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Oct 13
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Rappta Therapeutics Raises Series A Financing for the Development of Phosphatase 2A drugs

By Press Release, Private Companies, Rappta Therapeutics
Press Release.

 

  • Unique phosphatase technology platform offers a new paradigm in oncology
  • EUR 9M financing, co-led by NVF and Novo Holdings with participation from Advent Life Sciences and a family office
  • To advance lead compounds to clinical candidate stage

Helsinki, Finland, 13 October, 2020:  Rappta Therapeutics (“Rappta”), focused on developing first-in-class anti-cancer drugs activating protein phosphatase 2A (PP2A), announces today the closing of a EUR 9 million Series A financing co-led by Novartis Venture Fund (“NVF”) and Novo Holdings with participation from Advent Life Sciences and a family office. The company also announces it has successfully received funding from Business Finland, the Finnish innovation funding organization.

PP2A is a critical enzyme regulating protein de-phosphorylation and a key tumor suppressor which to date has been very difficult to target pharmaceutically. Rappta has developed proprietary tools and a unique understanding of PP2A which allows it to therapeutically reactivate PP2A. As a result of PP2A’s central role in the regulation of protein de-phosphorylation, Rappta’s PP2A-reactivating technologies offer the potential to develop multiple lead compounds and build a platform for a new class of anti-cancer drugs.

Rappta has assembled a strong scientific, management, and commercial team based in Finland and the US. Rappta’s scientific team, led by CSO and co-founder, Professor Goutham Narla, Division Chief of Genetic Medicine at the University of Michigan, represents world-leading expertise in PP2A. The scientific team has published seminal papers on the structural, functional, and biological mechanisms of PP2A inactivation in human cancer. The team will be supported by the Scientific Advisory Board led by Dr. William Hahn, a Professor of Medicine at the Harvard Medical School and the Chief Scientific Officer of the Dana-Farber Cancer Institute.

Goutham Narla, Rappta’s CSO, board member and co-founder, commented:

“I am thrilled to be working on this opportunity to build a new platform and a novel class of pharmaceuticals to treat cancer. We have a unique team whose deep understanding of the PP2A biochemistry, structural biology, biogenesis, medicinal chemistry and drug development represent the perfect combination of expertise to translate these discoveries to the clinic.”

Mikko Mannerkoski, Rappta’s CEO, board member and co-founder, commented:

“We are very pleased to attract such a strong syndicate of international investors which validates our approach to developing novel therapies to target the previously undruggable target protein PP2A. This funding will enable us to accelerate the development of our platform and advance the lead compounds towards clinical development.”

Beat Steffen from NVF, Jeroen Bakker from Novo Seeds, and Raj Parekh from Advent Life Sciences, will join Mikko Mannerkoski and Goutham Narla on the Board of Directors with Beat Steffen serving as the chairperson.

For more information please contact:

Rappta Therapeutics
Mikko Mannerkoski, CEO
+358 (0) 40 55 55 268
mikko.mannerkoski@rappta-therapeutics.com

Optimum Strategic Communications
Mary Clark, Manel Mateus
+44 (0) 20 3922 1906
rappta@optimumcomms.com

About Rappta Therapeutics
Rappta Therapeutics, a private biotech with operations in Finland and the US, is developing first-in-class anti-cancer drugs activating protein phosphatase 2A (PP2A). It has developed proprietary tools and a unique understanding of PP2A which allows it to therapeutically reactivate PP2A, a critical enzyme regulating protein de-phosphorylation and tumor growth, with the potential to create a new class of anti-cancer drugs. Rappta has a strong scientific, management and commercial team. Its scientific team, led by CSO and co-founder, Professor Goutham Narla, Division Chief of Genetic Medicine at the University of Michigan, represents world-leading expertise in PP2A. It is backed by blue-chip investors Advent Life Sciences, Novartis Venture Fund, Novo Seeds and a family office. For more information, go to www.rappta-therapeutics.com.

About PP2A
Reversible phosphorylation is a fundamental mechanism controlling all cell signaling and communication and this process is regulated through the opposing actions of phosphatases (which remove phosphate groups from proteins) and kinases (which add phosphate groups to proteins). Altered cellular signaling as a result of protein hyperphosphorylation, results in the sustained growth of malignant cells and is a hallmark of human cancer development and progression.

Protein Phosphatase 2A (PP2A) is a serine/threonine phosphatase that functions as a tumor suppressor by negatively regulating multiple oncogenic signaling pathways responsible for driving cancer progression. PP2A is made up of three subunits, that form a complete and active enzyme when bound together. The active enzyme is comprised of a scaffolding subunit (A), serving as the structural platform for the assembly of the catalytic (C) subunit and one substrate directing regulatory (B) subunit. In cancer, the tumor-suppressive activity of PP2A is often disrupted as a result of the inability of the three subunits to bind together correctly, rendering the PP2A enzyme inactive. This inactivation of PP2A, leads to increased oncogenic signaling, driving cancer progression and growth. Therefore, the reactivation of PP2A affords a unique therapeutic strategy to restore PP2A activity and cellular homeostasis, that can be used for the treatment of cancer and a broad range of other diseases.

About Novartis Venture Fund
Novartis Venture Fund is a financially driven corporate life science venture fund whose purpose is to foster innovation, drive significant patient benefit and generate superior returns by creating and investing in innovative life science companies at various stages of their development. For more information, go to www.nvfund.com.

About Novo Holdings A/S
Novo Holdings A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation. It is the holding and investment company of the Novo Group, comprising Novo Nordisk A/S and Novozymes A/S, and is responsible for managing the Novo Nordisk Foundation’s assets. Novo Holdings is recognized as a leading international life science investor, with a focus on creating long-term value. As a life science investor, Novo Holdings provides seed and venture capital to development-stage companies and takes significant ownership positions in growth and well-established companies. Novo Holdings also manages a broad portfolio of diversified financial assets. Further information: http://www.novoholdings.dk

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

Sep 02
Love0

Highlight Therapeutics announces first patient dosed in Phase IIa study in liver metastasis

By Highlight Therapeutics, Press Release, Private Companies
Press Release.

 

Second collaboration with MSD to evaluate combination of BO-112 and KEYTRUDA®

•    New research studies may further accelerate delivery of novel treatment strategies for melanoma

Madrid, Spain – September 2, 2020: Highlight Therapeutics (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, announces it has entered into a second Phase II trial collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the U.S. and Canada.

The collaboration will focus on the Phase II evaluation of the combination of BO-112, Highlight’s lead program, and KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients that have progressed on anti-PD-1-based therapy in refractory advanced malignant melanoma.

The incidence of malignant melanoma is estimated to be 3-5 cases per 100,000 individuals in Europe. Activating therapeutic anti-tumor immunity by the modulation of the host immune system has become a key approach for treating melanoma. Antagonistic monoclonal antibodies (mAb) against immune inhibitory molecules such as CTLA4 (cytotoxic T-lymphocyte associated protein 4) and PD-1 (programmed death receptor-1) have improved the prognosis of patients with malignant melanoma and have been incorporated into oncology treatment guidelines as a standard of care. However, most patients treated in this way do not achieve a clinical response and many of those who do respond eventually develop progressive disease.

The trial, named Spotlight 203, will evaluate the combination of stimulation of the innate immune system by direct intra-tumoral administration of BO-112, combined with systemic administration of pembrolizumab, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as the percentage of patients achieving a complete response or partial response as primary endpoint.

Spotlight 203 will also seek to further characterize the clinical activity of intra-tumoral BO-112 in combination with pembrolizumab by evaluating disease control rates, duration of response, progression-free and overall survival, as well as safety, tolerability and pharmacokinetics. A total of 40 patients are planned to be enrolled. The sample size for a subsequent randomized portion of the study will be determined based on efficacy results.

Marisol Quintero, CEO of Highlight Therapeutics, commented:

“Spotlight 203 is designed to address the high unmet need of patients with unresectable stage III or IV melanoma who have failed anti-PD-1 therapy. Phase 1 data suggest the potential of BO-112 to sensitize the immune system against the tumor, including enhanced sensitivity to anti-PD-1 treatment. Based on clinical and pre-clinical studies, we believe intra- tumoral BO-112 has the potential to overcome resistance to anti-PD-1 therapy. We are pleased to build on our fruitful collaboration with MSD, whose extensive expertise in immune-oncology makes them the ideal partner.

“This partnership seeks to accelerate the development of therapies for patients with malignant melanoma. We are delighted to commence Spotlight 203 and to be able to combine our capabilities to accelerate the research of medicines in diseases with such a poor prognosis.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ. A Phase 2 clinical study of intra-tumoral BO-112 in combination with pembrolizumab in patients with liver metastases from colorectal or gastric/gastro-esophageal junction cancer is also currently underway.

For more information, please contact:

Highlight Therapeutics S. L.    info@highlighttherapeutics.com

Marisol Quintero, CEO
Mo PR Advisory    Tel: +44 (0) 7876 444977 / 07860 361746
Mo Noonan/Jonathan Birt

Notes to Editors

About melanoma
Almost 288,000 new cases of melanoma and more than 60,000 deaths were estimated worldwide in 2018 [Ferlay 2019]. In North America, melanoma is the fifth most common cancer in males and sixth most common cancer in females [Siegel 2018]. In the U.S, it is estimated that more than 100,000 patients will be diagnosed with melanoma in 2020, with almost 7,000 deaths recorded. Advanced or metastatic melanoma (unresectable Stage III, Stage IV) remains a lethal disease with a high proportion of patients resistant to approved therapies. There are currently limited treatment options for patients who progress on targeted therapy or immunotherapy, creating a high unmet need for novel therapies for advanced melanoma patients who have failed existing treatments.

About Highlight Therapeutics
Highlight, formerly known as Bioncotech Therapeutics S.L, is a private, clinical-stage company dedicated to unlocking the full potential of immuno-oncology. Its lead drug candidate BO-112 is a best-in-class RNA-based therapy which has been demonstrated to initiate a powerful immune response, leveraging a unique multi- target approach to turn ‘cold’ tumors ‘hot’ and therefore visible to the immune system. It has the potential to rescue patients who are resistant to current checkpoint inhibitor therapy, a very large market opportunity. BO-112 is currently being investigated in a range of clinical trials as a monotherapy and in combination with checkpoint inhibitors. In addition to in-house research, Highlight Therapeutics has a number of external collaborators, including Merck & Co and UCLA.

Aug 12
Love0

F2G Closes US$60.8 Million Financing to fund late stage development of novel mechanism antifungal agent

By F2G, Press Release, Private Companies
Press Release.

 

Financing round led by Cowen Healthcare Investments with strong support from existing investors Novo Holdings, Morningside Ventures, Brace Pharma Capital and Advent Life Sciences

MANCHESTER, UK / VIENNA, Austria – 12th August 2020 – F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that it has secured US $60.8 million in new financing from new and existing investors. The financing round is led by Cowen Healthcare Investments and includes strong participation from existing investors Novo Holdings, Morningside Ventures, Brace Pharma Capital and Advent Life Sciences.

Proceeds from the financing will be used to fund F2G’s late-stage clinical programs for their novel antifungal agent olorofim and organisational scale-up in preparation for commercialisation.

Olorofim (formerly F901318) is F2G’s lead candidate and is in a Phase 2b open-label study focussing on rare and resistant life-threatening invasive fungal infections, such as invasive aspergillosis (including azole-resistant strains), scedosporiosis, lomentosporiosis, fusariosis, scopulariopsosis, and coccidioidomycosis (Valley Fever). Olorofim was granted Breakthrough Therapy designation (BTD) for the indication of ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’ in November 2019 by the US Food and Drug Administration (FDA), the only antifungal agent ever to have been awarded this status. Olorofim has the potential to be the first truly novel mechanism antifungal therapy for nearly twenty years and represents a very significant market opportunity in an area of high unmet clinical need.

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:

“Following a successful year during which F2G has received FDA Breakthrough Therapy designation for olorofim, as well as FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever), and QIDP designation in multiple fungal infections, today’s announcement is a significant milestone. We are delighted to welcome Cowen Healthcare Investments to F2G, and I would like to thank our existing investors for their continued support. This financing marks the continued commitment of our shareholders and paves the way for the advanced development and potential approval of the first new antifungal treatment in 20 years, offering hope for patients with very limited treatment options and a high medical need.”

Tim Anderson, Managing Director at Cowen Healthcare Investments said:

“The necessity for the discovery and development of treatments to tackle infectious diseases is today more apparent than ever. F2G’s antifungal candidate demonstrates significant promise in terms of safety, tolerability, and efficacy. With our focus on supporting transformational science that can deliver real clinical outcomes, we are pleased to work with this proven management team and group of renowned investors to build on F2G’s significant scientific and commercial potential.”

Joining the F2G Board in conjunction with the financing will be Tim Anderson, Managing Director at CHI, Will West, Investment Advisor at Morningside Ventures and Naveed Siddiqi, Partner at Novo Ventures. Naveed takes over from Martin Edwards who is retiring from the Board.

Ian Nicholson added:

“We welcome Tim Anderson, Will West and Naveed Siddiqi who replaces Martin Edwards as the representative of Novo Holdings on the Board of Directors. On behalf of the Board we would like to thank Martin for his contribution to F2G. His industry expertise and counsel have been instrumental in guiding F2G through recent developmental and financing milestones, and we wish him the very best.”

Contact:

F2G Ltd
Ian Nicholson | Chief Executive Officer
Ralf Schmid | Chief Financial Officer
Tel: +44 (0)161 785 1271 (UK) / +43 (0)1 997 4267 (A)

Optimum Strategic Communications
Mary Clark / Supriya Mathur / Charlotte Hepburne-Scott
Tel: +44 (0) 203 922 0891
Email: F2G@optimumcomms.com

Notes to Editors:

About F2G
F2G is a world-leading UK- and Austria-based biotech company (F2G Ltd and F2G Biotech GmbH)
focused on the discovery and development of novel therapies to treat life-threatening invasive fungal
infections. F2G has discovered and developed a completely new class of antifungal agents called the
orotomides. The orotomides target dihydroorotate dehydrogenase (DHODH), a key enzyme in the de
novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the
currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range
of rare and resistant fungal mould infections. Olorofim (formerly, F901318) is F2G’s leading candidate
from this class. www.f2g.com

About Olorofim
Olorofim is currently being investigated in an open-label single-arm Phase 2b study (ClinicalTrials.gov
Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive
aspergillosis (IA) with limited treatment options (refractory disease, resistance, or intolerance to
available agents). On 7 November 2019, olorofim was granted Breakthrough Therapy designation (BTD)
by the US Food and Drug Administration (FDA), the only antifungal agent ever to have been awarded
this status.

About Cowen Healthcare Investments
Cowen Healthcare Investments invests fiduciary capital in private healthcare companies across the
biopharma, diagnostics and digital health sectors. Cowen Healthcare Investments is a strategy of Cowen
Investment Management, which develops differentiated, actively managed products on behalf of its
clients. Cowen Investment Management is a division of Cowen Inc. Learn more at www.cowen.com

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Aug 12
Love0

PIC Therapeutics Appoints Dr. Katherine Bowdish as Chief Executive Officer

By PIC Therapeutics, Press Release, Private Companies
Press Release.

 

NATICK, MA – August 12, 2020 – PIC Therapeutics (“PIC”), a biotechnology company
focused on transforming the treatment of cancer through the selective modulation of
oncogene translation, today announced the appointment of Katherine Bowdish, Ph.D.,
as its President and Chief Executive Officer. Dr. Bowdish will also join the Board of
Directors of PIC.

Dr. Bowdish brings more than 20 years of biopharmaceutical business and scientific
leadership to PIC Therapeutics. Kathy was most recently at Sanofi, where she
launched and led Sanofi Sunrise, a venture investment and partnering vehicle to
accelerate early stage pioneering science for patients benefit through unique
relationships with leading entrepreneurs, and more recently served as Vice President
and Head of R&D Strategy. Prior to her leadership roles at Sanofi, Kathy co-founded or
led several early-stage life science companies focused on biological therapies.
Kathy’s positions include President & CSO, Permeon Biologics; Co-founder, President
& CEO, Anaphore; President, Alexion Antibody Technologies and Senior Vice
President, Alexion Pharmaceuticals; and Founder, CEO & CSO, Prolifaron, prior to its
acquisition by Alexion.

Kathy has served on the Boards of Directors of MyoKardia, Warp Drive Bio, Portal
Instruments, Thermalin, Permeon Biologics, Anaphore and Prolifaron, and most
recently served as an Observer on the DiCE Molecules Board. Kathy received her
Ph.D. in molecular genetics from Columbia University College of Physicians and
Surgeons, and her B.Sc. degree from the College of William and Mary.

“We are thrilled to have Dr. Bowdish joining PIC as CEO. Her proven strategic leadership
and investment experience will be vital to realizing the full potential of PIC’s scientific
platform as it advances PIC’s drug candidates toward human clinical studies,” stated PIC
Therapeutics’ Executive Chairman, Alan Walts. “Kathy additionally has deep experience
in developing the kind of innovative strategic partnerships that will be a critical part of
PIC’s success.”

“The promise of addressing broad-based genomic anomalies in cancer through
modulating translation of oncogene RNA provides a unique opportunity to create
impactful new therapies for patients with cancer,” said Dr. Bowdish. “I am excited to be
joining the PIC Therapeutics team and look forward to leading the company as we
advance drug candidates through remaining preclinical and translational studies, and
into the clinic for patients in need.”

About PIC Therapeutics

PIC Therapeutics is a Natick, MA-based biotechnology company focused on
fundamentally changing how we treat cancer by developing a new generation of
therapeutics based on the modulation of RNA translation. PIC’s therapeutics target the
“master switch” of cancer signaling pathways, selectively blocking oncogene protein
production by modulating the Pre-Initiation Complex (PIC) that drives their mRNA
translation. PIC Therapeutics’ selective approach has the potential to simultaneously
modulate multiple oncogenic drivers leading to a powerful new generation of cancertreating
therapeutics that address drug resistance and tumor heterogeneity, issues that
plague many existing treatments. For more information visit www.pictherapeutics.com.

PIC is guided by a dedication to improving cancer patient outcomes and to realizing the
potential of our technology to their benefit.

Contact:
Kathy Bowdish
kbowdish@pictherapeutics.com
(617) 528-8715

Aug 11
Love0

Advent Life Sciences announces sale of its portfolio Company KaNDy Therapeutics to Bayer AG for USD 425M upfront plus USD 450M in potential development milestones followed by further potential commercial milestones.

By Advent Life Sciences, Press Release
Press Release.

 

KaNDy’s lead asset NT-814 is a potential novel non-hormonal oral treatment option for women during menopause

11th August, London – Advent Life Sciences, a leading European life sciences venture capital firm, today announced the sale of its portfolio company, KaNDy Therapeutics Ltd, (“KaNDy”), to Bayer AG for an upfront consideration of USD 425 million plus potential milestone payments of up to USD 450 million until launch followed by potential additional triple digit million sales milestone payments.

KaNDy recently completed the Phase IIb with NT-814, a once-daily, oral neurokinin-1,3 receptor antagonist, publishing positive data for the treatment of frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The start of Phase III clinical trial is expected to commence in 2021. Once the deal completes, Bayer AG, a global leader in women’s healthcare, will assume full responsibility for completing Phase III studies of NT-814, registration, and marketing and sales.

KaNDy Therapeutics is a spin-out from NeRRe Therapeutics, a Stevenage, UK, based Company, which Advent Life Sciences co-founded with Mike Trower in 2012 based on a portfolio of Neurokinin modulators.  Advent Life Sciences has supported the company since inception and remained the largest shareholder throughout. In 2015, Dr Mary Kerr, then an Operating Partner at Advent Life Sciences, became full time CEO of NeRRe and in 2017 Advent introduced Andrew Kay (previously CEO of Algeta, a realised Advent portfolio company) as Chairman.

Kaasim Mahmood, General Partner at Advent Life Sciences, said:

“KaNDy is another example of our hands-on approach to achieving our twin objectives – to provide strong returns to our Investors while enabling the discovery and development of truly innovative medicines. We hope that NT-814 will fulfil the potential shown in the Phase IIb studies and provide a much-needed non-hormonal treatment for the alleviation of menopause symptoms.”

Mary Kerr, CEO and Co-Founder of KaNDy, said:

“Advent Life Sciences has played a central role in building this company from the very beginning, leveraging its extensive network to introduce new investors and providing strategic guidance to advance this potential novel medicine and become an important non-hormonal treatment option for women suffering debilitating symptoms of the menopause.”

Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.

ENDS

Contact details:

Katja Stout, Scius Communications
katja@sciuscommunications.com
+447789435990

Kasim Mahmood, Advent Life Sciences
Kaasim.mahmood@adventls.com
+442079322100

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

About KaNDy Therapeutics
KaNDy Therapeutics Ltd. is a UK-based private clinical-stage biotech that was founded in 2017 as a spin-off from NeRRe Therapeutics Ltd. It is led by an experienced management team and backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and Longitude Capital. KaNDy Therapeutics is based at the state-of-the-art Stevenage Bioscience Catalyst, a leading location for companies to develop and commercialise cutting edge therapeutics.

About NT-814
NT-814 is a non-hormonal, orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.

Aug 06
Love0

Acutus Medical Announces Pricing of Initial Public Offering

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

August 6, 2020

CARLSBAD, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (NASDAQ: AFIB) today announced the pricing of its initial public offering of 8,823,529 shares of its common stock at a price to the public of $18.00 per share. All of the shares are being offered by Acutus. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Acutus, are expected to be approximately $158.8 million. The shares are expected to begin trading on The Nasdaq Global Select Market on August 6, 2020, under the symbol “AFIB.” The offering is expected to close on August 10, 2020, subject to the satisfaction of customary closing conditions. In addition, Acutus has granted the underwriters a 30-day option to purchase up to an additional 1,323,529 shares of Acutus’ common stock at the initial public offering price, less the underwriting discounts and commissions.

J.P. Morgan and BofA Securities are acting as joint book-running managers. William Blair is also acting as book-running manager. Canaccord Genuity and BTIG are acting as co-managers.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on August 5, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

About Acutus Medical, Inc.
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

Investor Contact:
Caroline Corner
Westwicke ICR
D: 415-314-1725
Caroline.corner@westwicke.com

Holly Windler
M: 619-929-1275
media@acutusmedical.com

Caution Regarding Forward-Looking Statements
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. These forward-looking statements include, without limitation, references to Acutus’ expectations regarding the commencement of trading on The Nasdaq Global Select Market and the completion, timing and size of the public offering. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, risks and uncertainties related to completion of the public offering and the satisfaction of customary closing conditions related to the public offering. Additional factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors, timing of regulatory approvals, the impact of the recent coronavirus (COVID-19) pandemic and our response to it, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release

Jul 16
Love0

Zikani Therapeutics Appoints Chief Scientific and Medical Officer

By Press Release
Press Release.

 

Vijay Modur, M.D., PhD, to Lead Company’s TURBO-ZMTM Technology Platform
into First in Human Trials

WATERTOWN, MA – JULY 16, 2020 – Zikani Therapeutics, a company leveraging its unique TURBO-ZMTM platform to develop novel ribosome modulating agents (RMAs) for the treatment of rare, nonsense mutation-driven diseases, today announced the appointment of Vijay Modur M.D., Ph.D., as its Chief Scientific and Medical Officer to lead the company in advancing its ribosome-modulating scientific platform into the next stage of drug development.

Dr. Modur was previously Global Project Head in Rare Disease Clinical Development at Sanofi-Genzyme where he oversaw key functions responsible for advancing venglustat  for the treatment of conditions caused by lysosomal dysfunction and other investigational therapies for several rare diseases, many with the potential for accelerated approval. Before joining Sanofi-Genzyme, Dr. Modur served as Chief Medical Officer and Vice President of Translational Research for HTG Molecular. Dr. Modur previously held clinical development leadership roles at Novartis and Merck.

“Zikani’s top priority is to advance its current nonsense mutation readthrough programs from lead optimization to candidate selection for first in human clinical trials following the positive, pre-clinical data demonstrated in multiple disease areas,”

said Sumit Aggarwal, President and CEO, Zikani Therapeutics.

“We’re optimistic about the opportunity to impact diseases with limited or no treatment options including: APC mutant colon cancer, familial adenomatous polyposis (FAP), class 1 cystic fibrosis, and recessive dystrophic and junctional epidermolysis bullosa (RDEB and JEB), and Vijay’s experience and leadership will strengthen our capabilities to pursue this important work,”

added Aggarwal.

“Zikani has focused its technology on where it holds the most promise and with the addition of Vijay is building a leadership team that will advance the company into the next phases of preclinical and clinical development,”

said Alan Walts, Ph.D., Executive Chairman of Zikani’s Board of Directors.

Dr. Modur earned his MBBS at Karnatak University, Dharwad, India and his Ph.D. in Experimental Pathology at the University of Utah. He completed his residency at Washington University, St. Louis where he served as Chief Resident, Laboratory Medicine. Dr. Modur is board certified in Clinical Pathology.

“The promise of impacting rare diseases through such novel technology that builds upon the science of modulating protein translation is compelling,”

said Modur.

“The TURBO-ZMTM technology platform and the proof of cellular concept demonstrated across multiple disease states provides a compelling approach to treating rare diseases. I’m excited to join the team and look forward to making an impact on behalf of patients,”

added Modur.

Ribosomal RNAs form the translation machinery that generates function proteins from genetic sequences. Ribosome modulation provides a therapeutic approach to addressing a number of diseases, but the development of disease-specific ribosome modulators has been a challenge.

About Zikani Therapeutics
Zikani Therapeutics is an emerging leader in the science of ribosome modulation, leveraging its innovative TURBO-ZMTM chemistry technology platform to develop novel ribosome modulating agents (RMAs) as therapeutics for people with limited treatment options. Zikani’s TURBO-ZMTM platform allows rapid synthesis of novel compounds that can be optimized to modulate the ribosome in a disease specific manner. As the company evolves its focus from early-stage to clinical-stage research, Zikani is actively moving into pre-clinical development to target select rare diseases including inherited diseases and cancers caused by nonsense mutations. For more information, visit zikani.com.

Contact
Outcomes Communication Group
Laureen Cassidy
laureen@outcomescg.com

Jun 24
Love0

Artax Biopharma Announces the Formation of Scientific Advisory Board to Advance Autoimmune Disease Therapy AX-158

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Renowned Global Leaders are Experts in Immunology, Autoimmune Disease, and T Cell Signaling

Cambridge, Mass., June 24, 2020 – Artax Biopharma, Inc., a biotechnology company focused on transforming autoimmune disease treatment, today announces the formation of their Scientific Advisory Board (SAB). The SAB is comprised of experts in Immunology, Autoimmune Disease, and T Cell Signaling, and was formed to guide the company as it proceeds into future clinical trials with a first-in-class, oral small molecule autoimmune disease immunomodulator AX-158.

Artax Biopharma is poised to enter clinical trials with the small molecule AX- 158, a novel approach to treat multiple autoimmune diseases without causing the immunosuppression commonly associated with current autoimmune disease therapies.

Balbino Alarcón, PhD, Chairman of Artax’s Scientific Advisory Board, commented,

“I am privileged to lead Artax’s Scientific Advisory Board, which mobilizes global leaders in Immunology, Autoimmune Disease, and T Cell Signaling. Collectively we are enthusiastic to collaborate on, and contribute to, important development initiatives related to Artax’s innovative approach to autoimmune disease treatment.”

“Artax Biopharma’s Nck inhibitor AX-158 has shown impressive experimental biologic and mechanistic impact on T cell modulation – managing autoimmune disease without inducing the profound immunosuppression or interference with memory response associated with conventional or biological therapies,”

stated Dr. Lawrence Steinman, Stanford University Zimmerman Professor of Neurology and Neurosciences, Pediatrics, and Genetics and Scientific Advisory Board member.

“Convening a Scientific Advisory Board is a critical step as we accelerate our clinical development program,”

stated Artax Biopharma Chief Executive Officer Joseph Lobacki.

“The clinical expertise and knowledge of these experts is unparalleled and will be instrumental in informing our development strategy across several autoimmune diseases.”

The SAB will be comprised of five experts, and is being led by
Professor Balbino Alarcón, PhD, co-founder of Artax Biopharma:

Balbino Alarcón, PhD
Dr. Alarcón is Program Director at the National Research Council of
Spain (CSIC) and Head of the TCR-mediated Signal Transduction
Laboratory.

Raif Geha, MD
Dr. Geha is the James L. Gamble Professor of Pediatrics at Harvard
Medical School and Chief of the Allergy/Immunology/Rheumatology and
Dermatology Division at Children’s Hospital in Boston.

Menno de Rie, MD
Prof. de Rie is a board-certified dermatologist and vice-chair of the
department of Dermatology of the Amsterdam University Medical Centres/
University of Amsterdam.

Lawrence Steinman, MD
Dr. Steinman is the George A. Zimmermann professor of Neurology
and Neurological Sciences, Pediatrics, and Genetics at Stanford University.

Cox Terhorst, PhD
Dr. Terhorst is Chief of Immunology at Beth Israel Deaconess Medical
Center and Professor at Harvard Medical School.

About Immunomodulation
A healthy immune system eliminates harmful foreign pathogens, while
being tolerant of self-tissues and organs. When the immune system
malfunctions, cells (T Cells) attack self-tissues and organs, causing
autoimmune disease. Current autoimmune disease therapies suppress the
immune system, helping to minimize these self-attacks, but also raise
susceptibility to harmful foreign pathogens. Immunomodulation, the process
in which the immune system reduces self-attacks while properly reacting to
fight foreign pathogens, holds great potential for autoimmune disease.

About Artax-158
AX-158 is a first-in-class, oral small molecule, preclinical
immunomodulating agent in development for the treatment of autoimmune
diseases. AX-158 employs a novel mechanism of action that selectively
modulates, or adjusts, T cell responses that play a critical role in immune
system function. By selectively inhibiting Nck, a protein, AX-158 selectively
modulates self-directed T Cell activation which is a cause of autoimmune
disease. Importantly, data suggest AX-158 is not immunosuppressive and
does not impact the immune system’s ability to mount a strong response to
foreign pathogens and infections. Further, AX-158’s ability to modulate T cell
responses allows the possibility to broadly target several autoimmune
diseases, therefore potentially transforming autoimmune disease treatment.

About Artax Biopharma
Artax Biopharma is a biotechnology company transforming
autoimmune disease treatment. Artax is a life science industry leader in
autoimmune disease immunomodulation science, developing an
innovative small molecule approach to treat autoimmune disease that
modulates the immune system to both treat autoimmune disease and
allow the body to fight foreign pathogens. The company is examining a
first-in-class oral immunomodulating agent as a new way to treat multiple
autoimmune diseases without causing the immune suppression commonly
associated with currently available autoimmune disease therapies. For
more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Jun 04
Love0

Artax Biopharma Announces Series B Financing Extension to Advance First-in-Class Autoimmune Disease Therapy

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

– Extension Brings in Additional Investor –

Cambridge, MA, June 4, 2020 – Artax Biopharma, Inc., a biotechnology company focused on transforming autoimmune disease treatment, today announces the completion of an extension to its Series B financing led by Columbus Venture Partners.

AX-158 is a first-in-class, oral small molecule, immunomodulating agent in development for the treatment of autoimmune diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function.  Proceeds from the financing will be used to support activities for a planned Q4 2020 filing of a Clinical Trial Application (CTA) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for AX-158.

“We are pleased to welcome Columbus Venture Partners as a new investor,”

said Joseph Lobacki, Chief Executive Officer of Artax Biopharma.

“The support of Columbus Venture Partners is a testament to the transformative potential of our science, which has the potential to address autoimmune disease without causing immunosuppression.

” Javier García, Founder and Partner with Columbus Venture Partners, stated, “Columbus Venture Partners is pleased to have led the extension to this round of financing. We believe Artax’s highly experienced leadership team is well positioned to deliver on a truly innovative therapeutic program.”

About Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs.  When the immune system malfunctions, cells (T Cells) attack self-tissues and organs, causing autoimmune disease. Current autoimmune disease therapies suppress the immune system, helping to minimize these self-attacks, but also raise susceptibility to harmful foreign pathogens.Immunomodulation, the process in which the immune system reduces self-attacks while properly reacting to fight foreign pathogens, holds great potential for autoimmune disease therapies.

About Artax-158

AX-158 is a first-in-class, oral small molecule, preclinical immunomodulating agent in development for the treatment of autoimmune diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function. By selectively inhibiting Nck, a protein, AX-158 selectively modulates self-directed T Cell activation which is a cause of autoimmune disease. Importantly, data suggests that AX-158 is not immunosuppressive and does not impact the immune system’s ability to mount a strong response to foreign pathogens and infections. Further, AX-158’s ability to modulate  T  cell  responses  allows  the  possibility  to  broadly  target  several autoimmune diseases, therefore potentially transforming autoimmune disease treatment.

About Artax Biopharma

Artax Biopharma is a biotechnology company transforming autoimmune disease treatment.  Artax is a life science industry leader in autoimmune disease immunomodulation science, developing an innovative small molecule approach to treat autoimmune disease that modulates the immune system to both treat autoimmune disease and allow the body to fight foreign pathogens.  The company is examining a first-in-class oral immunomodulating agent as a new way to treat multiple  autoimmune  diseases  without  causing  the  immune  suppression commonly associated with currently available autoimmune disease therapies. For more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Jun 03
Love0

Axonics® Announces U.S. Food & Drug Administration Approval of Wireless Patient Remote Control with SmartMRI Technology

By Axonics, Press Release
Press Release.

 

June 3, 2020 at 6:00 AM EDT

IRVINE, Calif.–(BUSINESS WIRE)–Jun. 3, 2020– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable Sacral Neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced U.S. Food & Drug Administration (FDA) approval of its new wireless patient Remote Control with SmartMRI™ technology for the Axonics r-SNM® System under a premarket approval (PMA) supplement.

The new Remote Control simplifies the process by which patients can receive a full-body MRI. An MRI technician can perform a simple check using a patient’s Remote Control immediately prior to an MRI, avoiding the need for the patient to visit their implanting physician’s office or involving personnel from Axonics. The new patient Remote Control with SmartMRI technology will be included in all new orders of the Axonics r-SNM System in the United States beginning this month.

The Axonics r-SNM System is approved for 1.5T full-body MRI scans in the United States and both 1.5T and 3.0T full-body MRI scans in Canada and Europe. In April 2020, Axonics submitted a PMA supplement to the FDA for the purpose of gaining full-body MRI conditional labeling for 3.0T MR scanners in the United States. The FDA review of this expansion of labeling is expected to be completed in early Q4 2020.

Raymond W. Cohen, CEO of Axonics commented,

“Delivering a superior experience to patients, physicians and their staff has been the key focus of our product development initiatives since Axonics’ founding. The introduction of this new patient Remote Control provides for significant convenience and reduces the burden on physician practices. This FDA approval follows the recent approval of both our next generation implantable neurostimulator and programmer and is part of a cadence of product enhancements that we are committed to pursuing.”

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impact quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first long-lived rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200603005156/en/

Neil Bhalodkar
Investor Relations
949-336-5293
ir@axonics.com

Source: Axonics