6.20 BioFluidica

6.21 BioGenex

6.22 BioIVT

6.23 Biolidics Ltd

6.24 bioMerieux Diagnostics

6.25 Bioneer Corporation

6.26 Bio-Rad Laboratories, Inc

6.27 Bio-Reference Laboratories

6.28 Bio-Techne

6.29 Bioview

6.30 Bolidics

6.31 Boreal Genomics

6.32 Bristol-Myers Squibb

6.33 Burning Rock

6.34 Cardiff Oncology

6.35 Caris Molecular Diagnostics

6.36 Castle Biosciences, Inc.

6.37 Celemics

6.38 CellCarta

6.39 CellMax Life

6.40 Cepheid (Danaher)

6.41 Charles River Laboratories

6.42 Circulogene

6.43 Cizzle Biotech

6.44 Clinical Genomics

6.45 Cytolumina Technologies Corp.

6.46 Datar Cancer Genetics Limited

6.47 Diagnologix LLC

6.48 Diasorin S.p.A.

6.49 Dxcover

6.50 Enzo Biochem

6.51 Epic Sciences

6.52 Epigenomics AG

6.53 Eurofins Scientific

6.54 Exact Sciences

6.55 Fabric Genomics

6.56 Fluxion Biosciences

6.57 Freenome

6.58 FUJIFILM Wako Diagnostics

6.59 Fulgent Genetics

6.60 Fyr Diagnostics

6.61 GeneFirst Ltd.

6.62 Genetron Holdings

6.63 GenomOncology

6.64 GILUPI Nanomedizin

6.65 Guardant Health

6.66 HansaBiomed

6.67 HeiScreen

6.68 Helomics

6.69 HTG Molecular Diagnostics

6.70 iCellate

6.71 ICON PLC

6.72 Illumina

6.73 Incell Dx

6.74 Inivata

6.75 INOVIQ

6.76 Integrated Diagnostics

6.77 Invitae Corporation

6.78 Invivogen

6.79 Invivoscribe

6.80 Janssen Diagnostics

6.81 Lunglife AI Inc

6.82 MDNA Life SCIENCES, Inc.

6.83 MDx Health

6.84 Menarini Silicon Biosystems

6.85 Mesa Laboratories, Inc.

6.86 Millipore Sigma

6.87 Miltenyi Biotec

6.88 miR Scientific

6.89 Myriad Genetics/Myriad RBM

6.90 NantHealth, Inc.

6.91 Natera

6.92 NeoGenomics

6.93 NGeneBio

6.94 Novogene Bioinformatics Technology Co., Ltd.

6.95 Oncocyte

6.96 OncoDNA

6.97 Ortho Clinical Diagnostics

6.98 Oxford Nanopore Technologies

6.99 PamGene

6.100 Panagene

6.101 Perkin Elmer

6.102 Personal Genome Diagnostics

6.103 Personalis

6.104 Precipio

6.105 Precision Medicine Group

6.106 PrecisionMed

6.107 Predicine

6.108 Promega

6.109 Qiagen

6.110 Rarecells SAS

6.111 RareCyte

6.112 Roche Molecular Diagnostics

6.113 Screencell

6.114 Sema4 Holdings

6.115 Sense Biodetection

6.116 Siemens Healthineers

6.117 simfo GmbH

6.118 Singlera Genomics Inc.

6.119 Singulomics

6.120 SkylineDx

6.121 Standard BioTools

6.122 Sysmex Inostics

6.123 Tempus Labs, Inc.

6.124 Thermo Fisher Scientific Inc.

6.125 Todos Medical

6.126 Variantyx

6.127 Veracyte

6.128 Volition

6.129 Vortex Biosciences

6.130 Vyant Bio

6.131 Zhejiang Orient Gene Biotech

For more information about this report visit https://www.researchandmarkets.com/r/4fiz4z

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Global Biotechnology Licensing Agreements Analysis Report 2024 with Directory of Deals Signed Since 2019 – ResearchAndMarkets.com

Global Biotechnology Licensing Agreements Analysis Report 2024 with Directory of Deals Signed Since 2019 – ResearchAndMarkets.com




Global Biotechnology Licensing Agreements Analysis Report 2024 with Directory of Deals Signed Since 2019 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Licensing Deals in Biotechnology 2019-2024” report has been added to ResearchAndMarkets.com’s offering.


Licensing Deals in Biotechnology provides a detailed understanding and analysis of how and why companies enter licensing deals. Fully revised and updated, the report provides details of licensing deals from 2019 to 2024.

The report provides access to licensing deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal terms. Understanding the flexibility of a prospective partner’s negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred – contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of licensing deals announced since 2019 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual licensing contract documents as submitted to the Securities Exchange Commission by companies and their partners.

The initial chapters of this report provide an orientation of licensing dealmaking and business activities.

Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview and analysis of the trends in licensing as well as a discussion on the merits of the type of deal.

Chapter 3 provides an overview of the structure of licensing deals.

Chapter 4 provides a review of the leading licensing deals since 2019. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database.

Chapter 5 provides a comprehensive listing of the top 25 most active licensing dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 6 provides a comprehensive and detailed review of licensing deals organized by company A-Z, therapy, technology and industry type signed and announced since 2019 where a contract document is available. Contract documents provide an indepth insight into the actual deal terms agreed between the parties with respect to the licensing deal.

The deal directory includes a comprehensive listing of all licensing deals announced since 2019. Each listing is organized as a deal directory by company A-Z, therapeutic area and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document.

The report also includes numerous table and figures that illustrate the trends and activities in licensing dealmaking since 2019.

In conclusion, this report provides everything a prospective dealmaker needs to know about licensing alliances.

Key Benefits

  • Understand deal trends since 2019
  • Browse licensing deals
  • Benchmark analysis – identify market value of transactions
  • Financials terms – upfront, milestone, royalties
  • Directory of deals by company A-Z, therapy focus and technology type
  • Leading deals by value
  • Most active dealmakers
  • Identify assets and deal terms for each transaction
  • Access contract documents – insights into deal structures
  • Due diligence – assess suitability of your proposed deal terms for partner companies
  • Save hundreds of hours of research time

Licensing Deals in Biotechnology includes:

  • Trends in licensing dealmaking in the biopharma industry
  • Overview of licensing deal structure
  • Directory of licensing deal records covering pharmaceutical and biotechnology
  • The leading licensing deals by value
  • Most active licensing dealmakers
  • The leading licensing partnering resources

Analyzing contract agreements allows due diligence of:

  • What are the rights granted or optioned?
  • What rights are granted by the agreement?
  • What exclusivity is granted?
  • What is the payment structure for the deal?
  • How are sales and payments audited?
  • What is the deal term?
  • How are the key terms of the agreement defined?
  • How are intellectual property rights handled and owned?
  • Who is responsible for commercialization?
  • Who is responsible for development, supply, and manufacture?
  • How is confidentiality and publication managed?
  • How are disputes resolved?
  • Under what conditions can the deal be terminated?
  • What happens when there is a change of ownership?
  • What sublicensing and subcontracting provisions have been agreed?
  • Which boilerplate clauses does the company insist upon?
  • Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
  • Which jurisdiction does the company insist upon for agreement law?

Key Topics Covered:

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in licensing dealmaking

2.1. Introduction

2.2. Definition of licensing deal

2.3. Trends in licensing deals since 2019

2.3.1. Licensing dealmaking by year, 2019-2024

2.3.2. Licensing dealmaking by phase of development, 2019-2024

2.3.3. Licensing dealmaking by industry sector, 2019-2024

2.3.4. Licensing dealmaking by therapy area, 2019-2024

2.3.5. Licensing dealmaking by technology type, 2019-2024

2.3.6. Licensing dealmaking by most active company, 2019-2024

2.4. Reasons for entering into licensing partnering deals

2.5. The future of licensing deals

Chapter 3 – Overview of licensing deal structure

3.1. Introduction

3.2. Licensing agreement structure

Chapter 4 – Leading licensing deals

4.1. Introduction

4.2. Top licensing deals by value

Chapter 5 – Top 25 most active licensing dealmakers

5.1. Introduction

5.2. Top 25 most active licensing dealmakers

Chapter 6 – Licensing deals including contracts directory

6.1. Introduction

6.2. Licensing deals with contracts 2019-2024

Deal directory

Deal directory – licensing dealmaking by companies A-Z

Deal directory – licensing dealmaking by therapy area

Deal directory – licensing dealmaking by technology type

For more information about this report visit https://www.researchandmarkets.com/r/18u7cl

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Distribution Deal Trends in Diagnostics Report 2024 with Analysis of Deals Signed Since 2016 – ResearchAndMarkets.com

Distribution Deal Trends in Diagnostics Report 2024 with Analysis of Deals Signed Since 2016 – ResearchAndMarkets.com




Distribution Deal Trends in Diagnostics Report 2024 with Analysis of Deals Signed Since 2016 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Distribution Deals in Diagnostics 2016 to 2024” report has been added to ResearchAndMarkets.com’s offering.


Distribution Deals in Diagnostics provides a detailed understanding and analysis of how and why companies enter distribution deals.

Fully revised and updated, the report provides details of distribution deals from 2016 to 2024. The report provides access to distribution deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal terms.

Understanding the flexibility of a prospective partner’s negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred – contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of distribution deals announced since 2016 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual distribution contract documents as submitted to the Securities Exchange Commission by companies and their partners.

The initial chapters of this report provide an orientation of distribution dealmaking and business activities.

Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview and analysis of the trends in distribution as well as a discussion on the merits of the type of deal.

Chapter 3 provides an overview of the structure of distribution deals.

Chapter 4 provides a review of the leading distribution deals since 2016. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database.

Chapter 5 provides a comprehensive listing of the top 25 most active distribution dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

The deal directory includes a comprehensive listing of all distribution deals announced since 2016. Each listing is organized as a deal directory by company A-Z, therapeutic area and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document.

The report also includes numerous table and figures that illustrate the trends and activities in distribution dealmaking since 2016.

In conclusion, this report provides everything a prospective dealmaker needs to know about distribution alliances.

Distribution Deals in Diagnostics provides the reader with the following key benefits:

  • Understand deal trends since 2016
  • Browse distribution deals
  • Benchmark analysis – identify market value of transactions
  • Financials terms
  • Directory of deals by company A-Z, therapy focus and technology type
  • Leading deals by value
  • Most active dealmakers
  • Identify assets and deal terms for each transaction
  • Due diligence – assess suitability of your proposed deal terms for partner companies
  • Save hundreds of hours of research time

Distribution Deals in Diagnostics includes:

  • Trends in distribution dealmaking in the biopharma industry
  • Overview of distribution deal structure
  • Directory of distribution deal records covering diagnostics
  • The leading distribution deals by value
  • Most active distribution dealmakers
  • The leading distribution partnering resources

In Distribution Deals in Diagnostics, the available deals are listed by:

  • Company A-Z
  • Headline value
  • Therapeutic area
  • Technology type

Analyzing contract agreements allows due diligence of:

  • What are the rights granted or optioned?
  • What rights are granted by the agreement?
  • What exclusivity is granted?
  • What is the payment structure for the deal?
  • How are sales and payments audited?
  • What is the deal term?
  • How are the key terms of the agreement defined?
  • How are intellectual property rights handled and owned?
  • Who is responsible for commercialization?
  • Who is responsible for development, supply, and manufacture?
  • How is confidentiality and publication managed?
  • How are disputes resolved?
  • Under what conditions can the deal be terminated?
  • What happens when there is a change of ownership?
  • What sublicensing and subcontracting provisions have been agreed?
  • Which boilerplate clauses does the company insist upon?
  • Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
  • Which jurisdiction does the company insist upon for agreement law?

Key Topics Covered:

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in distribution dealmaking

2.1. Introduction

2.2. Definition of distribution deal

2.3. Trends in distribution deals since 2016

2.3.1. Distribution dealmaking by year, 2016-2024

2.3.2. Distribution dealmaking by phase of development, 2016-2024

2.3.3. Distribution dealmaking by therapy area, 2016-2024

2.3.4. Distribution dealmaking by technology type, 2016-2024

2.3.5. Distribution dealmaking by most active company, 2016-2024

2.4. Reasons for entering into distribution partnering deals

Chapter 3 – Overview of distribution deal structure

3.1. Introduction

3.2. Distribution agreement structure

Chapter 4 – Leading distribution deals

4.1. Introduction

4.2. Top distribution deals by value

Chapter 5 – Top 25 most active distribution dealmakers

5.1. Introduction

5.2. Top 25 most active distribution dealmakers

Deal directory

Deal directory – distribution dealmaking by companies A-Z

Deal directory – distribution dealmaking by therapy area

Deal directory – distribution dealmaking by technology type

For more information about this report visit https://www.researchandmarkets.com/r/gm3n02

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update




Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

– Data for masked anti-CTLA-4 SAFEbody® ADG126 (muzastotug) highlight best-in-class therapeutic index and demonstrate clinical benefits in metastatic microsatellite-stable (MSS) colorectal cancer (CRC) with higher, more frequent and repeat dosing of anti-CTLA-4 therapy in combination with anti-PD-1 –

– Ongoing combination phase 2 dose expansion in MSS CRC increased to over 50 patients, including initiation of a new, unprecedented 20 mg/kg loading dose regimen, with data anticipated during 2024 –

– Validation of SAFEbody masking technology by Exelixis and Sanofi showcases versatility of platform across modalities including antibody-drug conjugates, bi-specific and monoclonal antibodies –

– Cash balance of approximately US$110 million funds streamlined operations into 2026 –

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

“The SAFEbody precision masking technology platform remains at the core of our value proposition given its ability to enhance next generation antibody-based therapies that span modalities, including bispecific T-cell engagers and antibody-drug conjugates, both areas where a wider therapeutic index is needed to fully address solid tumors,” said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene.

He continued, “Turning to our clinical pipeline, we remain steadfast in our belief that anti-CTLA-4 therapy can be reimagined as a cornerstone of cancer care by enabling higher, more frequent and repeated doses in combination with anti-PD-1 and other therapies. With our SAFEbody platform, we have a 30-fold improved therapeutic index for ADG126 and a mechanism enabling CTLA-4 mediated intratumoral Treg depletion. We are taking anti-CTLA-4 therapy to a new level unleashing this proven immunotherapy where safety has limited its therapeutic potential.”

“In particular, our new loading dose regimen in late-stage MSS CRC patients enables our masked anti-CTLA-4 therapy to reach a high initial concentration, close to the steady state of activated species within the tumor tissue to immediately engage the CTLA-4 pathway and stop the tumor from aggressive growth. This loading dose strategy, together with repeated maintenance doses at 10 mg/kg showing limited treatment-related grade 3 and no higher toxicities with minimal late-onset toxicities for ADG126, is expected to engage the CTLA-4 target consistently, thereby maintaining and sustaining clinical benefit, via both the initial response rate and prolonged survival benefit. We look forward to reporting more clinical results for the ADG126 combination dose expansion in MSS CRC later this year.”

PIPELINE HIGHLIGHTS

  • Phase 1b/2 data for ADG126, a masked anti-CTLA-4 SAFEbody targeting a unique epitope of CTLA-4 on regulatory T cells (Tregs) in tumor tissue as driven by the fundamental biology of CTLA-4, showed a potential best-in-class profile in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)*, in MSS CRC, PD-1 experienced and PD-L1 low tumors:
    • Results presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Symposium from dose escalation and dose expansion cohorts of ADG126 in combination with pembrolizumab (200 mg/Q3W) demonstrated a differentiated safety profile for ADG126 at doses from 6 mg/kg to 10 mg/kg in heavily pre-treated advanced/metastatic patients (N=46):
      • Limited dose-dependent toxicities were observed.
      • Grade 3 TRAEs occurred in 5/46 patients (10.8%), with no Grade 4 or 5 TRAEs and a discontinuation rate of 6.5% (3/46).
    • In dose escalation across tumor types, two partial confirmed responses (PRs) were observed among the three patients treated with ADG126 10 mg/kg Q3W, which triggered expansion cohorts at this dosing regimen. One of the patients had PD-1 refractory cervical cancer and the other had endometrial cancer. Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
    • In dose expansion of patients with MSS CRC, 12 evaluable patients without liver metastases were treated at the active, potent dose of 10 mg/kg Q3W:
      • Two confirmed PRs were observed in nine of these patients without peritoneal and liver metastases, resulting in an overall response rate of 22% in this subset.
      • An additional seven of these nine patients experienced stable disease (SD) for an overall disease control rate of 100% (2 PRs and 7 SD).
      • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
    • In a preliminary progression-free survival (PFS) analysis of those MSS CRC patients free of liver and peritoneal metastasis, a median PFS of seven months was observed in those treated with ADG126 10 mg/kg at two dosing frequencies pooled together [every three weeks (n=9) and every six weeks (n=6)]. The durable clinical activity of ADG126 in combination with pembrolizumab will continue to be evaluated as a larger cohort of subjects becomes evaluable at the 10 mg/kg Q3W dose level.
    • Following the ASCO GI Symposium, Adagene announced progress and expansion of the ADG126 clinical program, which increases the ongoing phase 2 dose expansion in MSS CRC to over 50 patients. Updates included:
      • Enrollment of 12 additional patients in the second stage of the Simon’s 2-stage design was completed in the fourth quarter of 2023 for the ongoing phase 2 dose expansion cohort evaluating ADG126 10 mg/kg Q3W in combination with pembrolizumab in MSS CRC. These Part 2 results will supplement data from Part 1 of the dose expansion in MSS CRC as recently presented at the 2024 ASCO GI Symposium.
      • Given the ADG126 safety profile, evaluation of the 20 mg/kg loading dose regimen has been initiated in combination with pembrolizumab in patients with advanced/metastatic cancer. Pending outcome of the ongoing safety evaluation, the company plans to evaluate the efficacy profile of the loading dose regimen in expansion cohorts, followed by maintenance with ADG126 10 mg/kg Q3W in combination with pembrolizumab at sites in the US and Asia Pacific.
      • Clearance received from China’s Center for Drug Evaluation to initiate clinical evaluation of ADG126 in combination with pembrolizumab. This enables the company to broaden its dose expansion cohorts for MSS CRC at selected dosing regimens, and potentially in other tumor types, in its clinical trial collaboration and supply agreement with Merck.
    • Additionally, the company recently initiated dosing of a small number of patients with advanced/metastatic cancers at 30 mg/kg ADG126 monotherapy Q3W in China to define the potential maximum tolerated dose of ADG126 monotherapy.
  • Phase 1b/2 data for ADG116, an unmasked anti-CTLA-4 NEObody™ targeting a unique epitope, showed a favorable safety profile and clinical responses, both in monotherapy and in combination with anti-PD-1:
    • ADG116 monotherapy has demonstrated a favorable safety profile at doses up to 15 mg/kg (N=59) and an overall response rate (ORR) of 13% (3/23 evaluable), including confirmed and durable PRs in multiple tumor types.
    • In combination with anti-PD-1 therapy, ADG116 (3 mg/kg Q6W) (N=22) showed a manageable safety profile and an encouraging efficacy profile in dose escalation. Clinical responses from the combination cohorts include a complete response (CR) sustained for nearly two years in a head and neck squamous cell carcinoma (HNSCC) patient dosed with repeat cycles of ADG116 3 mg/kg (initially every three weeks, then every six weeks) plus toripalimab (ORR = 20%; 1/5 evaluable). An initial PR was also observed in a patient with MSS CRC dosed with repeat cycles of ADG116 3 mg/kg every six weeks plus toripalimab, further demonstrating the potential clinical benefit associated with targeting a unique epitope of CTLA-4 and the essential effects of Treg depletion.
    • ADG116 is clinically active and ready to advance into further clinical development as resources allow.
  • Phase 1 evaluation is ongoing for ADG206, a masked, IgG1 FC-enhanced anti-CD137 POWERbody™ in patients with advanced/metastatic tumors:
    • Adagene has enrolled 10 patients in an ongoing phase 1 trial of ADG206 to evaluate safety, efficacy and tolerability profiles for this next generation anti-CD137 candidate. Dose escalation continues with a cohort ongoing at 3 mg/kg Q3W. No maximum tolerated dose (MTD) has yet been reached.
    • Preclinical data demonstrated that ADG206 was well tolerated and had robust anti-tumor activity as a single agent in multiple tumor models, with 4-fold stronger anti-CD137 agonistic activity of its activated form than a benchmark antibody (urelumab analog) that displayed dose-dependent liver toxicity with an MTD of 0.1 mg/kg Q3W.
    • ADG206 is the company’s first SAFEbody with Fc enhancement, called a POWERbody, to advance into clinic. ADG206 combines SAFEbody precision masking, Fc enhancement and targeting of a unique epitope to solve the safety and efficacy challenges of anti-CD137 therapies, reflecting versatility of Adagene’s dynamic antibody discovery and masking platform.

COLLABORATIONS

  • Exelixis: In June 2023, Adagene received a US$3.0 million milestone payment from Exelixis for the successful nomination of lead SAFEbody candidates for the second collaboration program under a technology licensing agreement to develop novel masked antibody-drug conjugate candidates.
  • Sanofi: Adagene and Sanofi are collaborating to develop both bispecific and monoclonal SAFEbody antibody candidates, preparing preclinical candidates using Adagene’s SAFEbody precision masking technology for future development and commercialization by Sanofi. The collaboration announced in March 2022 included an upfront payment of US$17.5 million for the initial two programs, an option fee for two additional programs, potential milestone payments of up to US$2.5 billion, and tiered royalties.
  • Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC). Adagene retains global development and commercialization rights to ADG126.

CHANGE OF BOARD OF DIRECTORS

The following changes to Adagene’s Board of Directors will be effective upon the filing of its 2023 annual report on Form 20-F (“2023 Annual Report”), unless otherwise noted:

  • Dr. Ulf Grawunder will join the Board of Directors (the “Board”) as an independent director and serves as a member of Audit Committee and Strategy Committee of the Board. Dr. Grawunder is an experienced Swiss/German life-science entrepreneur with over 20 years of experience in the therapeutic antibody development industry.
  • Dr. Zhu Li, currently an independent director, will serve as a member of Compensation Committee of the Board.
  • Term of Mr. Andy (Yiu Leung) Cheung, Dr. Mervyn Turner and Mr. Man Kin (Raymond) Tam will be extended.
  • Dr. Min Li, currently an independent director and a member of Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee, and Ms. Yan Li, Senior Vice President of Bioinformatics and Information Technology and currently a member of the Board, will resign as directors of the Board and membership of the various committees, as applicable, due to person reasons. Ms. Yan Li’s resignation from the board will be effective on June 15, 2024, after which she will continue to serve as an observer to the Board. Each of Dr. Min Li and Ms. Yan Li confirmed that he or she has no disagreement with the Board, and there is no other matter relating to his or her resignation that needs to be brought to the attention of the shareholders of the company.

The Board would like to take this opportunity to express their sincere gratitude to Dr. Min Li and Ms. Yan Li for their valuable contributions to the Board during their tenure. Background of the newly appointed directors and their terms are detailed in the 2023 Annual Report.

2024 MILESTONES & CASH RUNWAY INTO 2026

Consistent with ongoing initiatives to prudently manage its cash balance, Adagene expects its current cash balance to fund activities into 2026, with the following milestones:

  • Data from the ongoing phase 1b/2 clinical trial of ADG126 in combination with pembrolizumab, including dose expansion cohorts in MSS CRC, are anticipated throughout 2024:
    • Follow up of Part 1 evaluable patients at 10 mg/kg Q3W (n=12) and 10 mg/kg Q6W (n=10)
    • Data from Part 2 patients at 10 mg/kg Q3W (n=12)
    • Evaluation of 20 mg/kg loading doses for Project Optimus requirements:
      • Safety data with repeat doses
      • Dose expansion in MSS CRC (n~10)
    • Additional patients in China (n≥10)
  • Additional technology licensing agreement(s) and/or milestone(s).

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents
Cash and cash equivalents were US$109.9 million as of December 31, 2023, compared to US$143.8 million as of December 31, 2022. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$21.9 million as of December 31, 2023 from US$27.8 million as of December 31, 2022. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.

Net Revenue:
Net revenue was US$18.1 million for the year ended December 31, 2023, compared to US$9.3 million in 2022. The increase of approximately 95% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Exelixis and Sanofi, respectively. Net revenue also included a milestone payment of US$3.0 million from Exelixis received in June 2023.

Research and Development (R&D) Expenses:
R&D expenses were US$36.6 million for the year ended December 31, 2023, compared to US$81.3 million in 2022. The decrease of approximately 55% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:
Administrative expenses were US$8.7 million for the year ended December 31, 2023, compared to US$11.9 million in 2022. The decrease was due to both a reduction in personnel and in office-related expenses as a result of cost-control measures.

Other Operating Income, Net:
Other operating income, net was US$3.5 million for the year ended December 31, 2023. Other operating income, net included a one-time compensation payment from a contract manufacturer for a preclinical-related outsourcing arrangement.

Net Loss:
Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.

Ordinary Shares Outstanding:
As of December 31, 2023, there were 55,145,839 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

Non-GAAP Net Loss:
Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$11.7 million for the year ended December 31, 2023, compared to US$69.5 million in 2022. Please refer to the section in this press release titled “Reconciliation of GAAP and Non-GAAP Results” for details.

Non-GAAP Financial Measures
The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the year, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year help identify underlying trends in the company’s business that could otherwise be distorted by the effect of certain expenses that the company includes in its loss for the year. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making.

Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year should not be considered in isolation or construed as an alternative to operating profit, loss for the year or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the year and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the company’s data. The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year represent net loss attributable to ordinary shareholders for the year excluding share-based compensation expenses. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The company believes that the exclusion of share-based compensation expenses from the net loss in the Reconciliation of GAAP and Non-GAAP Results assists management and investors in making meaningful period-to-period comparisons in the company’s operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the company’s underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation.

Please see the “Reconciliation of GAAP and Non-GAAP Results” included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the year to net loss attributable to ordinary shareholders for the year/period.

About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science.

Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues.

Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc enhanced antibodies, antibody-drug conjugates, and bi/multispecific T-cell engagers.

For more information, please visit: https://investor.adagene.com. Follow Adagene on WeChat, LinkedIn and Twitter.

SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

*KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the outbreak of a widespread health epidemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s annual report for the year of 2023 on Form 20-F filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Investor & Media Contact:
Ami Knoefler
650-739-9952
ir@adagene.com

FINANCIAL TABLES FOLLOW

Unaudited Consolidated Balance Sheets

  December 31,
2022
December 31,
2023
  US$ US$
ASSETS    
Current assets:    
Cash and cash equivalents 143,758,678   109,934,257  
Amounts due from related parties 619,432   222,027  
Prepayments and other current assets 4,937,323   3,287,445  
Total current assets 149,315,433   113,443,729  
Property, equipment and software, net 2,782,963   1,835,121  
Operating lease right-of-use assets 191,877   365,103  
Other non-current assets 109,572   84,885  
TOTAL ASSETS 152,399,845   115,728,838  
LIABILITIES AND SHAREHOLDERS’ EQUITY    
Current liabilities:    
Accounts payable 3,666,124   3,093,752  
Contract liabilities 15,107,276    
Amounts due to related parties 19,323,337   16,714,326  
Accruals and other current liabilities 3,212,809   3,001,508  
Income tax payable   52,884  
Short-term borrowings 10,768,745   4,235,673  
Current portion of long-term borrowings 2,850,128   4,161,549  
Current portion of operating lease liabilities 151,983   195,955  
Total current liabilities 55,080,402   31,455,647  
Long-term borrowings 14,146,541   13,540,034  
Operating lease liabilities 53,834   173,660  
Other non-current liabilities 28,718    
TOTAL LIABILITIES 69,309,495   45,169,341  
Commitments and contingencies    
Shareholders’ equity:    
Ordinary shares (par value of US$0.0001 per share; 640,000,000 shares authorized, and 54,065,709 shares issued and outstanding as of December 31, 2022; and 640,000,000 shares authorized, and 55,145,839 shares issued and outstanding as of December 31, 2023) 5,497   5,547  
Treasury shares, at cost (1 share as of December 31, 2022 and December 31, 2023) (4 ) (4 )
Additional paid-in capital 342,739,268   350,105,518  
Accumulated other comprehensive loss (849,305 ) (1,800,088 )
Accumulated deficit (258,805,106 ) (277,751,476 )
Total shareholders’ equity 83,090,350   70,559,497  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 152,399,845   115,728,838  


Unaudited Consolidated Statements of Comprehensive Loss

  For the Year Ended December 31, 2022 For the Year Ended December 31, 2023
  US$ US$
Revenues    
Licensing and collaboration revenue 9,292,724   18,111,491  
Operating expenses and income    
Research and development expenses (81,339,540 ) (36,639,146 )
Third parties (46,212,077 ) (33,978,642 )
Related parties (35,127,463 ) (2,660,504 )
Administrative expenses (11,873,867 ) (8,672,843 )
Other operating income, net   3,480,632  
Loss from operations (83,920,683 ) (23,719,866 )
Interest income 377,501   4,283,085  
Interest expense (693,323 ) (1,107,820 )
Other income, net 2,168,388   1,843,437  
Foreign exchange gain, net 2,555,325   1,446,202  
Loss before income tax (79,512,792 ) (17,254,962 )
Income tax expense (459,055 ) (1,691,408 )
Net loss attributable to Adagene Inc.’s shareholders (79,971,847 ) (18,946,370 )
Other comprehensive loss    
Foreign currency translation adjustments, net of nil tax (755,324 ) (950,783 )
Total comprehensive loss attributable to Adagene Inc.’s shareholders (80,727,171 ) (19,897,153 )
Net loss attributable to Adagene Inc.’s shareholders (79,971,847 ) (18,946,370 )
Net loss attributable to ordinary shareholders (79,971,847 ) (18,946,370 )
Weighted average number of ordinary shares used in per share calculation:    
—Basic 54,135,084   54,737,530  
—Diluted 54,135,084   54,737,530  
Net loss per ordinary share    
—Basic (1.48 ) (0.35 )
—Diluted (1.48 ) (0.35 )


Reconciliation of GAAP and Non-GAAP Results

  For the Year Ended December 31, 2022 For the Year Ended December 31, 2023
  US$ US$
GAAP net loss attributable to ordinary shareholders (79,971,847 ) (18,946,370 )
Add back:    
Share-based compensation expenses 10,520,282   7,271,700  
Non-GAAP net loss (69,451,565 ) (11,674,670 )
Weighted average number of ordinary shares used in per share calculation:    
—Basic 54,135,084   54,737,530  
—Diluted 54,135,084   54,737,530  
Non-GAAP net loss per ordinary share    
—Basic (1.28 ) (0.21 )
—Diluted (1.28 ) (0.21 )

Elicio Therapeutics Reports 2023 Financial Results and Provides Corporate Updates

Elicio Therapeutics Reports 2023 Financial Results and Provides Corporate Updates




Elicio Therapeutics Reports 2023 Financial Results and Provides Corporate Updates

  • ELI-002 2P clinical immunogenicity data were accepted for a poster presentation at the AACR Annual Meeting 2024
  • ELI-007 and ELI-008 preclinical data were accepted for a poster presentation at the AACR Annual Meeting 2024
  • Phase 2 randomized trial in PDAC is underway with enrollment expected to complete in the fourth quarter of 2024
  • ELI-002 7P initial clinical trial data expected in the second quarter of 2024
  • Private placement with gross proceeds of $6.0 million closed in March 2024

BOSTON, March 29, 2024 (GLOBE NEWSWIRE) — Elicio Therapeutics, Inc. (Nasdaq: ELTX,“Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today reported financial results for the year ending December 31, 2023, and provided recent business highlights.

“2023 was a momentous year for Elicio with the completion of a successful reverse merger, presenting clinical data from our first-in-human trial and advancing ELI-002 into a randomized Phase 2 trial,” said Robert Connelly, Elicio’s Chief Executive Officer. “Already in 2024 we have built on 2023’s progress with our Phase 1a clinical data being published in Nature Medicine and announcing the first patients were dosed in the randomized Phase 2 trial. We continue to focus on advancing our lead cancer vaccine candidate, ELI-002, and the progression of our randomized Phase 2 study as a monotherapy for patients with PDAC. We have an exciting year ahead as we expect to share data from the AMPLIFY-7P Phase 1 study of ELI-002 7P in the second quarter.”

Corporate Updates

AMPLIFY-7P Phase 1a:

  • Completed enrollment of 14 patients in the third quarter of 2023 with initial clinical data for ELI-002 7P expected in the second quarter of 2024.
  • The independent data monitoring committee completed the safety review of ELI-002 7P Phase 1 trial patients and confirmed the recommended Phase 2 trial dose.

AMPLIFY-7P Phase 2:

  • First patients dosed in a randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (“PDAC”).

AMPLIFY-201 Phase 1a: 

  • Data from the first-in-human study of ELI-002 2P published in Nature Medicine shows:
    • The data were as of September 6, 2023, based on 25 patients with solid tumors (20 pancreatic, 5 colorectal) who were positive for minimal residual mKRAS disease after locoregional treatment.
    • Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and CD8+).
    • Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3 colorectal).
    • At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months.
    • Efficacy correlated with T cell response (≥ versus < median: 12.75-fold over baseline):
    • Median tumor biomarker reduction was -76.0% compared to -10.2% in above versus below median T cell responders, respectively (p<0.0014).
    • Median RFS was not reached compared to 4.01 months in above versus below median T cell responders, respectively (HR 0.14, 95% CI 0.03 to 0.63, p=0.0167).
    • Patients with greater than median T cell response had an 86% reduction in the risk of progression or death.
    • The association of RFS with T cell response was not correlated to baseline prognostic variables including tumor stage, recovery from prior cytotoxic therapy as assessed by absolute neutrophil count or immune system subsets such as %CD4+ or %CD8+ of CD3+ lymphocytes.
    • RFS was shorter in patients who began treatment with a low absolute lymphocyte count.
    • No safety concerns were identified, and no dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed.

2023 Financial Results

R&D expense for 2023 was $23.8 million, compared to $18.1 million for 2022. The increase in R&D expense was primarily due to increased manufacturing and clinical trial expenses as Elicio initiated the AMPLIFY-7P Phase 1a study and generated a clinical trial product to supply the ongoing Phase 2 trial.

G&A expense for 2023 was $11.9 million, compared to $5.6 million 2022. The increase in G&A expense was primarily attributable to professional fees, personnel expenses, and insurance associated with operating as a public company.

Net loss for 2023 was $35.2 million, compared to $28.2 million for 2022. Net loss per share for 2023 was $6.96 compared to $89.27 for 2022.   The reduction in net loss per share was primarily due to an increase in weighted average common shares outstanding as a result of the reverse merger with Angion Biomedica Corp. in June 2023.

Cash and cash equivalents as of December 31, 2023, were $12.9 million, compared to $6.2 million as of December 31, 2022.

 
ELICIO THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)

     
    Year Ended
December 31,
     2023     2022 
Operating expenses:        
Research and development   $ 23,849     $ 18,103  
General and administrative     11,896       5,630  
Total operating expenses     35,745       23,733  
Loss from operations     (35,745 )     (23,733 )
Total other income (expense)     550       (4,475 )
Net Loss     (35,195 )     (28,208 )
Other comprehensive income:        
Foreign currency translation adjustment     (197 )      
Comprehensive loss   $ (35,392 )   $ (28,208 )
Net loss per common share, basic and diluted   $ (6.96 )   $ (89.27 )
Weighted average common shares outstanding, basic and diluted     5,056,225       315,998  
 

ELICIO THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)

 
  December 31,
2023
  December 31,
2022
Assets      
Cash and cash equivalents $ 12,894   $ 6,156
Other current assets 3,454   4,561
Total current assets 16,348   10,717
Other  assets 10,798   11,947
Total assets $ 27,146   $ 22,664
       
Liabilities and stockholders’ equity      
Current liabilities $ 9,766   $ 6,868
Long-term liabilities 6,007   6,881
Total liabilities 15,773   13,749
       
Total stockholders’ equity (deficit) 11,373   8,915
       
Total liabilities and stockholders’ equity $ 27,146   $ 22,664
           

About Elicio Therapeutics

Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (“AMP”) immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants, and vaccines for an array of aggressive cancers.

About the Amphiphile Platform

Our proprietary Amphiphile (“AMP”) platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in the induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies.

Our AMP platform, originally developed at the Massachusetts Institute of Technology has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving immune responses of increased magnitude, function, and durability.

Cautionary Note on Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, the expected participation and presentation at upcoming conferences, and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s financial condition, including its ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio’s ability to continue as a going concern; Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio’s planned clinical trials, including Elicio’s expected completion of enrollment for the Phase 2 randomized trial in PDAC in the fourth quarter of 2024; the timing of the availability of data from Elicio’s clinical trials, including data from the AMPLIFY-7P Phase 1 study of ELI-002 7P expected in the second quarter of 2024; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; Elicio’s ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Elicio’s product candidates; Elicio’s commercialization, marketing and manufacturing capabilities and strategy; Elicio’s ability to identify additional products or product candidates with significant commercial potential; Elicio’s ability to advance ELI-002 outside of PDAC monotherapy and Elicio’s pipeline programs; developments and projections relating to Elicio’s competitors and our industry; the impact of government laws and regulations; Elicio’s ability to protect its intellectual property position; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the Annual Report on Form 10-K that is expected to be filed with the SEC on March 29, 2024, under the heading “Risk Factors”, and any subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.

Media Contact
Kristin Politi 
LifeSci Communications 
kpoliti@lifescicomms.com
646-876-4783

Investor Relations Contact
Heather DiVecchia
Elicio Therapeutics
IR@elicio.com 
857-209-0153

Molecular Templates, Inc. Reports Fourth Quarter 2023 Financial Results and Business Update

Molecular Templates, Inc. Reports Fourth Quarter 2023 Financial Results and Business Update




Molecular Templates, Inc. Reports Fourth Quarter 2023 Financial Results and Business Update

AUSTIN, Texas, March 29, 2024 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of action for cancer, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Company Highlights

  • Durable single agent activity observed with MT-6402, a PD-L1 targeting direct-cell kill agent, in heavily pre-treated patients with low PD-L1+ head and neck cancer who had progressed on multiple prior therapies including checkpoint and EGFR antibodies.
  • Enrollment is on-going in the dose escalation study with MT-8421, a novel CTLA-4 targeting agent designed to potently deplete Tregs in the tumor environment. Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases observed in patients.
  • Recently completed $9.5 million private placement supports continued funding of clinical stage programs.

Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM, stated, “We are very excited to see objective responses in heavily pre-treated, checkpoint-experienced head and neck cancer patients, a setting with high unmet medical need, with MT-6402. We are seeing evidence of monotherapy activity of long duration and in patients refractory to checkpoint therapy through a novel mechanism of tumor microenvironment remodeling. We believe these data demonstrate a new and potentially best-in-class approach to targeting the PD-1-PD-L1 axis.” Dr. Poma further added, “MT-8421 is currently in dose escalation as a novel direct cell-kill approach targeting CTLA-4 to potently deplete Tregs in the tumor microenvironment. Through the first dose cohort, we are already seeing promising and differentiate pharmacodynamic effects including dramatic Treg depletion in patients.”

MT-6402 (PD-L1 ETB) 

  • MT-6402 was designed to activate T-cells through direct cell-kill of immunosuppressive PD-L1+ immune cells resulting in a remodeling of the tumor microenvironment.
  • In addition, MT-6402 can deliver and induce the presentation of an MHC class I CMV antigen on tumor cells for pre-existing CD8 T-cell recognition and destruction in HLA-A*02/CMV+ patients with high PD-L1 expression on their tumors.  
  • Compelling signal of monotherapy activity with MT-6402 at higher doses in relapsed or refractory head and neck cancer (R-R HNSCC) with dose expansion study planned in low PD-L1+ R-R HNSCC patients.
    • 10 patients with R-R HNSCC in dose escalation
    • Patients dosed at 63, 83 (MTD), or 100 mcg/kg; median # of prior treatments of greater than 3
    • 2 patients currently in responses; 1 patient (63 mcg/kg) has a confirmed PR with 70% reduction in tumor volume at cycle 18 (1 cycle = 4 weeks)
    • 1 patient (83 mcg/kg) has an uPR(37% reduction) at cycle 8 w/ reductions of 3%, 9%, and 15% across three previous cycles; the patient is on therapy in cycle 9
    • 2 patients (one uPR and one 15% reduction) came off therapy for Gr1 hs-Trop elevation; guidelines now revised to allow patients to continue therapy despite advent of Gr1 hs-Trop elevation. In all instances, Gr1 hs-Trop elevations were asymptomatic and without evidence of cardiac changes. Similar troponin changes are observed in patients receiving checkpoint inhibitors.
    • No gr 4 or gr 5 drug-related toxicities were observed
    • Patients with responses/tumor reduction had low PD-L1
  • Dose expansion is on-going in patients with high PD-L1+ tumors.

MT-8421 (CTLA-4 ETB)

  • MT-8421, along with MT-6402, represents our unique approach to immuno-oncology based on remodeling the tumor microenvironment through the elimination of immunosuppressive cells and activation of CD8 T-cells.
  • MT-8421 is designed to potently destroy CTLA-4+ Tregs via enzymatic ribosome destruction but does not have activity against low CTLA-4 expressing peripheral Tregs.
  • Two of the three patients enrolled in the first cohort remain on study in cycle 5. Both patients show evidence of Treg clearance and T-cell activation. Enrollment is on-going in the second cohort of 48 mcg/kg for the phase I study of MT-8421.

MT-0169 (CD38 ETB)

  • MT-0169 is designed to destroy CD38+ tumor cells through internalization of CD38 and cell destruction via a novel mechanism of action (enzymatic ribosomal destruction and immunogenic cell death).
  • A phase 1 study in patients with relapsed or refractory multiple myeloma was closed on Dec 2023 due to slow patient enrollment in the wake of multiple new approvals in myeloma. This study enrolled 14 patients and no drug-related Grade 4 or 5 adverse events have been observed. One patient with IgA myeloma who was quad-refractory was treated at 5 mcg/kg and had a stringent Complete Response for 16 cycles (1 cycle = 4 weeks) before discontinuing treatment for progression of disease.
  • MTEM is evaluating plans to initiate an investigator sponsored study to evaluate MT-0169 in relapsed or refractory CD38+ AML patients.

Second Closing of July 2023 Private Placement

On March 28, 2024, the Company and certain institutional and accredited investors (the “March 2024 Purchasers”) entered into an Amended and Restated July 2023 Purchase Agreement pursuant to which the Company will issue common stock, prefunded warrants, and common warrants with an aggregate purchase price of $9.5 million on amended and restated second tranche terms. The second tranche, as amended and restated, will consist of the sale and issuance of (i) 1,209,612 shares of the Company’s common stock (and, in lieu thereof, prefunded warrants to purchase 2,460,559 shares of the Company’s common stock (the “March 2024 Prefunded Warrants”)) for a purchase price of $2.35 per share of the Company’s common stock (the closing price of our common stock on March 27, 2024 as reported by the Nasdaq Capital Market) and $2.349 per March 2024 Prefunded Warrant, and (ii) common stock warrants (the “March 2024 Common Warrants”) to purchase up to 7,340,342 shares of the Company’s common stock (or March 2024 Prefunded Warrants in lieu thereof) at an exercise price of $2.35 per share of the Company’s common stock underlying the March 2024 Common Warrants. The March 2024 Common Warrants will be sold at a price of $0.125 per underlying share of common stock and will have a term of five years. The March 2024 Prefunded Warrants will expire when fully exercised in accordance with their terms. The March 2024 Prefunded Warrants and March 2024 Common Warrants may not be exercised if the aggregate number of shares of our common stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation (4.99%/9.99%/19.99%); provided, however, that a holder may increase or decrease the beneficial ownership limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 19.99%. The Amended and Restated July 2023 Purchase Agreement contains customary representations and warranties and agreements of the Company and the Purchasers and customary indemnification rights and obligations of the parties. The second tranche will include gross proceeds of approximately $9.5 million and net proceeds, following the payment of related offering expenses, of approximately $8.9 million.

Key Milestones for 2024

  • Clinical data on MT-6402 expansion cohorts in low and high PD-L1+ HNSCC patients
  • Clinical data from dose escalation study for MT-8421 Treg depleting agent in solid tumors

Bristol-Myers Squibb Collaboration Agreement

On March 13, 2024, Bristol-Myers Squibb notified the Company that following a corporate portfolio prioritization process, it does not intend to continue the research collaboration it entered into with the Company pursuant to the BMS Collaboration Agreement and would be terminating the BMS Collaboration Agreement in its entirety. The termination will be effective on June 13, 2024, or 90 days following the Company’s receipt of Bristol-Myers Squibb’s written notice of termination. MTEM plans to reduce costs related to the Collaboration Agreement.

Conferences

MTEM will present an abstract, “First-in-human, dose escalation and expansion study of MT-6402, a novel engineered toxin body (ETB) targeting PD-L1, in patients with PD-L1 expressing relapsed/refractory advanced solid tumors: Interim Data”, Tuesday, April 9, 2024, 9am – 12:30pm ET (Section 48, Poster #19, Abstract #CT191), at the American Association for Cancer Research (“AACR”) Annual Meeting taking place in San Diego, CA.

Financial Results

The net loss attributable to common shareholders for the fourth quarter of 2023 was $3.9 million, or $0.73 per basic and diluted share. This compares with a net loss attributable to common shareholders of $22.0 million, or $5.87 per basic and diluted share, for the same period in 2022.

Revenues for the fourth quarter of 2023 were $7.0 million, compared to $2.6 million for the same period in 2022. Revenues for the fourth quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol-Myers Squibb and grant revenue.

Total research and development expenses for the fourth quarter of 2023 were $8.8 million, compared with $17.6 million for the same period in 2022. Total general and administrative expenses for the fourth quarter of 2023 were $3.6 million, compared with $6.1 million for the same period in 2022.

As of December 31, 2023, MTEM’s unrestricted cash and cash equivalents totaled $11.5 million. MTEM anticipates a cash runway into the second quarter of 2024. Following the completion of the recent Second Closing of the July 2023 Private Placement, the Company anticipates that cash runway will extend to the end of the fourth quarter 2024.

For more details on MTEM’s financial results for 2023, refer to Form 10-K filed with the SEC.

 
Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
 
  Three Months Ended
December 31,
  Year Ended
December 31,
    2023       2022       2023       2022  
Research and development revenue $ 6,639     $ 2,611     $ 52,625     $ 19,754  
Grant revenue   377             4,681        
        Total revenue   7,016       2,611       57,306       19,754  
Operating expenses:                  
Research and development   8,796       17,590       48,875       82,425  
General and administrative   3,591       6,080       18,897       26,200  
        Total operating expenses   12,387       23,670       67,772       108,625  
Loss from operations   5,371       21,059       10,466       88,871  
Interest and other income, net   178       425       1,208       988  
Interest and other expense, net   (39 )     (1,351 )     (2,654 )     (4,716 )
Gain on extinguishment of debt               1,795        
Change in valuation of contingent value right   1,273             2,457        
Loss on disposal of property and equipment         (37 )     (475 )     (66 )
Loss before provision (benefit) for income taxes   3,959       22,022       8,135       92,665  
Provision (benefit) for income taxes   (11 )     27       (11 )     53  
Net loss attributable to common shareholders $ 3,948     $ 22,049     $ 8,124     $ 92,718  
Net loss per share attributable to common shareholders:                  
Basic and diluted $ 0.73     $ 5.87     $       1.80     $ 24.69  
Weighted average number of shares used in net loss per share calculations:              
Basic and diluted   5,374,268       3,756,711       4,501,206       3,755,564  

 
Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
 
  December 31,
2023
  December 31,
2022
ASSETS          
Current assets:          
Cash and cash equivalents $ 11,523     $ 32,190  
Marketable securities, current         28,859  
Prepaid expenses   2,195       3,459  
Grants revenue receivable   250        
Other current assets   2,804       3,790  
Total current assets   16,772       68,298  
Operating lease right-of-use assets   9,161       11,132  
Property and equipment, net   7,393       14,632  
Other assets   2,057       3,486  
   Total assets $ 35,383     $ 97,548  
LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT)            
Current liabilities:            
Accounts payable $ 1,523     $ 504  
Accrued liabilities   4,279       8,823  
Deferred revenue, current   9,031       45,573  
Other current liabilities   2,488       2,182  
Total current liabilities   17,321       57,082  
Deferred revenue, long-term         5,904  
Long-term debt, net of current portion         36,168  
Operating lease liabilities, long term portion   9,742       12,231  
Contingent value right liability   2,702        
Other liabilities   1,406       1,295  
Total liabilities   31,171       112,680  
Commitments and contingencies          
Stockholders’ equity/(deficit)            
Preferred stock, $0.001 par value per share:          
Authorized: 2,000,000 shares as of December 31, 2023 and 2022; Issued and outstanding: 250 shares as of December 31, 2023 and 2022          
Common stock, $0.001 par value per share:          
Authorized: 150,000,000 shares as of December 31, 2023 and 2022; Issued and outstanding: 5,374,268 shares as of December 31, 2023 and 3,756,711 shares as of December 31, 20221   5       4  
Additional paid-in capital1   457,099       429,698  
Accumulated other comprehensive loss         (66 )
Accumulated deficit   (452,892 )     (444,768 )
Total stockholders’ equity/(deficit)   4,212       (15,132 )
   Total liabilities and stockholders’ equity/(deficit) $ 35,383     $ 97,548  
 

1. Prior period amounts have been retrospectively adjusted for the 1-for-15 reverse stock split that was effective August 11, 2023.

About Molecular Templates

Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted biologic therapeutics. Our proprietary drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer.

Forward-Looking Statements 

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements, other than statements of historical facts, included in this press release, including, but not limited to those regarding strategy, future operations, the Company’s ability to execute on its objectives, prospects, plans, future clinical development of the Company’s product candidates, any implication that the preliminary results, interim results, or the results of earlier clinical trials or ongoing clinical trials will be representative of the results of future or later clinical trials or final results, the potential benefits, safety or efficacy and any evaluations or judgements regarding the Company’s product candidates, [the results of any strategic process which are inherently uncertain at the present time] and future execution of corporate goals. In addition, when or if used in this press release, the words “may,” “could,” “should,” “continue”, “anticipate,” “potential”, “believe,” “estimate,” “appears”, “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Molecular Templates may identify forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors including, but not limited to the following: the continued availability of financing on commercially reasonable terms, whether Molecular Templates’ cash resources will be sufficient to fund its continuing operations; the results of MTEM’s ongoing clinical studies and the ability to effectively operate MTEM, and those risks identified under the heading “Risk Factors” in Molecular Templates’ filings with the Securities and Exchange Commission (the “SEC”), including its Form 10-K for the year ended December 31, 2023 and any subsequent reports filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Molecular Templates specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.

Contacts:
grace.kim@mtem.com

 

KALA BIO Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

KALA BIO Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update




KALA BIO Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

— Advancing ongoing Phase 2b CHASE trial of KPI-012 for PCED; topline data targeted by year-end 2024 —
— Exploring opportunities to expand KPI-012 into additional corneal indications —
— Cash resources as of December 31, 2023, together with proceeds from the March 2024 private placement and anticipated funding remaining from CIRM award, expected to fund operations into 3Q 2025 —

ARLINGTON, Mass., March 29, 2024 (GLOBE NEWSWIRE) — KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.

“In 2023, we focused on clinical execution, advancing our Phase 2b CHASE trial of KPI-012 for the treatment of PCED. In March 2023, we announced positive safety data from the first cohort of patients, reinforcing the promising safety and tolerability profile of high dose KPI-012, and allowing us to progress into the multicenter, randomized, double-masked efficacy cohort, which we are targeting to read out by year-end 2024,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. “Based on its multifactorial mechanism of action, we believe KPI-012 may address a significant unmet need, potentially offering patients and physicians a highly differentiated product profile and the first therapy for PCED that addresses the multiple underlying etiologies of the disease. We look forward to topline data from the CHASE trial, as we work to establish KPI-012 as a safe, well-tolerated, easily administered and effective treatment for the nearly 100,000 patients living with PCED in the U.S.”

Fourth Quarter and Recent Business Highlights:

Development-Stage Pipeline:
KALA is advancing an innovative pipeline based on its proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA believes the multifactorial mechanism of action of its MSC-S platform technology may enable it to generate products for a range of ocular orphan diseases and is evaluating the potential development of this technology for multiple rare, front- and back-of-the-eye diseases.

KPI-012 combines growth factors, protease inhibitors, matrix proteins and neurotrophic factors to potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases.

KALA is initially developing KPI-012 for the treatment of persistent corneal epithelial defect (PCED), a persistent, non-healing corneal defect or wound that is refractory to conventional treatments which, if left untreated, can lead to significant complications, including infection, corneal perforation/scarring and vision loss. PCED has an estimated incidence of approximately 100,000 patients in the U.S. and represents a sizeable market opportunity; there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication for all underlying etiologies of PCED.

  • KALA is actively enrolling patients in the primary safety and efficacy portion of the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED and is targeting to announce topline data by year-end 2024.
  • If the results are positive, and subject to discussion with regulatory authorities, KALA believes the CHASE Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application (BLA) to the FDA.

KALA is also evaluating the potential of KPI-012 for additional rare, front-of-the-eye diseases, such as Limbal Stem Cell Deficiency (LSCD) and other corneal diseases that threaten vision. LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, neovascularization, conjunctivalization, inflammation and other sequalae that can lead to loss of corneal clarity and vision impairment. Like PCED, LSCD represents a substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S.

KPI-014, KALA’s preclinical program to evaluate the utility of its MSC-S platform for inherited retinal degenerative diseases, contains neurotrophic factors, growth factors, anti-inflammatory or immune-modulatory factors and antioxidant inhibitors with the potential to protect and preserve retinal cell function. Secretomes have demonstrated a neuroprotective effect in both in vitro and in vivo models of retinal degeneration. KALA believes KPI-014 could offer a gene-agnostic approach for the treatment of rare inherited retinal diseases and has initiated preclinical studies to evaluate the utility of KPI-014 for conditions such as Retinitis Pigmentosa and Stargardt Disease.

Corporate:
In December 2023 and March 2024, KALA announced private placement financings with an institutional investor, priced at-the-market under Nasdaq rules. Aggregate gross proceeds from the financings were approximately $2.0 million and $8.6 million, respectively.

Financial Results:

Cash Position: As of December 31, 2023, KALA had cash and cash equivalents of $50.9 million, compared to $56.1 million as of September 30, 2023. This decrease reflects cash used in operations and gross proceeds of $2.0 million received from KALA’s December 2023 private placement financing. Based on its current plans, KALA anticipates that its cash resources as of December 31, 2023, together with gross proceeds of $8.6 million received from its March 2024 private placement financing and anticipated funding under the CIRM award, will enable it to fund operations into the third quarter of 2025.

Financial Results for the Three Months Ended December 31, 2023:

  • SG&A Expenses: For the quarter ended December 31, 2023, selling, general and administrative (SG&A) expenses were $4.6 million, compared to $5.8 million for the same period in 2022. The decrease was primarily due to the sale of KALA’s commercial portfolio to Alcon Inc. (Alcon) in July 2022.
  • R&D Expenses: For the quarter ended December 31, 2023, research and development (R&D) expenses were $4.7 million, compared to $3.3 million for the same period in 2022. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs.
  • Loss on Fair Value Remeasurement of Deferred Purchase Consideration: There was no gain or loss on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio, for the quarter ended December 31, 2023 due to the settlement of the liability in March 2023. The loss on fair value remeasurement of deferred purchase consideration was $0.4 million for the same period in 2022.
  • Loss on Fair Value Remeasurement of Contingent Consideration: For the quarter ended December 31, 2023, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.3 million, compared to a loss of $0.7 million for the same period in 2022.
  • Operating Loss: For the quarter ended December 31, 2023, loss from operations was $9.6 million, compared to $10.3 million for the same period in 2022.
  • Net Loss: For the quarter ended December 31, 2023, net loss was $8.6 million, or $3.18 per share, compared to a net loss of $12.8 million, or $7.97 per share, for the same period in 2022. The weighted average number of shares used to calculate net loss per share was 2.7 million for the quarter ended December 31, 2023, and 1.6 million for the quarter ended December 31, 2022.

Financial Results for the Full Year Ended December 31, 2023:

  • Net Product Revenues: KALA did not recognize product revenues in the full year ended December 31, 2023 as a result of the sale of its commercial portfolio to Alcon in July 2022. For the full year ended December 31, 2022, Kala reported net product revenues of $3.9 million.
  • Cost of Product Revenues: KALA did not record cost of product revenues in the full year ended December 31, 2023 as a result of the sale of its commercial portfolio to Alcon in July 2022. For the full year ended December 31, 2022, cost of product revenues was $2.6 million.
  • SG&A Expenses: For the full year ended December 31, 2023, SG&A expenses were $20.6 million, compared to $65.0 million for the same period in 2022. The decrease was primarily due to the sale of KALA’s commercial portfolio to Alcon.
  • R&D Expenses: For the full year ended December 31, 2023, R&D expenses were $18.6 million, compared to $17.7 million for the same period in 2022. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs, partially offset by a decrease in other research and development costs, which primarily included preclinical studies related to KALA’s former pipeline programs and facility related costs.
  • (Gain) Loss on Fair Value Remeasurement of Deferred Purchase Consideration: For the full year ended December 31, 2023, the gain on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio, was $0.2 million, compared to a loss of $0.6 million for the same period in 2022.
  • Loss (Gain) on Fair Value Remeasurement of Contingent Consideration: For the full year ended December 31, 2023, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.7 million, compared to a gain of $0.3 million for the same period in 2022.
  • Operating Loss: For the full year ended December 31, 2023, loss from operations was $39.7 million, compared to $81.7 million for the same period in 2022.
  • Loss on Extinguishment of Debt: For the full year ended December 31, 2023, KALA did not report a loss on extinguishment of debt, compared to a loss of $2.6 million in the same period in 2022 as a result of a partial prepayment of outstanding principal and related fees under its loan agreement with Oxford Finance LLC in connection with the closing of the sale of its commercial business to Alcon.
  • Gain on Sale of Commercial Business: For the full year ended December 31, 2023, KALA did not report a gain on sale of commercial business, compared to a gain of $47.0 million for the same period in 2022 related to the sale of its commercial business to Alcon.
  • Net Loss: For the full year ended December 31, 2023, net loss was $42.2 million, or $17.35 per share, compared to a net loss of $44.8 million, or $29.48 per share, for the same period in 2022. The weighted average number of shares used to calculate net loss per share was 2.4 million for the full year ended December 31, 2023, and 1.5 million for the full year ended December 31, 2022.

About KALA BIO, Inc.

KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. For more information on KALA, please visit www.kalarx.com.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s expectations with respect to potential advantages of KPI-012 and its MSC-S platform; the clinical utility of KPI-012 for PCED; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; KALA’s belief that the Chase Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a BLA to the FDA; KALA’s plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; expectations about the potential benefits and future operation of the CIRM award; KALA’s ability to achieve the specified milestones and obtain the full funding under the CIRM award; the sufficiency of KALA’s existing cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: KALA’s ability to comply with the requirements under the CIRM award; uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE Phase 2b clinical trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; KALA’s ability to retain and hire key personnel; KALA’s ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Financial Tables:

 
KALA BIO, Inc.
Balance Sheet Data
(in thousands)
(unaudited)
             
    December 31,   December 31,
    2023   2022
Cash and cash equivalents   $ 50,895   $ 70,495
Total assets     55,949     86,820
Working capital(1)     44,524     60,257
Long-term debt, net of discounts     34,190     37,937
Other long-term liabilities     5,909     4,224
Total stockholders’ equity     7,504     18,974
 
(1) The Company defines working capital as current assets less current liabilities. See the Company’s consolidated financial statements for further information regarding its current assets and current liabilities.

KALA BIO, Inc.
Consolidated Statement of Operations
(In thousands, except share and per share data)
(Unaudited)
 
    Three Months Ended   Year Ended
    December 31,   December 31,
    2023   2022   2023   2022
                   
Product revenues, net   $   $   $   $ 3,892
                         
Costs and expenses:                        
Cost of product revenues                 2,560
Selling, general and administrative     4,623     5,831     20,567     65,035
Research and development     4,718     3,323     18,586     17,653
Loss (gain) on fair value remeasurement of deferred purchase consideration         433     (230)     638
Loss (gain) on fair value remeasurement of contingent consideration     278     664     740     (288)
Total operating expenses     9,619     10,251     39,663     85,598
Loss from operations     (9,619)     (10,251)     (39,663)     (81,706)
Other income (expense):                        
Interest income     610     354     2,711     664
Interest expense     (1,468)     (1,577)     (5,814)     (7,266)
Grant income     1,855         4,825    
Loss on extinguishment of debt                 (2,583)
Gain on sale of commercial business                 46,995
Other income (expense), net     (5)     (1,369)     (4,258)     (926)
Total other income (expense)     992     (2,592)     (2,536)     36,884
Net loss   $ (8,627)   $ (12,843)   $ (42,199)   $ (44,822)
Net loss per share attributable to common stockholders—basic and diluted   $ (3.18)   $ (7.97)   $ (17.35)   $ (29.48)
Weighted average shares outstanding—basic and diluted     2,712,475     1,611,375     2,432,008     1,520,611
 


Investor Contact:

Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update




Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update

NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.

Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We have been focused on advancing our Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly known as NASH) cirrhosis program. We completed enrollment and randomization for the NAVIGATE Phase 2b/3 trial in 2023, and belapectin has consistently shown an encouraging safety profile, which was determined by our independent Data and Safety Monitoring Board on multiple reviews.

We are pleased with the recent addition of Khurram Jamil, M.D., to our team. Dr. Jamil’s extensive experience in advanced liver disease, specifically for late-stage cirrhotic patients, is a tremendous asset to our program. Echoing Dr. Boudes’ comments from early March, Dr. Jamil’s breadth of expertise in clinical development and regulatory interactions will be critical for the Company as we continue to execute the trial. We look forward to sharing the top-line interim analysis readout from NAVIGATE in Q4 2024.

Finally, we are pleased to report that, once again, our Chairman, Mr. Richard Uihlein, has provided significant financing for the Company via an additional $10 million credit facility to the Company. This funding extends our cash runway through March 2025. On behalf of the Board and management I want to thank Mr. Uihlein for his confidence in our team and our program.”

Pol Boudes, M.D., Chief Medical Officer added, “We were pleased by the very recent U.S. Food and Drug Administration approval of resmetirom for the treatment of patients with MASH with moderate to advanced liver fibrosis; this will bring renewed attention to the field. However, the population of patients in our NAVIGATE trial of belapectin have progressed beyond advanced liver fibrosis, to liver cirrhosis and portal hypertension and have the most pressing medical need. Currently, for them, the only curative treatment is liver transplantation, a process whose access is severely limited, highly complex and very costly. Our hope is that our belapectin MASH program, which has a Fast Track Designation, will for the first time offer a new medical treatment option for the increasing number of patients affected with MASH associated liver cirrhosis. We look forward to the upcoming interim analysis of the adaptive Phase 2b/3 NAVIGATE study which, we believe, has the potential to demonstrate belapectin’s ability to stop the progression of portal hypertension in cirrhotic patients and prevent the development of esophageal varices, which are a leading cause of morbidity and mortality in this population.”

Q4 2023 Belapectin Program Highlights

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis.

NASH Cirrhosis

  • The NAVIGATE Phase 2b/3 trial (NCT04365868) evaluating the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis completed randomization of 357 patients in 14 countries on five continents.
    • The fourth Data Safety and Monitoring Board (DSMB) meeting authorized the continuation of the trial as designed and without modifications.
    • Upcoming milestone remains on track for top-line data readout from NAVIGATE interim analysis in Q4 2024.
  • Presented five posters at the Liver Meeting™ 2023 of the American Association for the Study of Liver Diseases (AASLD) including the safety profile of belapectin and the fact that its pharmacokinetics properties are not affected by the degree of liver impairment.

Corporate Updates

  • Appointed Benjamin S. Carson, Sr., M.D. as a new member of the Board of Directors, following his service as a senior advisor to the Company since 2021.

Full Year 2023 Financial Highlights

  • As of December 31, 2023, the Company had $25.7 million of cash and cash equivalents. Additionally, the Company has $20 million remaining available under a $60 million line of credit provided by its chairman to fund operations and a newly executed $10 million line of credit also provided by our chairman. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through March 31, 2025.
  • Research and development expenses for the year ended December 31, 2023 were $32.1 million compared with $31.7 million for the year ended December 31, 2022. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities.
  • General and administrative expenses for the year ended December 31, 2023 were $5.9 million, compared to $6.6 million for the year ended December 31, 2022. The decrease was primarily due to non-cash stock-based compensation expense.
  • For the year ended December 31, 2023, the Company reported a net loss applicable to common stockholders of $44.8 million, or ($0.74) per share, compared to a net loss applicable to common stockholders of $38.9 million, or ($0.65) per share for the year ended December 31, 2022. The increase is largely due to an increase in noncash interest expense of $1.8 million and a noncash charge related to modification of common stock purchase warrants of $3.6 million.
  • These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

About Galectin Therapeutics

Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need and a significant drug development opportunity . Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect,” “look forward,” “believe,” “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

Company Contact:

Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com

Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com

Chris Calabrese
ccalabrese@lifesciadvisors.com

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin.

Condensed Consolidated Statements of Operations

  Year Ended
December 31,
    2023     2022  
     
Operating expenses:    
     
Research and development $ 32,130   $ 31,737  
General and administrative   5,942     6,615  
Total operating expenses   38,072     38,352  
Total operating loss   (38,072 )   (38,352 )
Other income (expense):    
     
Interest income   230     52  
Interest expense   (2,792 )   (1,033 )
Change in fair value of derivatives   (432 )   557  
Total other income   (2,994 )   (424 )
             
Net loss $ (41,066 ) $ (38,776 )
Preferred stock dividends   (120 )   (97 )
Warrant modification   (3,619 )  
         
Net loss applicable to common stock $ (44,805 ) $ (38,873 )
             
Basic and diluted net loss per share $ (0.74 ) $ (0.65 )
Shares used in computing basic and diluted net loss per share   60,159     59,391  


Condensed Consolidated Balance Sheet Data

    December 31, 2023   December 31, 2022
    (in thousands)
Cash and cash equivalents $ 25,660   $ 18,592  
Total assets   28,200     21,285  
Total current liabilities   15,676     13,012  
Total liabilities   88,441     53,479  
Total redeemable, convertible preferred stock   1,723     1,723  
Total stockholders’ equity (deficit) $ (61,964 ) $ (33,917 )

Global Cell Counting Market to Hit $15.72 Billion by 2029, Fueled by Advancements in Cell Biology and Therapy – ResearchAndMarkets.com

Global Cell Counting Market to Hit $15.72 Billion by 2029, Fueled by Advancements in Cell Biology and Therapy – ResearchAndMarkets.com




Global Cell Counting Market to Hit $15.72 Billion by 2029, Fueled by Advancements in Cell Biology and Therapy – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global Cell Counting Market: Analysis By Product, By Application, By End-User, By Region Size, Trends and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.


The global cell counting market was valued at US$9.98 billion in 2023 and is expected to reach US$15.72 billion by 2029. The market is expected to grow at a CAGR of approx. 8% during the forecasted period of 2024-2029.

The global cell counting market is witnessing significant growth due to various factors. Advancements in cell biology, biotechnology, and medical research are driving demand for precise cell counting, especially with the rise of personalized medicine and regenerative therapies. The expansion of biopharmaceutical and biotechnology sectors further fuels market growth. Future growth is anticipated due to technological advancements, including automation, artificial intelligence, and miniaturization, facilitating high-throughput analysis and integration with laboratory systems. Moreover, the focus on point-of-care diagnostics and decentralized testing, along with increasing healthcare investments and the prevalence of chronic diseases, will continue to propel market expansion.

Market Segmentation Analysis:

By Product: The consumables & accessories held the highest share in the market and is expected to be the fastest-growing segment in the forecasted period. Consumables and accessories play a crucial role in the cell counting process, supporting sample preparation, analysis, and data interpretation. As the volume of cell-based research and bioprocessing activities continues to increase, there is a corresponding rise in the demand for consumables such as cell counting chambers, slides, reagents, and disposable cuvettes.

By Application: Life science research segment held the highest share in the market, whereas the cell based therapy segment is expected to be the fastest-growing segment in the forecasted period. The demand for cell counting applications in cell-based therapy is increasing due to the rapid advancement and commercialization of cell-based treatments for various diseases and medical conditions. Cell counting is essential throughout the cell therapy development and manufacturing process, from initial research and development to clinical trials and commercialization. With the increasing focus on personalized medicine and regenerative therapies, there is a growing demand for accurate and reliable cell counting technologies to support the development and manufacturing of cell-based therapies tailored to individual patients.

By End-User: Research & academic institutes held the highest share in the market, whereas hospitals & diagnostic laboratories segment is expected to be the fastest growing segment in the forecasted period. The increasing emphasis on interdisciplinary research and collaborative initiatives has led to the integration of cell counting technologies into multidisciplinary research projects and academic consortia. As a result, research and academic institutes continue to invest in advanced cell counting instruments, consumables, and software tools to support their research endeavors, foster innovation, and train the next generation of scientists.

By Region: North America held the major share in the market. In recent years, the cell and gene therapy market has grown significantly in the US. The increase in cell and gene therapy launches in the US creates a higher demand for accurate cell counting technologies throughout the therapy development process, from research and development to manufacturing and quality control. On the other hand, according to the National Cancer Institute, in 2020, an estimated 603,989 people were living with lung and bronchus cancer in the US. Therefore, the rise in solid tumor cases prompts an increase in active clinical trials for developing new treatments and therapies. These trials require extensive cell counting for patient monitoring, efficacy assessment, and safety evaluation, driving demand for cell counting technologies and contributing to market growth.

Germany has a robust healthcare system and a growing emphasis on personalized medicine, leading to increased investment in cell-based therapies for treating various diseases and medical conditions. The country’s supportive regulatory environment, coupled with government funding initiatives and collaborations between academia and industry, accelerates the adoption of cell counting technologies.

Market Dynamics:

Growth Drivers: The global cell counting market has been growing over the past few years, due to factors such as an increasing number of active cell and gene therapy trials, rising spending on pharmaceutical R&D, funding in the biopharma sector, developments in advanced cell-based research, government initiatives for promoting cell therapeutics research, and many other factors. CGT is a relatively new type of niche that has the potential to treat many diseases for which there is currently no effective alternative. While decades of research have gone into CGT, developing this innovative treatment gathered momentum after the FDA approved the first CAR-T therapy in 2017 (Novartis’s Kymriah for acute lymphoblastic leukemia). The increasing number of active cell and gene therapy trials has driven the demand for advanced cell counting technologies and solutions. Cell and gene therapies require precise characterization and quantification of therapeutic cells, vectors, and target cells, both during manufacturing processes and in preclinical and clinical studies. As the field of regenerative medicine expands and more therapies move towards commercialization, there is a growing need for accurate and reliable cell counting instruments, flow cytometry systems, and image-based analysis platforms.

Challenges: The market growth would be negatively impacted by various challenges such as high cost of cell analysis, sample heterogeneity, etc.

Trends: The market is projected to grow at a fast pace during the forecast period, due to various latest trends such as growing number of new clinical trials, rising demand for personalized medicine, advancements in cell counting technologies, shift towards portable and point-of-care cell counting devices, integration of AI and ML, increasing adoption of automation, etc. Cell counting instrument sales growth is tightly connected to the number of CGT approvals.

At the end of May 2023, Krystal Biotech’s Vyjuvek – a gene therapy for the treatment of dystrophic epidermolysis bullosa (DEB) – received FDA approval. On the other hand, at the end of June 2023, Sarepta Therapeutics received FDA approval for its Duchenne muscular dystrophy (DMD) treatment. The FDA has missed most of its PDUFA target dates in the CGT area during 2023. However, the Center for Biologics Evaluation and Research (CBER), the arm of the FDA that evaluates CGT therapies, has been authorized to hire another 125 reviewers under PDUFA VII. Such an expansion could help the administration meet its target deadlines, going forward. PDUFA dates for therapies could translate into an order book boost for the cell counting players in the market, resulting in market growth.

Competitive Landscape:

The global cell counting market is consolidated, with top five players holding approximately 70% share of the market. The key players in the global cell counting market are:

  • ChemoMetec
  • Thermo Fisher Scientific
  • Merck (MilliporeSigma)
  • Agilent Technologies, Inc.
  • Revvity
  • Bio-Rad Laboratories
  • Becton, Dickinson
  • Danaher
  • Olympus
  • Sysmex
  • Aligned Genetics
  • DeNovix

Key Topics Covered:

1. Executive Summary

2. Introduction

3. Global Market Analysis

  • Product Analysis
  • Application Analysis
  • End-User Analysis

4. Regional Market Analysis

5. Impact of COVID-19

6. Market Dynamics

Growth Drivers

  • Increasing Sale of Cell and Gene Therapy Products
  • Rising Spending on Pharmaceutical R&D
  • Aging Population
  • Funding in Biopharma Sector
  • Developments in Advanced Cell Based Research
  • Increasing Prevalence of Chronic and Infectious Diseases
  • Government Initiatives for Promoting Cell Therapeutics Research

Challenges

  • High Cost of Cell Analysis
  • Sample Heterogeneity

Market Trends

  • Increasing Number of Active Cell and Gene Therapy Trials
  • Growing Number of New Clinical Trials
  • Rising Demand for Personalized Medicine
  • Cell and Gene Therapy Pipeline
  • Advancements in Cell Counting Technologies
  • Increasing Adoption of Automation
  • Shift Towards Portable and Point-of-Care Cell Counting Devices
  • Integration of AI and ML

7. Competitive Landscape

7.1 Global Cell Counting Players by Market Share

7.2 Global Cell Counting Players by Product Comparison

7.3 Global Cell Counting Players by Low Throughput Offerings

7.4 Global Cell Counting Players by High Throughput Offerings

7.5 Global Cell Counting Players by Bioprocessing Cell Counters and Analyzers

8. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/h449qg

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900