PureTech Presents Research Highlighting Burden of Idiopathic Pulmonary Fibrosis (IPF) and Use of a Bayesian Statistical Analysis for LYT-100 (Deupirfenidone) at CHEST 2024 Annual Meeting




PureTech Presents Research Highlighting Burden of Idiopathic Pulmonary Fibrosis (IPF) and Use of a Bayesian Statistical Analysis for LYT-100 (Deupirfenidone) at CHEST 2024 Annual Meeting

IPF patient survey provides new insights into disease burden and patient experience one decade after the approval of the first antifibrotics for IPF

Clinical abstract reviews the ability of Bayesian analysis to maximize statistical power and reduce the number of patients on placebo in Phase 2b ELEVATE IPF trial of LYT-100

Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 expected by the end of 2024

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, presented two oral presentations and one poster supporting its clinical and patient engagement strategies related to LYT-100 (deupirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) at the CHEST 2024 Annual Meeting in Boston, Massachusetts.

“This month marks a decade since the first two antifibrotics for the treatment of IPF were approved, and since then, limited therapeutic advances have been made and people with IPF still face substantial challenges,” said Camilla Graham, MD, MPH, Vice President of Medical Affairs at PureTech Health. “At PureTech, we are investing in changing this paradigm and this research highlights ongoing gaps with symptom management and supportive care in IPF. We hope this research will help improve communications between people with IPF and their healthcare teams. It also informs our work to develop a new IPF treatment option, which we believe will address key limitations of the current standard-of-care medicines.”

PureTech presented qualitative and quantitative research that highlights both the burden of IPF as well as gaps in disease management that exacerbate the quality of life for people with IPF. The 90-person survey found that the majority of participants experience a high burden of disease that interferes with their normal activities, including shortness of breath (86%), fatigue (78%) and cough (77%). In addition to the burden of the disease itself, comorbidities, side effects of antifibrotic treatment and the use of supplemental oxygen interfere with patients’ quality of life, suggesting a need for improved interventions to manage symptoms.

Beyond this, PureTech’s research revealed commonalities and differences in the patient experience for those receiving care at interstitial lung disease (ILD) centers (n=45) versus community pulmonary practices (CPP) (n=45). When asked about their top resources for IPF information, nearly all people in both care settings listed their pulmonologist as their primary source, and the majority in each were very satisfied with their communications about their IPF diagnosis. Antifibrotic treatment rates at ILD centers and CPPs were similar, but differences existed in perceived communication around antifibrotic treatment options. 76% of people receiving care in ILD centers reported that their pulmonologist had discussed both FDA-approved antifibrotics with them, while this was only true of 56% of those receiving care at CPPs. Across a series of quality-of-life parameters, patients at CPPs indicated a higher impact and severity of their disease than patients at ILD centers, reflecting an important discrepancy that merits further investigation.

PureTech also presented a clinical abstract reviewing its plan to evaluate the primary outcome of the Phase 2b ELEVATE IPF clinical trial using a prespecified Bayesian approach. ELEVATE IPF is PureTech’s randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy, tolerability, safety and dosing regimen of LYT-100 in patients with IPF compared to placebo. The trial will also assess the relative efficacy of two doses of LYT-100. Participants have been randomized in a ratio of 1:1:1:1 to receive either 550 mg of LYT-100, 825 mg of LYT-100, pirfenidone or placebo three times a day (TID) for up to 26 weeks and have the option to enroll in an open-label extension. The primary endpoint is the rate of decline in Forced Vital Capacity (FVC) for the combined LYT-100 arms versus placebo over the 26-week treatment period using a Bayesian linear mixed effects model including dynamic borrowing. This approach augments the placebo arm sample size with external placebo data from historical IPF trials. A Bayesian approach has the advantage of enhancing overall statistical power and improving decision-making while limiting the number of patients required to be treated with placebo in a fatal disease. This approach has been used previously in Phase 2 trials of novel IPF therapeutics.

“Bayesian dynamic borrowing allows us to leverage historical trial data for the placebo arm to maximize the number of patients exposed to active treatment arms and minimize the number exposed to placebo,” said Carol Ann Satler, MD, PhD, Senior Director, Clinical Development at PureTech. “IPF is a rare, fatal disease, underscoring the importance of efficient clinical trial design. Bayesian analyses have previously been leveraged in IPF studies for this reason, especially given the substantial historical placebo dataset in IPF, and we look forward to sharing results from our Phase 2b trial by the end of this year.”

Topline results from the Phase 2b ELEVATE IPF trial are expected by the end of 2024. A streamlined development program for LYT-100 is planned using the same endpoints that have supported past IPF product approvals. Pending positive clinical outcomes and regulatory feedback, the program will advance into a Phase 3 clinical trial. PureTech believes the results of the Phase 2b trial, together with a successful Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.

About Idiopathic Pulmonary Fibrosis (IPF)

IPF is a rare, progressive and fatal lung disease with a median survival of 2-5 years.¹ Pirfenidone is one of only two drugs approved to treat IPF, and for those patients able to tolerate treatment, it has been shown to improve survival by approximately 2.5 years compared to supportive care alone.¹ However, tolerability issues with both of the standard-of-care drugs result in patients discontinuing treatment or reducing their dose. This contributes to nearly three out of every four people with IPF choosing to forego treatment with these otherwise efficacious medicines.²

About LYT-100 (Deupirfenidone)

LYT-100 (deupirfenidone) is being advanced for the treatment of conditions involving inflammation and fibrosis, including IPF. It is a deuterated form of pirfenidone that is designed to retain the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated PK profile. LYT-100 has also demonstrated favorable tolerability across multiple clinical studies in more than 400 individuals.

Pirfenidone is one of the two standard-of-care treatments approved for IPF, along with nintedanib, both of which are efficacious but associated with significant tolerability issues. These tolerability issues result in treatment discontinuations and/or dose reductions below the FDA-approved dose, thereby limiting the effectiveness of these otherwise efficacious medicines. With LYT-100, PureTech aims to deliver better outcomes for patients by enabling individuals to maintain comparable or higher pirfenidone-equivalent doses for longer. PureTech believes LYT-100 has the potential both to supplant the current standard-of-care treatments and to serve a larger market of patients who are unable to tolerate current therapies. Topline data for the global Phase 2 ELEVATE IPF trial are expected by the end of 2024.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the LYT-100 development program and development plans, its potential benefits to patients, the timing for results from the Phase 2b clinical trial of LYT-100, the advancement of the program into a Phase 3 trial, and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

_________________________

¹ Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary Fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. https://doi.org/10.18553/jmcp.2017.23.3-b.s17
² Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com

UK/EU Media
Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com

US Media
Justin Chen

+1-609-578-7230

jchen@tenbridgecommunications.com

Scholar Rock Announces Pricing of Upsized $300 Million Public Offering of Common Stock and Pre-Funded Warrants




Scholar Rock Announces Pricing of Upsized $300 Million Public Offering of Common Stock and Pre-Funded Warrants

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Scholar Rock Holding Corporation (Nasdaq: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced the pricing of an upsized underwritten public offering of 10,265,488 shares of its common stock at a public offering price of $28.25 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase 353,983 shares of common stock at a public offering price of $28.2499 per pre-funded warrant, which represents the per share public offering price for the shares of common stock less the $0.0001 per share exercise price for each pre-funded warrant. All of the shares and pre-funded warrants are being offered by Scholar Rock. The offering is expected to close on October 10, 2024, subject to the satisfaction of customary closing conditions. In addition, Scholar Rock has granted the underwriters a 30-day option to purchase up to an additional 1,592,920 shares of common stock at the public offering price, less the underwriting discounts and commissions.

The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Scholar Rock and assuming no exercise of the pre-funded warrants, are expected to be approximately $300 million. Scholar Rock intends to use the net proceeds from the offering to support commercialization of apitegromab, to advance its ongoing and future clinical programs, to further develop its technology platform to continue to advance its clinical and preclinical pipeline, and for working capital and other general corporate purposes.

J.P. Morgan Securities LLC, Jefferies and Piper Sandler & Co. are acting as joint book-running managers for the offering. BMO Capital Markets Corp., Wedbush Securities Inc. and Raymond James & Associates, Inc. are acting as co-managers for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on October 7, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on October 7, 2024, and are available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388, or by email at prospectus_department@jefferies.com; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924, or by email at prospectus@psc.com.

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

About Scholar Rock

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, Scholar Rock has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients.

Scholar Rock^® is a registered trademark of Scholar Rock, Inc.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated closing date of the offering and the expected use of proceeds from the offering. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in Scholar Rock’s stock price, changes in market conditions and satisfaction of customary closing conditions related to the public offering and those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the SEC. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Contacts

Scholar Rock:
Investors
Rushmie Nofsinger

Scholar Rock

rnofsinger@scholarrock.com
ir@scholarrock.com
857-259-5573

Media
Molly MacLeod

Scholar Rock

mmacleod@scholarrock.com
media@scholarrock.com
802-579-5995

Devonian Announces the Grant of Stock Options




Devonian Announces the Grant of Stock Options

QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, announces that its Board of Directors has approved the grant of options to purchase Shares (the “Options”) at an exercise price of $0.16 for a period of 10 years from the date of grant. An aggregate of 3,298,611 Options was granted to officers of the Corporation. These Options are exercisable on the grant date.

About Devonian

Devonian is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines.

Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies.

Devonian was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF).

For more information, visit www.groupedevonian.com

Forward Looking Statements

This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and dermo-cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and dermo-cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21^st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.

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

Contacts

Mr. Luc Grégoire

President and Chief Executive Officer

Devonian Health Group Inc.

Telephone: 1 (450) 979-2916

Courriel: investors@groupedevonian.com

Novanta Inc. Schedules Earnings Release and Conference Call for Tuesday, November 5, 2024




Novanta Inc. Schedules Earnings Release and Conference Call for Tuesday, November 5, 2024

BEDFORD, Mass.–(BUSINESS WIRE)–Novanta Inc. (Nasdaq: NOVT) (the “Company”), a trusted technology partner to medical and advanced technology equipment manufacturers, will release its third quarter 2024 results on Tuesday, November 5, 2024.

The Company will host a conference call on Tuesday, November 5, 2024, at 10:00 a.m. ET to discuss these results. To access the call, please dial (888) 346-3959 before the scheduled conference call time. Alternatively, the conference call can be accessed online via a live webcast on the Events & Presentations page of the Investors section of the Company’s website at www.novanta.com.

A replay of the audio webcast will be available approximately three hours after the conclusion of the call on the Events & Presentations page of the Investors section of the Company’s website at www.novanta.com. The replay will remain available until Monday, December 30, 2024.

About Novanta

Novanta is a leading global supplier of core technology solutions that give medical and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary technology expertise and competencies in precision medicine and manufacturing, medical solutions, and robotics and automation with a proven ability to solve complex technical challenges. This enables Novanta to engineer core components and sub-systems that deliver extreme precision and performance, tailored to our customers’ demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation and customer success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol “NOVT.”

More information about Novanta is available on the Company’s website at www.novanta.com. For additional information, please contact Novanta Inc. Investor Relations at (781) 266-5137 or InvestorRelations@novanta.com.

Contacts

Novanta Inc.
Investor Relations Contact:

Ray Nash

(781) 266-5137

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024




Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases.

“Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.”

“As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.”

Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below:

* =multiple Pfizer co-authors

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information for ABRYSVO^® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com/ and https://abrysvomaternal.pfizerpro.com/.

Please see full Prescribing Information for COMIRNATY^® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com.

Please see full Prescribing Information for CRESEMBA^® (Isavuconazonium Sulfate) or visit www.cresemba.com.

Please see full Prescribing Information for PAXLOVID^TM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com.

Please see full Prescribing Information for PREVNAR 20^TM (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com/.

Please see full Prescribing Information for PREVNAR 13^® (Pneumococcal 13-valent Conjugate Vaccine).

Please see full Prescribing Information for ZAFICEFTA^® (Ceftazidime-Avibactam).

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Contacts

Media Contact:

PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor Contact:

IR@Pfizer.com
+1 (212) 733-4848

Virometix appoints Christina Ackermann as Chair and Tim Ramdeen as member of the Board




Virometix appoints Christina Ackermann as Chair and Tim Ramdeen as member of the Board

SCHLIEREN, Switzerland–(BUSINESS WIRE)–Virometix AG, a privately held Swiss biotechnology company developing a new generation of fully synthetic vaccines to generate targeted and protective immune responses against infectious diseases and cancer today announces the appointment of Christina Ackermann as Chairwoman and Tim Ramdeen as a new member of its Board of Directors. Ms. Ackermann brings over 27 years of legal and management experience within the healthcare industries. Mr. Ramdeen has nearly a decade of experience in private equity, hedge fund investing, and capital markets.

Christina Ackermann and Tim Ramdeen have led clinical and commercial companies through product development, growth, and commercialization while raising significant capital. Christina Ackermann succeeds Harry Welten, who resigns after six years on the Board of Directors.

“Christina and Tim are exceptional leaders. Their broad expertise across commercial and legal affairs as well as their network among investors will be key as we prepare for the next development steps of our serotype-independent vaccine candidates,” said Anna Sumeray, CEO of Virometix. “We look forward to working with Christina and Tim and we will greatly benefit from their business acumen and broad networks as we advance our pipeline towards the next key milestones. I would like to thank Harry for his dedication and guidance as Chair over the last five years.”

Christina Ackermann brings over 27 years of legal and management experience across the pharmaceutical, device, and consumer products industries. Ms. Ackermann was instrumental in establishing various global legal functions, strategic initiatives, and transactions at Bausch + Lomb, Novartis, Bristol-Myers Squibb, and DuPont. She currently serves as a non-executive member of the boards of Verona Pharma plc (NASDAQ: VRNA), Oculis Holding AG (NASDAQ: OCS), and private boards/NGOs. Ms. Ackermann holds a Post Graduate Diploma in EC Competition Law from King’s College at the University of London, UK, and an LLB from Queen’s University, Kingston, Canada.

Tim Ramdeen has nearly a decade of experience in private equity, hedge fund investing, capital markets, and company formation. Since 2022, Mr. Ramdeen has been the founder and managing partner of Dharma Capital Advisors. Mr. Ramdeen currently serves as a non-executive member of the boards of Onconetix Inc. (NASDAQ: ONCO) and Entero Therapeutics Inc. (NASDAQ: ENTO). He received his B.S. in Biology from Temple University. Additionally, Mr. Ramdeen earned his MBA in Finance from the NYU Stern School of Business.

About Virometix

Virometix AG is a privately held Swiss biotechnology company developing a new generation of fully synthetic vaccines to generate targeted and protective immune responses against infectious diseases and cancer. There is a considerable medical need for vaccines to combat infectious as well as a number of chronic human diseases, including cancer. Rational molecular design, chemical synthesis and Virometix’ proprietary “Synthetic Virus-Like Particle” platform technology allow for the rapid production and optimization of vaccine candidates with the potential to demonstrate superior properties in terms of safety, efficacy, ease and cost of manufacturing and stability.

Contacts

Mana Rezvani

Strategy & Communication

Email: press@virometix.com

Kyowa Kirin Announces Positive Interim Real-world Data for Mogamulizumab (Poteligeo®) in Cutaneous T-cell Lymphoma at EORTC-CLTG 2024




Kyowa Kirin Announces Positive Interim Real-world Data for Mogamulizumab (Poteligeo®) in Cutaneous T-cell Lymphoma at EORTC-CLTG 2024

Interim real-world data reinforces effectiveness and tolerability of mogamulizumab for mycosis fungoides (MF) or Sézary Syndrome (SS) in routine clinical practice

GALASHIELS & MARLOW, England–(BUSINESS WIRE)–Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), today announced it will present interim findings from three real-world studies in cutaneous T-cell lymphoma (CTCL) at the annual meeting of the European Organisation for Research and Treatment of Cancer’s Cutaneous Lymphoma Tumour Group (EORTC-CLTG), taking place from 9th–11th of October 2024 in Lausanne, Switzerland.

The three studies include participants from Europe, the United States (US) and the United Arab Emirates (UAE), and aim to collect evidence in the real-world clinical setting for mogamulizumab. Mogamulizumab is a first-in-class humanised monoclonal antibody (mAb) therapy approved in Europe and the United Arab Emirates for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.¹ In the United States and Switzerland, mogamulizumab is approved for the treatment of adult patients with relapsed or refractory MF or SS who have received at least one prior systemic therapy.^2,3

“For most patients, treatment of CTCL aims to prolong time to disease progression, reduce the burden of disease and preserve or enhance quality of life,” said Professor Emmanuella Guenova, chief physician of dermatology and venereology at Lausanne University Hospital and chair of the EORTC-CLTG 2024 Annual Meeting. “The real-world evidence being established by Kyowa Kirin is invaluable information for physicians to understand response to treatment in the real world as they determine the best path forwards for their patients.”

This will be the second interim analyses from these studies:

• MINT (Germany) and MIBERIC (Spain and Portugal) – study the effectiveness and tolerability of mogamulizumab in real-world clinical practices and are broadly in line with efficacy and safety data demonstrated in global clinical trials. Across both studies, no new safety signals were seen.
• PROSPER (US, UAE, Spain, Italy, Netherlands, UK) – an ongoing study investigating the impact of mogamulizumab in patients with MF and SS from the patient perspective, assessing symptoms and health-related quality of life, as well as impact on their primary care partners, also in the real-world clinical setting. Patients receiving mogamulizumab experienced improvements in skin symptoms (pain, itch, flaking and redness), sleep problems and body temperature within four weeks and improvements in patient-reported fatigue and health-related quality of life within 24 weeks.

“The studies being presented at EORTC-CLTG build on our presentations at last year’s annual meeting and reinforce our commitment to providing the community with a wide breadth of real-world data to inform clinical decision-making and hopefully improve patient outcomes,” said Dr Nicholas Kronfeld, Senior Vice President, Head of Medical Affairs, Kyowa Kirin International. “Our ongoing research programme in CTCL reinforces mogamulizumab’s clinical utility across a diverse range of patient profiles and healthcare systems.”

Kyowa Kirin is committed to sharing scientific knowledge at EORTC-CTLG 2024, with three accepted abstracts to be presented.

Table 1. Overview of Kyowa Kirin presentations at EORTC-CTLG 2024 Annual Meeting

About Poteligeo^® (mogamulizumab)

Mogamulizumab is a first-in-class humanised monoclonal antibody directed against CC-chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS.^4-6 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.⁷

About MF and SS

MF and SS are two subtypes of CTCL,⁸ which is itself a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin.^9,10 CTCL is treatable, but is not generally considered to be curable, and there has been a clear unmet need for novel treatment options. As well as the obvious impact of symptoms upon patients, there can be significant erosions to quality of life for those caring for an individual living with CTCL.¹¹

MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.^12,13 These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin.^4-6 When these cancerous T cells move to the skin, this results in the visible early skin symptoms of red patches or plaques which can resemble psoriasis or eczema in the early stages of the disease.^4,12,14-17 Later, for some patients, skin involvement may evolve to include tumours or reddening of the majority of the skin’s surface (erythroderma).

MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs and is typically indolent,¹⁰ characterised by skin symptoms including patches or plaques, skin redness and tumours.¹⁸ SS is much rarer, accounting for around 5% of CTCLs,¹⁹ and is more aggressive,¹² with high levels of blood involvement.²⁰ It can cause severe itching, erythroderma, intense scaling of the skin and frequent hair loss.^14,21 CTCL can take on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.²²

About Kyowa Kirin

Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions—Japan, Asia Pacific, North America, and EMEA/International.

You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

Contacts

Contacts for Kyowa Kirin Co., Ltd.
Media
Stacey Minton

Email: Stacey.Minton@kyowakirin.com

Incyte Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Incyte Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that it granted restricted stock unit awards (RSUs) representing an aggregate of 22,107 shares of the Company’s common stock to 26 new employees. The awards were made under the Company’s 2024 Inducement Stock Incentive Plan, with a grant date and vesting commencement date of October 1, 2024, and were approved by the compensation committee of the Company’s board of directors as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

Each RSU vests as to 25% of the shares subject to the RSU on each of the first four anniversaries of the vesting commencement date, subject to the employee’s continued service with the Company on each such date.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

Pharmanovia Acquires Exclusive Rights to Treatment for Parkinson’s Disease




Pharmanovia Acquires Exclusive Rights to Treatment for Parkinson’s Disease

– The Agreement Covers Australia and New Zealand

– Pharmanovia Will Take Over Rights From CSL Seqirus and Will Be Responsible for All Commercial and Regulatory Activities

– Deal Strengthens Foothold in Australia and New Zealand and Further Expands Our CNS Portfolio Offering

BASILDON, U.K.–(BUSINESS WIRE)–Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its neurology portfolio with a new licensing agreement for XADAGO® (safinamide), an add-on treatment for adult patients with idiopathic Parkinson’s disease licensed by Zambon, an Italian multinational pharmaceutical company committed to innovating cure and care to make patients’ lives better.

The agreement will see Pharmanovia acquire the rights from existing licensee, CSL Seqirus in Australia and New Zealand, with Pharmanovia exclusively responsible for regulatory and commercial activity in the region. Pharmanovia will also become MAH holder.

Parkinson’s is the fastest growing neurological condition in the world according to the World Health Organization¹.

Pharmanovia CEO, James Burt commented: “Today’s announcement brings us a new chemical entity (NCE), with clear synergies to our existing CNS portfolio. In XADAGO® (safinamide) we have an important medicine helping patients to control Parkinson’s symptoms and we’re excited to use our platform to continue to bring this medicine to patients.

“CSL Seqirus’ trust in handing over this product to us, further reinforces our ability as a core commercial partner in Australia and New Zealand, and as a partner more broadly for novel therapeutics”.

Danielle Dowell, CSL Seqirus Executive Director for Commercial Operations APAC, added: “Pharmanovia has strong capabilities and presence both in ANZ and in CNS. They are experienced at bringing differentiated products to patients and we’re confident that they will leverage their portfolio to help reach even more people living with Parkinson’s.”

About Pharmanovia

Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally.

We do this by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and through strategic partnerships on established and novel medicines.

Our diverse and growing team operate in over 160 countries across the globe, delivering high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology.

About CSL Seqirus

CSL Seqirus is part of CSL (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus offers a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

In Australia, CSL Seqirus operates the only local manufacturing facility for seasonal and pandemic influenza vaccine and produces a range of unique medicines in the national interest, including antivenoms and the world’s only human vaccine for Q fever. Our commitment to Australia’s health also extends to providing access to paediatric and adult vaccines, and innovative pharmaceuticals for patients living with allergies, cardiovascular disease, severe pain, dry eye disease, iron deficiency, kidney diseases, rare diseases and neurological conditions.

References

¹https://www.who.int/publications/i/item/9789240050983

Contacts

Alison Dyson, Director of Communications, Pharmanovia

07912887250/ communications@pharmanovia.com
Or
pharmanovia@67health.co.uk

Devonian Announces Amendment to its Articles of Amalgamation and Resignation of its Interim Chief Financial Officer




Devonian Announces Amendment to its Articles of Amalgamation and Resignation of its Interim Chief Financial Officer

Not for distribution to United States newswire services or for dissemination in the United States

QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXV: GSD; OTCQB: DVHGF) announced that it is amending its articles of amalgamation (the “Amended Articles“), in accordance with the approval by the shareholders at the Annual General and Special Meeting held on February 20, 2024.

Devonian currently has one class of shares listed on the TSX Venture Exchange (the “Exchange“): the subordinate voting shares (the “Subordinate Voting Shares“) which carry one vote per share. The Amended Articles will: (i) create a new class of shares, consisting of an unlimited number of common shares (the “Common Shares“) which will carry one vote per share, (ii) convert each issued and outstanding Subordinate Voting Share into Common Shares, and (iii) after giving effect to the above-mentioned, repeal the following classes of shares of the Corporation and the rights, privileges, restrictions and conditions attached:

1. an unlimited number of Multiple Voting of the Corporation;
2. an unlimited number of Exchangeable Voting Shares of the Corporation; and
3. an unlimited number of Subordinate Voting Shares of the Corporation.

(collectively, the “Reclassification“).

The Reclassification is expected to take effect on October 10, 2024. All Subordinate Voting Shares are expected to be delisted from the Exchange prior to the opening of markets on October 10, 2024, while the Common Shares are expected to trade on the Exchange at the opening of markets on October 10, 2024, under the current symbol “GSD”. Following the Reclassification, the shareholders of the Subordinate Voting Shares will not need to take any action to receive the Common Shares.

In addition, all security-based plans of the Corporation will cover Common Shares of the Corporation as of the Reclassification date.

Resignation of the Interim Chief Financial Officer

The Corporation also announced the resignation of Ms. Colette Laurin as Interim Chief Financial Officer of the Corporation, effective January 5, 2025, to pursue personal interests. The Corporation would like to thank Ms. Laurin for her tireless efforts and valuable contributions throughout her term and wishes her much success in her future endeavors. The Corporation has begun a process to find a replacement for Ms. Laurin.

About Devonian

Devonian Health Group Inc. is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines.

Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies.

Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the Exchange (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF).

For more information, visit www.groupedevonian.com

Cautionary Note Regarding Forward-Looking Statements

All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating, the Reclassification, the replacement of the Chief Financial Officer, and, generally, the above “About Devonian” paragraph, which essentially describes the Company’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release.

Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.

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

Contacts

Devonian Health Group Inc.
Luc Grégoire

President and CEO

Telephone: 1 (450) 979-2916

E-mail: investors@groupedevonian.com