Combined company to be Nasdaq-listed,
clinical-stage biopharmaceutical company focused on advancing
Tectonic’s novel GPCR-targeted therapeutic proteins
$130.7 million in private financing commitments
with new and existing leading life sciences investors in connection
with merger
Combined company expected to have approximately
$165 million in cash and cash equivalents at close to provide cash
runway into mid-2027
Funding is expected to advance lead asset TX45,
a potential best-in-class Fc-relaxin fusion protein, through
multiple clinical data catalysts
Tectonic’s first two programs address
indications with high unmet need and no approved therapies
Companies to host joint webcast today, January
30, 2024 at 8:30 a.m. ET
AVROBIO, Inc. (Nasdaq: AVRO) and Tectonic Therapeutic, Inc.
(“Tectonic”), a privately-held biotechnology company developing
GPCR (G-protein coupled receptor)-targeted therapeutic proteins,
co-founded by Timothy A. Springer and Andrew C. Kruse of Harvard
Medical School, today announced that the companies have entered
into a definitive merger agreement to combine in an all-stock
transaction (the “Merger”). Under the terms of the agreement,
AVROBIO will acquire 100% of the outstanding equity interests of
Tectonic. Upon completion of the Merger, the combined company is
expected to operate under the name Tectonic Therapeutic, Inc. and
trade on Nasdaq under the ticker symbol “TECX.”
In connection with the Merger, Tectonic has raised or entered
into agreements for a $130.7 million private placement with a
syndicate of new and existing leading life sciences investors, led
by a major mutual fund, TAS Partners, 5AM Ventures, EcoR1 Capital,
Polaris Partners, funds and accounts advised by Farallon Capital
Management, Vida Ventures, PagsGroup, and other investors. The
combined company is expected to have approximately $165 million of
cash and cash equivalents at closing, inclusive of the proceeds to
be received in the private placement. These proceeds will be used
to advance Tectonic’s pipeline through multiple clinical data
catalysts and are expected to fund the combined company’s
operations into mid-2027. The private placement is expected to
close in conjunction with the Merger in the second quarter of
2024.
“We are delighted to merge with AVROBIO at this important time
for Tectonic. We are grateful to our investors for their commitment
to our mission and to advancing our pipeline of uniquely
differentiated molecules. Using biologics to unlock the therapeutic
utility of targeting GPCRs which are not optimally drugged by small
molecules could result in important advances for patients,” said
Alise Reicin, M.D., Chief Executive Officer of Tectonic. “GPCRs are
central to human biology and are the target of more than 30% of all
currently approved drugs. However, many GPCRs remain unexplored and
have proven to be challenging targets for drug development. Our
GEODeTM platform makes it possible to discover a broad pipeline of
biologics addressing some of the most challenging receptors in the
class. This transaction enhances our ability to execute on an
efficient plan to advance our clinical-stage and potential
best-in-class Fc-relaxin fusion protein, TX45, as well as
additional assets in our pipeline. We anticipate multiple clinical
catalysts over the next three years.”
“This transaction is the culmination of a comprehensive review
of strategic alternatives, and our Board believes that the Merger
with Tectonic is in the best interests of our shareholders,” said
Erik Ostrowski, interim Chief Executive Officer and Chief Financial
Officer of AVROBIO. “Tectonic has unparalleled expertise in the
biochemistry and biophysics of GPCRs, and a highly accomplished
team poised to advance their rich pipeline of innovative
therapies.”
Tectonic’s Portfolio and Platform Overview
Tectonic is developing novel GPCR-targeted therapeutic proteins.
The company is prioritizing compelling GPCR targets to address
indications that are not currently well-served by small
molecule-based approaches. The selectivity and specificity profile
of biologics is one of the most important advantages of Tectonic’s
approach over traditional small molecule drug discovery. However,
most GPCRs have not historically been amenable to standard
biologics discovery methods because of the instability and
conformational heterogeneity of the GPCRs themselves. Tectonic’s
GEODeTM platform was developed to overcome the challenges of
GPCR-targeted biologics discovery by combining GPCR biochemistry
and receptor engineering strategies, proprietary antibody libraries
and screening protocols, and structure-guided protein engineering
for therapeutic candidate optimization.
Tectonic’s rich pipeline addresses high-value targets across a
range of indications. The first two targets are in indications with
no approved therapies:
- Tectonic’s lead program, TX45, a Fc-relaxin fusion protein, is
a potential best-in-class agent derived from its internal protein
engineering efforts. TX45 has been optimized with an aim to
overcome multiple limitations associated with the natural human
hormone to achieve both optimal in vitro (biophysical and
developability), and in vivo (pharmacokinetic and pharmacodynamic,
or “PK/PD”) properties. Following completion of the ongoing dose
escalation safety and PK/PD studies in healthy volunteers,
development of TX45 is planned to focus on an area of very high
unmet need, Group 2 Pulmonary Hypertension in patients with Heart
Failure with preserved Ejection Fraction (HFpEF), which impacts
over 600,000 people in the U.S.
- Preliminary data from the Phase 1a study has demonstrated PK/PD
effects for TX-45 that are consistent with a potential
best-in-class profile for TX45 and monthly dosing. Additional PK/PD
data from the ongoing Phase 1a study are expected in mid-2024.
Phase 1b hemodynamic Proof of Concept data is expected in 2025 and
Phase 2 randomized data is expected in 2026.
- Tectonic’s second program addresses Hereditary Hemorrhagic
Telangiectasia (HHT), an autosomal dominant disease that causes
abnormal blood vessel formation. HHT affects approximately 75,000
patients in the U.S. The target population for development is the
10-20% of patients that are considered to have severe disease
because of frequent bleeding, anemia, and in some cases, the need
for frequent blood transfusions. Tectonic plans to initiate human
studies in this program during the Q4 2025 to Q1 2026
timeframe.
- Tectonic’s third program is focused on fibrosis, using a
bispecific approach to inhibit two different receptors with
complementary / non-overlapping modes of action.
About the Proposed Transaction: Financials, Management and
Organization
Upon completion of the Merger, pre-Merger AVROBIO shareholders
are expected to own approximately 22.3% of the combined company and
pre-Merger Tectonic shareholders are expected to own approximately
40.2% of the combined company, and in each case after giving effect
to the aforementioned private placement financing. The percentage
of the combined company that AVROBIO shareholders will own as of
the close of the transaction is subject to adjustment based on the
amount of AVROBIO net cash at the closing date, which is currently
estimated to be approximately $65 million. Immediately prior to the
closing of the Merger, AVROBIO shareholders will be issued
contingent value rights representing the right to receive certain
payments from proceeds received by the combined company, if any,
related to certain pre-transaction assets of AVROBIO.
Following the closing of the Merger, the combined company will
be led by Dr. Reicin and other members of the Tectonic management
team. AVROBIO will be renamed Tectonic Therapeutic, Inc. and the
corporate headquarters will be located in Watertown, Mass. The
merger agreement provides that post-merger, one board member from
AVROBIO will join the Board of Directors of the combined
company.
The Merger has been approved by the Board of Directors of both
companies and is expected to close in the second quarter of 2024
subject to customary closing conditions, including the approvals by
the shareholders of each company, the closing of the private
placement financing and other customary closing conditions.
In connection with the Merger, directors, officers, and certain
shareholders of AVROBIO and Tectonic have executed support
agreements, pursuant to which they have agreed to vote all of their
shares of capital stock in favor of the Merger.
Leerink Partners is serving as exclusive financial advisor to
Tectonic and Cooley LLP is serving as legal counsel to Tectonic.
Leerink Partners and TD Cowen are acting as joint placement agents
to Tectonic in connection with the private placement. Piper Sandler
is acting as capital markets advisor to Tectonic. TD Cowen is
serving as lead financial advisor, Houlihan Lokey is serving as
co-financial advisor, and Goodwin Procter LLP is serving as legal
counsel to AVROBIO.
Webcast Presentation
The companies will host a webcast presentation to discuss the
proposed transaction today, January 30, at 8:30 a.m. ET. Listeners
can register for the webcast via this link. A copy of the slides
being presented will be available via AVROBIO’s investor website.
Those who plan on participating are advised to join 15 minutes
prior to the start time. A replay of the webcast will also be
available via AVROBIO’s investor website approximately two hours
after the call’s conclusion.
About AVROBIO
AVROBIO is a gene therapy company with a purpose to free people
from a lifetime of genetic disease. The company has been focused on
developing potentially curative HSC gene therapies to treat
patients with rare diseases following a single dose treatment
regimen.
About Tectonic Therapeutic
Tectonic Therapeutic, co-founded by Andrew Kruse and Tim
Springer of Harvard Medical School, is transforming the discovery
of antibodies and other biologic drugs targeting GPCRs to develop
novel therapies for patients inadequately served by current
treatments. With its proprietary GEODeTM platform, Tectonic aims to
unlock the therapeutic utility of some of the most difficult
receptors in the class, where small molecule pharmacology may be
intractable.
Participants in the Solicitation
AVROBIO, Tectonic, and their respective directors and certain of
their executive officers may be considered participants in the
solicitation of proxies from AVROBIO’s shareholders with respect to
the proposed merger transaction under the rules of the U.S.
Securities and Exchange Commission. Information about the directors
and executive officers of AVROBIO is set forth in its Annual Report
on Form 10-K for the year ended December 31, 2022, which was filed
with the SEC on March 23, 2023, subsequent Quarterly Reports on
Form 10-Q and other documents that may be filed from time to time
with the SEC. Additional information regarding the persons who may
be deemed participants in the proxy solicitations and a description
of their direct and indirect interests, by security holdings or
otherwise, will also be included in a registration statement filed
on Form S-4 that will contain a proxy statement (and prospectus and
other relevant materials) to be filed with the SEC when they become
available. You may obtain free copies of this document as described
above.
No Offer or Solicitation
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities nor a solicitation
of any vote or approval with respect to the proposed transaction or
otherwise. No offering of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the U S.
Securities Act of 1933, as amended, and otherwise in accordance
with applicable law.
Additional Information and Where to Find It
This communication relates to the proposed merger transaction
involving AVROBIO and Tectonic (the “Merger”) and may be deemed to
be solicitation material in respect of the proposed Merger. In
connection with the proposed Merger, AVROBIO will file relevant
materials with the SEC, including a registration statement on Form
S-4 (the “Form S-4”) that will contain a proxy statement (the
“Proxy Statement”) and prospectus. This communication is not a
substitute for the Form S-4, the Proxy Statement or for any other
document that AVROBIO may file with the SEC and/or send to
AVROBIO’s shareholders in connection with the proposed Merger.
BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS
OF AVROBIO ARE URGED TO READ THE FORM S-4, THE PROXY STATEMENT AND
OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY
WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT AVROBIO, THE PROPOSED MERGER AND RELATED
MATTERS.
Investors and security holders will be able to obtain free
copies of the Form S-4, the Proxy Statement and other documents
filed by AVROBIO with the SEC through the website maintained by the
SEC at http://www.sec.gov. Copies of the documents filed by AVROBIO
with the SEC will also be available free of charge on AVROBIO’s
website at www.avrobio.com, or by contacting AVROBIO’s Investor
Relations at https://investors.avrobio.com/.
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, including but not limited
to, express or implied statements regarding the structure, timing
and completion of the Merger; the combined company’s listing on
Nasdaq after the closing of the proposed Merger (the “Closing”);
expectations regarding the ownership structure of the combined
company; the anticipated timing of the Closing; the expected
executive officers and directors of the combined company;
expectations regarding the structure, timing and completion of the
private placement financing, including investment amounts from
investors, timing of closing, expected proceeds and impact on
ownership structure; each company’s and the combined company’s
expected cash position at the Closing and cash runway of the
combined company following the Merger and private financing; the
future operations of the combined company, including
commercialization activities, timing of launch, buildout of
commercial infrastructure; the nature, strategy and focus of the
combined company; the development and commercial potential and
potential benefits of any product candidates of the combined
company,; the location of the combined company’s corporate
headquarters; anticipated clinical drug development activities and
related timelines; and other statements that are not historical
fact. All statements other than statements of historical fact
contained in this communication are forward-looking statements.
These forward-looking statements are made as of the date they were
first issued, and were based on the then-current expectations,
estimates, forecasts, and projections, as well as the beliefs and
assumptions of management. There can be no assurance that future
developments affecting AVROBIO, Tectonic, the Merger or the private
placement financing will be those that have been anticipated.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond AVROBIO’s control. AVROBIO’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
(i) the risk that the conditions to the Closing are not satisfied,
including the failure to timely obtain stockholder approval for the
transaction, if at all; (ii) uncertainties as to the timing of the
consummation of the proposed Merger and the ability of each of
AVROBIO and Tectonic to consummate the proposed Merger; (iii) risks
related to AVROBIO’s ability to manage its operating expenses and
its expenses associated with the proposed Merger pending the
Closing; (iv) risks related to the failure or delay in obtaining
any required consents necessary to consummate the proposed Merger;
(v) the risk that as a result of adjustments to the exchange ratio,
AVROBIO stockholders and Tectonic stockholders could own more or
less of the combined company than is currently anticipated; (vi)
risks related to the market price of AVROBIO’s common stock
relative to the value suggested by the exchange ratio; (vii)
unexpected costs, charges or expenses resulting from the
transaction; (viii) potential adverse reactions or changes to
business relationships resulting from the announcement or
completion of the proposed Merger; (ix) the uncertainties
associated with Tectonic’s product candidates, as well as risks
associated with the clinical development and regulatory approval of
product candidates, including potential delays in the completion of
clinical trials; (x) risks related to the inability of the combined
company to obtain sufficient additional capital to continue to
advance these or other product candidates; (xi) uncertainties in
obtaining successful clinical results for product candidates and
unexpected costs that may result therefrom; (xii) risks related to
the failure to realize any value from product candidates currently
being developed and anticipated to be developed in light of
inherent risks and difficulties involved in successfully bringing
product candidates to market; (xiii) risks associated with the
possible failure to realize certain anticipated benefits of the
proposed Merger, including with respect to future financial and
operating results; and (xiv) the risk that the private placement
financing is not consummated upon the Closing. Actual results and
the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and
uncertainties. These and other risks and uncertainties are more
fully described in periodic filings with the U.S. Securities and
Exchange Commission (the “SEC”), including the factors described in
the section titled “Risk Factors” in AVROBIO’s Annual Report on
Form 10-K for the year ended December 31, 2022, which was filed
with the SEC on March 23, 2023, subsequent Quarterly Reports on
Form 10-Q filed with the SEC, and in other filings that AVROBIO
makes and will make with the SEC in connection with the proposed
Merger, including the Proxy Statement described below under
“Additional Information and Where to Find It.” You should not place
undue reliance on these forward-looking statements, which are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements. AVROBIO expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statements are based. This communication does not purport to
summarize all of the conditions, risks and other attributes of an
investment in AVROBIO or Tectonic.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240130047688/en/
AVROBIO:
Media: Ed Trissel / Carly King Joele Frank, Wilkinson Brimmer
Katcher (212) 355-4449
Investor: Christopher F. Brinzey Westwicke, an ICR Company (339)
970-2843 chris.brinzey@westwicke.com
Tectonic Therapeutic:
Investor: Christian Cortis, PhD Tectonic Therapeutic
ccortis@tectonictx.com (781) 327-2606
Media: Karen Sharma MacDougall ksharma@macdougall.bio (781)
235-3060
Grafico Azioni AVROBIO (NASDAQ:AVRO)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni AVROBIO (NASDAQ:AVRO)
Storico
Da Dic 2023 a Dic 2024
