Cystic Fibrosis Foundation

BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, April 3, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Initial top line results of the Phase 2 trial are expected in the first quarter of 2025.
  • However, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
  • ET to discuss its fourth quarter and full year 2023 financial results and to provide a corporate update.

BiomX Announces Closing of the Acquisition of Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Retrieved on: 
Monday, March 18, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the closing of its previously announced (March 6, 2024) acquisition (the “Acquisition”) of Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, and its previously announced $50 million private placement to certain institutional accredited investors, which was led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital.

Key Points: 
  • “We are very pleased to announce the closing of the APT acquisition, which creates a leading phage company and an advanced pipeline that includes two Phase 2 assets each aimed at treating serious infections with unmet medical need,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “We also appreciate the continued support of leading institutional healthcare investors.
  • Haynes and Boone, LLP served as legal counsel to BiomX.
  • Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to the placement agents.

CF Foundation Provides Up to $8.5M to SpliSense to Support a Clinical Trial for a Potential Treatment for Splicing Mutations

Retrieved on: 
Wednesday, April 3, 2024

The Foundation's funding will support a planned Phase 2 clinical trial to test the efficacy of SpliSense’s inhaled ASO drug as a potential treatment for the lungs of people with the splicing mutation 3849+10Kb C-to-T. A recent Phase 1a study indicated the drug was safe and well tolerated.

Key Points: 
  • The Foundation's funding will support a planned Phase 2 clinical trial to test the efficacy of SpliSense’s inhaled ASO drug as a potential treatment for the lungs of people with the splicing mutation 3849+10Kb C-to-T. A recent Phase 1a study indicated the drug was safe and well tolerated.
  • The objective of the clinical trial is to generate a proof-of-concept for ASO technology in cystic fibrosis.
  • If the clinical trial is successful, it could validate other similar therapeutic approaches in SpliSense's pipeline that address rare CF mutations.
  • In 2021, the Foundation invested $8.4 million in SpliSense to develop a therapy for splicing mutations, in addition to $400,000 the Foundation provided in 2017.

BiomX Announces Entry into Merger Agreement with Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Retrieved on: 
Wednesday, March 6, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 06, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that it has entered into a definitive merger agreement with Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections (the “Acquisition”). Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT. The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement. Concurrently with entering into the definitive merger agreement, BiomX entered into a definitive purchase agreement for the sale of shares of newly created non-voting convertible preferred stock (“Series X Preferred Stock”) and warrants to purchase shares of BiomX common stock in a private placement to certain institutional accredited investors led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital. The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses. The proceeds from the private placement are expected to provide funding through the results from a planned Phase 2b trial that will evaluate BiomX’s lead product candidate, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) in CF patients expected in the third quarter of 2025 and Phase 2 results from APT’s clinical-stage product candidate, now named BX211, for the treatment of Staphylococcus aureus (S. aureus) infections in DFO patients expected in the first quarter of 2025. The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

Key Points: 
  • Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT.
  • The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement.
  • The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses.
  • The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

Prime Medicine Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 1, 2024

CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the full year ended December 31, 2023 and provided a business update.

Key Points: 
  • “In 2024, we anticipate undergoing a significant transformation, maturing into a clinical-stage company and bringing the first-ever Prime Editing-based therapeutic candidate to patients.
  • This funding will allow Prime Medicine to progress two distinct strategies for applying Prime Editing to treat CF: hotspot editing and PASSIGE™ (Prime Assisted Site Specific Integrase Gene Editing).
  • Gross proceeds to Prime Medicine from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $161.0 million.
  • In January 2024, Prime Medicine announced the appointment of Allan Reine, M.D., as the Company’s Chief Financial Officer.

Prime Medicine Receives Up to $15 Million from Cystic Fibrosis Foundation to Advance Hotspot and PASSIGE™ Prime Editors for Cystic Fibrosis

Retrieved on: 
Thursday, January 25, 2024

Funding from the CF Foundation will allow Prime Medicine to progress two distinct strategies for applying Prime Editing to treat CF: hotspot editing and PASSIGE™ (Prime Assisted Site Specific Integrase Gene Editing).

Key Points: 
  • Funding from the CF Foundation will allow Prime Medicine to progress two distinct strategies for applying Prime Editing to treat CF: hotspot editing and PASSIGE™ (Prime Assisted Site Specific Integrase Gene Editing).
  • Through hotspot editing, the Company aims to address multiple mutations at mutational hotspots with a small number of Prime Editors.
  • Prime Medicine has begun preclinical research to use hotspot Prime Editors to correct the G542X nonsense CFTR mutation, and plans to extend this work to develop hotspot Prime Editors for other clusters of CFTR mutations.
  • Prime Medicine is eligible for an additional $6 million upon achieving certain preclinical milestones, with up to $3 million in supplementary funding upon mutual agreement.

Cystic Fibrosis Foundation Funds Up to $15 Million to Prime Medicine to Pursue Gene Editing in CF

Retrieved on: 
Thursday, January 25, 2024

Today, the Cystic Fibrosis Foundation announced that it will provide up to $15 million to Prime Medicine for preclinical research into gene editing for cystic fibrosis.

Key Points: 
  • Today, the Cystic Fibrosis Foundation announced that it will provide up to $15 million to Prime Medicine for preclinical research into gene editing for cystic fibrosis.
  • Prime Medicine is using a gene editing technology called prime editing — a technology that enables insertions or deletions of small segments of DNA at precise sites.
  • Prime Medicine — founded by researchers who pioneered the development of this unique editing technology — is investigating whether prime editing could treat several diseases, including CF.
  • Prime Medicine intends to use prime editing to fix the CFTR gene by inserting a part of the DNA that codes for the CFTR gene.

Clarametyx Biosciences Announces $33M Series A Financing to Advance Anti-Biofilm Biologics for Serious Bacterial Infections

Retrieved on: 
Friday, January 5, 2024

(“Clarametyx”), a clinical stage company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the successful completion of a $33 million Series A round.

Key Points: 
  • (“Clarametyx”), a clinical stage company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the successful completion of a $33 million Series A round.
  • Clarametyx was launched in 2020 to advance a novel, immune-enabling antibody technology licensed from Nationwide Children’s Hospital.
  • The company is evaluating its anti-biofilm technology in both therapeutic and preventive settings to address the global challenge of persistent bacterial infection and antibiotic resistance.
  • “We graciously welcome our new investors and appreciate the continued commitment of our existing investors.

Sail Biomedicines Provides Update on Research with Cystic Fibrosis Foundation and Pioneering Medicines

Retrieved on: 
Friday, January 5, 2024

Sail Biomedicines, Inc., a Flagship Pioneering company and leader in RNA-based programmable medicines, today provided an update on its research funded by the Cystic Fibrosis Foundation (CF Foundation), with preclinical data that suggest that Sail’s Endless RNA™ (eRNA™) may offer the potential to treat the 10%-15% of people with CF for whom existing treatments are not an option.

Key Points: 
  • Sail Biomedicines, Inc., a Flagship Pioneering company and leader in RNA-based programmable medicines, today provided an update on its research funded by the Cystic Fibrosis Foundation (CF Foundation), with preclinical data that suggest that Sail’s Endless RNA™ (eRNA™) may offer the potential to treat the 10%-15% of people with CF for whom existing treatments are not an option.
  • Sail’s programmable eRNA platform is designed to enable the in vivo expression of any protein, potentially targeting any tissue.
  • Cystic fibrosis is a progressive, genetic disease caused by mutations in the CFTR gene that affect the lungs, pancreas, and other organs.
  • “We are extremely hopeful about the impact this work could have for the CF community.”
    “The collaboration between Pioneering Medicines and the Cystic Fibrosis Foundation aims to accelerate the path to potential treatments and cures for all people living with cystic fibrosis,” said Paul Biondi, President, Pioneering Medicines and Executive Partner, Flagship Pioneering.

ViaNautis Bio announces $25 million Series A financing to drive the next generation of genetic nanomedicines

Retrieved on: 
Monday, November 13, 2023

Formerly known as SomaServe, ViaNautis has secured support from a consortium of prominent global investors enabling the advancement of its proprietary drug delivery platform – polyNaut®.

Key Points: 
  • Formerly known as SomaServe, ViaNautis has secured support from a consortium of prominent global investors enabling the advancement of its proprietary drug delivery platform – polyNaut®.
  • ViaNautis’s polyNaut® platform applies advanced polymer materials and in silico screening to precisely guide genetic molecules such as pDNA, mRNA, siRNA and ASOs to their intended targets.
  • ViaNautis presents an excellent opportunity in the world of genetic therapies by enabling the delivery of cargoes to otherwise inaccessible sites of action in the body.
  • It opens a plethora of novel prospects in the world of genetic therapies, offering the ability to reach previously inaccessible treatment sites.