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RYSE Asset Management invests in Curio Digital Therapeutics to support the development of new therapeutics for underserved women’s mental health conditions

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  • Investment round in the women’s health space also includes investment from pharma and specialist investors
  • Financing to support continued commercialization with health plans and insurers in the US, UK and India
  • MamaLift PlusTM is the first prescription digital therapeutic for the treatment of postpartum depression

LONDON, Aug. 28, 2024 /PRNewswire/ — RYSE Asset Management, the healthcare investor supporting innovative early-stage companies transforming lives, announced it has participated in a double digit investment round for Curio Digital Therapeutics Inc., (Curio), an innovative US company treating postpartum depression (PPD) and other underserved women’s mental health conditions. Strategic investor ONCE, the nutraceuticals venture capital arm of Otsuka; Bridge Point Capital and Avestria also participated in the round.

New Jersey based Curio has received FDA approval for its lead product MamaLift Plus. MamaLift Plus is the women’s health first prescription digital therapeutic to receive SaMD Class2 approval. It treats postpartum depression, a complex mental health disorder affecting as many as one in seven women with a recent live birth experience.i  The FDA approved MamaLift Plus is a prescription–only digital therapeutic for patients aged 22 years and older in conjunction with clinician–managed outpatient care. It is intended to be administered over eight weeks for the treatment of mild to moderate PPD. MamaLift is underpinned by a Connected Care platform which assesses women’s risk of depression and integrates her treatment with her existing healthcare providers. This is particularly significant for providers who are required to report on levels of depression amongst their female populations.

Curio is currently working with health plans, insurers and corporate employee benefit plans in the US and India. They also work at a strategic level with pharma companies and others who seek to engage with Curio’s data and underlying connected care platform which spans post-natal depression, fertility and menopause.

The RYSE investment comes from its Special Opportunities Fund that focuses on the most promising early-stage investments globally between seed and series A. Dedicated to transforming lives through cutting edge digital solutions, the fund has an investment focus on digital diagnostics, digital therapeutics and medical devices that will help solve the challenges facing the NHS and other health and care delivery systems globally. The fund recently welcomed new investors including Future Care Capital, as a cornerstone investor, and established global endowments, family offices and sophisticated investors.

Vivien de Tusch-Lec, General Partner at RYSE said: “This financing is a significant milestone for RYSE Asset Management. As a clinically validated, fully scalable, revenue generating solution, Curio is taking a holistic approach to tackling women’s health by designing interventions that address behavioural management and physiological conditions across Women’s Life Cycle. We see a significant opportunity for Mama Lift Plus, and for the other products in the Company’s pipeline.”

Shailja Dixit, MD, MPH, MS, CEO & Founder of Curio Digital Therapeutics said: “Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health. MamaLift Plus is the first and only digital solution that can help address the serious unmet need uniquely faced by women who have recently delivered, and help make a conscious shift in women’s health. We are grateful to have the backing of RYSE, and our committed new investors as we bring these products to new markets.”

ABOUT RYSE ASSET MANAGEMENT
RYSE Asset Management is a venture firm backing innovators in healthcare. RYSE was born out of  a unique relationship with the NHS to identify, support and invest in leading early-stage digital healthcare companies to help them scale globally. Based in London, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. RYSE has evolved to collaborate with health systems and partners globally – with private and public providers, pharmaceutical, insurance, medical device companies – to drive revenue and exit.

Through the team’s strategic partnerships with all sides of the healthcare ecosystem RYSE’s Special Opportunities Fund provides early-stage entrepreneurs with the resources and support needed to scale their ventures and make a meaningful impact in healthcare.
For more information, please visit https://www.ryseam.com/en/ and follow us on LinkedIn

ABOUT CURIO DIGITAL THERAPEUTICS, INC.
Curio Digital is a pioneer in developing digital therapeutics solutions and interventions across the behavioral health continuum for women throughout the cycle of life. Curio aims to create a world where every woman can access a behavioral health solution at her fingertips. Curio is reshaping maternal mental health care by leveraging proprietary algorithms, clinically validated screening tools, and personalized digital behavioral interventions to facilitate timely identification and care. Curio aspires to make women’s health products and solutions across their life cycle. MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. Curio’s AI-driven predictive algorithm, Curio-I, identifies and risk stratifies women who would go on to develop common behavioral health conditions. For more information, visit Curio at www.curiodigitaltx.com.

ABOUT POSTPARTUM DEPRESSION
Postpartum depression is estimated to affect approximately one in seven women who have given birth in the U.S. or approximately 500,000 women annually.i ii Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy.iii Clinical guidelines for treatment of postpartum depression recommend medication and cognitive behavioral therapy. However, many women may not be able to access these medications and treatments due to national shortages in mental health providers, insurance coverage, childcare challenges, transportation issues, or breastfeeding status. Hence, there is an unmet need for novel treatment modalities.

i March of Dimes. https://www.marchofdimes.org/find-support/topics/postpartum/postpartum-depression#:~:text=PPD%20is%20the%20most%20common,women%20(about%2015%20percent).
ii Bauman BL, et al. Morbidity and Mortality Weekly Report, 2020;69(19):575-581.X
iii “ACOG Committee Opinion No. 757: Screening for Perinatal Depression.” Obstetrics and gynecology vol. 132, 5 (2018): e208-e212. Doi:10.1907/AOG.0000000000002927.

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Telix to Acquire Next-Generation Therapeutic Assets and Innovative Biologics Technology Platform

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MELBOURNE, Australia and INDIANAPOLIS, Jan. 12, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has entered into an asset purchase agreement with antibody engineering company ImaginAb, Inc. (ImaginAb) to acquire a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities.

This transaction adds a pipeline of early-stage drug candidates against high-value targets including DLL3[1] and integrin αvβ6[2], as well as several other novel targets in discovery stage. These next generation drug candidates fit synergistically with Telix’s therapeutics pipeline, enabling expansion to future therapy areas with unmet clinical need. The acquired intellectual property utilizes small engineered antibody formats that enable highly specific cancer targeting, combined with fast tumor uptake and blood clearance. This technology has the potential to be highly effective for imaging and treating tumors with a broad range of radioisotopes, with alpha emitters of particular interest.

The transaction also includes a state-of-the-art research facility in California, staffed by a talented team of discovery, protein engineering and radiopharmaceutical development experts. Together, these assets will provide Telix with further in-house capabilities in antibody engineering and preclinical development, as well as a novel biologics platform to create the next generation of Telix precision medicine and therapeutic products, beyond the current clinical-stage pipeline. 

Richard Valeix, Chief Executive Officer, Therapeutics, Telix, said, “The combination of a proprietary drug discovery platform, pipeline of promising theranostic assets and a talented team of subject matter experts will enhance Telix’s research and innovation capability now and into the future. This acquisition will enable Telix to explore new disease areas with state-of-the-art radiotherapeutic technology.”

Dr. Anna M. Wu, Co-Founder and Board Member, ImaginAb, added, “As the radiopharmaceutical sector gains momentum there is a significant need for targeting agents to be more selective, deliver less off-target radiation, and better match the pharmacology and radiobiology of a given radionuclide. The team’s deep expertise in antibody engineering and the resulting development of a valuable, proprietary platform technology has led to clinical proof-of-concept. Telix is the right partner to unlock the future therapeutic potential of this platform.”

Transaction details

Telix will acquire these assets through an asset purchase agreement with a concurrent technology license agreement to be signed at closing. The purchase price for the transaction is US$45 million (AU$73 million)[3], comprised of US$10 million in cash and US$31 million in equity at closing, and a deferred payment of up to US$4 million in equity at the conclusion of a 15-month indemnity period.

Upon achievement of specific key development and commercial milestones, Telix will pay up to a total of US$185 million (AU$299 million), a portion of which may be paid in cash or equity at Telix’s election[4]. Royalties are also payable on net sales in the low single digits on a limited number of platform and early-stage products after the first four products have been developed, as well as single-digit sublicense fees, as applicable. 

Telix will issue ordinary shares to ImaginAb within its Listing Rule 7.1 placement capacity as consideration for the acquisition. Upfront equity consideration will be subject to voluntary escrow (lock-up/leak-out) restrictions with equal tranches being released from escrow 60, 90 and 120 days after closing. Completion of the transaction is subject to customary conditions, including regulatory approvals and other third-party consents. Telix cannot guarantee this transaction will close in any specific timeframe or on the terms summarized here, if at all.

Refer to Telix disclosures and Appendix 3B lodged with the ASX today for further information.

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About ImaginAb, Inc.

ImaginAb is a clinical stage, revenue-generating global biotechnology company developing the next generation of radiopharmaceutical and imaging agent products. These patented products contain engineered antibodies that maintain the specificity of full-length antibodies while remaining biologically inert in the body. Used with widely available positron emission tomography (PET) and optical imaging technology, these novel targeting agents are able to bind specifically to cell surface targets.

Following closing of its transaction with Telix Pharmaceuticals, ImaginAb, Inc. will be focused on developing its lead imaging candidate, CD8 ImmunoPET, which is currently in Phase 2 clinical trials and has been licensed by numerous pharmaceutical and biotech companies for use in imaging within immunotherapy clinical trials, primarily in oncology.

Jefferies LLC and Stifel, Nicolaus & Company, Incorporated served as financial advisors to ImaginAb on the transaction.

Disclosures

Telix Managing Director and Group Chief Executive Officer, Dr. Christian Behrenbruch, is a non-affiliated shareholder of ImaginAb, holding less than 1% of its capital stock as his only interest in the company. Dr. Behrenbruch abstained from the transaction process and the Telix Board’s approval of the arm’s length acquisition. Dr. Behrenbruch has voluntarily elected, via a binding undertaking, to donate any enrichment from the transaction as the result of his shareholding to charity.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).

Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[5], by the Australian Therapeutic Goods Administration (TGA) [6], and by Health Canada[7]. No other Telix product has received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

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Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

[1] Delta-like ligand 3, a cell surface protein overexpressed in high-grade neuroendocrine tumors and small cell lung cancer (SCLC).

[2] Integrin αvβ6 is a cell surface protein overexpressed during wound healing and in cancer.

[3] All references to AUD have been converted at the AUD/USD exchange rate of 1.614.  

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[4] Refer to Appendix to this announcement and Appendix 3B lodged with the ASX today for further details.

[5] Telix ASX disclosure 20 December 2021.

[6] Telix ASX disclosure 2 November 2021.

[7] Telix ASX disclosure 14 October 2022.

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Rule 10b-5 Private Securities-Fraud Litigation Peaked in 4Q’24

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BETHESDA, Md., Jan. 10, 2025 /PRNewswire/ — SAR, a data analytics company specialized in the securities litigation risk of U.S. public companies, today published the Securities Class Action Rule 10b-5 Exposure Report for 4Q 2024. According to the report, securities litigation exposure of public company defendants that trade in the NYSE and NASDAQ peaked during the fourth quarter of 2024, when records were set across the buoyant U.S. equity markets. During the bullish market conditions of 2024, shareholders claimed approx. $665.2 billion in market capitalization losses due to alleged violations of Rule 10b-5 – the most in the last five years.

According to the report, global quarterly Rule 10b-5 securities litigation exposure in 2024 was 17% greater than the average of 2023. Actual monetary settlements with investor plaintiffs last year were, on average, 23% greater than during the last six years.

SAR data and analysis indicate that the litigation exposure of U.S. public company defendants amounts to approximately $380.3 billion in 2H 2024. Shareholders claimed approximately $4.0 billion in market capitalization losses per securities class action filing, and approximately $2.0 billion per allegedly fraud-related stock drop in 2H 2024. The former metric increased by 32.1%, and the latter by 15.4% during the second half of 2024.

“Our data and analyses indicate that securities litigation exposure against U.S. public companies peaked in the fourth quarter of last year. This peak may be short-lived with an expected increase in volatility and new headwinds for U.S. equities given greater shareholder scrutiny of corporate disclosures. With average Rule 10b-5 settlements over 20% greater in 2024 than during the last six years, litigation activity is expected to increase in 2025,” said Anthony Kabanek, EVP of SAR.

According to the report, in 2023 and 2024 investor plaintiffs claimed $13.6 billion and $20.5 billion, respectively, in private Rule 10b-5 securities-fraud class actions that relied on short-seller research.

Key takeaways:

  • 86 U.S. issuers were sued for alleged violations of Rule 10b-5 during 2H 2024. Based on allegations presented in the first-filed class action complaint against each defendant issuer, U.S. SCA Rule 10b-5 Exposure amounts to $259.4 billion. U.S. SCA Rule 10b-5 Exposure decreased -5.4% relative to 1H 2024.
  • U.S. SCA Rule 10b-5 Exposure peaked in the 2nd and 3rd quarters, followed by a decline to trend in the 4th quarter of 2024.
  • 9 Non-U.S. issuers were sued for alleged violations of Rule 10b-5 during 2H 2024. Based on allegations presented in the first-filed class action complaint against each defendant issuer, ADR SCA Rule 10b-5 Exposure amounts to $120.9 billion. ADR SCA Rule 10b-5 Exposure increased by 11.3x relative to 1H 2024.
  • An anomalously high 4th quarter exposure among Non-U.S. issuers contributed to a remarkably volatile year for ADR SCA Rule 10b-5 Exposure.

  • Rule 10b-5 private securities-fraud filing frequency and potential loss severity need not move in tandem. Global exposure increased by approximately 34% in the 2H 2024 relative to 1H 2024, while filing frequency remained relatively stable.
  • 38 U.S. Large Caps were sued for alleged violations of Rule 10b-5 in 2H 2024, the same observed frequency as 1H 2024. The U.S. Large Cap SCA Rule 10b-5 Exposure amounts to $233.7 billion, a decrease of 10.1% relative to 1H 2024.
  • 22 U.S. Mid Caps were sued for alleged violations of Rule 10b-5 In 2H 2024. The U.S. Mid Cap SCA Rule 10b-5 Exposure amounts to $19.8 billion, more than 3 times the amount in 1H 2024.
  • 26 U.S. Small Caps were sued for alleged violations of Rule 10b-5. The U.S. Small Cap SCA Rule 10b-5 Exposure amounts to $5.9 billion, a decrease of 33% relative to 1H 2024.
  • 9 Non-U.S. issuers that trade via ADRs in the U.S. public markets were sued for alleged violations of Rule 10b-5. The ADR SCA Rule 10b-5 Exposure increased by over 11.3x to ~$121 billion, relative to 1H 2024.

Media contact: [email protected]

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Sobi’s full year 2024 revenue higher than previous estimate

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STOCKHOLM, Jan. 10, 2025 /PRNewswire/ — Swedish Orphan Biovitrum AB (publ) (Sobi®) (STO:SOBI) announces today that revenue for the full year 2024 was higher than previous estimate. Full-year revenue was approximately SEK 26,000 M, representing approximately 19% growth at constant exchange rate (CER) (1). Adjusted EBITA margin (1,2) was in the mid-30s per cent of revenues.

The main reasons for the increased revenue are higher sales than expected in Q4 across the Haemophilia portfolio and for Kineret.

  • Altuvoct: Higher than expected rate of new patients switching to Altuvoct in markets where the product has been launched, mainly Germany and Switzerland.
  • Elocta: Benefited from higher patient numbers across markets and in markets where Altuvoct is launched there were less switches than expected from Elocta. Favorable gross-to-net effects were also observed.
  • Alprolix: Higher than expected number of new patients as well as increase in on-demand treatments across Europe.
  • Kineret: Higher than expected sales driven mainly by positive gross-to-net adjustments and favorable order phasing but also supported by increased demand.
  • The adjusted EBITA margin remained in the expected range as the stronger revenue performance was offset by negative mix effects on the gross margin as well as investments into our launch and pipeline products in the fourth quarter.

At the publication of the Q3 2024 report on 24 October 2024 Sobi stated the outlook for the full year 2024 to be: Revenue was anticipated to grow by a mid-teens percentage at CER and adjusted EBITA margin was anticipated to be in the mid-30s per cent of revenue.

Sobi will announce its fourth quarter and full year 2024 report on Wednesday 5 February 2025 at 8:00 am CET.

About Sobi
Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 18:00 CET on 10 January 2025.

Gerard Tobin
Head of Investor Relations

[1] Alternative Performance Measures (APMs).
[2] Excluding items affecting comparability (IAC).

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