Cabaletta Bio Announces Appointment of Steve Gavel as Chief Commercial Officer and Award of Inducement Grant

Rhea-AI Summary

Cabaletta Bio (Nasdaq: CABA) appointed Steve Gavel as Chief Commercial Officer effective Oct 14, 2025, to lead global commercial strategy and execution for rese-cel (resecabtagene autoleucel) and future pipeline opportunities. The company anticipates a first BLA submission in myositis in 2027. Gavel previously led CAR T launch and commercialization at Legend Biotech (2018–2025) including CARVYKTI, and has prior roles at Celgene, Takeda and Johnson & Johnson.

On Oct 13, 2025 Cabaletta granted an inducement award of 275,000 non-qualified stock options at an exercise price of $2.49 (Nasdaq close Oct 13), 10-year term, vesting over four years under the 2025 Inducement Plan.

Positive

• Named experienced CAR T commercial leader with launch track record
• Company set BLA target for myositis in 2027
• Inducement aligns executive incentives: 275,000 options granted

Negative

• Option exercise price equals recent close at $2.49, offering no immediate intrinsic value
• Vesting spreads dilution risk over 4 years, potentially increasing share count at future dates

– Gavel brings highly relevant CAR T experience from Legend Biotech where he led the launch and commercialization of CARVYKTI® from 2018 until 2025 –

PHILADELPHIA, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced the appointment of Steve Gavel as Chief Commercial Officer, effective immediately. In his role, Mr. Gavel will join the leadership team and will lead all aspects of global commercial strategy and execution for rese-cel (resecabtagene autoleucel, formerly CABA-201), for which the Company anticipates its first Biologics License Application (BLA) submission in myositis in 2027, as well as potential future pipeline opportunities.

“Steve is an outstanding leader with a track record of success launching and commercializing cellular therapies. His extensive cell therapy experience will enhance our efforts to maximize the value of rese-cel for patients, payers and providers,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta Bio. “We are confident Steve’s leadership will attract a world-class team to prepare for and to execute the potential launch of rese-cel.”

Prior to joining Cabaletta, from 2018 to 2025, Mr. Gavel was Senior Vice President, Global Cell Therapy Commercial Development at Legend Biotech reporting to the CEO, where he created and scaled its commercial organization and led implementation of all CAR T logistics and management of the leading CAR T centers in the U.S., in partnership with Johnson & Johnson, to successfully launch CARVYKTI, a treatment for patients with relapsed or refractory multiple myeloma. Earlier, Mr. Gavel led U.S. commercial strategy and development at Celgene (now Bristol Myers Squibb). Previously, he held commercial roles of increasing seniority at companies including Takeda Pharmaceuticals, Johnson & Johnson and Immunex. He holds a B.S. in Finance and Business Administration from Millersville University of Pennsylvania.

“I am honored to join the team at Cabaletta as the Company moves into the next phase of growth with an enhanced focus on commercial planning, development and execution,” said Mr. Gavel. “With a planned first BLA submission for myositis in 2027, I look forward to drawing on my previous experience with successful CAR T launches building robust commercial foundations and teams that can scale quickly with success and provide enduring value to all stakeholders in my role.”

Inducement Grant
In connection with the appointment of Mr. Gavel as Chief Commercial Officer, on October 13, 2025, Cabaletta granted Mr. Gavel an inducement equity award, which was approved in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement award consisted of non-qualified stock options to purchase an aggregate of 275,000 shares of the Company’s common stock with an exercise price of $2.49 per share, which is equal to the closing price of the Company’s common stock as reported by Nasdaq on October 13, 2025. The option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grant, and the remainder vesting in 12 equal quarterly installments for the three years thereafter. The stock option is subject to the terms and conditions of the Company’s 2025 Inducement Plan and the terms and conditions of the stock option agreement covering the grant.

About Cabaletta Bio
Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s business plans and objectives as a whole; Cabaletta’s ability to grow its autoimmune-focused pipeline; Cabaletta’s ability to realize its vision of launching the first curative targeted cell therapy designed specifically for patients with autoimmune diseases; Cabaletta’s ability to successfully complete research and further development and commercialization of its drug candidates in current or future indications, including the timing and results of Cabaletta’s clinical trials and its ability to conduct and complete clinical trials; statements regarding the timing of interactions with regulatory authorities, including such authorities’ review of safety information from Cabaletta’s ongoing clinical trials and potential registrational pathway for rese-cel; Cabaletta’s expectations around the potential success and therapeutic benefits of rese-cel; Cabaletta’s expectations surrounding the potential BLA submission in myositis and timing thereof; and the anticipated contribution of Cabaletta’s executives, specifically Mr. Gavel, to its operations and progress, including his ability to accelerate and enhance Cabaletta’s ability to maximize the value of rese-cel for patients, payers and providers, to attract a world-class team to prepare for and to execute the launch of rese-cel and his ability to leverage previous experience and provide enduring value to Cabaletta.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs 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, but are not limited to: risks related to regulatory filings and potential clearance; the risk that signs of biologic activity or persistence may not inform long-term results; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of rese-cel; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results we seek to achieve with rese-cel; risks that modifications to trial design or approach may not have the intended benefits and that the trial design may need to be further modified; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

Contacts:

Anup Marda
Chief Financial Officer
investors@cabalettabio.com

FAQ

Who is Steve Gavel and what will he do as Cabaletta Bio CCO (CABA)?

Steve Gavel joins as Chief Commercial Officer to lead global commercial strategy and launch planning for rese-cel and future programs.

When does Cabaletta expect to submit the BLA for rese-cel in myositis (CABA)?

The company anticipates a first BLA submission in myositis in 2027.

What are the terms of Steve Gavel’s inducement option award at Cabaletta (CABA)?

Grant of 275,000 non-qualified stock options at an exercise price of $2.49, 10-year term, vesting over four years under the 2025 Inducement Plan.

How does Steve Gavel’s background relate to Cabaletta’s plans (CABA)?

He led CAR T commercialization and the CARVYKTI launch at Legend Biotech (2018–2025), providing experience relevant to rese-cel launch planning.

Was the inducement grant approved under Nasdaq rules for Cabaletta (CABA)?

Yes; the award was approved in accordance with Nasdaq Listing Rule 5635(c)(4).

What is the vesting schedule for Gavel’s Cabaletta stock options (CABA)?

Options vest 25% at one year, then the remainder in 12 equal quarterly installments over the next three years.