REG - RTW Biotech Opp. - Monthly Valuation Update and Factsheet

RTW Biotech OpportunitiesAnnouncement

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RNS Number : 2332Z  RTW Biotech Opportunities Ltd  15 September 2025

LEI: 549300Q7EXQQH6KF7Z84

15 September 2025

 

RTW Biotech Opportunities Ltd

Monthly Valuation Update and Factsheet

RTW Biotech Opportunities Ltd (the "Company") announces that its monthly
factsheet and with commentary as at 31 August 2025 is now available at
https://www.rtwfunds.com/rtw-biotech-opportunities-ltd/factsheets-letters/
(https://www.rtwfunds.com/rtw-biotech-opportunities-ltd/factsheets-letters/) .

 

The Company's unaudited net asset value attributable to its ordinary shares as
at 31 August 2025 was US$1.98 per share, an increase of +7.8% from the
previous month vs +4.9% for the Nasdaq Biotech Index and +8.0% for the Russell
2000 Biotech Index. The Company has delivered +11.3% annualised NAV per
ordinary share performance since launch in October 2019.

 

Top 10 Positions

 Holding   Public / Private  % NAV
 Avidity   Public "RNA"      8.4%
 Corxel    Private           7.9%
 UroGen    Public "URGN"     5.6%
 Kailera   Private           4.3%
 PTC       Public "PTCT"     4.1%
 Stoke     Public "STOK"     4.1%
 Madrigal  Public "MDGL"     3.8%
 Akero     Public "AKRO"     3.3%
 Tarsus    Public "TARS"     2.9%
 Uniqure   Public "QURE"     2.8%

 

Top YTD Contributors and Detractors

 Holding  % NAV  Contribution
 Avidity  4.4%   +4.7%
 UroGen   6.0%   +3.3%
 Akero    8.7%   +3.2%
 Rocket   1.2%   (4.0%)
 Artios   2.2%   (2.9%)
 Dyne     2.1%   (1.9%)

Note: % NAV as at period end based on economic exposure.

 

Sector Update

Manufacturing-related tariffs now appear largely resolved, with seven of the
largest pharmaceutical companies agreeing to reshore nearly $300 billion in
production. President Trump stated in July that a 200 percent tariff would be
imposed after a 12- to 18-month grace period, but this has since been
interpreted as providing enough time for companies to adjust supply chains.
The main unresolved issue is MFN, but a broad US-EU trade deal is likely to
remove tariffs as a threat. The administration's remaining tools to force
price matching are limited and slow, with Medicare changes unlikely to have a
major impact. Other solutions, such as a shift to direct-to-consumer models
and the concept of a unified EU list price, are promising. Regardless of where
MFN policy lands, RTW Bio's portfolio risk remains low.

The FDA has become more transparent and flexible under Makary, who has
introduced new initiatives such as a formal framework for single-arm trials in
ultrarare diseases and a National Priority Review programme that could reduce
approval times from 10 months to just weeks. Regulatory activity has remained
steady, with the FDA's Centre for Drug Evaluation and Research (CDER) and
Centre for Biologics Evaluation and Research (CBER) maintaining approval rates
in line with historical norms. Although the number of drug approvals was
slightly down year-on-year, the overall pace remained healthy. The FDA's
decision-making process continued to align with advisory committee
recommendations in the majority of cases, and fears of a more stringent or
unpredictable agency have not been realised. Notably, the FDA's leadership
changes and staffing fluctuations are not disrupting core functions, and the
agency has reaffirmed its commitment to expediting pathways for rare disease
drugs and psychedelics.

M&A activity reflected a renewed push by large pharmaceutical companies to
strengthen their pipelines, particularly in neuroscience, rare diseases, and
oncology. Notable deals included AbbVie's agreement to acquire Gilgamesh
Pharmaceuticals, a developer of therapies for depression, in a transaction
valued at around $1 billion. Novartis was also reported to be considering a
takeover of RTW Bio's largest holding, Avidity Biosciences. For Novartis,
which is facing generic competition for top-selling drugs like Entresto,
Xolair, and Cosentyx, a deal for Avidity would be one of the largest under CEO
Vas Narasimhan and would further its recent strategy of targeted acquisitions
to offset revenue loss from patent expiries. The overall M&A landscape
showed that while the number of mega-deals remained limited, strategic
acquisitions and structured financings continued to get done.

The broader IPO market for biotech and healthcare showed signs of recovery.
Heartflow, a digital health company focused on AI-powered cardiovascular
diagnostics completed its IPO in August and is trading up 75% from its issue
price. Further afield, Guangzhou Innogen Pharmaceutical, focused on the GLP-1
/ metabolic space, is planning its IPO in Hong Kong. Notably, after dropping
16% in 2024, the Hang Seng Biotech Index is up 110% YTD.

Portfolio Update

Avidity Biosciences was the subject of a takeover rumour by Novartis, driving
Avidity's share price up 27% over August. As at 31 August, Avidity represented
8.4% of NAV.

On 20 August, Rocket Pharmaceuticals announced that the FDA had lifted the
clinical hold on the pivotal Phase 2 trial of RP-A501 for the treatment of
Danon disease. The hold was lifted in under three months, underscoring the
efficiency of the FDA's review process and Rocket's commitment to
expeditiously optimise safety and resume the trial. As at 31 August, Rocket
represented 1.2% of NAV.

On 14 August, RTW Bio participated in the $75 million strategic funding
arrangement with Aquestive, via the 4010 Royalty Fund. The financing will
support Aquestive to bring Anaphylm (epinephrine) to market. Anaphylm is the
first and only orally delivered film that has the same target indication as
that for epinephrine injection in the emergency treatment of Type 1 allergic
reactions, including anaphylaxis. The transaction is subject to FDA approval
of Anaphylm.

 

 

 

 Enquiries:

 RTW Investments, LP - Investment Manager

 Oliver Kenyon                              +44 (0)20 7959 6362

 Woody Stileman                             biotechopportunities@rtwfunds.com

 Krisha McCune (Investor Relations)

 Cadarn Capital - PR & IR Partner

 Lucy Clark (PR)                            +44 (0)7984 184 461 / lucy@cadarncapital.com

 David Harris (Distribution)                +44 (0)7368 883 211 / david@cadarncapital.com

 Deutsche Numis - Joint Corporate Broker    +44 (0)20 7260 1000

 Freddie Barnfield

 Nathan Brown

 BofA Securities - Joint Corporate Broker   +44 (0)20 7628 1000

 Edward Peel

 Alex Penney

 Altum (Guernsey) Limited                   +44 (0)1481 703 100

 Joanna Duquemin Nicolle

 Sadie Morrison

 

About RTW Biotech Opportunities Ltd:

RTW Biotech Opportunities Ltd (LSE: RTW) is an investment fund focused on
identifying transformative assets with high growth potential across the
biopharmaceutical and medical technology sectors. Driven by a long-term
approach to support innovative businesses, RTW Biotech Opportunities Ltd
invests in companies developing next-generation therapies and technologies
that can significantly improve patients' lives. RTW Biotech Opportunities Ltd
is managed by RTW Investments, LP, a leading healthcare-focused
entrepreneurial investment firm with deep scientific expertise and a strong
track record of supporting companies developing life-changing therapies.

Visit the website at www.rtwfunds.com/rtw-biotech-opportunities-ltd
(http://www.rtwfunds.com/rtw-biotech-opportunities-ltd)  for more
information.

 

***********

The information in this announcement may include forward-looking statements,
which are based on the current expectations and projections about future
events, and in certain cases can be identified by the use of terms such as
"may", "will", "should", "expect", "anticipate", "project", "estimate",
"intend", "continue", "target", "believe" (or the negatives thereon) or other
variations thereon or comparable terminology. These forward-looking
statements, as well as those included in any related materials, are subject to
risks, uncertainties and assumptions about the Company and/or its underlying
investments, including, among other things, the development of the applicable
entity's business, trends in its operating industry, expected use of financing
proceeds and future capital expenditures and acquisitions. In light of these
risks, uncertainties and assumptions, the events in the forward-looking
statements may not occur.

The information contained in this announcement is given at the date of its
publication (unless otherwise marked). No reliance may be placed for any
purpose whatsoever on the information or opinions contained in this
announcement or on its completeness, accuracy or fairness.

***********

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