Montreal, Quebec – August 15, 2023 – Thryv Therapeutics Inc., a clinical stage biotechnology company developing therapies for rare diseases including Congenital Long QT Syndrome (LQTS), atrial fibrillation, and resistant cancers, announced today FDA clearance of its Investigational New Drug application (IND) for THRV-1257.  THRV-1257 is being investigated for the treatment of advanced Anaplastic Thyroid Cancer (ATC), including those patients with the common BRAF mutation V600E.  The first in human study will determine the optimal dosing of THRV-1257 in patients with solid tumors, followed by treatment in combination with approved cancer therapies.   

At the same time, the company announces acceptance of a late breaking poster that will be presented at the upcoming American Thyroid Association (ATA) annual meeting in Washington DC, on September 30th, 2023, from 10:00 a.m. to 1:00 p.m. The presentation will highlight in vitro and in vivo preclinical results of SGK1 inhibition in models of ATC.

“Preclinical evaluation of our SGK1 inhibitors uncovered novel biology and synergy with existing cancer treatments to extend their activity and reverse resistance.  These studies have revealed a significant opportunity to intervene in several oncology treatment paradigms with an SGK1 inhibitor” Eric Campeau, Vice President, Translational Research.

According to the ATA, approximately 64,000 people in the United States are diagnosed with thyroid cancer each year. ATC makes up approximately 2% of these cases.  Although ATC is rare compared to other thyroid cancers, it is one of the fastest growing and most aggressive of all cancers. Rapid evaluation and diagnosis are critical for ATC patients, as the disease manifests as a rapidly growing neck mass that impairs speech, swallowing and breathing. Activation of Serine and Glucocorticoid Kinase 1 (SGK1) was determined to be a critical component of ATC cell proliferation, including in tumor cell lines with mutated BRAF. Inhibition of SGK1 was unique in its capacity to suppress ATC cell proliferation compared to other inhibitors tested. Thryv Therapeutics is collaborating with expert scientists and oncologists in ATC to evaluate its SGK1 inhibitors as a potential treatment option to improve the outcome of people with this devastating disease.

“We are excited to advance our portfolio of potent SGK1 inhibitors into the treatment of aggressive, treatment resistant cancers.  SGK1 has been implicated in a number of treatment-resistance oncology pathways and our work has demonstrated the potential to delay resistance and restore activity of approved therapies and ultimately improve progression free and overall survival outcomes,” Debra Odink, President, and Chief Development Officer.

About Thryv Therapeutics Inc.

Thryv Therapeutics Inc. (previously LQT Therapeutics Inc.) is a privately owned company based in Montreal, Quebec, Canada.  Thryv Therapeutics is pioneering a precision medicine approach to treat genetic and drug-induced Long QT Syndromes, atrial fibrillation, and resistant cancers with potent and selective inhibitors of Serum Glucocorticoid inducible Kinase. For more information, please visit www.thryvtrx.com.

Media Inquiries

daphne@thryvtrx.com +1 (514) 973 0915

TORONTO, June 13, 2023 — DAMONA Pharmaceuticals, a preclinical biopharmaceutical company focused on the discovery and development of first-in-class small molecules for the treatment and prevention of cognitive symptoms associated with brain disorders and aging, today announced the appointment of John Reilly as the company’s Chief Executive Officer and member of the Board of Directors.

Prior to joining DAMONA, Mr. Reilly co-founded and served as President and CEO of Apic Bio, a gene therapy company developing first-in-class treatments for rare neurological and liver diseases. At Apic, he secured multiple funding rounds, oversaw development programs, and orchestrated a global licensing agreement with uniQure for the company’s lead program to treat superoxide dismutase 1 (SOD1), a rare, genetic form of ALS. Previously, Mr. Reilly held a number of senior management positions at various biopharmaceutical companies, including Vice President of Business Development at Tetragenetics, which was acquired by Abcellera (Nasdaq: ABCL). Prior to Tetragenetics, he co-founded and served as CEO of Gendyne Therapeutics. Mr. Reilly holds a B.A. from Hamilton College and M.S. and M.B.A. degrees from Cornell University.

“I am very excited to join DAMONA as CEO and look forward to working with the board, management, and scientific team to continue the company’s impressive progress as we advance the preclinical pipeline and lead program for the treatment of cognitive symptoms associated with depression and diseases of aging into a Phase 1 clinical study,” said John Reilly, CEO of DAMONA Pharmaceuticals.

About DAMONA Pharmaceuticals
DAMONA is a privately held preclinical biopharmaceutical company developing small molecule therapeutics that transform the treatment of cognitive deficits and restore normal brain functions for underserved and understudied mental health conditions and for aging populations. DAMONA was founded by Etienne Sibille, Ph.D., and the Centre for Addiction and Mental Health (CAMH). In 2022, DAMONA closed a seed financing round co-led by Lumira Ventures and the Noetic Fund. For more information, please visit: www.damonapharma.com.

Contact:
Mary Moynihan
M2Friend Biocommunications
+1 (802) 951-9600
mary@m2friend.com

SOURCE DAMONA Pharmaceuticals

Cadence Neuroscience announced that it has secured $26 million in Series B financing. The round was led by Angelini Lumira Biosciences Fund (co-managed by Lumira Ventures and Angelini Ventures) and included other new investors F-Prime Capital, LivaNova USA, Angelini Ventures, Spectrum Financial Services, and Mayo Clinic, as well as the company’s Series A lead investor JAZZ Venture Partners. Gerry Brunk of Lumira Ventures and Kevin Chu of F-Prime Capital have joined the company’s board of directors.

Cadence is a clinical-stage company developing a novel neuromodulation therapy for treating pediatric and adult patients with focal drug resistant epilepsy based on research by a Mayo Clinic Neurology and Neurosurgery team, led by Gregory Worrell M.D., Ph.D., lead investigator and Mayo Clinic epileptologist. The therapy utilizes chronic subthreshold cortical stimulation to modulate EEG biomarkers associated with epilepsy to reduce or eliminate seizures. The company will use the Series B funds to complete pivotal clinical studies and pursue FDA clearance.

“The Cadence team has extensive domain expertise in developing active neural implants and conducting human clinical studies in the field,” said Kent Leyde, Cadence’s co-founder and Chief Executive Officer. “During the last three years, we have been closely collaborating with Mayo Clinic in the design, manufacture, and engineering tests of our therapy system. These efforts are nearing completion and will enable us to begin clinical testing.”

“As an active investor in both medical devices and pharmaceutical therapies for epilepsy, we believe Cadence is well-positioned to drive important advances in the field of neuromodulation, with the potential to revolutionize the treatment of drug refractory epilepsy, a disease which affects millions of people across the world,” said Gerry Brunk, Managing Director at Lumira Ventures. “We believe Cadence’s platform solution has the potential to become an important standard of care in drug-resistant epilepsy as well as other difficult-to-treat brain disorders,” said Paolo Di Giorgio, CEO of Angelini Ventures. 

“We think the precise, patient-specific stimulation method being developed by Cadence is unique and exciting,” said Kevin Chu, healthcare team Principal at F-Prime Capital. “We are thrilled to join the team on its important mission to bring life-changing therapies to this debilitating and difficult-to-treat disease.”

About Cadence Neuroscience
Cadence Neuroscience is a medical device company developing new therapies for the treatment of epilepsy and other neurological disorders. The company’s core technology was developed at Mayo Clinic and is under clinical evaluation. Founded in 2017 and headquartered in Redmond, Washington, Cadence is led by seasoned executives with extensive backgrounds in neural implant product development and clinical studies.

About Angelini Lumira Biosciences Fund
Lumira Ventures and Angelini Ventures partnered to create the Angelini Lumira Biosciences Fund in 2021 to invest in early-stage companies in North America developing innovative therapies for disorders of the central nervous system. Founded in 2007, Lumira Ventures is a multi-sector healthcare venture capital firm with offices in Toronto, Boston, Montreal and Vancouver. Angelini Ventures is the corporate venture capital arm of Angelini Industries, an Italian multi-sector group that operates in 21 countries in the health, industrial technology and consumer goods sectors, with 5,800 employees and revenues of €2 billion. With €300M in investment capital, Angelini Ventures creates and invests in companies developing innovative solutions in the fields of biotechnology, life sciences and digital healthcare.

Related Links
https://www.cadenceneuro.com/  
https://www.lumiraventures.com/ 
https://fprimecapital.com/
https://www.jazzvp.com/ 
https://www.livanova.com/ 
https://www.angeliniventures.com/ 
https://businessdevelopment.mayoclinic.org/ 

Mayo Clinic and Dr. Worrell have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Media Contact:
Kent Leyde
425-298-3184
359168@email4pr.com 

The study met secondary study endpoints and long-term sensor use was associated with significant improvements in patient quality-of-life metrics and low event rates for heart failure hospitalization and death.

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive 12-month data from the SIRONA 2 clinical trial that demonstrated long-term use of the Cordella Pulmonary Artery (PA) Sensor was associated with significant improvements in patient quality-of-life metrics and low HF hospitalization and death (HFH/D) event rates for New York Heart Failure (NYHA) class III patients. The results expand on the previously published positive 90-day primary endpoint data on device safety and pressure accuracy for the Cordella PA Sensor. The 12-month results were presented on May 20th at the European Society of Cardiology’s annual conference, Heart Failure 2023, by Professor Birgit Aßmus, a heart failure cardiologist at the University of Giessen in Giessen, Germany.

“Adding to a robust foundation of clinical evidence supporting the use of Cordella, the 12-month SIRONA 2 data further validates the benefit of PA pressure-guided therapy to improve patient outcomes for NYHA class III patients,” stated Prof.  Aßmus. “Cordella’s comprehensive approach consists of PA pressure data plus non-invasive data, including blood pressure, weight, and heart rate, which enables my team to efficiently titrate key HF medications remotely and help patients feel better. By actively monitoring the trended health data, we can bring down the PA pressures to avoid acute HF hospitalizations which delivers meaningful benefits to our overall health system and to patient lives.”

The Cordella solution is the first and only patient management platform to provide both critical PA pressure data with an implanted sensor, and noninvasive vitals for comprehensive clinical management delivered in the patient’s home. The easy-to-use devices securely transmit a patient’s daily health status for trended insights that support optimal dosing of guideline-directed medical therapy (GDMT) across all types of heart failure. The patient-friendly system engages the patient and allows them to view their trended health data which has been shown in clinical evaluation to support healthy lifestyle choices. The streamlined workflow enhances current clinical practice, providing a scalable solution that enables new treatment standards to reduce and prevent HF congestion.

SIRONA 2 is an open-label, single-arm trial of 70 European patients that met its primary endpoints for safety and accuracy with the previously reported 90-day results. The 12-month results extended both the strong safety profile, with no PA sensor failures and no additional device/system-related complications (DSRC=1.3%), as well as accurate PA pressure measurement, with good agreement with the gold standard fluid-filled reference catheter (Swan Ganz). The recent results also met secondary endpoints for validated patient quality-of-life metrics and demonstrated low event rates for HF Hospitalization / Death (HFH/D) as indicated below.

12-Month SIRONA 2 Key Findings

• Significant improvement in patient quality-of-life metrics, including NYHA classification over 12 months (p<0.0001) and 6-minute walk test distance at both 3 months (p=0.005) and 12 months (p=0.02)
• Low event rates for HF Hospitalization/Death and only 5 deaths (7.1%) at 12 months
  • Cumulative hazard rate for HFH (0.27) and HFH/D (0.33)
• 78.6% reduction in HFH rate in the year following implant compared to the year prior
• Consistently high patient compliance with daily submissions of heath data – 95% at 12 months

“We are thrilled with the significant improvement in patient quality of life and low event rates demonstrated in the 12-month SIRONA 2 data, which sets the stage for upcoming PROACTIVE-HF trial results in early next year,” commented Harry Rowland, CEO of Endotronix. “Together, this clinical evidence will serve as the foundation for our upcoming commercial launch and enable clinicians to improve patients’ lives for the better.”

About Endotronix

Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF).  The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor which directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice, and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

The Cordella Sensor is under clinical investigation and is not available for commercial use in any geography. The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

SOURCE Endotronix, Inc.

Proceeds to Support Key Efficacy Studies for ABI-2280 including Phase 2 Trial in High-Grade Cervical Intraepithelial Neoplasia (CIN 2,3) and Exploratory Study as Treatment for High-Risk HPV Infections

Antiva Biosciences, Inc. biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, today announced the closing of a $53 million Series E equity financing. The financing was supported by a syndicate of premier life science investors led by MPM-BioImpact Capital, and joined by the company’s existing investors including Canaan Partners, Sofinnova Investments, Adjuvant Capital, GV and Lumira Ventures, among others. In conjunction with the financing, president and chief executive officer Gail Maderis is transitioning to chairman of the company’s board of directors and is being succeeded as CEO by Kristine Ball. Additionally, Ms. Ball, along with Florencia Segal, M.D., and Brian Goodman, Ph.D., both of MPM-BioImpact Capital, will join the Antiva board.

Proceeds from the financing, which will fund the company into late 2025, will support the advancement of the company’s lead development candidate, ABI-2280, into key efficacy studies following completion of its ongoing Phase 1 trials. Planned studies include a Phase 2 clinical trial in high-grade cervical intraepithelial neoplasia (CIN 2,3) and an exploratory study as a potential treatment for high-risk HPV infection, specifically in subtypes that can lead to cancer. ABI-2280 has potent antiviral activity across all serotypes of HPV and works by both directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells. Antiva has leveraged its development expertise to formulate a vaginal tablet of ABI-2280 that will enable self-administration at diagnosis and facilitate worldwide distribution, increasing impact potential for patients.

The treatment of high-risk HPV infections with ABI-2280 holds the potential to address a significant global health challenge. HPV infections account for nearly all cases of cervical cancer around the world and an accessible and effective treatment holds the promise to dramatically reduce these cancers. Currently, there are no treatments available to resolve HPV infections and prevent their development into cancer. This remains a crucial unmet medical need with more than 5.5 million women in United States alone affected by high-risk HPV infections each year despite ready access to vaccines.

“We believe that Antiva has the opportunity to make a transformative impact on global health across several large, unmet therapeutic indications with its ABI-2280 program and are thrilled to be able to lead this round of financing. The company has advanced the development of ABI-2280 to patients with CIN 2,3 and is now poised to expand clinical development into high-risk HPV infection. ABI-2280 can make the World Health Organization’s screen-and-treat approach to HPV infection a reality,” said Dr. Segal.

Dr. Goodman added, “With MPM-BioImpact’s growing focus on the field of virology, Antiva represents the type of impactful investment that we are looking to make in this space. We look forward to supporting Kristine in her new role as CEO and seeing the continued progress that is made under her leadership.”

Ms. Ball joins Antiva with more than 20 years of executive experience in the life sciences industry across companies of all stages ranging from discovery to clinical to commercial. She has significant transactional expertise, having participated in multiple initial public offerings, corporate M&A deals, partnerships and financings. Ms. Ball most recently served as chief executive officer of Soteria Biotherapeutics, a venture backed immuno-oncology company and previously held leadership positions at Menlo Therapeutics, Relypsa, Inc., and KAI Pharmaceuticals, and served on the board of Forty Seven, Inc., until its acquisition by Gilead.  Ms. Ball currently sits on the board of Atreca, Inc., a publicly traded, clinical-stage oncology company.

“I am deeply grateful for this opportunity to join Antiva at such an exciting time in the company’s maturation. ABI-2280 has tremendous potential to play a significant role in advancing both global health and women’s health, bringing about a long-needed breakthrough in HPV infections and HPV-related cancers in both men and women,” stated Ms. Ball. “I am eager to carry forward the significant momentum that has been generated by the Antiva team and look forward to the important upcoming clinical development milestones that will move us closer to this goal. I am also excited to be able to work closely with Gail in her new role as board chair, leaning on the experience and knowledge she has gained during her time as president and CEO.”   

“I take great pride in turning the CEO role over to Kristine with the company in such a strong position following this transformative financing. She is a talented and experienced life science executive who is perfectly suited to lead Antiva as it expands clinical development of ABI-2280,” said Ms. Maderis. “I look forward to remaining intimately connected to the company in the role of board chair and offer a special thanks to Steve James, who has provided Antiva with great leadership and guidance as board chair and will remain an executive advisor to the company.”

About HPV-Related Diseases and Cervical Cancer

Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections the body is capable of clearing, but this typically takes months to years.  When the infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers.

The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need.

Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 604,000 women were diagnosed with cervical cancer worldwide and approximately 342,000 women died from the disease in 2020.

About Antiva Biosciences
Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in South San Francisco, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego. The company’s lead drug candidate, ABI-2280 is being developed as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection.

For more information, please visit: www.antivabio.com.

Contact Information:

Kristine Ball
Antiva Biosciences, Inc.
650-822-1400
info@antivabio.com

Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com

PIC Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first-in-mechanism, first-in-class allosteric small molecule therapies targeting eIF4E, is presenting pre-clinical data today on the company’s advancing eIF4E program for breast cancer in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, FL.

Advanced or metastatic breast cancers represent a large patient population with limited long-term solutions that address both the heterogenous nature of resistant tumors and the aggressiveness of their proliferation. The aim of our therapies is to drive strong mechanistic responses, in a majority of breast cancer tumor subtypes, that induce a rapid commitment to cell death. To accomplish this, our approach addresses a key fundamental mechanism in protein translation at the convergence of many oncogenic signaling pathways through which resistance arises.

eIF4E is a key component of protein translation that often becomes dysregulated in breast cancer, supporting cell survival and metastasis alongside therapeutic resistance. PIC compound regulation of eIF4E induces rapid commitment to apoptosis and selective proteomic shifts that are consistent with canonical eIF4E regulation including cell cycle impacts, e.g. effects on cyclin family members and CDKs, DNA repair regulation and metabolic proteins. PIC Compounds also potently impact multiple clinical drivers for ER+ and Triple Negative Breast Cancers, which are evidenced by mRNA signatures that include changes consistent with proteomic impacts to key transcription factors.

Previous communications revealed our eIF4E regulators potently cause cell death in primary breast cancer organoid models, but spared models derived from healthy tissue. Expanding our efforts in this domain, the impact on normal immune cells was evaluated by exposing PBMCs, CD4+ T cells, and bone marrow mononuclear cells to our compounds. Our eIF4E regulators did not impair survival of these cells up to a maximum tested dose of 25 micromolar. Primary CD4+ T cells were also found to be functional in the presence of eIF4E regulators up to 5 micromolar, which included assessments of CD3/CD28 stimulated cytokine production and proliferative responses, highlighting its remarkable differentiated impact on normal cells compared to tumor cells.

“We continue to uncover interesting and distinctive preclinical data sets that underscore the potential for unique therapeutic advantages of allosterically regulating eIF4E, as a promising strategy for patients with various subtypes of breast cancer,” said Kathy Bowdish, Ph.D., President and Chief Executive Officer of PIC Therapeutics.

Our findings suggest that allosteric regulation of eIF4E provides a unique and efficient way to address multiple resistance mechanisms while sparing normal immune cellular function. Our eIF4E regulators represent a potential beneficial therapeutic approach to address multiple resistant cancer patient populations and fulfill the promise of this elusive target.

Presentation details:
Title: eIF4E allosteric regulators cause rapid commitment to apoptosis in cancer cells while sparing immune cells
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Date and Time: Monday April 17, 9:00 AM – 12:30 PM
Location: Section 17
Poster Board Number: 14
Abstract Number: 1624

About PIC Therapeutics, Inc.

PIC Therapeutics is a preclinical-stage biotechnology company pioneering the discovery and development of first-in mechanism, first-in-class small molecule medicines focused on fundamentally changing how we treat cancer by developing therapeutics that regulate protein translation in a context dependent manner. PIC Therapeutics targets a “master switch” of cancer signaling pathways, selectively impacting oncogene protein production by altering the Pre-Initiation Complex (PIC) that drives their mRNA translation. PIC Therapeutics’ selective approach regulates cancer cell proteomes, impacting multiple dysregulated oncogenic drivers leading to a powerful new generation of cancer-treating therapeutics. Our agents offer the opportunity to address both drug resistance and tumor heterogeneity, issues that plague many existing treatments. For more information visit www.pictherapeutics.com

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the clearance of investigational new drug (IND) applications for [²²⁵Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [¹¹¹In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the companies’ multi-asset collaboration agreement.

FPI-2068 is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

“The IND filing for FPI-2068 is an important milestone for Fusion as we advance this novel TAT, created by combining our radiopharmaceutical expertise, actinium supply and manufacturing infrastructure with AstraZeneca’s bispecific antibody which preferentially binds to cancer cells that express both EGFR and cMET,” said Fusion Pharmaceuticals Chief Executive Officer John Valliant, Ph.D. “FPI-2068, which we believe will be the first TAT for two validated targets to enter the clinic, was designed to provide enhanced tumor specificity resulting from the co-expression of the two targets when compared to individual monoclonal antibodies against each of these targets. We are excited about the innovative work with AstraZeneca as we advance this and other programs under our broad collaboration agreement.”

Fusion’s radiopharmaceuticals are a type of precision medicine whereby the cancer-targeted vector (e.g., the bispecific antibody) can be used to screen patients for expression of a tumor biomarker when combined with a corresponding imaging isotope (e.g., indium-111), and subsequently used for therapy when combined with the alpha-emitting radionuclide, actinium-225. Using imaging to identify patients who show uptake of the drug in tumors increases the likelihood of response to therapy. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening in order to better predict the cadence of patient enrollment. 

FPI-2068 will be the first program to enter clinical development under the Company’s previously announced collaboration agreement with AstraZeneca, which includes joint discovery, development and the option to co-commercialize novel TATs leveraging Fusion’s proprietary Fast-Clear™ linker technology platform with antibodies from AstraZeneca’s oncology portfolio, as well as exploration of potential combination strategies involving existing assets in their respective portfolios. Fusion will be operationally responsible for the Phase 1 study, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development.

About FPI-2068

[²²⁵Ac]-FPI-2068 (FPI-2068) is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are validated cancer targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. FPI-2068 will be evaluated in a Phase 1 study.

About Fusion

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical.

Forward-Looking Statements

This press release contains “forward-looking statements” for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.’s (the “Company”) future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “expect,” “plans,” “anticipates,” “intends,” “will,” and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company’s potential drug candidates, including any expressed or implied statements regarding the successful development of its product candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance FPI-2068 in the clinic, through the regulatory process or to commercialization; management’s expectations could be affected by unexpected patient recruitment delays or regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials; the Company’s ability to obtain additional funding required to conduct its business activities; and changes in the Company’s business plan or objectives. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management’s expectations are described in greater detail under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the year ended December 31, 2022, as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company’s estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company’s views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company’s estimates change.

Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, www.fusionpharma.com, including, but not limited to, company disclosures, investor presentations, SEC filings, and press releases. The information that Fusion posts on this website could be deemed to be material information. As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis.

Contact:
Amanda Cray
Senior Director of Investor Relations & Corporate Communications
(617) 967-0207
cray@fusionpharma.com

SOURCE Fusion Pharmaceuticals

Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory disease, today announced it has entered into a Research Collaboration and License agreement with Incyte to discover and develop targeted protein degraders for novel oncology targets.

“We are pleased to embark on this collaboration with Incyte to identify targeted protein degraders for novel oncology targets. Biotheryx and Incyte share a commitment to finding new, transformative treatment options for people living with cancer,” said Philippe Drouet, President and Chief Executive Officer of Biotheryx. “Our PRODEGY platform is designed to increase efficiency in degrader discovery and design, enabling the development of therapies for previously undruggable targets. We look forward to leveraging this differentiated approach in our collaboration with Incyte and in the continued advancement of our pipeline of first-in-class, next generation bifunctional degraders and molecular glues for the treatment of cancers and inflammatory disease.”

Under the terms of the agreement, Biotheryx will utilize its distinctive PRODEGY platform to identify and initially develop molecular glue degraders for multiple historically undruggable oncology targets. For the initial target, Biotheryx will receive a technology access fee of $7 million plus up to an additional $6 million in potential research and development funding from Incyte for costs associated with the collaboration. Biotheryx is also eligible to receive potential future regulatory and commercial milestones of up to $347 million plus tiered single-digit royalties on global net product sales for the initial target. Incyte will be solely responsible for further development and commercialization of any molecular glue degraders discovered by Biotheryx’s PRODEGY platform. Additionally, under the terms of the agreement, the collaboration can be expanded under the same financial terms. Further financial terms of the deal were not disclosed.

“As we work to transform the oncology treatment landscape, Incyte is harnessing breakthrough science that may offer patients with unmet needs new treatment options,” said Dashyant Dhanak, Ph.D., Executive Vice President and Chief Scientific Officer of Incyte. “The Biotheryx team has significant expertise in targeted protein degradation, one of the most promising modalities in oncology, and we look forward to collaborating to develop therapies that can help improve patient lives.”

About Biotheryx, Inc.

Biotheryx is a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders, including bifunctional degraders and molecular glues. Our initial focus is on deploying the differentiated potential of degraders towards validated targets in cancer and inflammatory disease. Members of our founding and scientific teams previously developed the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and we have applied our expertise in Cereblon binding to build our proprietary PRODEGY platform. Our pipeline of bifunctional degraders includes the first-ever degraders of SOS1 for pan-KRAS mutant cancers, CDK4/6 for solid tumors and PDE4 for inflammatory diseases. Our pipeline of molecular glues includes BTX-1188, a rationally designed, dual-targeting molecular glue degrader of GSPT1 and IKZF1/3 for acute myeloid leukemia and solid tumors. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

SOURCE Biotheryx, Inc.

Deka Biosciences (“Deka”), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced today that the first subject has been dosed in a Phase 1 clinical trial of DK2¹⁰ (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK2¹⁰ (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

“We are beyond thrilled to begin the clinical trial of DK2¹⁰ (EGFR), marking our first program to enter clinical development,” said John Mumm, Ph.D., President and CEO of Deka. “Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first Diakine^TM, establishing a solid foundation for the expanded use of this treatment in cancer patients.”

DK2¹⁰ (EGFR) is the first of several experimental therapeutics developed as part of Deka’s platform of molecules, which combines the cytokines full strength IL-2 and a high affinity IL-10. While IL-2 is known to be toxic, when coupled with IL-10, toxicity is not only reduced but its potency is increased, thereby creating a more tolerable and effective treatment for patients. It is the first of several experimental therapeutics in Deka’s platform of molecules which are being developed to treat both cancer and inflammatory diseases. These therapeutics, known as Diakines^TM, involve coupling two cytokines together onto a single chain variable fragment (scFv) targeting system to enhance their precision in targeting specific tissues. Furthermore, the scFv scaffold used in the Diakine^TM platform also improves efficacy, safety and manufacturability of each treatment.

About Deka Biosciences

Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, testing and clinical development. Deka has developed disease specific Diakines™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient’s immune response to different Diakines™, Deka hopes to maximize the impact of its Diakines™ by building specific targeted therapies for everyone.

SOURCE Deka Biosciences

OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, announced a significant milestone for the Company as the SavvyWire has been successfully used by physicians in 1,000 procedures. The SavvyWire is OpSens’ sensor-guided solution for transcatheter aortic valve replacement procedures, TAVR or TAVI, to treat aortic valve stenosis.

“The successful use of the SavvyWire in 1,000 patients marks an important milestone towards full-scale commercialization of our innovative device. The early commercialization phase is progressing steadily and the impressive number of procedures completed demonstrates the acceptance and relevance of the SavvyWire within the structural heart market” said Louis Laflamme, President and Chief Executive Officer of OpSens.

“We are gaining positive traction in the U.S. and Canada with our proprietary 3-in-1 solution for TAVR  procedures. Our sales team is operating at a high level as they educate cardiologists on the benefits of the SavvyWire to expand the number of accounts and drive adoption. Additionally, signing a GPO agreement last month with one of the largest group purchasing organizations in the United States and SavvyWire being featured in two live case broadcasts during the CRT conference is expected to drive continuous growth going forward,” Mr. Laflamme concluded.

The SavvyWire is the first and only Sensor-Guided solution for TAVR procedures to treat aortic valve stenosis. It uniquely provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)

OpSens focuses mainly on cardiology. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of more than 200,000 patients in more than 30 countries. It is approved for sale in the United States, the European Union, the United Kingdom, Japan and Canada.

OpSens has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR). This unique guidewire is a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.

OpSens’ SavvyWire is on trend with a minimalist approach to TAVR and advances the procedure, allowing patients to leave the hospital earlier, sometimes the same day.

The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027.

OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

SOURCE OpSens Inc.

For further information: Louis Laflamme, CPA, President and Chief Executive Officer, 418.781.0333; John Hannigan, FCA, Chief Financial Officer, 418.781.0333

HistoSonics, (www.histosonics.com), the developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the first kidney patient has been treated using the Company’s histotripsy platform. The procedure was performed in Leeds, UK, by Professor Tze Min Wah, Senior Consultant Radiologist and Clinical Lead for Interventional Oncology Program at Leeds Teaching Hospitals NHS Trust, UK. This procedure marks the initial treatment in the HistoSonics sponsored “CAIN” Trial which is a Phase I prospective, multi-center study designed to evaluate the safety and technical success of the Company’s histotripsy system in targeting and destroying primary solid renal tumors, completely non-invasively and without the need for incisions or needles. The trial is named in honor of Charles Cain PhD, former Chair of Biomedical Engineering at the University of Michigan, co-inventor of histotripsy, and co-founder of HistoSonics, who passed away in March of 2020.

Professor Tze Min Wah commented, “I was delighted to lead the clinical team in carrying out this world’s first kidney tumor treatment using histotripsy and a real privilege to have the trust of the patient and their family in translating this innovative technology into our clinic. The CAIN Trial represents a significant milestone for treatment of solid renal tumors with histotripsy as a needle-less technology and is a paradigm shift from this point onwards.”

HistoSonics’ image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with precision and control. The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted tissue at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology provides significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

HistoSonics histotripsy systems are not currently available for sale. Any use is limited to clinical investigations. The HistoSonics Edison™ System is pending FDA review for a destruction of liver tissue indication. The CAIN Trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on the continued development of its Edison^™ Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced its PROACTIVE-HF pivotal study successfully completed enrollment. Designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S.

About Endotronix

Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF).  The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella PA Sensor is an implantable pulmonary artery (PA) pressure sensor which directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

The Cordella™ PA Pressure Sensor System is an investigational device and is not currently approved for clinical use in any geography.

CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for Clinical Investigation.

The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

Congruence Therapeutics, a biotechnology company working at the interface of computational and experimental drug discovery to design novel small molecules for diseases of protein misfolding, announced today the close of an extension to its Series A financing, bringing the total amount raised to over US$65 million. This extension was led by new investor BDC Capital’s Thrive Venture Fund, with participation from current investors Amplitude Ventures, Fonds de solidarité FTQ, OrbiMed, Investissement Quebec (IQ), SilverArc, and others.

“This financing provides further evidence of the emerging role that technology must play to drive innovation in biotechnology. We are proud to be pioneers in tech-enabled drug discovery with the support of high-quality investors who share our commitment to developing computational tools that will re-invent the way that drugs are discovered,” said Dr. Clarissa Desjardins, CEO of Congruence. “These additional proceeds will allow us to accelerate our pace, advancing our Revenir™ platform and our pipeline of first-in-class and best-in-class programs for devastating genetic, rare and neurological diseases toward the clinic.”

Michelle Scarborough, Managing Partner, Thrive Venture Fund at BDC Capital added, “With an incredible team led by Clarissa and a first-of-its-kind discovery platform, Congruence will quickly emerge as a leading biotechnology company who is well-positioned to disrupt traditional drug discovery and deliver real benefits to patients. We are proud to lead this investment round and look forward to supporting Congruence through its next phase of growth.”

In February 2022, Congruence announced the close of its Series A financing of US$50 million, led by Amplitude Ventures and Fonds de solidarité FTQ, with participation from Lumira Ventures, Investissement Quebec, OrbiMed Advisors, Driehaus Capital Management, and others. Congruence Therapeutics was founded in 2021 by Clarissa Desjardins, Ph.D., previously the founder and chief executive officer of Clementia Pharmaceuticals, a company developing therapies for rare pediatric bone diseases and sold to Ipsen in early 2019 for US$1.3 billion. Clementia’s lead product, Sohonos^™ (palovarotene), was recently approved in Canada and is under review at the FDA as the first treatment for Fibrodysplasia Ossificans Progressiva, a debilitating and progressive rare bone disorder. At Congruence, Dr. Desjardins has put into place a team of ‘drug hunters’ with experience in rare disease strategy and clinical development, computational chemistry, medicinal chemistry, and business development.

About Congruence Therapeutics

Congruence Therapeutics is a drug discovery company that is uniquely harnessing the power of innovative fields such as protein dynamics, biophysics, machine learning, AI, and computational chemistry to advance drug discovery. Our ground-breaking discovery engine, Revenir^TM, captures the biophysical features of functional proteins and their pathogenic counterparts in order to discover functional allosteric and cryptic pockets which can lead to small molecule hits at unprecedented speed. 

For more information, please visit www.congruencetx.com.

Company Contact
Tanya Borsuk
EVP of Corporate and Business Development
tborsuk@congruencetx.com

Media Contact
Amy Conrad
Juniper Point
amy@juniper-point.com 
858-366-3243

No serious adverse events related to drug product were reported
Patients demonstrated improvements in exercise capacity and reductions in episodes of chest pain
Cardiac imaging results provide mechanistic evidence supporting the therapeutic potential of XC001 in cardiovascular disease

XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced completion of the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.  EXACT met both safety and efficacy objectives. There were no safety issues related to drug product or unexpected serious adverse events related to XC001 administration.  Six-month data from 28 patients in the Phase 2 portion of the study showed improvements in several key efficacy measures, including reduction in ischemic burden.

“We are excited to see EXACT completing its 6-month endpoint.  The trial met all of its safety and exploratory objectives, showing intriguing benefits in these needy patients across a variety of objective and subjective measures,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “The strong range of mechanistic evidence demonstrate that administration of XC001 is a scientifically-sound approach for achieving a biological effect that has the potential to improve patients’ quality of life.”

XC001 is a one-time gene therapy designed to reduce ischemic burden by creating new blood vessels in  the heart. In the Phase 2 portion of the EXACT trial, evidence of the drug’s mechanism of action was demonstrated by the reduction of ischemic burden measured by cardiac positron emission tomography (PET) imaging.  The reduction in ischemic burden was accompanied by an improvement in total exercise duration, an important measure of exercise capacity. Prior to treatment, almost all subjects had marked limitations on ordinary physical activity. Six months after treatment, nearly half of all subjects were able to conduct ordinary physical activity without causing angina. The data from the Phase 2 EXACT study are potentially meaningful for patients with refractory angina, which includes more than one million people in the United States, who have no treatment options.

“We are excited to share this positive topline data from the Phase 2 portion of the EXACT trial, reinforcing our confidence in XC001 as a novel therapeutic approach with the potential to address the significant unmet medical needs of people with refractory angina,” said Al Gianchetti, President and CEO of XyloCor. “We now look forward to pursuing key upcoming milestones in XC001’s continued development, including finalizing our pivotal trial design through our ongoing discussions with the FDA and other regulatory authorities.”

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About the EXACT Study

The recently completed Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial was a Phase 1/2 multicenter, open-label, single-arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial in which additional subjects were enrolled at the highest tolerated dose (1 x 10¹¹ vp, the highest tested dose). The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by a cardiac surgeon.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain.

About XyloCor

XyloCor Therapeutics is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Corporate and Investor Relations:

Brian Davis, XyloCor Therapeutics

brian.davis@xylocor.com

610-541-2056

Media Contact:

Mike Beyer, Sam Brown Inc. Healthcare Communications

mikebeyer@sambrown.com

312-961-2502

Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CYR-064, paving the way for the company to initiate a randomized, placebo-controlled multi-dose Phase 2 clinical trial of its soft mist nasal spray therapy to treat patients who have lost their sense of smell following recovery from a viral infection.  There is currently no FDA-approved drug therapy to treat post-viral smell loss.

“Clearance of the IND for CYR-064 brings us one step closer to our goal of developing medicines with the potential to benefit post-viral hyposmia patients, especially those affected by COVID-19,” said Rick Geoffrion, Chief Executive Officer of Cyrano Therapeutics. “Our clinical team has been diligently preparing for this moment and is now laser focused on enrolling our first patient, which we expect will occur in the second quarter of 2023.”

“Loss of the sense of smell has a significant impact on quality of life and presents safety issues for all who are affected. As a practicing otolaryngologist-head and neck surgeon, the inability to offer any proven intervention for patients with this common condition is very frustrating,” said Ron Kuppersmith, MD, Chief Medical Advisor of Cyrano Therapeutics and Past-President of the American Academy of Otolaryngology – Head and Neck Surgery. “While the inability to administer any therapy that can help is a challenge for physicians, the situation is even more frustrating for patients suffering with the condition. The potential for CYR-064 to help patients with post-viral hyposmia will represent a major breakthrough for these patients and address a major unmet clinical need.”

The Phase 2 clinical trial is designed to assess the local safety, tolerability, and effectiveness of treating post-viral hyposmia. The study is expected to enroll patients at twenty clinical sites in the United States and will evaluate treatment over a six-month time period.

About Post-Viral Hyposmia

Post-viral smell loss is a growing global issue.  Prior to the COVID-19 pandemic, 8 million patients in the U.S. and EU suffered from long-term post-viral smell loss.  This has grown to more than 40 million patients since the beginning of the COVID-19 pandemic.  Approximately 15% of 2020-era COVID-19 patients and ~5% of 2021 and 2022-era COVID-19 patients suffer from long-term smell loss.  At current rates, >10,000 patients each day in the U.S .and >10,000 patients each day in the EU are contracting long-term smell loss.

About Cyrano Therapeutics

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company.  Since our foundation, we have been working diligently to develop therapies for people struggling with the loss of smell and flavor. To learn more, please visit cyranotherapeutics.com.

SOURCE Cyrano Therapeutics

Funds Expected to Support Enrollment in U.S. Pivotal EMPOWER Trial and European Commercial Expansion for Carillon Mitral Contour System®.

Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced it has closed a $35 million Series D financing round. The financing was co-led by existing investor Horizon 3 Healthcare and an undisclosed strategic investor, with all other existing investors participating, including Arboretum Ventures, Hostplus, EQT Life Sciences (formerly LSP), Lumira Ventures, and M. H. Carnegie & Co.

“Having two high quality co-lead investors, including a new strategic investor, as well as the continued financial support of all existing investors, continues to validate Cardiac Dimensions’ solution for heart failure patients suffering from mitral regurgitation. This funding will enable us to continue providing Carillon therapy to a large population of patients in dire need of treatment,” said Cardiac Dimensions CEO Rick Wypych. “We anticipate accelerating enrollment in our EMPOWER pivotal trial where we can now bring Carillon’s benefits to earlier-stage patients with much lower grades of mitral regurgitation. With strong reimbursement in place in key European markets, we also look forward to expanding adoption in these markets and adding new geographies this year.”

“We have been impressed with Carillon’s ability to improve patients’ lives both in clinical studies and in real-world use, and with the company’s ability to leverage these results to grow adoption and commercial sales,” said Matt McNamara, Chief Investment Officer and Board Director for Horizon 3 Healthcare. “We are enthusiastic about the device’s potential to treat heart failure at a much earlier stage than other device therapies, which could make it a frontline treatment with the potential to change the course of the disease.”

In 2021, Carillon therapy was added to the European Society of Cardiology (ESC) Guidelines covering the Diagnosis and Treatment of Acute and Chronic Heart Failure for the treatment of secondary mitral regurgitation (SMR). The guidelines note that the therapy met its primary endpoint in the blinded, sham-controlled, randomized REDUCE FMR trial, has a shorter learning curve and fewer technical requirements than clipping, and does not preclude other heart failure-related procedures.

Data encompassing 101 patients across Germany from the CINCH European post-market registry were recently presented at the 2022 Transcatheter Therapies (TCT) conference. The data showed that an MR grade of 2+ or less was achieved for 96 percent of patients at 12 months and 100 percent of patients by five years. More than 69 percent of patients had a NYHA class of II+ or less at one year, which improved to 79 percent of patients at five years. Safety data showed no device-related significant adverse events out to one year. At two years, the mortality and heart failure hospitalization rates were also notably better than both standard medical management and published data from other commercial device therapies. Previously published survival data on the Carillon device out to six years show favorable survival when compared to medical management.

About the Carillon Mitral Contour System

Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.

To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial is currently enrolling patients in the U.S., as well as in select centers worldwide.

The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.

Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.

Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

Contacts

Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274

AmacaThera, a clinical-stage biotechnology company developing advanced injectable biomaterials for local, sustained delivery of oncology and pain therapeutics, has received grant funding from the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma.

The program, launched by Johnson & Johnson Innovation- JLABS (JLABS) with the Johnson & Johnson Office of Military and Veterans Affairs, was created with the goal of advancing technologies that benefit veterans.

“We founded AmacaThera to revolutionize the range of treatment options available to patients using a range of therapeutic agents, such as small molecules, antibodies, proteins or peptides,” says Dr. Michael J. Cooke, CEO and co-founder of AmacaThera. “We’re honoured to be among the companies selected to participate in this program, and excited to form new collaborations.” Molly Shoichet, co-Founder and CSO, added, “Our unique, responsive hydrogel strategy enables us to achieve success in this innovative approach to lung cancer treatment.”

About AmacaThera
AmacaThera is a clinical-stage biotechnology company transforming therapeutics to make a difference in patient health. Our unique, injectable hydrogel platform provides localized, sustained drug delivery to improve patient outcomes across multiple therapeutic areas, including post‑surgical pain management, cancer and other hard‑to‑reach target areas. To learn more, visit amacathera.ca.

SOURCE AmacaThera Inc.

For further information: Media Contact: Mike J. Cooke, CEO and Co-Founder, AmacaThera Inc., mikejcooke@amacathera.ca

Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients.

TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company’s application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs.

The Fast Track program provides Edesa with the opportunity for more frequent communication with the agency to discuss the development path for EB05 as a treatment for ARDS in critically ill Covid-19 patients. Investigational drugs that receive Fast Track designation are also eligible for rolling review of their marketing application as well as potential pathways for accelerated regulatory approval. To receive this designation, drug candidates must both treat a serious disease and have non-clinical or clinical data that demonstrate the potential to address an unmet medical need.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that FDA’s decision is a significant development milestone for the company. “Fast Track designation provides additional validation of EB05’s potential to address a significant unmet need in hospitalized patients with ARDS,” said Dr. Nijhawan. “The Fast Track designation will facilitate our interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program.”

Edesa recently reported that Phase 2 results offered statistically significant evidence of EB05’s ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

About EB05

EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses.

About Acute Respiratory Distress Syndrome (ARDS)

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential life-saving impact of its EB05 monoclonal antibody candidate; the FDA’s Fast Track program’s ability to get new drugs to market earlier; the company’s ability or intention to have more frequent communication with FDA regarding the development path of EB05; the eligibility for EB05 to receive rolling review of a future potential marketing application or accelerated regulatory approval; the company’s belief that EB05 has the potential to address a significant unmet need in hospitalized patients with severe disease, and that Fast Track designation for EB05 will facilitate its interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program; and the company’s timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

Important Regulatory Milestone Provides Runway to Move DK2¹⁰ (EGFR) into the Clinical Phase

GERMANTOWN, Md., Dec. 27, 2022 /PRNewswire/ — Today, Deka Biosciences, Inc. (Deka), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on December 23, 2022. The IND application supports Deka’s DK2¹⁰ (EGFR), a promising new cancer treatment that combines normal interleukin-2 with a high affinity interleukin-10, that is designed to accumulate in tumors by binding to the epidermal growth factor receptor (EGFR).

“With no dual cytokine therapy currently approved for the treatment of cancer, this IND application brings us one step closer to fulfilling our mission – to bring cures to patients with cancer and inflammatory diseases,” said John Mumm, CEO & Co-Founder of Deka. “We are thrilled to advance DK2¹⁰ (EGFR) to the clinical phase and anticipate beginning our Phase 1 trial as soon as possible after the FDA’s acceptance of our IND.”

The IND filing comes nearly 18 months after the discovery of DK2¹⁰ (EGFR), and the company is projecting to dose its first patient in early 2023.

DK2¹⁰ (EGFR) is the first of many experimental therapeutics developed as part of Deka’s platform of molecules. Each Diakine^™ in Deka’s platform consists of two complementary cytokines coupled together via attachment to a single chain variable fragment that enables the cytokines to accumulate more specifically in targeted tissues. The combination of the two cytokines increases potency and reduces toxicity while the targeting system also improves the drug’s efficacy, safety, and manufacturability. Deka has also identified genetic markers that are related to the differentiated responses to each Diakine^™. These markers will be evaluated in early clinical trials with the hope of using them as potential diagnostic tools to match patients with the most effective Diakine^™ treatment in later stage trials.

About Deka Biosciences

Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, and testing. Deka has developed disease specific Diakines^™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient’s immune response to different Diakines^™, Deka hopes to maximize the impact of its Diakines^™ by building these targeted therapies for everyone.

SOURCE Deka Biosciences

Financings Planned to Support Rapid Expansion of Histotripsy Platform as Company Welcomes Silk Road Medical CEO, Erica Rogers, to its Board of Directors

HistoSonics, Inc. (www.histosonics.com), the developer of a non-invasive, novel sonic beam therapy, announced today that it has raised $85 million in a financing led by Johnson & Johnson Innovation – JJDC, Inc., with participation from existing investors including Venture Investors, Lumira Ventures, Yonjin Venture, and the State of Wisconsin Investment Board, among others. Concurrently, HistoSonics also secured a commitment for a $15 million expansion of the amount available under its existing debt facility with Signature Bank, which the company may access to accelerate strategic projects. Proceeds of the financings will be used to support HistoSonics anticipated commercial launch, additional clinical trials, and to expand application development of Edison™, the company’s novel histotripsy therapy platform, throughout the body.

Mike Blue, President and CEO of HistoSonics, commented, “These financings are an extraordinary vote of confidence in our team, as well as the novel platform and solution we have developed to transform experiences for patients and physicians who deal with the many challenges associated with significant disease, starting in the liver.”  The number of patients in the US who have primary liver tumors has increased 43% in the past 16 years and is expected to grow another 40% by 2030. HistoSonics recently submitted safety and efficacy data from its #HOPE4LIVER Clinical Trials to the US Food and Drug Administration (FDA) and expects market authorization in 2023.

HistoSonics also announced today the appointment of Erica Rogers, President and CEO of Silk Road Medical, Inc., to the company’s Board of Directors. Rogers brings decades of leadership experience in the medical technology sector and has a track record of delivering significant value creation for the companies she leads. Most recently, Rogers led Silk Road Medical from an early-stage start-up to explosive growth and a successful IPO in 2019. Silk Road Medical currently has a market cap of approximately $2.0 billion. “I have been following HistoSonics’ progress for years and believe that histotripsy offers a unique non-invasive solution capable of addressing a variety of significant unmet clinical needs. I look forward to being a part of the HistoSonics team, helping to ensure the Edison platform reaches its full potential to treat patients with significant disease across global markets and a broad number of care settings,” commented Rogers.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors at sub-cellular levels. The company is currently focused on the development of its Edison™ platform, combining advanced imaging with proprietary sensing technology to deliver personalized external beam treatments with unparalleled precision and control, and with the promise of reducing many of the side effects of conventional therapies. The Edison™ platform is not currently available for sale and is intended for use in the destruction of liver tissue. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Dmitri Bobilev, M.D., as chief medical officer.

“We are pleased to welcome Dmitri to Fusion’s leadership team at a time when Fusion has three Phase 1 novel targeted alpha therapy (TAT) programs and a multi-product development collaboration with AstraZeneca,” said Fusion Chief Executive Officer John Valliant, Ph.D. “Dmitri brings to our team his expertise as a seasoned drug developer and practicing medical and radiation oncologist with an impressive track record of success and clinical trial planning and execution. We look forward to his leadership in guiding our clinical development programs as we seek to bring our TATs to cancer patients in need.”

Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development until the company’s acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinical development strategy for vidutolimod. Prior to Checkmate, Dr. Bobilev was vice president, head of clinical development at Vedanta Biosciences. He previously held clinical development leadership roles with Tesaro and Sanofi. Dr. Bobilev spent more than 10 years as a practicing medical and radiation oncologist.

Dr. Bobilev commented, “The next wave of radiopharmaceuticals based on alpha emitting isotopes are poised to make a significant impact on the landscape of cancer therapy. Fusion has established itself as a leader in targeted alpha therapies, combining internal R&D capabilities, with manufacturing and supply chain expertise to create a fully-integrated radiopharmaceutical company. I’m excited about the opportunity to guide the clinical strategy for a company with such a rich pipeline of innovative cancer therapies.”

Inducement Equity Award
Fusion’s Compensation Committee of the Board of Directors approved a grant of stock options to Dr. Bobilev to purchase 550,000 of Fusion’s common shares. Each option was granted as an inducement equity award outside Fusion’s 2020 Stock Option and Incentive Plan and was made as an inducement material to Dr. Bobilev’s acceptance of employment with Fusion. The options have an exercise price of $1.98 per share, which is equal to the closing price of Fusion’s common stock on November 7, 2022. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal installments for 36 months thereafter, subject to Dr. Bobilev’s continued service with Fusion through the applicable vesting dates.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s first program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 study; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), which has received FDA investigational new drug (IND) clearance and will begin a Phase 1 study imminently. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF and Niowave, Inc.

For further information: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-967-0207, cray@fusionpharma.com

SOURCE Fusion Pharmaceuticals Inc.

• Financing Round Led by OrbiMed with participation from Lumira Ventures, Harrington Discovery Institute and existing investors Advent Life Sciences and Belinda Termeer

• Therapy development focused on addressing a fundamental mechanism in cancer-driving oncogenes

October 19, 2022 – PIC Therapeutics, Inc., a biopharmaceutical company dedicated to developing life-changing medicines for patients with cancer, today announced the closing of a $35 million Series A financing led by OrbiMed. Other new investors participating in this financing include Lumira Ventures and Harrington Discovery Institute. The company’s existing investors including Advent Life Sciences and Belinda Termeer also participated and provided initial seed financing instrumental to meeting key milestones.

Proceeds from the financing will be used to advance the company’s development-stage small molecule drug, an allosteric protein translation modulator targeting eIF4E, into first-in-man, first-in-mechanism clinical studies in advanced metastatic breast cancer. The proceeds will also support expansion of the company’s pipeline of emerging oncology indications.

PIC Therapeutics is targeting a fundamental mechanism at the convergence of many oncogenic signaling pathways that results in apoptotic cancer cell death while sparing normal cells. Allosteric modulation of eIF4E offers many advantages to previous approaches, and simultaneously addresses multiple drivers of pharmacology, allowing the company’s small molecules to truly drive differential CAP dependent translation in target cells.

Preclinical studies show that PIC compounds modulate, but do not block, protein translation. PIC compounds mechanistically modulate cellular proteomes, leading to rapid and significant reduction in cancer cell viability via apoptosis. Inducing apoptosis rather than senescence is an important distinguishing feature of PIC’s approach to this elusive target.

“This financing from a committed and distinguished investor syndicate, which includes new and existing investors, underscores the progress we’ve made to advance our lead program toward our goal of cancer therapies that broadly address cancer-driving oncogenes via a fundamental mechanism in protein translational modulation” said Katherine Bowdish, Chief Executive Officer of PIC Therapeutics. “We are well positioned to build a leading mechanistic-based oncology company that brings promising science to cancer patients with drug resistant tumors.”

“We are excited to partner with PIC Therapeutics as they build a differentiated targeted oncology company, and we look forward to supporting the team as they work towards achieving key development goals over the coming years,” said Tal Zaks, Partner of OrbiMed Advisors.

“Founded on the scientific work of Dr. Gerhard Wagner at Harvard University and Dr. Nahum Sonenberg at McGill University, PIC Therapeutics has developed a truly novel approach for eIF4E, an important target in resistant cancers. We are pleased to work with the PIC team and its investors to enable new frontiers in targeted mechanistic oncology with the potential to transform the treatment paradigm for cancer patients” commented Gerry Brunk, Managing Director of Lumira Ventures.

About PIC Therapeutics

PIC Therapeutics is a biotechnology company pioneering the discovery and development of first-in mechanism, first-in-class small molecule medicines focused on fundamentally changing how we treat cancer by developing therapeutics that modulate protein translation. PIC Therapeutics targets a “master switch” of cancer signaling pathways, selectively impacting oncogene protein production by altering the Pre-Initiation Complex (PIC) that drives their mRNA translation. PIC Therapeutics’ selective approach modulates cancer cell proteomes, impacting multiple dysregulated oncogenic drivers leading to a powerful new generation of cancer-treating therapeutics. Our agents offer the opportunity to address both 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 programs to their benefit.

About OrbiMed

OrbiMed is a leading healthcare investment firm, with approximately $18 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 130 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. www.orbimed.com

About Lumira Ventures

Lumira Ventures is a North American healthcare venture capital firm whose companies have brought dozens of biomedical innovations to patients worldwide over the past two decades. Lumira invests across multiple stages, sectors and therapeutics areas, partnering with mission-driven entrepreneurs and co-investors to build transformative healthcare companies. Lumira has offices in Toronto, Montréal, Vancouver and Boston. For more information please visit www.lumiraventures.com

Contacts

Matt Burke

mattdavidburke@gmail.com

TORONTO, Ontario, September 26, 2022 — DAMONA Pharmaceuticals today announced the closing of a seed stage financing round to support the development of its lead therapeutic for the treatment of cognitive symptoms associated with depression and diseases of aging. The syndicated investment was co-led by the Angelini Lumira Biosciences Fund and Noetic Fund and included participation from Toronto Innovation Acceleration Partners (TIAP), and several family offices. In addition to the equity financing, the company has received significant financial support from the Centre for Addiction and Mental Health (CAMH) and the Ontario Brain Institute and additional early stage development programs. Proceeds from these financings will support the development of the company lead, AC-101, which was licensed from CAMH, UWM Research Foundation Inc., University of Tours and University of Belgrade-Faculty of Pharmacy, and additional early stage development programs.

DAMONA’s mission is the discovery and development of first-in-class modulators of GABA neurotransmitters that target and restore impaired brain functions in patients suffering from cognitive symptoms. Promising data generated from testing in preclinical models has demonstrated the ability of AC-101 to specifically target and activate impaired brain receptors and to rapidly improve cognitive symptoms while renewing and repairing underlying brain dysfunctions, thereby offering the potential of reversing the impairment and in doing so resolve previously unresolvable symptoms.

“The Lumira team was first drawn to the DAMONA opportunity by the quality and depth of the science being generated by company founder Dr. Etienne Sibille, a world-leading scientist in the areas of neuroscience and neuropharmacology. Over the past several years, we built a strong working relationship with Dr. Sibille which enabled us to see the terrific progress culminating in the selection of its lead, AC-101, which the company now plans to take into IND enabling studies.” said Jacki Jenuth, Partner and COO of Lumira Ventures.

“Currently, there are no medications available to treat cognitive symptoms such as memory loss and inability to focus that occur in association with depression, aging, and other mental illnesses. DAMONA’s lead program and pre-clinical pipeline offer real hope for patients suffering from these devastating disorders,” said Sri Teja Mullapudi, Principal of Noetic Funds.

“We are grateful for the support from all of our investors and supporters who have brought us to where we are today,” said Dr. Etienne Sibille, Interim CEO and Chief Scientific Officer of DAMONA Pharmaceuticals. “We look forward to working with our new partners and utilizing the
capital from this financing to complete our pre-clinical studies and take our program to the clinic.”

“As a world leader in mental health and brain sciences research, we are proud to work with Angelini, Lumira, Noetic, TIAP, OBI and others to move this critical work to its next stage,” added Dr. Aristotle Voineskos, Vice President of Research and Director of the Campbell Family Mental Health Research Institute at CAMH. “This investment brings us one step closer to helping the millions of people affected by cognitive symptoms associated with depression and diseases of aging.”

About DAMONA Pharmaceuticals
DAMONA is a privately held pre-clinical pharmaceutical company founded by Dr. Etienne Sibille and the Centre for Addiction and Mental Health (CAMH) on a mission to develop small molecule therapeutics that transform the treatment of cognitive symptoms and restore normal life functions for underserved and understudied mental health and aging populations.

About Angelini Lumira Biosciences Fund
Angelini Lumira Biosciences Fund is a venture capital fund established by Angelini Pharma in partnership with Lumira Ventures. The Fund focuses on early stage investments in North American based companies developing products targeted at rare and central nervous system diseases. Angelini is an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutics areas of central nervous system and mental health, rare diseases, and consumer healthcare. Angelini Pharma operates directly in 25 countries employing almost 3,000 people and commercializes its products in more than 70 countries through strategic alliances with leading international pharmaceutical groups. Lumira Ventures is a North American healthcare venture capital firm with two-decades of experience of investing in and helping to build transformative life science based companies. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston. For more information, please visit www.lumiraventures.com

About Noetic
Noetic was founded in early 2020 with a vision to disrupt how mental health indications are treated and managed. Through its venture capital funds, Noetic invests globally to build emerging technologies in molecular therapeutics/biotech, digital health, medical devices, and wellness with a focus on mental health, pain, and other complications resulting from the central nervous system.

About CAMH
The Centre for Addiction and Mental Health (CAMH) is Canada’s largest mental health and addiction teaching hospital and a world leading research centre in this field. CAMH combines
clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental illness and addiction. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please visit camh.ca or follow @CAMHnews on Twitter.

For More Information:
DAMONA pharmaceuticals
Etienne Sibille
Etienne.sibille@damonapharma.com

GERMANTOWN, Md., Sept. 8, 2022 /PRNewswire/ — Deka Biosciences (“Deka”), a biotech company focused on the development of novel cytokine therapies to treat cancer and inflammatory diseases, announced today the appointment of Charlotte Moser, MD, PhD, MSc, MBA as Chief Medical Officer (CMO) and Deb Kientop, MBA as Vice President, Clinical Operations.

Dr. Moser joins Deka from Nanocan Therapeutics Corporation  where she served as Chief Scientific Officer. With over 28 years working as an oncologist, 15 of which she has spent specifically in drug development, Dr. Moser has obtained extensive clinical operational and regulatory knowledge and broad clinical trial design and execution experience. “I’m keen to propel Deka from a preclinical to clinical stage company and drive the development of more tolerable and selective immunotherapies at a fast pace,” shared Dr. Moser.

Deb Kientop comes to Deka from ErgoMed, where she served as the Senior Vice President, Oncology Strategy and Innovation. Deb has over 27 years working in oncology drug development, from bench research at the University of Wisconsin, to medical affairs and clinical development roles within pharma and CRO. “I’m excited to be a part of the expert team that is bringing next generation targeted cytokines to the clinic. I look forward to the opportunity to bring precision therapies to those with cancer and autoinflammatory diseases,” shared Ms. Kientop.

About Deka Biosciences

Deka Biosciences is a biotech company focused on the development of novel cytokine therapies to treat cancer and inflammatory diseases such as Crohn’s, psoriasis, rheumatoid arthritis and sepsis. The company is led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization and testing. Deka has developed disease specific Diakines™ that maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function via targeted delivery of dual and complimentary cytokines to affected tissues or cells. Using precision medicine, Deka will maximize the impact of its Diakines™ by building targeted therapies for every patient. To learn more, visit www.dekabiosciences.com.

SOURCE Deka Biosciences

Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced completion of subject enrollment in the Company’s ongoing STS101 SUMMIT pivotal Phase 3 efficacy trial, with more than 1,400 subjects randomized. Satsuma expects to announce topline results from the SUMMIT trial in the fourth quarter of 2022.  

“We are pleased to report completion of subject enrollment in the STS101 SUMMIT Phase 3 efficacy trial, the largest-ever randomized and controlled trial of a DHE product,” stated John Kollins, Satsuma’s President and Chief Executive Officer. “This marks an important milestone in our STS101 development program. We look forward to reporting SUMMIT trial topline results in the fourth quarter of 2022, and, in the interim, to reporting further STS101 development program progress and clinical data, including topline results from our ongoing STS101 ASCEND Phase 3, open-label, long-term safety trial.”

STS101 SUMMIT Pivotal Phase 3 Efficacy Trial
The STS101 SUMMIT pivotal Phase 3 efficacy trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in more than 1,400 subjects with migraine that is being conducted in the United States. The trial is designed in accordance with recommendations contained in the U.S. Food and Drug Administration’s (FDA) current guidance document for industry (Migraine Developing Drugs for Acute Treatment, February 2018) and the International Headache Society’s (IHS) published guidelines for controlled trials of acute treatment of migraine attacks in adults.¹   The SUMMIT trial, the largest-ever randomized and controlled trial of a DHE product, provides a basis for STS101 to become the first and only DHE product to demonstrate efficacy in a randomized and controlled trial on co-primary endpoints (freedom from pain and freedom from most bothersome symptom at two hours post-treatment) currently recommended by the FDA and IHS.   Based on Satsuma’s communications with the FDA, including a Type B, clinical pre-NDA videoconference meeting held in May 2022, the Company believes the SUMMIT trial, if successful, will support inclusion of differentiating efficacy claims in the STS101 prescribing information, presuming STS101 is approved for marketing.

After establishing full eligibility, SUMMIT trial participants are randomized (1:1) to receive either STS101 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. Following randomization, participants have 56 days in which to treat the qualifying migraine attack.

The co-primary endpoints of the SUMMIT trial, to be assessed at two hours after STS101 administration, are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea). The trial is designed for greater than 99% statistical power for the freedom from pain endpoint and greater than 95% statistical power for the freedom from most bothersome symptom endpoint. In addition, the SUMMIT trial incorporates a number of secondary endpoints and prospective evaluations of the clinical performance of STS101 that could differentiate the clinical profile of STS101.

Satsuma expects to report topline results from the SUMMIT trial in the fourth quarter of 2022.

For further information regarding the STS101 SUMMIT Phase 3 efficacy trial, see www.ClinicalTrials.gov, identifier NCT04940390: A Randomized, Double-Blind, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT).

About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary nasal delivery device.  STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained DHE plasma levels over time with low dose-to-dose variability. STS101 also now incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring an easy-to-carry and easy-to-use dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND and SUMMIT trials, the timing of data readouts for ongoing clinical trials, the anticipated timing for a potential STS101 NDA submission, the potential for STS101 to be an important and differentiated acute treatment option, and the expected cash runway of the Company. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; and the risk that the COVID-19 worldwide pandemic may negatively impact the Company’s business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:         

Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

¹ Diener et al., Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth Edition, Cephalalgia, 2019

X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel CXCR4 targeted small molecule therapeutics to benefit people with rare immune system disorders, today announced that it has agreed to sell an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 50,925,365 shares of common stock, to certain institutional accredited investors in a private investment in public equity (PIPE) financing. X4 anticipates that gross proceeds from the PIPE will be approximately $55 million, before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The closing of the financing is expected to occur on or about July 6, 2022, subject to customary closing conditions.

In addition, on June 30, 2022, contemporaneous with the execution of the PIPE, X4 entered into an amendment to its loan and security agreement with Hercules Capital Inc. to extend the interest-only period of its loan facility by up to twelve months (into 2024), subject to achieving certain financial and business milestones. This amendment results in a potential reduction of X4’s cash burn by $20 million over the interest-only period.

Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE, X4 will issue an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 50,925,365 shares of common stock. The purchase price per share and accompanying warrant is $1.095 (or $1.094 per pre-funded warrant and accompanying warrant). The warrants will have a per share exercise price of $1.095 and may be exercised at any time on or after the closing date and through the fifth anniversary of the closing date. The price per share and accompanying warrant was based in part upon the last reported sale price of the common stock on the Nasdaq Capital Market. If exercised for cash, the warrants would result in additional gross proceeds to X4 of up to approximately $55 million.

X4 expects to use these funds for continued clinical development and commercial readiness of its lead candidate, mavorixafor, and for business development activities, working capital, and general corporate purposes.

The PIPE financing included participation from new investors including co-lead investor New Enterprise Associates (NEA), Acorn Bioventures and Lumira Ventures, as well as existing investors including co-lead investor Bain Capital Life Sciences, OrbiMed, AXA Investment Managers and Hercules Capital, Inc (NYSE: HTGC). Stifel served as sole placement agent for the financing. B. Riley Securities and H.C. Wainwright & Co. acted as financial advisors to X4 in the financing.

The securities sold in this financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. X4 has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of its common stock underlying the pre-funded warrants and accompanying warrants sold in this financing. In connection with the PIPE, the Company has agreed to convene a special meeting of its stockholders no later than 90 days following the closing to seek approval of an increase in the number of its authorized shares of common stock.

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

About X4 Pharmaceuticals, Inc.
X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company leading the discovery and development of novel therapies for people with rare diseases of the immune system. The company’s lead candidate is mavorixafor, a first-in-class, small molecule antagonist of chemokine receptor CXCR4 that is being developed as a once-daily oral therapy. Due to mavorixafor’s ability to antagonize CXCR4 and improve the healthy maturation and trafficking of white blood cells, X4 believes that mavorixafor has the potential to provide therapeutic benefit across a wide variety of diseases, including primary immunodeficiencies (PIDs) and certain types of cancer. Mavorixafor has already demonstrated clinical potential in a Phase 2 trial in people with WHIM syndrome, a rare PID. Its efficacy and safety continue to be evaluated in a global Phase 3 clinical trial in WHIM (fully enrolled) and in two Phase 1b clinical trials – one, as monotherapy in people with chronic neutropenia, including Severe Congenital Neutropenia (SCN), and another in combination with ibrutinib in people with Waldenström’s macroglobulinemia (also fully enrolled). X4 is continuing to leverage its insights into CXCR4 biology at its corporate headquarters in Boston, Massachusetts and at its research facility in Vienna, Austria, to discover and develop additional product candidates.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4’s expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, statements regarding the timing, use of proceeds and closing of the PIPE. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, as a result of market and other conditions; the risk that the conditions to the closing of the proposed PIPE are not satisfied; the risk that the Company fails to timely obtain stockholder approval to increase its authorized share capital, if at all; as well as other risks and uncertainties described in the section entitled “Risk Factors” in X4’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2022, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

Contacts:

Daniel Ferry (investors)
Managing Director, LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

Mónica Rouco Molina, Ph.D. (media)
Account Supervisor, LifeSci Communications
mroucomolina@lifescicomms.com

• New Name Emphasizes Relentless Pursuit of an Expanded and Rare Disease Portfolio
• Oncology Programs added to existing Long QT Syndrome Program (“LQTS”)
• Additional US$15M Financing Provides Fuel for Proof-of-Concept in LQTS

LAVAL, Québec, Canada | 11 July 2022 | Thryv Therapeutics Inc. is excited to announce the evolution of its portfolio to include treatments for resistant and rare cancers. The new name, Thryv Therapeutics Inc., embodies our commitment to relentlessly pursue therapies which provide lifelong benefits to patients, families, doctors, nurses and stakeholders. Recent discoveries implicating Serum Glucocorticoid Kinase 1 (“SGK1”) provided a strong rationale for additional funding, acceleration of a portfolio of compounds to target these new opportunities of high unmet medical need, and a new corporate name – Thryv Therapeutics Inc.

“We are grateful to our investors who recognize the significant potential of our SGK1 platform to treat resistant and rare cancers in addition to the on-going development of our compounds for Long QT Syndrome,” said Debra Odink, PhD, Chief Development Officer. “Recent internal research combined with our collaborators results confirms what various researchers have demonstrated. SGK1 is a novel, yet unexplored target that may provide an opportunity to address treatment resistance in oncology.”

In various genetic and acquired disease states, SGK1 may be mutated and overexpressed leading to the development of serious resistance to existing therapies. The development of SGK1 inhibitors represents a novel approach to target treatment-resistant cancers, and complement existing therapies.

Ongoing external collaborations with leading academic institutions are evaluating Thryv Therapeutics’ internally developed SGK1 inhibitors as potential treatments for patients with treatment-resistant breast, prostate and anaplastic thyroid cancer. This strategic evolution triggered a significant new investment from investors allowing for the completion of a proof-of-concept study in patients with Long QT Syndrome, acceleration of several in vivo proof of concept studies in cancer and Long QT, and submission of an IND for the treatment of resistant cancers.

About Thryv Therapeutics

Thryv Therapeutics Inc., previously called LQT Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. They have been pioneering a precision medicine approach to treat Long QT Syndrome via SGK1 inhibition since 2019 and have since evolved their portfolio to include the treatment of resistant and rare cancers. The development of SGK1 inhibitors represents a novel approach to target treatment-resistant cancers, and complement existing therapies. This strategic evolution has secured an additional US$15M financing fueling Thryv to complete a proof-of-concept study for LQTS, and submit an IND for the treatment of resistant cancer.

Media Inquiries:

Daphne Doucet | admin@thryvtrx.com | +1 (514) 973-0915

• Positive Phase 1 results reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) revealed XC001 is well tolerated at all dose levels
• Phase I data support XC001 therapeutic effect and potential dose response
• Topline Phase 2 data readout expected in February 2023 with interim results in the second half of this year

XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced it has achieved enrollment of target number of subjects in the Phase 2 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina. Topline results from the Phase 2 study are expected in February 2023 with interim results in the second half of this year.

“Achievement of this important milestone in the Phase 2 portion of the study is a testament to the clinical need in this patient population and I am eager to see the Phase 2 results as they emerge,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “Patients with refractory angina have no treatment options, and the results from the Phase 1 portion of the EXACT trial suggest a dose response and therapeutic potential which is encouraging for the development of XC001 as a treatment to improve these patients’ quality of life. We are very excited to see this more definitive evaluation of the safety and efficacy of this approach.”

“We are pleased to announce this important milestone in enrollment for our Phase 2 study especially during this unprecedented and challenging time,” said Al Gianchetti, President and CEO of XyloCor. “An estimated one million people suffer from refractory angina in the United States, and we are encouraged that XC001 may address the high unmet need in this patient group. XyloCor also plans to study XC001 in other patient groups as well, including as adjunctive therapy in patients undergoing bypass surgery.”

Individuals with refractory angina experience pressure or intense pain in the chest due to insufficient blood flow to the heart muscle. These symptoms can severely impact quality of life and may worsen comorbidities.

XyloCor’s lead investigational drug, XC001 (encoberminogene rezmadenovec) is a locally administered, single-dose gene therapy currently in development as a novel approach to treating patients with refractory angina who have no other medical and surgical options. The treatment strategy is to use local administration to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects. XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open-label, single-arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial with target enrollment of 27 additional subjects at the highest tolerated dose (1 x 10¹¹ vps, the highest tested dose). The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by an experienced cardiac surgeon at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain.

About XyloCor

XyloCor Therapeutics is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Contacts

Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s fourth fiscal quarter and fiscal year ended March 31, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise.

Financial Highlights

• Delivered total revenue of $20.3 million in fiscal Q4 2022, an increase of 15% compared to fiscal Q4 2021 and, as expected, a decrease of 5% compared to fiscal Q3 2022 partly due to a large order in late fiscal Q3 2022 originally anticipated in fiscal Q4 2022.
• Generated total revenue of $76.7 million in fiscal year 2022, a decrease of 4% compared to fiscal year 2021.
• Achieved adjusted EBITDA* of $1.1 million in fiscal Q4 2022 compared to $(1.6) million in fiscal Q4 2021 and $1.9 million in fiscal Q3 2022.
• Generated adjusted EBITDA* of $(3.9) million in fiscal year 2022 compared to $8.2 million in fiscal year 2021.
• Produced net loss of $5.3 million in fiscal Q4 2022 and $2.9 million in fiscal year 2022 compared to $10.5 million in fiscal Q4 2021 and $28.3 million in fiscal year 2021.
• Generated adjusted net loss* of $4.6 million in fiscal Q4 2022 and $24.0 million in fiscal year 2022 compared to $5.2 million in fiscal Q4 2021 and $7.6 million in fiscal year 2021.
• Cash and cash equivalents of $10.0 million (with $11.2 million of total available liquidity) at end of fiscal Q4 2022.

*  Refer to “Non-GAAP Measures” at the end of this press release for information about adjusted EBITDA and adjusted net income (loss).

Ken d’Entremont, Chief Executive Officer of Medexus, commented, “We are very pleased with the strength and stability we have seen in our base business. We continue to see strong performance in Rasuvo, and Rupall has continued to gain market share and benefit from another strong Canadian allergy season. IXINITY sales have normalized and, with the manufacturing improvements Medexus and our contract manufacturer are undertaking, we expect to realize operational efficiencies going forward that will positively impact our margins down the road.”

Mr d’Entremont continued, “Looking forward at our growth products, the transition for Gleolan in the U.S. is going better than expected and we will begin recognizing product revenue partway through fiscal Q2 and fully in fiscal Q3. We previously estimated that Gleolan had generated US$3 million to US$4 million in revenue in the last full quarter before we licensed the product, and we hope to continue that strong performance following our U.S. relaunch of this product over the coming months. Turning to treosulfan, our partner medac’s collection of data recently requested by the FDA is progressing well, and we are confident we will see an NDA resubmission in July. The review clock for the NDA resubmission, which will run for up to six months, will start after the response is considered complete by the FDA. An FDA approval would then allow a commercial launch of treosulfan in the U.S. in the first half of calendar year 2023.”

Operational Highlights

Operational highlights for the three-month period ended March 31, 2022 and subsequent period include:

• Treosulfan: medac, a strategic partner of Medexus, continues to collect data requested by the FDA in May 2022 to complete the resubmission of medac’s New Drug Application (NDA) for treosulfan. The data collection process is progressing well, and medac continues to expect to respond to the FDA’s information requests in July 2022.
• Gleolan: In March 2022, Medexus acquired the exclusive right to commercialize Gleolan in the United States. Medexus expects to complete the transition of full responsibility for commercializing Gleolan in the United States, and begin recognizing product revenue, in fiscal Q2 2023.
• IXINITY: Unit demand for IXINITY continues to grow, and net sales of IXINITY increased in fiscal Q4 2022 as pharmacy and wholesale customers have now worked through much of their accrued inventory and return to buying patterns better aligned with patient unit demand. Medexus continues to invest in an ongoing initiative to improve the IXINITY manufacturing process. Medexus expects the resulting operational efficiencies to ultimately improve IXINITY gross margins over the coming quarters.
• Rupall: Increasingly severe allergy seasons across Canada and successful sustained execution of sales and marketing initiatives yielded continued strong growth in Rupall sales in fiscal year 2022. This performance continues to position Rupall as one of the fastest-growing antihistamines in the Canadian prescription market. (Source: IQVIA CDH units – Drugstores and hospitals purchases, MAT March 2022.)

Operating and Financial Results Summary for Fiscal Q4 2022

Total revenue reached $20.3 million for fiscal Q4 2022, compared to revenue of $17.6 million for fiscal Q4 2021. The $2.6 million increase is primarily attributable to an increase in net sales of IXINITY during the quarter, and also the continued strong performance of Rasuvo, which is efficiently supported by a moderate allocation of sales personnel, and Rupall.

Operating loss for fiscal Q4 2022 was $2.5 million, compared to an operating loss of $4.6 million for fiscal Q4 2021.

Adjusted EBITDA was $1.1 million for fiscal Q4 2022, compared to $(1.6) million for fiscal Q4 2021. The $2.7 million increase is primarily attributable to the increase in net sales of IXINITY in fiscal Q4 2022 and a $0.9 million expense related to a one-time destruction of IXINITY inventory in fiscal Q4 2021.

Net loss was $5.3 million for fiscal Q4 2022, compared to $10.5 million for fiscal Q4 2021.

Operating and Financial Results Summary for Fiscal Year 2022

Total revenue reached $76.7 million for fiscal year 2022, a decrease of $3.0 million, or 3.8%, compared to fiscal year 2021. The decrease year over year was primarily attributable to a drop in net sales of IXINITY which was partially offset by strong Rupall sales. Unit demand for IXINITY continues to grow, but net sales were lower in fiscal year 2022 as pharmacy and wholesale customers continued to work through inventory on hand for much of the year.

Operating loss for fiscal year 2022 was $15.0 million compared to $1.4 million for fiscal year 2021.

Adjusted EBITDA was $(3.9) million for fiscal year 2022, compared to $8.2 million for fiscal year 2021. The decrease was primarily attributed to significant investments in personnel and infrastructure to support Medexus’s anticipated future growth, the reduction in IXINITY net sales discussed above, and a $1.9 million increase in cost of goods sold related to previously disclosed failed batches during the IXINITY manufacturing process earlier in the fiscal year.

Net loss was $2.9 million for fiscal year 2022, compared to $28.3 million for fiscal year 2021.

Additional Information

Medexus’s financial statements and management’s discussion and analysis for the fiscal year ended March 31, 2022 are available on Medexus’s corporate website at www.medexus.com and in the company’s corporate filings on SEDAR at www.sedar.com.

Conference Call Details

Medexus will host a conference call at 8:00 AM Eastern Time on Thursday, June 23, 2022, to discuss the company’s operating and financial results and corporate updates for fiscal Q4 2022 and fiscal year 2022.

A replay of the call will be available approximately one hour following the end of the call through Thursday, June 30, 2022. To access the replay, please dial the following numbers:

877-481-4010 for Canadian and U.S. callers
+1 919-882-2331 for international callers

Conference ID: 45811

A replay of the webcast will be available on the Investors—News & Events—IR Calendar section of Medexus’s corporate website until Friday, June 23, 2023.

About Medexus

Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products. Our current focus is on the therapeutic areas of hematology, auto-immune diseases, and allergy. We continue to build a highly differentiated company with a growing portfolio of innovative and high-value orphan and rare disease products that will underpin our growth for the next decade.

Our current leading products are Rasuvo™ and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY®, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B (a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding); and Rupall®, an innovative prescription allergy medication with a unique mode of action. We also hold exclusive US and Canadian rights to commercialize Gleolan™ (aminolevulinic acid hydrochloride or ALA HCl), an FDA-approved, orphan drug designated optical imaging agent currently indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

We have also licensed treosulfan, part of a preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, for commercialization in the United States and Canada. Treosulfan was approved by Health Canada in June 2021 and is marketed in Canada as Trecondyv®. Treosulfan is currently the subject of a regulatory review process with the U.S. Food and Drug Administration.

Our mission is to provide the best healthcare products to healthcare professionals and patients. We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration.

Contacts

For more information, please contact any of the following:

Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words “anticipates”, “believes”, “expects”, “will”, “plans”, “potential”, and similar words or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements regarding Medexus’s business strategy or outlook and future growth plans, expectations regarding future financial or operating performance (including with respect to the expected benefits of improvements made to the IXINITY manufacturing process and expected results from sales of Gleolan in the United States), ability to obtain FDA and other regulatory approvals for treosulfan and other product candidates, the timing of treosulfan launch in the United States, and competitive position of and anticipated trends and challenges in the company’s business and the markets in which it operates, among others. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in Medexus’s materials filed with the Canadian securities regulatory authorities from time to time, including Medexus’s most recent annual information form and management’s discussion and analysis; future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; Medexus’s ability to implement its business plan; Medexus’s ability to leverage its U.S. and Canadian infrastructure to promote additional growth; regulatory approval by relevant health authorities, including the FDA; product reimbursement by third party payers; litigation or expiry with respect to patents or other intellectual property rights; litigation risk; stock price volatility; government regulation; and potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which are made only as of the date hereof. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Trademarks and trade names

This press release contains references to trademarks and service marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and trade names referred to in this document may appear without the “®” or “™” symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders of the relevant intellectual property rights will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names.

Non-GAAP measures

Company management uses, and this press release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include “non-GAAP financial measures” and “non-GAAP ratios” (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus’s method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies.

In particular, management uses Adjusted Net Income (Loss) and Adjusted EBITDA as measures of Medexus’s performance. Adjusted Net Income (Loss), EBITDA (earnings before interest, taxes, depreciation, and amortization) and Adjusted EBITDA are non-GAAP financial measures. In addition, Adjusted Net Income (Loss) may be presented on a per share basis.

An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading “Preliminary Notes—Non-GAAP measures” in Medexus’s most recent management’s discussion and analysis. A reconciliation of each of these non-GAAP measures to the most directly comparable IFRS measure can be found under the heading “Reconciliation of Adjusted Net Income (Loss) and Adjusted EBITDA to Net Income (Loss)” below.

Reconciliation of Adjusted Net Income (Loss) and Adjusted EBITDA to Net Income (Loss) The following tables are derived from and should be read together with Medexus’s consolidated statement of operations for the three- and 12-month periods ended March 31, 2022. This supplementary disclosure is intended to more fully explain disclosures related to Adjusted Net Income (Loss) and Adjusted EBITDA and provides additional information related to Medexus’s operating performance. However, Medexus’s non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus’s financial information as reported under IFRS.

Existing investor syndicate supports atrial shunting as effective therapy for heart failure patients

TEWKSBURY, Mass., June 9, 2022 /PRNewswire/ — Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure (HF), today announced the closing of a $54 million equity financing from its existing investor syndicate. Funds will be utilized to support a confirmatory trial that builds on the extensive data and progressive learnings from the REDUCE LAP-HF II clinical trial of the Corvia® Atrial Shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

“We are grateful to have the ongoing support of our investors as we continue the work to expand access to this novel therapy,” said George Fazio, CEO of Corvia Medical, “Corvia is dedicated to bringing atrial shunt therapy to the millions of heart failure patients who might benefit, and this funding allows us to continue advancing toward this important goal.”

REDUCE LAP-HF II is the largest randomized controlled trial of device-based therapy for HFpEF patients and, as recently published in Circulation,¹ is the only study of an implantable therapeutic device to show clinical benefit in this population. 626 patients were randomized at 89 centers across the US, Canada, Europe, Australia, and Japan. Results showed that within a large responder population, representing 50% of study patients, treatment with the Corvia Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater improvement in quality of life compared to sham control.

“We are committed to ongoing support for the only interventional therapy that has demonstrated significant clinical benefit for a large group of heart failure patients,” commented Paul LaViolette, Board Chairman for Corvia Medical. “Corvia’s institutional and strategic investors continue to believe in the benefits of atrial shunt therapy and feel strongly that that the Corvia Atrial Shunt has the potential to change the way heart failure patients are treated.”

More than 26 million people worldwide have HF,² and over half those have HFpEF,³ which has been described as the largest unmet clinical need in cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF patients. The shunt is placed via catheter between the left and right atria, forming a passage that allows blood to flow from the high pressure left atrium to the lower pressure right atrium, with the aim of reducing HF symptoms and events and improving quality of life.

About Corvia Medical, Inc.

Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. The Corvia Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019.  Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed strategic investor. Visit https://corviamedical.com/.

MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
https://corviamedical.com/newsroom/

1.     Borlaug BA et al. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022;10.1161.
2.     Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017;3(1):7-11.
3.     Owan TE et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259.

SOURCE Corvia Medical, Inc.

Data Presented at ASCO Demonstrate Trilaciclib Helps Protect Against Severe Neutropenia, Severe Anemia, and Severe Thrombocytopenia When Given to Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Patients Prior to Chemotherapy

• Patients Receiving Trilaciclib Experienced a Lower Incidence of Single-Lineage and Multilineage Chemotherapy-Induced Myelosuppressive Events Compared with Patients Receiving Placebo
• Total Number of Patients Experiencing a Myelosuppressive Event was Lower with Trilaciclib Compared to Placebo

G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, announced on June 02, 2022, results of a post-hoc study analysis showing that ES-SCLC patients who received trilaciclib prior to chemotherapy had a lower incidence of single- and multilineage myelosuppressive events—fewer cases of severe neutropenia, severe anemia, and severe thrombocytopenia—compared to patients receiving placebo. Moreover, the proportion of patients who experienced at least one multilineage myelosuppressive event was lower in the trilaciclib arm compared to the placebo arm. The data, derived from a post-hoc analysis of Phase 2 trials, were presented in a poster at the 2022 American Society of Clinical Oncology (ASCO) annual meeting.

“Myelosuppression is a major toxicity of chemotherapy treatment for patients with extensive-stage small cell lung cancer that often results in chemotherapy dose delays and dose reductions, both of which can compromise clinical outcomes,” said Jerome Goldschmidt, M.D., medical oncologist with Blue Ridge Cancer Care in Blacksburg, VA, and lead author of the poster. “Both the patients and the healthcare system at large bear the complications of myelosuppressive events such as neutropenia, anemia, and thrombocytopenia, so it is imperative that we achieve clinically meaningful reductions in myelosuppression in multiple cell lineages and its consequences utilizing novel therapies such as trilaciclib.”

In the analysis, the researchers calculated the number of patients who experienced single lineage and multilineage myelosuppressive events as well as the total number of events each person experienced in both first-line and second/third-line chemotherapy settings. Only severe grade events (grade ≥ 3 per the National Cancer Institute) were included in the analysis, and 75 percent of patients were in the first-line setting.

Results of the analysis showed that throughout cycles one through four of first-line therapy, fewer patients treated with trilaciclib experienced single-lineage (neutrophil, red blood cell or platelet lineages) and multilineage myelosuppressive events—and fewer events occurred per person—than patients who received placebo.

Specifically, analyses of the pooled data showed that patients receiving trilaciclib in the first-line setting experienced fewer single-lineage myelosuppressive events, including:

• a 75% reduction (56.7% to 14.4%) in severe neutropenia compared to patients receiving placebo
• a 50% reduction (17.8% to 8.9%) in severe anemia compared to patients receiving placebo
• a 100% reduction (12.2% to 0.0%) in severe thrombocytopenia compared to patients receiving placebo

Additionally, analyses of the pooled data showed that patients receiving trilaciclib in the first-line setting experienced fewer concurrent, multilineage myelosuppressive events, including:

• a 100% reduction (2.2% to 0.0%) in concurrent severe anemia, severe neutropenia, severe thrombocytopenia compared to patients receiving placebo.
• a 100% reduction (13.3% to 0.0%) in concurrent severe neutropenia and severe thrombocytopenia compared to patients receiving placebo
• a 50% reduction (4.4% to 2.2%) in concurrent severe neutropenia and severe anemia compared to patients receiving placebo
• a 33% reduction (3.3% to 2.2%) in concurrent severe anemia and severe thrombocytopenia compared to patients receiving placebo

Concurrent events were defined as having two or three lineage-specific myelosuppressive events overlap for at least one day.

The ASCO poster, titled, “Impact of Trilaciclib on Multilineage Chemotherapy-Induced Myelosuppression Events in Patients with Extensive-Stage Small-Cell Lung Cancer: Post-Hoc Analyses of Data from Randomized Clinical Trials,” can be found here.

About Small Cell Lung Cancer

In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC. A majority (>90%) of ES-SCLC patients receive first-line chemotherapy at the time of treatment initiation.

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating trilaciclib in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

G1 Therapeutics™ and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to the potential value of, and need for, myeloprotective interventions such as trilaciclib in the management of multilineage myelosuppression, are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete a successful commercial launch for COSELA (trilaciclib); the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates other than COSELA (trilaciclib); the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

G1 Therapeutics Contacts:

Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com

Rebecca Levine
Director, Corporate Communications and Public Relations
(919) 667-8711
rlevine@g1therapeutics.com

Company Continues to Build as It Prepares for FDA Submission and Clearance of Its Breakthrough Therapy

HistoSonics, the developer and manufacturer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the fulfillment of patient enrollment required for regulatory submission of their Edison™ system to the US Food and Drug Administration (FDA). The company plans to use safety and efficacy data from combined parallel company-sponsored trials in an upcoming FDA submission. The ongoing studies providing these data, #HOPE4LIVER US and #HOPE4LIVER Europe, are designed to evaluate the safety and efficacy of using image guided histotripsy to destroy primary and secondary tumors of the liver.

“We are incredibly excited to have achieved this pivotal enrollment milestone in the #HOPE4LIVER clinical trials,” stated Mike Blue, President and CEO of HistoSonics. “It’s a significant achievement for our entire organization and team, including many who have spent the last 20 years advancing the science of histotripsy, and most recently, the development of our novel new platform. Additionally, I want to thank all the trials’ clinical investigators, their teams, and the patients who have entrusted us in these trials as we aim to demonstrate that histotripsy can be safely and effectively used in the liver”, continued Mr. Blue. HistoSonics plans on filing a De Novo submission with the FDA for the destruction of liver tissue using histotripsy later this year in anticipation of achieving US marketing authorization in 2023.

HistoSonics’ image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with precision and control. The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology provides significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real time visualization and control, unlike any modality that exists today.

This significant company milestone builds upon strategic accomplishments achieved over the past year including receipt of Breakthrough Device Designation by the FDA, awarding of a unique Category III CPT® Code for histotripsy of the liver by the AMA, and a published payment rate by CMS for the inpatient and outpatient use of histotripsy in the liver.

In addition to the clinical trial milestone, and in preparation for long term growth, HistoSonics has recently expanded its advanced research and development facility in Ann Arbor and is completing final renovations of its 30,000 sq. ft. Minneapolis headquarters. The company is also in the process of adding key personnel across most of the organization and has initiated discussions with the FDA on the next applications of its histotripsy platform.   

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on the continued development of its Edison™ Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

MINNEAPOLIS, May 23, 2022 — HistoSonics Inc., developer of a completely non-invasive platform using the science of histotripsy, today announced an agreement formalizing ongoing efforts to use GE Healthcare’s LOGIQ E10 Series ultrasound imaging platform to power the real time visualization features of HistoSonics’ novel sonic beam therapy.  As part of the agreement and upon market authorization, HistoSonics will distribute GE Healthcare’s LOGIQ E10 Series on a one-to-one basis with its breakthrough liver therapy system.

HistoSonics’ Edison™ system, currently in development, uses the novel science of histotripsy to non-invasively destroy targeted liver tissue. HistoSonics intends to utilize GE Healthcare’s LOGIQ E10 Series, currently the most technologically advanced ultrasound platform for guiding radiology interventions, to provide treating physicians with continuous visualization for key and unique elements of the histotripsy therapy procedure, including planning, monitoring, and immediate post-treatment verification. This agreement is aimed to support HistoSonics’ efforts to launch their Edison^TM system leveraging their deep domain expertise along with GE Healthcare’s world-class ultrasound imaging technologies, digital infrastructure, data analytics and clinical decision support capabilities.

“We are very excited to formalize our imaging partnership with GE Healthcare, which is a key part of bringing our transformative therapy platform, and an entirely new treatment option, to the clinic and to patients,” said Josh Stopek, HistoSonics Vice President of R&D.  “We’ve developed a very collaborative relationship with GE Healthcare and look forward to expanding our efforts to realize the full potential of histotripsy across clinical applications, specialties, and care settings.”

HistoSonics’ non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments using histotripsy to mechanically destroy and liquify targeted tissues at a sub-cellular level.  The company believes the novel mechanism of action of their proprietary technology may offer significant advantages to patients, including precise and predictable treatment zones with equivalent treatment effect throughout the entire treated volume. Early clinical and pre-clinical results also suggest that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and bile ducts within or adjacent to the treated volume of tissue. Additionally, histotripsy enables the treating physicians to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

The agreement between GE Healthcare and HistoSonics comes as HistoSonics continues enrollment in their U.S. and European #HOPE4LIVER Trials, evaluating the safety and efficacy of histotripsy for the destruction of targeted primary or metastatic liver tumors.  Additionally, the company recently was awarded “Breakthrough Device Designation” by the FDA for histotripsy of liver tissue, validating the company’s vision that histotripsy has the potential to provide advantages over existing therapies such as surgery, radiation therapy and thermal ablation.

The HistoSonics System is investigational and is not available for sale in the United States or Europe. It is limited to investigational use in the approved IDE and European studies.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors.  The company is currently focused on the continued development of its Edison^TM Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

• Data from the Phase 1 dose-escalation portion of the Phase 1/2 EXACT study demonstrate XC001 was well-tolerated at all dose levels tested; highest dose level evaluated selected for ongoing Phase 2 portion of the study
• Preliminary efficacy data highlight XC001 potential for patients with refractory angina with no other treatment options
• Treatment strategy is to use local administration to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects
• Completion of Phase 2 enrollment is expected by the end of May 2022

Wayne, PA, May 18, 2022 — XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced presentation of initial clinical data from the Phase 1 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina at the American Association for Thoracic Surgery (AATS) Annual Meeting on May 15, 2022, and at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting on May 18, 2022.

XC001: Locally administered, single-dose gene therapy candidate to address the unmet need in refractory angina
XyloCor’s lead investigational drug, XC001 (encoberminogene rezmadenovec), is under development as a novel approach to treating patients with refractory angina who have exhausted other medical and surgical options. This investigational gene therapy is designed to activate naturally occurring biological pathways by creating new vessels to improve blood flow to areas of the heart not receiving adequate blood supply. This restored blood supply could potentially improve patients’ quality of life by enabling them to resume physical activities and it could reduce episodes of chest pain associated with refractory angina.

In the Phase 1 portion of the EXACT study, 12 subjects with Canadian Cardiovascular Society (CCS) angina class 2-4 without revascularization options were divided into four escalating dose groups with three subjects each. Each subject received 15 epicardial injections of XC001 at one of the four dosage levels. Safety, efficacy and tolerability evaluations were measured as adverse events (AEs), serious adverse events (SAEs) and change from baseline from three to six months post-treatment in exercise capacity, ischemic burden by positron emission tomography (PET) imaging, and patient-reported symptomatology.

No drug-related SAEs, bleeding complications or ventricular arrhythmias were observed in this Phase 1 dose-escalation study. Over a six-month follow up there were a total of 17 SAEs in seven subjects. Eleven SAEs were related to the underlying disease process or other causes. The other six SAEs which occurred in four subjects were judged to be related to the administration procedure, with none of those being unexpected nor resulting in patient death.

“The administration of XC001 appears to have been well-tolerated at all tested doses,” said Nahush Mokadam, M.D., presenting author at AATS, Division Director, Cardiac Surgery, The Ohio State University Wexner Medical Center and Associate Director of the Heart and Vascular Center and site Principal Investigator for this study. “Objective criteria, including results from exercise tolerance tests and PET scans, suggest therapeutic potential.”

Although the Phase 1 portion of the study was primarily focused on safety and Phase 2 dose selection, initial clinical efficacy data appeared promising. Notably, the data showed positive trends in total exercise duration and reductions in patient symptoms and ischemic burden. Although patient numbers are small, preliminary data suggest that response may be correlated to administered dose.

“The preliminary efficacy evaluation suggests a dose response which is encouraging for the development of XC001 as a therapeutic strategy,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “We anticipate that the Phase 2 expansion portion of this study, which is testing the highest and most efficacious dose from Phase I, will complete enrollment this month. We are incredibly excited by the potential for this investigational therapy to improve the quality of life for these cardiac patients.”

“In many other gene therapy trials, safety concerns arose due to systemic administration of high viral particle loads,” added Dr. Povsic. “In contrast, because we can inject XC001 directly into the heart, we can dramatically reduce overall viral particle loads and systemic exposure while increasing efficacy.”

EXACT Phase 1/2 Study Data Presentations at AATS and ASGCT
Lead author, Dr. Mokadam presented three-month data from the Phase 1 study in the presentation, Dose Escalation Study of Encoberminogene Rezmadenovec (Adenoviral Vector with Multiple Isoforms of Vascular Endothelial Growth Factor) in Refractory Angina: Phase 1 Results at the AATS Annual Meeting.

Dr. Povsic will present six-month data from the Phase 1 study in the presentation, Preliminary Safety, Tolerability and Efficacy of Direct Epicardial Administration of Encoberminogene Rezmadenovec to Ischemic Myocardium in Patients with Refractory Angina: Six Month Phase 1 Data at the ASGCT 25th Annual Meeting.

About the EXACT Study
The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open-label, single-arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, to be followed by an expansion phase of the trial with 27 additional subjects at the highest tolerated dose. The trial is designed to assess the preliminary safety and efficacy of XC001. The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by an experienced cardiac surgeon. The EXACT trial is being conducted at top cardiovascular research sites across the United
States.

About Chronic Refractory Angina
In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain. An estimated one million people suffer from refractory angina in the United States.

About XyloCor
XyloCor Therapeutics is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University.

For more information, visit www.xylocor.com.

Media Contact
Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502