Full Press Release Details
AlloVir and Kalaris Therapeutics Announce Agreement for
Transformational Merger to Create Company Focused on
Diseases of the Retina
Kalaris is a clinical-stage biopharmaceutical company founded by Samsara BioCapital and focused
on development of TH103, a novel, differentiated and potentially transformative therapy for patients
with neovascular and exudative retinal diseases
Invented by VEGF pioneer Dr. Napoleone Ferrara, TH103 has demonstrated longer-acting and
increased anti-VEGF activity in head-to-head preclinical
studies against aflibercept, and could
potentially provide a meaningful advance in treatment in the global $14 billion branded
anti-VEGF retinal market
TH103 is in a Phase 1 clinical trial in patients with neovascular
age-related macular degeneration
with initial data expected in Q3 2025
The combined company is expected to have a cash balance of approximately $100 million at close,
which is anticipated in Q1 2025. Transaction expected to provide cash runway into Q4 2026
Companies to host webcast today, November 8, 2024 at 8:30 a.m. ET
WALTHAM, MA and Palo Alto, CA. Nov. 08, 2024 (GLOBE NEWSWIRE) AlloVir, Inc. (Nasdaq: ALVR) today announced that it has entered into a definitive merger
agreement to combine with Kalaris Therapeutics ( Kalaris ) in an all-stock transaction (the Merger ). Under the terms of the agreement, AlloVir will acquire 100% of the outstanding equity
interest of Kalaris. Upon completion of the Merger, pre-Merger AlloVir stockholders are expected to own approximately 25.05% of the combined company and pre-Merger
Kalaris stockholders are expected to own approximately 74.95% of the combined company, subject to certain adjustments described in the merger agreement. Upon closing, the combined company is expected to have approximately $100 million in cash,
which is expected to be sufficient to fund the combined company s operating expenses and capital expenditure requirements into the fourth quarter of 2026. After closing, the combined company is expected to operate under the name Kalaris
Therapeutics, Inc. and trade on Nasdaq under the ticker symbol KLRS.
On behalf of the AlloVir board, I am thrilled that we have entered
into this transformational merger agreement with Kalaris, said David Hallal, Chairman of the Board of AlloVir. The combination of our financial resources, with Kalaris TH103 asset from the lab of the renowned Dr. Napoleone
Ferrara, will help accelerate the clinical development of TH103 for neovascular age-related macular degeneration ( nAMD ) as well as other diseases such as diabetic macular edema ( DME )
and retinal vein occlusion ( RVO ). I am also looking forward to once again working with many members of the Kalaris board and management team with the goal of again ushering in a new era for the retina community by delivering an
innovation for targeted VEGF inhibition.
Kalaris is a clinical-stage biopharmaceutical company dedicated to the development and commercialization
of treatments for prevalent retinal diseases, founded by Samsara BioCapital and focused on development of TH103, a novel, differentiated anti-VEGF investigational therapy. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized,
recombinant fusion protein currently being evaluated in an ongoing, Phase 1 clinical trial for the treatment of nAMD, with plans to develop TH103 for other neovascular and exudative diseases of the retina. TH103 acts against VEGF as a decoy receptor
and has been engineered for improved VEGF inhibition and longer retention in the retina.
AlloVir ran a thorough and strategic process, and we believe that this transaction represents the
company s commitment to delivering value to the AlloVir stockholders, said Diana Brainard, CEO of AlloVir. Kalaris is strongly positioned with an innovative clinical stage asset with the potential to disrupt the large anti-VEGF
market, with near-term, value-inflecting milestones and a well-credentialed management team to lead the combined company.
TH103 has the potential to be a meaningful advance for patients suffering from a number of neovascular and exudative retinal diseases, said Andrew Oxtoby, CEO of Kalaris Therapeutics. Kalaris is currently enrolling a Phase 1 clinical
trial, and we look forward to reporting initial data in treatment na ve nAMD patients in the third quarter of 2025.
Vascular endothelial
growth factor A is the primary mediator and target of pathologic angiogenesis and exudation in retinal vascular diseases. Anti-VEGF agents have revolutionized treatment for these diseases, and the global market for branded anti-VEGF agents is
approximately $14 billion. Available data on real-world patient outcomes has consistently failed to replicate the results from registrational clinical trials, with most of this being attributed to suboptimal compliance1,2,3,4,5. Extending the interval between injections while maintaining visual acuity in the real-world setting has been the goal to improve clinical outcomes. A novel therapeutic that could provide longer
acting and increased VEGF inhibition may represent a clinically meaningful advance over the current standard-of-care.
Napo Ferrara is a true pioneer in the anti-VEGF space, and I am grateful that he reached out to Samsara in 2019 to discuss the potentially
market-changing therapy he was developing, commented Srini Akkaraju, MD, PhD, Managing Partner of Samsara BioCapital, and Kalaris co-founder and board member. TH103 may represent a significant
advance in the treatment of multiple retinal diseases and builds on Dr. Ferrara s legacy of developing anti-VEGF therapies over the past two decades. We are energized by the opportunity to enhance the standard-of-care and ease the treatment burden for patients.
Building on Dr. Akkaraju s
comments, TH103 inventor and Kalaris board member Napoleone Ferrara, MD, PhD added, This fusion protein was specifically engineered to utilize the natural configuration of important domains of VEGF Receptor 1 and has demonstrated both potent
anti-VEGF activity and sustained ocular residence time in preclinical studies. This could potentially lead to enhanced durability with less frequent dosing in the clinical setting.
Phase 1 Clinical Trial Details
Kalaris Phase 1 clinical trial of TH103 has commenced, with initial data expected in the third quarter of 2025. The clinical trial is investigating TH103 in treatment-na ve patients that have been
diagnosed with nAMD. The goals of the clinical trial are to evaluate safety, PK/PD, determine a maximum tolerated dose, and assess preliminary data supporting the anti-VEGF effect of TH103 on fluid and visual acuity.
About the Proposed Transaction: Management and Governance
Following the closing of the Merger, the combined company is expected to be led by current Kalaris Chief Executive Officer Andrew Oxtoby, current Kalaris Chief
Operating Officer Jeffrey Nau, PhD, MMS, and Matthew Feinsod, MD as the combined company s Medical Lead. The combined company s board of directors will be led by current AlloVir Chairman David Hallal, who will remain Chairman of the
combined company s board of directors. Samir Patel, MD, one of the Kalaris co-founders and the current Executive Chairman of Kalaris, is expected to become a member of the combined company s board of
directors, which is also planned to include Mr. Oxtoby, current Kalaris board member Anthony Adamis, MD, PhD, and Kalaris co-founders and current board members Napoleone Ferrara, MD, PhD, Srini Akkaraju,
MD, PhD, and Mike Dybbs, PhD. Two additional members are expected to be named to the combined company s board of directors, one to be selected by AlloVir and the other to be mutually agreed upon by the two companies. In addition to
Dr. Ferrara s expertise as a pioneer in the discovery of VEGF and anti-VEGF drug development, several board members bring significant experience from the field of retinal disease, with Mr. Hallal, Dr. Patel, and Dr. Adamis
all previously holding executive positions at a number of ophthalmology biotechnology companies over the past 20 years.
The transaction has been approved
by the Boards of Directors of both companies and is expected to close in the first quarter of 2025, subject to approvals by the stockholders of each company, the expiration or termination of the waiting period under the U.S. Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended, the effectiveness of a registration statement to be filed with the SEC to register the shares of AlloVir common stock to be issued in connection with the merger, AlloVir having a minimum of
$95.0 million of net cash as of the closing, and other customary closing conditions. In connection with the Merger, directors, officers, and certain stockholders of AlloVir and Kalaris 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 AlloVir, and Goodwin Procter LLP is serving as legal counsel to AlloVir. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Kalaris.
Webcast Presentation
The companies will host a webcast
presentation to discuss the proposed transaction today, November 8th at 8:30 a.m. ET. Listeners can register for the webcast via this LINK. 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 AlloVir s investor website approximately two hours after the webcast s conclusion.
AlloVir is an allogeneic T cell immunotherapy company that was focused on restoring natural immunity against life-threatening viral diseases in
pediatric and adult patients with weakened immune systems.
Kalaris is a clinical-stage biopharmaceutical company founded by Samsara BioCapital, dedicated to the development and commercialization of treatments for
prevalent retinal diseases with major unmet medical needs, such as neovascular Advanced Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO).
About Samsara BioCapital
Founded in 2017, Samsara BioCapital is a leading biotech investment firm focused on translating cutting-edge biology into new transformative medicines to treat
patients with unmet medical needs. Samsara takes a patient capital, long-term view to value creation across all stages of private and public life science companies and believes in a collaborative, hands-on
approach, working closely with entrepreneurs to harness exciting scientific advances and build companies. Samsara s goal is to work closely with a few of the next great biotech companies over a period of
10-20 years and invest across their full growth cycle. The Samsara team has deep expertise in biotech with significant experience working together prior to founding the firm. The team is led by Srini Akkaraju
who has over twenty-five years of industry experience and an MD, PhD in Immunology from Stanford University.
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 proposed merger by and between AlloVir and Kalaris; the combined company s listing on Nasdaq after
the closing of the proposed merger; expectations regarding the ownership structure of the combined company; expectations regarding the structure, timing and completion of any bridge financing, including investment amounts from investors; the
anticipated timing of the closing; the expected executive officers and directors of the combined company; 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 proposed merger and any bridge financing; the future operations of the combined company, including research and development activities; 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, including expectations around market exclusivity and intellectual property protection; the location of the
combined company s corporate headquarters; anticipated clinical drug development activities and related timelines, including the expected timing for announcement of data and other clinical results; expectations regarding the therapeutic
benefits, clinical potential and clinical development of TH103; 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 made, 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 AlloVir, Kalaris, the proposed merger or any bridge financing will be those that have been anticipated.
statements are subject to a number of important risks and uncertainties, many of which involve factors or circumstances that are beyond AlloVir s and Kalaris control. 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 proposed merger from both
AlloVir s and Kalaris stockholders, if at all; (ii) uncertainties as to the timing of the consummation of the proposed merger and the ability of each of AlloVir and Kalaris to consummate the proposed merger; (iii) risks related
to AlloVir s continued listing on Nasdaq until closing of the proposed merger; (iv) risks related to AlloVir s and Kalaris ability to manage their operating expenses and their expenses associated with the proposed merger pending
the closing, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the
combined company s cash resources; (v) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement; (vi) risks related to the failure or delay in obtaining
required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed merger; (vii) the risk that as a result of adjustments to the exchange ratio, AlloVir stockholders and Kalaris stockholders could own
more or less of the combined company than is currently anticipated; (viii) risks related to the market price of AlloVir s common stock relative to the value suggested by the exchange ratio; (ix) unexpected costs,
charges or expenses resulting from the proposed merger; (x) competitive responses to the proposed merger; (xi) potential adverse reactions or changes to business relationships resulting
from the announcement or completion of the proposed merger; (xii) the uncertainties associated with Kalaris product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates,