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Who We Are

Havah’s mission is to develop therapies with reduced side effects and early prevention and treatment of breast cancers including hormonal refractory ER+ breast cancer and metastatic cancer. Havah uses targeted modulation of the hormonal balance in the breast to achieve a more nuanced hormonal regulation than traditional hormonal therapies.

Treatment of early-stage hormone receptor positive breast cancer, clinically referred to as Ductal Carcinoma In-Situ (DCIS), is met with few options beyond drugs developed in the 1960s to disrupt estrogen’s promotion of cancerous breast tumors or through more invasive surgical routes, including lumpectomy, bi-lateral mastectomies and radiation therapy. Of the 300,000 women in the United States diagnosed every year with breast cancer, up to 25% are diagnosed with DCIS; globally >250,000 patients are diagnosed with DCIS. 2+ million women live with this condition. This represents an enormous opportunity to bring forward a new treatment option that reduces long term risk for disease progression and eliminates unnecessary surgeries that expose women to infections, prolonged physical pain and emotional pain due to feelings of reduced femininity and sexuality after surgery.

Havah boasts an advanced clinical stage product with >3,500 woman-years of clinical exposure. The company’s work has recently been published in Nature Medicine (Hickey et al 2021) and has garnered significant global attention.

OVER THE LAST 20 YEARS MANY ATTEMPTS HAVE BEEN MADE TO INTRODUCE AN ANDROGENIC PRODUCT FOR WOMEN, THERE IS STILL A LACK OF REGISTERED PRODUCTS AVAILABLE FOR CLINICIANS DESPITE OVER 4 MILLION OFF LABEL PRESCRIPTIONS PER ANNUM BEING WRITTEN FOR A TESTOSTERONE PRODUCT FOR WOMEN IN THE USA ALONE.

Background Science

ANDROGENS ARE AN ESSENTIAL HORMONE IN BOTH MEN AND WOMEN-THE BALANCE BETWEEN ESTROGENS AND ANDROGENS IS CRITICAL IN THE MAINTENANCE OF HORMONAL HOMEOSTASIS, CONTROL OF PROLIFERATION/DIFFERENTIATION AND THE INTERFACE BETWEEN HORMONAL FUNCTION AND THE IMMUNE SYSTEM.

Recent literature has shown the criticality of maintaining intra mammary concentrations of dihydroxy testosterone (DHT- the active metabolite of testosterone) levels sufficiently to maintain a homodimer form of the androgen receptor to support cellular processes which are antiproliferative

The Basis of the Havah Therapy

T+Ai was developed with the aim to provide a long term safe and well tolerated therapy to prevent breast cancer. Due to its unique properties in hormonal modulation – potential applications include use In ductal carcinoma In situ (DCIS) to prevent progression to Invasive breast cancer, and early treatment of ER+ cancers to prevent development of hormonal resistant disease.

Utilising careful dosing in the form of a subcutaneous extended-release therapy, the Havah T+Ai™ technology maintains breast tissue DHT levels which support prevention and reduction of tumor growth, and well as anti-inflammatory cell function.

The T+Ai™  pellet is a combination treatment containing testosterone and anastrozole, demonstrating a unique PK profile which drives the hormonal milieu of the breast.

The open label cohort study of Havah T+Ai™ technology has demonstrated statistically significant reductions in mammographic breast density (MBD) and Background Parenchymal Enhancement (BPE), both known indicators of breast cancer risk and both of which reduce the likelihood of detection of malignant and non-malignant breast disease.

Clinical trials have demonstrated reduction in aromatase inhibitor reduced arthralgia and characterised the unique PK profile of the subcutaneous pellet.

Key Properties:

  • Precise delivery of testosterone designed for women
  • Unique PK profile and extended release delivery
  • Utilization of specific intramammary enzymatic concentrations in the breast
  • Close to 100% compliance
  • Suitable for mono- or combination therapies

Executive Management

Matt Brewer, ceo and president

Matt has over 20 years of life science business development, operations, and finance experience. Previously, he served as Chief Business Officer of Ashvattha Therapeutics, raising over $65 million in capital to drive the company’s development efforts of novel therapeutics for intractable diseases of the brain including GBM and neurodegeneration. Matt was the Founder and CEO of BaroFold where he led the turnaround and management buyout of the predecessor company, successfully raising venture capital, closing numerous non-dilutive licensing arrangements with industry partners, and out-licensing BaroFold’s protein therapeutic clinical asset for treating multiple sclerosis. As Founder and Managing Partner of Crest Asset Management, Matt managed a private equity healthcare portfolio consistently outperforming industry benchmarks and generating a 2.5x return on paid in capital over four years.

John Adair, CFo

John has over 25 years of financial and operational experience in the pharmaceutical and medical device arenas. Prior to joining Havah Therapeutics, John was CFO of Bolder Surgical and led the M&A team during the successful sale of Bolder Surgical to Hologic, Inc. in December 2021. John also co-founded Micro-Imaging Solutions whereby he led the finance and business development efforts for over 15 years. Prior to that role, John spent most of his career as a finance executive with large, multi-national corporations including Akzo-Nobel NV, Amgen and Thermo Fisher Scientific. John is a graduate of both Colorado State University where he earned a BS in Accounting and the University of Colorado-Denver where he earned an MS in Finance. John is also a CPA.

MS CPA

Founder and Advisor

Stephen N Birrell, Founder and ADVISOR

Founder and inventor, 30-year breast cancer specialist/surgeon and renowned medical innovator, clinical oncologist, widely published molecular oncologist in leading journals incl. Nature, founder/ pioneer of three leading (Australian) multi-disciplinary breast centres in both the public and private sectors. Dr Birrell, with his scientific research partner, Prof Wayne Tilley, are internationally recognized for pioneering the use of androgens in breast disease.

MD PhD FRACS

Board Members

Ron Martell, Director

Ron is currently CEO of Jasper Therapeutics (Nasdaq: JSPR) with 35 years’ experience building companies from clinical stage through commercial launch.

Prior to joining Jasper, Ron served as the President and CEO of MorphImmune, Inc., a private platform company advancing a highly specific targeting technology that uses a ligand-linked payload to reprogram the immune system. Previously, he was President and CEO of Nuvelution Pharma. He was also Co-Founder and Executive Chairman of Indapta, Orca Bio and Co-Founder and CEO of Achieve Life Sciences, where he led the merger of the company with Oncogenex. Ron has served as the CEO of three public biopharmaceutical companies, including Sevion and NeurogesX, and has overseen billions of dollars in industry transactions.

Earlier in his career, Ron served as Senior Vice President of Commercial Operations at ImClone Systems, where he was instrumental in deals with Bristol-Myers Squibb and Merck KGaA and built ImClone Systems’ worldwide operations to market and commercialize Erbitux®. He also served in various leadership positions with Genentech where, as Group Manager, Oncology, he was responsible for building the company’s oncology franchise, including the launch of Herceptin® and Rituxan®.

Kathy Harrison, Director

With over 30 years life science experience, including 9 years in patent attorney practice, Kathy is a serial entrepreneur and leader specialising in transitioning early stage companies through Phase 2 and beyond. Kathy led the Australian founded Havah Therapeutics as CEO from 2019 until its transition to the USA in 2024, positioning the company for global growth. Other leadership roles in biotech companies have included CEO of ASX listed Dimerix Ltd and current Managing Director of Estrenue Pty Ltd. Kathy has extensive experience in commercial drug development strategy and including leveraging intellectual property strategy to acheive value growth.

MSc, FIPTA, GAICD

Jim Weiss, Director

Over the past 22 years, Jim Weiss evolved his one-person consultancy into Real Chemistry, a global health innovation company that uses real-world data, proprietary technologies and analytical insights to solve the health care industry’s most significant challenges. He is a pioneer in the application of analytics, data and precision targeting to the biopharma and health care industry.

Jim is a board member and investor in Indapta Therapeutics, a natural killer cell company focused on cancer, and a business advisor to IMIDomics, a discovery company for immune-mediated diseases; Corvus Pharmaceuticals, a clinical-stage biotech company focused on novel medicines for autoimmune diseases and cancer; and Dstillery, a custom audience solutions company.

He is also a Board member and contributor to several nonprofits, including the Foundation for the Institutes of Health, the Cancer Research Institute, American Cancer Society’s BrightEdge, LAGRANT Foundation, and the Healthcare Businesswomen’s Association.

 

 

Media Articles & Presentations

Get Real With The Chairman – Episode Five: Dr. Laura Esserman And Dr. Steve Birrell

Dr. Laura Esserman and Dr. Steve Birrell are changing the breast cancer treatment paradigm through their collaboration on an I-SPY trial, which is reevaluating the treatment of DCIS.

Since 1993, Dr. Esserman has worked at UCSF as a surgeon and oncology specialist and co-lead of their Breast Oncology Program. She’s published over 400 peer-reviewed articles, including the New York Times, where she published an editorial on whether Ductal Carcinoma in SITU should still be called cancer. In 2016, she was named one of TIME magazine’s 100 Most Influential People. She was also a member of President Obama’s Council of Advisors on Science and Technology.

Dr. Steve Birrell is the Founder of HAVAH Therapeutics based in Adelaide, Australia. His three-decade career in cancer spans many roles. He’s a specialist, surgeon, medical innovator, and one of the most published molecular oncologists. Havah is developing a potentially revolutionary testosterone-based approach to the treatment of breast cancer.

DCIS Press Conf/Webinar

Not Everything We Call Cancer Should Be Called Cancer

New Trial Aims to Change Treatment Approach for DCIS Patients

Quantum Leap Healthcare Collaborative (QLHC) has launched a groundbreaking clinical trial called Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) that aims to revolutionize the treatment of ductal carcinoma in situ (DCIS) and reduce unnecessary surgeries. The trial will enroll over 300 patients across 40 sites in the United States and evaluate three investigational endocrine therapy arms.

Not Everything We Call Cancer Should Be Called Cancer

By Laura Esserman and Scott Eggener

Dr. Esserman is a surgeon and breast cancer oncologist at the University of California, San Francisco. Dr. Eggener is a surgeon and urologic oncologist at the University of Chicago.

Dr Stephen Birrell Talk About Testosterone In Gynaecology At A National Meeting June 4Th 2022

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