Founded by the legendary Coco Chanel in the early 20th century, Chanel has remained at the forefront of fashion, redefining standards of style and sophistication for generations. From the revolutionary design of the Little Black Dress to the iconic Chanel No. 5 perfume, the house of Chanel epitomizes the epitome of luxury and refinement.

Commenting on the endowment, C.K. McWhorter stated, “Chanel represents the epitome of elegance and innovation in the world of fashion. Coco Chanel’s visionary approach to design continues to inspire and influence designers and fashion enthusiasts worldwide. With this endowment, we pay homage to Chanel’s timeless legacy and its unwavering commitment to excellence.”

Chanel’s enduring legacy is built on a foundation of unparalleled craftsmanship, attention to detail, and a revolutionary spirit that continues to shape the fashion landscape. From its iconic quilted handbags to its timeless tweed suits, each Chanel creation reflects a perfect harmony of tradition and modernity.

The McWhorter Family Trust’s endowment of Chanel underscores its dedication to recognizing and preserving excellence in the world of fashion. As a trailblazer in luxury couture, Chanel embodies the values of innovation, creativity, and uncompromising quality that resonate with the ethos of the McWhorter family.

About McWhorter Family Trust

The McWhorter Family Trust supports initiatives that promote excellence, innovation, and sustainability. With a broad focus luxury on asset classifications, and cultural preservation, the Trust is dedicated to making a meaningful impact on society and fostering a legacy of positive change.

Disclaimer, Disclosure & Legal Notice:
This press release is for informational purposes only and does not constitute legal, financial, or investment advice. It is not intended to provide specific recommendations, endorsements, or investment strategies. The information contained herein is subject to change without notice.

Regulatory Considerations:

This press release is not intended to constitute an offer to sell or the solicitation of an offer to buy securities. Any offers, sales, or purchases will be made in accordance with applicable securities laws and regulations. McWhorter Foundation has not registered with the U.S. Securities and Exchange Commission (SEC) and may operate under exemptions. Any investment decisions should be made in consultation with appropriate legal and financial advisors, considering the individual circumstances and objectives of potential investors.

Forward-Looking Statements:

Forward-looking statements involve inherent risks and uncertainties, and we caution you not to place undue reliance on forward-looking statements. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Actual results or outcomes may differ materially from those indicated or suggested by any forward-looking statements as a result of various factors, including, but not limited to, regulatory and legal developments, market conditions, and the outcome of negotiations. We disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cda46ccc-bdf6-4de5-ba9d-31c747d3a1fb

SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced its selection by the United Kingdom’s (UK) Government Innovation Agency (Innovate UK) to partake in the prestigious UK Antimicrobial Resistance (AMR) Inward Mission 2024. This event, set to take place from June 2-7, 2024, will spotlight the Company as one of the promising organizations from across the globe recognized for its potential to combat AMR.

“We are thrilled by the opportunity to collaborate with the UK’s leading AMR experts and institutions and thank the UK government for their support,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We believe this mission will be a catalyst for our continued growth and success in developing potentially life-saving antimicrobial treatments.”

Innovate UK’s rigorous selection process identified Recce as one of 18 organizations in the world from a large competitive pool of international candidates (Australia, Canada, France, India, Italy, Netherlands, Nigeria, Norway, Switzerland, and the USA), highlighting its innovative approach and potential to synergize with the UK’s AMR industry leaders.

The UK AMR Inward Mission 2024 will host a comprehensive program, including partnering sessions, visits to world-class AMR infrastructure, and interactions with key opinion leaders. A highlight of the event will be a reception in Cambridge with Professor Dame Sally Davies, former England Chief Medical Officer who acted as the UK government’s principal medical adviser and the professional head of all directors of public health in local government.

The selection of Recce for the UK AMR Inward Mission signifies an important geographic opportunity in its global strategy, particularly in establishing a foothold in the UK’s vibrant AMR research and development ecosystem. This engagement will enable Recce to forge essential partnerships, gain insights into regulatory pathways, and explore new markets, ultimately advancing its mission to provide innovative solutions to the pressing global health challenge of AMR.

About Innovate UK
Innovate UK is the UK’s national innovation agency. We support business-led innovation in all sectors, technologies and UK regions. We help businesses grow through the development and commercialisation of new products, processes, and services, supported by an outstanding innovation ecosystem that is agile, inclusive, and easy to navigate.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE^® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE^® 435 as an orally administered therapy for bacterial infections; and RECCE^® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

The FDA has awarded RECCE^® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE^® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE^® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au

Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au

Media (USA)
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com

Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com

Perth, Western Australia/April 10, 2024/Perseus Mining Limited (ASX/TSX: PRU) is hosting an investor webinar and conference call to discuss its March 2024 Quarterly Results, which are anticipated for release around 8:30am AEST on Wednesday April 24, 2024.

CALL DETAILS

Register for the investor webinar at the link below:

https://us02web.zoom.us/webinar/register/WN_eXx-JWGlT8eWeG20chaqgQ

After registering, you will receive a confirmation email containing information about joining the webinar.

To join the webinar via telephone, please use one of the following numbers and enter the Webinar ID: 828 5577 1169

For higher quality, dial a number based on your current location:

International numbers available: https://us02web.zoom.us/u/kdReOxTZn5

A recording of the conference call will be made available via Perseus’s website at www.perseusmining.com.

Halcones is currently evaluating opportunities in an effort to reactivate its business and build shareholder value.

About Halcones Precious Metals Corp.:

Halcones is focused on exploring for and developing gold-silver projects in the Maricunga Belt, Chile, the premiere gold mining district in South America. The Company has a team with a strong background of exploration success in the region.

For further information, please contact:

Vincent Chen
Investor Relations
vincent.chen@halconespm.com
www.halconespreciousmetals.com

Cautionary Note Regarding Forward-looking Information

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. Forward-looking information includes, without limitation, regarding the Project, the mineralization of the Project, the option agreement for the Project, the Company’s ability to identify and acquire projects and the Company’s future plans. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved”. Forward- looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Halcones, as the case may be, to be materially different from those expressed or implied by such forward-looking information, including but not limited to: general business, economic, competitive, geopolitical and social uncertainties; the actual results of current exploration activities; risks associated with operation in foreign jurisdictions; ability to successfully integrate the purchased properties; foreign operations risks; and other risks inherent in the mining industry. Although Halcones has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Halcones does not undertake to update any forward-looking information, except in accordance with applicable securities laws.

NEITHER TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

MANAUS, Brazil, April 09, 2024 (GLOBE NEWSWIRE) — Brazil Potash Corp. (“Brazil Potash” or the “Company”) is excited to announce the Amazon State Environmental Protection Institute (IPAAM), has granted the mine Installation License for the Autazes Potash Project (the “Project”) to the 100% owned Brazilian subsidiary Potassio do Brasil, allowing for construction to commence. This is a major milestone in the Company’s development and follows several years of environmental, social, and technical studies as well as the successful completion of local Indigenous People’s ‘free, prior, and informed consultations’.

Brazil Potash’s mine Installation License was granted at a ceremony organized by Amazon State Governor Wilson Lima, and attended by IPAAM President Juliano Valente, State Deputy Sinesio Campos, Potássio do Brasil President Adriano Espeschit, several other government officials, and major press outlets recognizing the importance of establishing a sustainable domestic source of potash in Brazil for global food security. The Company expects to start construction with the awarding of contracts for mine surface works and shaft construction.

Tadeu de Souza – Amazonas Vice Governor, Wilson Lima – Amazonas Governor, Anderson Cavalcante – Mayor Autazes, Silas Camara – Federal Deputy, Sinésio Campos – State Deputy, Ronney Peixoto – Mining Secretary of State, Kleber Mura – CIM Coordinator General

Extensive media attendance at license grant ceremony

BRAZIL AND THE NEED FOR FERTILIZERS

Global food security depends on the continued success of Brazilian agricultural exports. The country is a leading producer and exporter of orange juice, soybeans, corn, sugar and cotton as well as beef, poultry and pork. Abundant arable land, good year-round weather and efficient farming have made Brazilian farmers among the most productive globally, contributing roughly 30% to Brazil’s GDP. Critical to Brazil’s continuing productivity is access to affordable fertilizers. However, Brazil is highly exposed as it imports 85% of its fertilizer needs including 98% of its potash, half of which comes from countries currently at war or sanctioned, including Russia, Belarus, and Israel, when a massive potash basin exists in its own backyard. Now, with the License approval, Brazil can produce this essential mineral for its farmers in country, by-passing the risk and costs of imports. Potash is extremely important to efficiently grow food as it strengthens the stem of plants to make them more resilient to stresses caused by drought, extreme temperatures, and insect infestation.

ABOUT BRAZIL POTASH. GAME CHANGER FOR BRAZIL AND THE WORLD FOR FOOD SECURITY

Brazil Potash’s Autazes deposit can be mined and processed, using proven off the shelf environmentally friendly technology, to extract the ore using room and pillar mining, separate out the potash using hot water and return the remaining material (sodium chloride tailings) back underground. From an environmental perspective, this project has positive greenhouse gas credentials considering it will operate with predominantly green produced electric energy (Brazil has 84%+ renewable energy in its grid). Production in country also eliminates 12,000 to 20,000 kilometers of shipping to reach Brazil’s large soybean farmers in Mato Grosso resulting in clear benefits to Brazil and for global food security.

“We are thrilled to receive the mine installation license from the Amazon State Environmental Protection Institute.  For several years, Brazil Potash has been waiting for this moment to show that is possible to have a sustainable mining operation in the Amazon region. With the Autazes Potash Project’s support from the Mura Indigenous people, we can show the world that it is possible to have more development for local communities with a better quality of life. This truly marks a win-win for Brazil’s economy, its people, and the world,” said Adriano Espeschit, President of Potássio do Brasil. 

Brazil Potash’s CEO, Matt Simpson, commented, “I am very proud of the years of permitting, indigenous, government, and community relations work completed by our team in Brazil headed by our President Adriano Espeschit, which has resulting in securing the mine Installation License. This is a major milestone to advance and derisk the development of the Autazes Potash Project as we move closer to the start of project construction”.

EXTENSIVE USE OF GREEN ENERGY AND POSITIVE SOCIAL IMPACT

Brazil Potash will have a positive impact on the economy and environment of the Amazonas state by reducing green house gases by ~1.4 million tons per year. The Company will create an estimated 10,000 new jobs and will be largest contributor to the GDP for the state of Amazonas. In addition, the project will produce potash locally and sell it in local currency thus saving Brazil roughly US$1 billion in currency outflows. The Company is also committed to suppling potash in small quantities to domestic farmers as they need it and supporting the initiatives of the Brazilian Government to restore degraded land.

        For more information, please contact:
        Brazil Potash Investor Relations
        info@brazilpotash.com

Cautionary Note Regarding Forward-Looking Statements
All statements, other than statements of historical fact, contained in this shareholder update constitute “forward-looking statements” and are based on the reasonable expectations, estimates and projections of the Company as of the date of this letter. The words “plans,” “expects,” or “does not expect,” “is expected,” “budget,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates,” or “does not anticipate,” or “believes,” or variations of such words and phrases or statements that certain actions, events or results “may,” “could,” “would,” “might,” or “will be taken,” “occur” or “be achieved” and similar expressions identify forward-looking statements. Forward-looking statements include, without limitation, statements regarding the Mura’s Indigenous people consultation process; the potash market globally and in Brazil; geopolitical tensions and opportunities; the potential benefits to Brazil and the Mura Indigenous people and the world from the Project; government support of the Company and its project; population growth and Brazil’s natural resources, the importation of potash in Brazil, the growth of the potash market and price expectations, advancing construction financing, offtake agreements, raising capital, completing a strategic transaction with a third party, environmental or community benefits, expected industry demands, the Company’s business strategy, the Company’s forecast of annual production and sales of potash, appointment of directors, currency fluctuations, government regulation and environmental regulation. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. The estimates and assumptions contained in this letter, which may prove to be incorrect, include, but are not limited to, the various assumptions of the Company set forth herein. Known and unknown factors could cause actual results to differ materially from those projected in the forward-looking statements. Such factors include, but are not limited to fluctuations in the supply and demand for potash, changes in competitive pressures, including pricing pressures, timing and amount of capital expenditures, changes in capital markets and corresponding effects on the Company’s investments, changes in currency and exchange rates, unexpected geological or environmental conditions, changes in and the effects of, government legislation, taxation, environmental regulations, licensing, controls and regulations and political or economic developments in jurisdictions in which the Company carries on its business or expects to do business, success in retaining or recruiting officers and directors for the future success of the Company’s business, officers and directors allocating their time to other ventures; success in obtaining any required additional financing to make target acquisition or develop the Project; employee and community relations, and risks associated with obtaining any necessary licenses or permits. Many of these uncertainties and contingencies can affect the Company’s actual results and could cause actual results to differ materially from those expressed or implied in any forward-looking statements made by, or on behalf of, the Company. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. All of the forward-looking statements made in this letter are qualified by these cautionary statements. These factors are not intended to represent a complete list of the factors that could affect the Company. The Company disclaims any intention or obligation to update or revise any forward-looking statements, except to the extent required by applicable law. The reader is cautioned not to place undue reliance on forward-looking statements.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/4529432a-8480-4ad0-96c7-68a4c48dd28d

https://www.globenewswire.com/NewsRoom/AttachmentNg/4b2a4f5c-747c-4d93-9bbb-7e2c9fc9c213

NOT FOR DISTRIBUTION TO UNITED STATES NEWS WIRE SERVICES OR
FOR DISSEMINATION IN THE UNITED STATES

Boston, MA , April 09, 2024 (GLOBE NEWSWIRE) — MiniLuxe Holding Corp. (TSXV:MNLX) (“MiniLuxe” or the “Company”) is pleased to announce that Flow Capital Corp. (TSXV:FW) (“Flow Capital”), a leading provider of flexible growth capital and alternative debt solutions, has completed a follow-on investment of $2.0M USD from its initial term debt investment of $2.5M USD in 2021. The refinancing benefits the Company with incremental capital in the form of a non-amortizing loan, allowing for flexible use of the capital and an extension of the maturity date of the initial debt investment by Flow Capital to 2027. As part of the transaction the Company will be issuing to Flow Capital warrants to purchase 1,692,308 Subordinate Voting Shares of the Company at a strike price of $0.52 USD (~$.71 CDN) per share for a period of three years from the date of issuance. The warrants are subject to a hold period of four months and one day from the issuance date in accordance with applicable securities laws. The refinancing was conditionally approved by the TSX Venture Exchange and remains subject to their final approval.

“This follow-on investment in MiniLuxe reflects our confidence in the Company’s leadership and meaningful recent progress including continued growth of its core studio business that is achieving industry-leading metrics” said Alex Baluta, Chief Executive Officer of Flow Capital.

“We are pleased to continue our relationship with Flow Capital as they have been good partners with an ability to underwrite through an operator and financier lens. This new investment complementing other recent funding activities gives us greater flexibility across our working capital and growth investment needs with a company favorable structure,” said Anthony Tjan, CEO of MiniLuxe.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described in this news release. Such securities have not been, and will not be, registered under the U.S. Securities Act, or any state securities laws, and, accordingly, may not be offered or sold within the United States, or to or for the account or benefit of persons in the United States or “U.S. Persons”, as such term is defined in Regulation S promulgated under the U.S. Securities Act, unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from such registration requirements.

About MiniLuxe

MiniLuxe is a Delaware corporation based in Boston, Massachusetts. Miniluxe is a lifestyle brand and talent empowerment platform servicing the beauty and self-care industry. The Company focuses on delivering high-quality nail care and esthetic services and offers a suite of trusted proprietary products that are used in the Company’s owned-and-operated studio services. For over a decade, MiniLuxe has been elevating industry standards through healthier, ultra-hygienic services, a modern design aesthetic, socially responsible labor practices, and better-for-you, cleaner products. MiniLuxe aims to radically transform the highly fragmented and under-regulated self-care and nail care industry through its brand, standards, and technology platform that collectively enable best-in-class talent and client experiences. For its clients, MiniLuxe offers industry leading self-care services and better-for-you products, and for nail care and beauty professionals, MiniLuxe seeks to become the employer of choice. In addition to creating long-term durable economic returns for our stakeholders, the brand seeks to positively impact and empower one of the most diverse and largest hourly worker segments through professional development and certification, economic mobility, and company ownership opportunities (e.g., equity participation and future franchise opportunities). Since its inception, MiniLuxe has completed over 3.5 million services.

About Flow Capital 

Flow Capital is a diversified alternative asset investor and advisor, specializing in providing minimally dilutive capital to emerging growth businesses. For more information on Flow Capital, please visit www.flowcap.com.

For further information

Christine Mastrangelo
Corporate Secretary and Investor Relations, MiniLuxe Holding Corp.
cmastrangelo@miniluxe.com
miniluxe.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Potentially best-in-class CDK9 inhibitor, PRT2527, in Phase 1 development, is highly effective in preclinical hematological models as monotherapy and provides improved depth and duration of response in combination with BTK/BCL2 inhibition

Next Generation CDK4/6 Inhibitor, PRT3645, is highly effective in combination with other targeted therapies in preclinical models of breast cancer, CRC and NSCLC

WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) — Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.

“These presentations demonstrate our core competencies in medicinal chemistry and cancer biology to optimize and deliver compounds to the clinic with the potential to succeed as differentiated first- and/or best-in-class new therapies,” said Andrew Combs, Ph.D., Chief Chemistry Officer at Prelude Therapeutics. 

Peggy Scherle, Ph.D., Chief Scientific Officer at Prelude, stated, “Advancement of our second highly selective SMARCA2 degrader strengthens Prelude’s leadership position in the emerging use of SMARCA2 protein degradation as a potential treatment option for underserved patients with cancer. With both a first-in-class IV SMARCA2 degrader, PRT3789, in Phase 1 clinical development and now our oral SMARCA2 degrader, PRT7732, expected to enter the clinic later this year, we believe these distinct modalities may offer new therapies for patients with SMARCA4 mutations.”

Details on the poster presentations are as follows:

Title: Preclinical Characterization of PRT7732: A Highly Potent, Selective, and Orally Bioavailable Targeted Protein Degrader of SMARCA2

Summary:

• Identified potent, selective, well-tolerated and orally bioavailable SMARCA2 degrader, PRT7732
• PRT7732 exhibits >3000-fold selectivity for SMARCA2 over SMARCA4, with low nanomolar potency in cell based assays
• Prelude completed IND-enabling studies for PRT7732 and is on track to enter Phase 1 clinical trials in the second half of 2024

Link: http://investors.preludetx.com/static-files/7b590cab-9f51-4e87-9b13-844599099dbf

Title: PRT2527, a Novel Highly Selective Cyclin-Dependent Kinase 9 (CDK9) Inhibitor, Has Potent Antitumor Activity in Combination with BTK and BCL2 Inhibition in Various Lymphoid Malignancies

Summary:

• PRT2527 is efficacious as monotherapy in preclinical models of DLBCL, CLL and MCL, and combines with both BTK and BCL2 inhibition to improve depth and duration of responses
• PRT2527 is currently being evaluated in a Phase I clinical trial in patients with relapsed/refractory hematologic malignancies as monotherapy and in combination with zanubrutinib (NCT05665530)

Link: http://investors.preludetx.com/static-files/ffa3bc31-4e5c-4151-bff7-ebd161f3df85

Title: The Brain Penetrant CDK4/6 Inhibitor, PRT3645, is Highly Effective in Combination with Other Targeted Therapies in Preclinical Models of Breast Cancer, CRC and NSCLC

Summary:

• Next generation CDK4/6 inhibitor, PRT3645, demonstrates preclinical synergy with SERDs, as well as MEK1/2 and CDK2 inhibition
• PRT3645 has the potential to improve patient outcomes when used in combination with other targeted therapies

Link: http://investors.preludetx.com/static-files/8dd469c6-6652-41bc-a191-2dc1ef054a7a

About Prelude Therapeutics

Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. Prelude’s diverse pipeline is comprised of highly differentiated, potentially best-in-class proprietary small molecule compounds aimed at addressing clinically validated pathways for cancers with selectable underserved patients. Prelude’s pipeline includes: an IV administered, potent and highly selective SMARCA2 degrader, PRT3789, a preclinical oral SMARCA2 selective degrader, PRT7732, a potent and highly selective CDK9 inhibitor, PRT2527, and a next generation CDK4/6 inhibitor, PRT3645.

For more information, visit our website and follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates, the potential safety, efficacy, benefits, and the expected timeline for initiating clinical trials for Prelude’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “potential,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude’s ability to fund development activities and achieve development goals, Prelude’s ability to protect intellectual property, and other risks and uncertainties described under the heading “Risk Factors” in Prelude’s Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law. 

Investor Contact:
Lindsey Trickett
Vice President, Investor Relations
240.543.7970
ltrickett@preludetx.com

Media Contact:
Helen Shik
Shik Communications
617.510.4373
Helen@ShikCommunications.com

Robust preclinical monotherapy anti-tumor activity for both selective CBP and selective EP300 degrader programs

Progress with FHD-909, selective CBP, and selective EP300 degrader programs further validates Foghorn’s drug discovery engine

Conference call and webcast today at 5 pm ET / 2 pm PT

CAMBRIDGE, Mass., April 09, 2024 (GLOBE NEWSWIRE) — Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today announced new preclinical data for potential first-in-class medicines including FHD-909, a BRM (SMARCA2) selective inhibitor, selective CBP degrader, and selective EP300 degrader programs at the 2024 American Association for Cancer Research (AACR) Annual Meeting. Foghorn management will hold a conference call and webcast today at 5 p.m. ET to review important pipeline updates.

“We are pleased with the encouraging data for our highly selective and potent drug candidates, which address historically very challenging cancer targets,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “Notably, our first-in-class BRM selective inhibitor FHD-909 has demonstrated favorable tolerability and encouraging dose-dependent single agent activity in preclinical models of BRG1 mutated tumors. We believe FHD-909 offers a potential new approach for the treatment of cancer. The primary target patient population is BRG1 mutated non-small cell lung cancer (NSCLC), which accounts for about 10% of NSCLC. We look forward to continued progress with Lilly with an IND filing for FHD-909 on track for the second quarter of the year.”

Steve Bellon Ph.D., Chief Scientific Officer of Foghorn Therapeutics added, “CBP and EP300 are nearly identical proteins which has made targeted specific approaches challenging. Our selective CBP program demonstrates significant tumor growth inhibition in solid tumors without thrombocytopenia or anemia that have been observed with dual CBP/EP300 inhibition. Our selective EP300 program, which is earlier in development, also demonstrates promising preclinical efficacy with no thrombocytopenia or negative effects on megakaryocyte viability, which are often seen in dual approaches. Additionally, we are applying our long-acting formulation capabilities to our degrader programs, which further enhances the clinical potential of these drug candidates. These are exciting achievements in the development of protein degraders for major cancer types, and we look forward to further progress across these important targets.”

Presentation Highlights

FHD-909 Program
BRM and BRG1 are highly homologous and mutually exclusive subunits of the BAF complex. BRG1 mutations occur in a variety of tumor types, including approximately 10% of non-small cell lung cancers (NSCLC), and result in tumors being dependent on BRM activity for their survival. Selectively blocking BRM activity is a promising synthetic lethal strategy to induce tumor death while sparing healthy cells. However, the ATPase domains of BRM and BRG1are 92% identical which has made identifying a selective BRM inhibitor challenging.

Poster 3230 / 14: Discovery of selective BRM (SMARCA2) ATPase inhibitors for the treatment of BRG1 (SMARCA4) mutant cancers
Preclinical data presented at AACR support FHD-909 as an oral, novel, potent and selective BRM inhibitor with robust anti-tumor monotherapy activity:

• ~ 30-fold selectivity for BRM inhibition over BRG1 in cell-based assays
• Dose-dependent and robust tumor growth inhibition and regression as a monotherapy in multiple BRG1 mutant xenograft models
• Favorable tolerability with dose dependent modulation of BRM target genes in vivo
• Lilly plans to file an IND application for potential first-in-class orally bioavailable, selective BRM inhibitor, FHD-909, with initial focus in BRG1 mutated NSCLC in Q2 2024

Selective CBP and Selective EP300 Degrader Programs
CBP and EP300 are paralog histone acetyltransferases involved in many cellular processes. Dysregulation of one or both is implicated in various cancer types, and functional genomic screens have suggested a synthetic lethal relationship in tumor cells. Attempts to selectively inhibit CBP or EP300 individually have been challenging due to the high homology between the two proteins. Additionally, dual inhibition of CBP/EP300 has led to hematopoietic toxicity.

Selective CBP Program
Poster 6067 / 26: Identification of selective CBP degraders with robust preclinical PK, PD, efficacy, and safety across solid tumor indications
Preclinical pharmacodynamic and pharmacokinetic data presented at AACR support the identification of potent and selective CBP degraders with anti-tumor activity across various EP300 mutant cell lines from multiple indications:

• Deep and sustained CBP degradation leading to significant tumor growth inhibition in mouse xenograft solid tumor models
• Robust monotherapy anti-tumor activity that was not associated with significant body weight loss
• In vivo, no evidence of thrombocytopenia, which is attributed to the sparing of megakaryocytes, nor evidence of anemia
• Long-acting CBP-selective protein degrader formulations with first-in-class potential for patients with tumors harboring EP300 mutations

Selective EP300 Program
Poster 6064 / 23: Discovery of potent and selective EP300 degraders with anti-cancer activity
Preclinical pharmacodynamic and pharmacokinetic data presented at AACR support the identification of potent and selective EP300 degraders with anti-tumor activity in prostate and hematological malignancies:

• Reduced growth of androgen receptor positive prostate cells and attenuated androgen signaling
• Reduced the growth of prostate cancer xenograft tumors in mice
• Broad anti-tumor activity across a panel of multiple myeloma and DLBCL cell lines
• In vivo efficacy demonstrated in a DLBCL model
• Well tolerated in vivo with no observed decrease in platelet levels, additionally mechanistic studies ex vivo show no effects on megakaryocyte viability at pharmacologically relevant concentrations

Conference Call and Webcast Information
Foghorn management will hold a conference call and webcast today at 5 p.m. ET to review pipeline updates. The dial-in number for the conference call is 1-877-704-4453 (U.S./Canada) or 1-201-389-0920 (international). The conference ID for all callers is 13745314. The live webcast and replay may be accessed under Events and Presentations in the Investors section of the Foghorn’s website, www.foghorntx.com, and will be available for up to 30 days.

About FHD-909
FHD-909 is a highly potent, allosteric and orally available small molecule that selectively inhibits the ATPase activity of BRM over its closely related paralog BRG1, two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in BRG1 rely on BRM for BAF function. FHD-909 has shown significant anti-tumor activity across multiple BRG1-mutant lung tumor models.

About Foghorn Therapeutics
Foghorn^® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control^® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The Company is developing multiple product candidates in oncology. Visit our website at www.foghorntx.com for more information on the Company, and follow us on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include statements regarding the Company’s clinical trials, product candidates and research efforts, including statements relating to FHD-286, FHD-909 and its selective CBP and selective EP300 degrader programs, and other statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risks relating to our clinical trials and other factors set forth under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date on which it is made.

Contacts:
Greg Dearborn, Foghorn Therapeutics Inc. (Investors)
gdearborn@foghorntx.com

Karin Hellsvik, Foghorn Therapeutics Inc. (Investors & Media)
khellsvik@foghorntx.com

Adam Silverstein, ScientPR (Media)
adam@scientpr.com

Peter Kelleher, LifeSci Advisors (Investors)
pkelleher@lifesciadvisors.com

– FMC-376 is broadly active in KRASG12C mutant containing PDX models derived from patients with solid tumors, including from heavily treated patients, across innate and acquired resistance and in models of brain metastases

– The Phase 1/2 PROSPER clinical trial is currently evaluating FMC-376 in patients with KRASG12C cancers, regardless of prior KRAS inhibitor therapy

BOSTON and SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) — Frontier Medicines Corporation, a clinical-stage precision medicine company seeking to unlock the proteome to advance transformational therapies against otherwise undruggable disease-causing targets, today presented new preclinical data on its KRASG12C inhibitor, FMC-376, at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. The new findings demonstrate FMC-376’s potential to overcome known mechanisms of innate and acquired resistance and in a CNS model of metastasis as a monotherapy and increase the efficacy of PD-1 immunotherapy in combination.

“We really pushed FMC-376 pre-clinically to better understand its ability to overcome common resistance mechanisms that have plagued single-acting KRAS inhibitors and limited their ability to provide meaningful and durable benefits to people with KRAS G12C cancers,” said Andrew Krivoshik, M.D., Ph.D., chief medical officer, Frontier. “These data demonstrate FMC-376’s unmatched potential to overcome over 90 percent of known resistance mechanisms, including those cancers that have become refractory to approved KRAS inhibitors. We look forward to proving FMC-376’s best-in-class potential to help even the hardest-to-treat cancers in our ongoing PROSPER clinical trial.”

FMC-376 was discovered by applying the Frontier Platform to directly engage both ON+OFF KRASG12C with exquisite selectivity. The differentiated dual direct mechanism of action of FMC-376 offers the potential to overcome the resistance and lack of response seen with current KRASG12C single-acting treatments.

“From the start, we designed FMC-376 to deliver dual inhibition of ON+OFF state KRASG12C with a highly selective profile that is eminently suitable to provide benefit to patients both as a monotherapy and in combination use,” said Kevin Webster, Ph.D., Frontier’s chief scientific officer. “These exciting preclinical data demonstrate FMC-376’s broad activity regardless of resistance mechanism, the addition of FMC-376 to an immune checkpoint inhibitor may lead to improved response and survival rates in patients with lung cancer, compared to a PD-1 inhibitor alone and demonstrate FMC-376’s ability to overcome CNS metastases, which are known to lead to worse treatment outcomes.”

FMC-376 a dual inhibitor of ON and OFF states of KRASG12C is broadly active in PDX models of resistance (Abstract #5948)

In preclinical results, FMC-376 is shown to be highly active in models of G12C inhibitor resistance where ON state KRAS G12C is upregulated. FMC-376 is efficacious in KRASG12C mutant containing patient-derived xenograft (PDX) models derived from patients with colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and pancreatic cancer, including tumors derived from heavily-treated patients. These results reinforce that FMC-376 has the potential to overcome limitations of single-acting KRASG12C inhibitors.

The clinical dual KRASG12C inhibitor FMC-376 has demonstrated potential as both a monotherapy and in combination for the treatment of patients with KRASG12C mutation positive NSCLC (Abstract #5949)

These preclinical data demonstrate FMC-376 overcomes drivers of innate and acquired clinical resistance to OFF state inhibitors of KRASG12C, as demonstrated by robust anti-tumor activity across a broad panel of NSCLC PDX models. The combination of FMC-376 with an immune checkpoint inhibitor also leads to an increased response and survival in preclinical models. In addition, 27-42% of patients with KRASG12C positive NSCLC present with central nervous system CNS metastasis, and FMC-376 is highly active in an intracranial NSCLC model of CNS-metastasis, resulting in tumor regression.

About the PROSPER Trial
FMC-376 is currently being evaluated in the Phase 1/2 PROSPER clinical trial (NCT06244771), an open-label, multi-center dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of FMC-376 in participants with locally advanced unresectable or metastatic solid tumors which harbor the KRASG12C mutation. For more information on the PROSPER trial, please visit clinicaltrials.gov.

About Frontier Medicines
Frontier Medicines is a clinical stage precision medicine company pioneering groundbreaking medicines to transform treatment for genetically-defined patient populations, starting with oncology and immunology. Our proprietary chemoproteomics powered drug discovery engine, the Frontier Platform, leverages covalent chemistry and machine learning to unlock hard-to-treat disease causing proteins for drug development. Today, we are advancing a diversified pipeline of wholly-owned precision medicines against the most important drivers of cancer and high-value immunology programs. Our lead candidate, FMC-376, is a dual inhibitor of ON+OFF KRASG12C. FMC-376 is a potential best-in-class therapy designed to completely block both forms of the KRAS mutation to overcome the lack of response and resistance seen with single-acting KRASG12C inhibitors. For more information, please visit www.frontiermeds.com. Follow Frontier on LinkedIn.

Frontier Medicines Contact:
Victoria Fort
SVP, Strategy and Corporate Affairs
202.361.0445
Victoria.Fort@frontiermeds.com

According to Business Group on Health, the 54 companies demonstrably enhanced the health and well-being of employees and their families through leading-edge initiatives. In addition, these companies have novel and impactful approaches focused on critical workforce issues, such as mental health and health equity.

“This first-time award for HII represents the strides we are making at providing a diverse mix of best-in-class benefits and well-being programs for our employees and their families,” said Edmond Hughes, HII’s executive vice president and chief human resources officer. “We are very proud to be recognized for the full portfolio of offerings we provide our employees to ensure they can build a career, and that they and their families can live their best lives, enjoying physical, financial, and emotional well-being. We can’t succeed without them — and we must continue to put their safety and well-being first.”

Photos accompanying this release are available at: https://hii.com/news/hii-best-employer-health-well-being-award-2024/.

The award, now in its 19th year, was announced in Tucson, Arizona, at the Business Group on Health 2024 Annual Conference. HII was one of three defense contractors on the list. The 2024 winners represented banking/financial services, health care, insurance, manufacturing, professional services, technology and utilities, among others. A full list of winners is available here.

“The 2024 awardees’ successes provide a roadmap for employers as they develop health and well-being strategies,” said Pamela Rich, Business Group vice president. “All of the winners deserve praise for having exemplary leadership.”

About Business Group on Health

Business Group on Health is the leading non-profit organization representing large employers’ perspectives on optimizing workforce strategy through innovative health, benefits and well-being solutions and on health policy issues. The Business Group keeps its membership informed of leading-edge thinking and action on health care cost and delivery, financing, affordability and experience with the health care system. Business Group members include the majority of Fortune 100 companies, mid-sized companies, as well as large public-sector employers, which collectively provide health and well-being programs for more than 60 million individuals in 200 countries. For more information, visit https://www.businessgrouphealth.org/.

Employment at HII

HII offers to employees a welcoming environment, competitive benefits, and valuable educational and training programs. Additionally, HII offers wellbeing programs and resources to employees and their families at no or low cost, including near-site family health centers, virtual and in-person wellness classes and coaching, personal finance education, and a variety of support services. To learn more about career opportunities at HII, visit https://hii.com/careers/.

About HII

HII is a global, all-domain defense provider. HII’s mission is to deliver the world’s most powerful ships and all-domain solutions in service of the nation, creating the advantage for our customers to protect peace and freedom around the world.

As the nation’s largest military shipbuilder, and with a more than 135-year history of advancing U.S. national security, HII delivers critical capabilities extending from ships to unmanned systems, cyber, ISR, AI/ML and synthetic training. Headquartered in Virginia, HII’s workforce is 44,000 strong. For more information, visit:

Contact:

Danny Hernandez
Danny.J.Hernandez@hii-co.com
(202) 264-7143

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e39c73f4-45a5-421e-b30e-e627a352aabd