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Lifecore Biomedical Signs New Agreement with Indomo to Support Innovative Drug/Device Combination Acne Treatment

(Positive)
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Lifecore Biomedical (NASDAQ: LFCR) signed a development services agreement with Indomo to manufacture engineering and clinical batches of DT-001, a corticosteroid formulation intended for use with Indomo’s ClearPen™ intradermal self-injection device. Lifecore will supply batches to support planned studies and prepare DT-001 for anticipated Phase 2 clinical trials in 2026.

The agreement expands Lifecore’s work beyond ophthalmics into device-enabled injectable therapeutics and continues a prior collaboration on formulation and process optimization for DT-001.

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Positive

  • Lifecore to produce engineering and clinical batches for DT-001
  • Program advancing toward anticipated Phase 2 clinical trials in 2026
  • Expanded CDMO scope beyond ophthalmic therapies into autoinjector technologies

Negative

  • DT-001 still pre-Phase 2, commercial outcomes remain uncertain
  • Current corticosteroid injection adoption is low: 1M patients receive injections versus 50M affected

News Market Reaction – LFCR

-0.57%
-0.57% Session close to close

In the Mar 5 session, LFCR declined 0.57%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds another CDMO development agreement, supporting Lifecore’s focus on injectable...
Analysis

This announcement adds another CDMO development agreement, supporting Lifecore’s focus on injectable therapeutics by supplying engineering and clinical batches of DT-001 ahead of planned Phase 2 studies in 2026. It builds on a prior Indomo formulation agreement and complements earlier CDMO wins, such as the large multinational deal disclosed on Dec 17, 2025. Investors may track execution on this program alongside existing factors like the Form S-3 for 20,456,637 registered shares and previously reported internal control weaknesses.

Key Figures

Acne prevalence U.S.: 50 million Americans Corticosteroid injection patients: 1 million people Dermatologists in U.S.: 12,000 dermatologists +5 more
8 metrics
Acne prevalence U.S. 50 million Americans People affected annually by acne in the U.S.
Corticosteroid injection patients 1 million people Americans regularly receiving corticosteroid injections for inflammatory lesions
Dermatologists in U.S. 12,000 dermatologists Dermatologist count driving access constraints
Dermatologist coverage 1 per 28,000 Americans Dermatologist-to-population ratio cited in article
Shelf registered shares 20,456,637 shares Form S-3 shelf for resale by selling stockholders
Issued shares registered 6,556,521 shares Common shares already issued included in S-3
Convertible preferred shares 13,900,116 shares Shares issuable upon conversion of Series A Convertible Preferred Stock
PIK dividend rate 7.5% per annum Series A Convertible Preferred Stock dividend rate

Historical Context

5 past events · Latest: Feb 17 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Feb 17 Conference participation Neutral +1.1% Announced participation at DCAT Week 2026 for customer and partner meetings.
Jan 16 Equity inducement grants Neutral +0.4% Reported RSU and option grants to newly hired employees under inducement plan.
Dec 18 Index inclusion Positive -0.6% Planned addition to the Nasdaq Biotechnology Index following annual reconstitution.
Dec 17 CDMO master agreement Positive +9.9% Signed CDMO master services deal with large multinational pharma for injectable product.
Dec 16 Conference participation Neutral -2.2% Announced participation in the 44th Annual J.P. Morgan Healthcare Conference.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive commercial/partnership news has often aligned with gains, while index/conference items show mixed reactions.

Recent Company History

Over the past several months, Lifecore has issued a series of strategic and corporate updates. A Dec 17, 2025 CDMO master services agreement with a large multinational customer coincided with a 9.86% gain, highlighting market focus on contract wins. Inclusion in the Nasdaq Biotech Index on Dec 18, 2025 saw a modest -0.59% move, and conference participation headlines in December 2025 and February 2026 produced small, mixed reactions. The new Indomo agreement extends this CDMO-focused trajectory, adding another development services relationship to the company’s growing pipeline of injectable programs.

Key Terms

intradermal, self-injection device, cdmo, corticosteroid, +4 more
8 terms
intradermal medical
"its investigational intradermal self-injection device, the ClearPen™"
Intradermal means delivering a drug or vaccine into the middle layer of the skin rather than into muscle or under the skin. Investors care because this delivery route can change how much of a product is needed, how fast it works, and what safety or regulatory testing is required—similar to placing a small patch inside the layers of a cake to get a different effect than spreading it on top.
self-injection device technical
"its investigational intradermal self-injection device, the ClearPen™"
A self-injection device is a user-friendly tool—often a pen-like injector or spring-loaded syringe—designed so patients can give prescribed medicines to themselves safely and easily outside a clinic. It matters to investors because such devices can broaden a drug’s customer base, improve treatment adherence, affect production costs, and carry regulatory, patent and supply-chain implications that influence sales, pricing and company risk.
cdmo financial
"a fully integrated injectables contract development and manufacturing organization (“CDMO”)"
A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.
corticosteroid medical
"continued development of its corticosteroid drug candidate, DT-001."
A corticosteroid is a class of prescription medicines that reduce inflammation and calm an overactive immune response, like turning down an overly sensitive alarm system in the body. Investors care because these drugs are common in treating many conditions, can drive sales or liability risks based on safety and regulatory decisions, and often affect the value of companies developing, manufacturing, or testing related therapies.
triamcinolone acetonide medical
"a modernized formulation of triamcinolone acetonide to enable consistent dosing"
Triamcinolone acetonide is a synthetic steroid medication used to reduce inflammation and suppress immune responses, available as creams, injections, inhalers, and eye drops. Investors pay attention because approval, patent status, supply issues, or new uses can change sales expectations for drug makers—think of it as a widely used tool whose availability and regulatory standing can raise or lower a company’s revenue forecasts.
microneedle medical
"pairs a proprietary self-injection device and microneedle with a modernized formulation"
A microneedle is a tiny, often patch-like array of microscopic needles designed to deliver drugs, vaccines or other substances through the outer layer of the skin with minimal pain. Think of it as a bandage with very fine pins that bypass the skin barrier to release medicine directly where it can be absorbed faster and more reliably. Investors care because microneedle technology can create new product formats, improve patient uptake, reduce dosing costs and manufacturing challenges, and affect market size, regulatory pathways and intellectual property value.
intralesional injections medical
"Intralesional injections of triamcinolone acetonide, a corticosteroid backed by more than 50 years"
A procedure in which a drug or therapeutic agent is injected directly into an abnormal area of tissue (a lesion), such as a skin spot, tumor, or localized inflammation, so the treatment acts where the problem is. Investors care because this targeted delivery can boost effectiveness and lower systemic side effects versus whole-body dosing, which can mean smaller doses, clearer regulatory results, niche clinical uses, and potential pricing advantages—like dabbing a cleaner on a stain instead of washing the entire garment.
phase 2 medical
"prepare the product for anticipated advancement into Phase 2 clinical trials in 2026."
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

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Indomo Developing Fast-Acting, At-Home Treatment for Inflammatory Acne Lesions to be Administered with the ClearPen, its Proprietary Intradermal Self-Injection Device

Lifecore to Manufacture Drug Batches in Preparation for Planned Clinical Trials

CHASKA, Minn. and BOSTON, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated injectables contract development and manufacturing organization (“CDMO”), and Indomo, a clinical-stage company dedicated to expanding access to quality healthcare via innovative device-enabled therapeutics, today announced that the companies have entered into a new development services agreement through which Lifecore will provide Indomo with a range of CDMO services to support the continued development of its corticosteroid drug candidate, DT-001. Indomo is developing DT-001 to be combined with its investigational intradermal self-injection device, the ClearPen, as a treatment for inflammatory acne lesions.

This represents the second agreement signed by the companies, with Lifecore having previously been selected to provide formulation and process optimization activities in support of the DT-001 program. Under the terms of the latest agreement, Lifecore will be responsible for producing and supplying engineering and clinical batches of DT-001 to Indomo for planned studies designed to prepare the product for anticipated advancement into Phase 2 clinical trials in 2026.

“We are thrilled to continue to grow our relationship with Indomo and support a customer that possesses such high-quality leadership and ambitious plans for innovation. This work with Indomo highlights the success of our continued efforts to expand beyond our traditional focus in ophthalmic therapies, while also enhancing our leadership in rapidly growing autoinjector technologies,” said Paul Josephs, president and chief executive officer of Lifecore. “We are excited to get to work on producing engineering and clinical batches for Indomo and supporting the company’s plans to move into Phase 2 studies.”

Built by a team with deep expertise in medical devices, consumer health, and skincare, Indomo’s investigational ClearPen system pairs a proprietary self-injection device and microneedle with a modernized formulation of triamcinolone acetonide to enable consistent dosing for at-home administration.

Intralesional injections of triamcinolone acetonide, a corticosteroid backed by more than 50 years of clinical use and a strong safety profile, are recommended as one of the first-line treatments for acne by the American Academy of Dermatology. Acne is the most common skin condition in the U.S., affecting 50 million Americans annually, yet only one million people are regularly receiving corticosteroid injections to treat their inflammatory lesions. The root cause of this issue is accessibility. With only 12,000 dermatologists in the U.S., there is only one dermatologist for every 28,000 Americans. Indomo aims to improve access by pursuing an at-home approach intended to empower patients with timely access to care.

“As we progress toward Phase 2 studies, it was critical for Indomo to partner with a CDMO that combines technical excellence with a forward-looking approach to innovation. Lifecore’s expanding leadership in injectable therapeutics and their commitment to speed and high-quality execution position them as a key partner in advancing our therapeutic pipeline. We are excited to deepen this collaboration as we move into the next phase of development,” said Rick Bente, chief executive officer of Indomo.

About Lifecore Biomedical
Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com.

About Indomo
Indomo is reimagining clinical dermatology with trusted science and precision technology, bringing medical-grade care into the home. A clinical-stage therapeutics company, Indomo pairs proven medicines with novel delivery systems to create fast-acting, self-administered treatments for inflammatory skin conditions. Its debut product, the ClearPen, will combine an established, trusted therapeutic with a novel microneedle device for at-home acne treatment. Indomo is backed by leading investors including Atomic, Foresite Capital, and Polaris Partners. Founded by leaders from Hims & Hers, Medtronic, and Starface, Indomo brings together deep expertise in telehealth, medical devices, and consumer skincare. To learn more about Indomo and their Phase 2 clinical trials, head here.

Disclaimer: The Indomo ClearPen has not yet been approved or cleared by the U.S. Food and Drug Administration and is considered investigational; preparations are underway for Phase 2 clinical trials.

Important Cautions Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding future events and Lifecore’s future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding Lifecore’s expansion of Lifecore’s CDMO business, broadening of Lifecore’s commercial customer base, the anticipated advancement of Indomo’s DT-001 program into Phase 2 clinical trials in 2026, our efforts to expand beyond Lifecore’s traditional focus in ophthalmic therapies, enhancing Lifecore’s leadership in rapidly growing autoinjector technologies, Lifecore’s forward-looking approach to innovation, Lifecore’s expanding leadership in injectable therapeutics, and Lifecore’s commitment to speed and high-quality execution are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, the timing and amount of future expenses, revenue, net income (loss), Adjusted EBITDA, cash flow and capital requirements, and timing and availability of and the need for additional financing; Lifecore’s ability to maintain or expand Lifecore’s relationships with Lifecore’s current customers, including the impact of changes in consumer demand for the products Lifecore manufactures for Lifecore’s customers; Lifecore’s ability to grow and diversify Lifecore’s business with new customers, including the potential loss of development customers or delays in our development customers’ programs if they do not receive required funding or regulatory approvals, or for other reasons; Lifecore’s ability to comply with covenants under Lifecore’s credit agreements and to pay required interest and principal payments when due; Lifecore’s ability to fund any redemptions of shares of its outstanding Series A Convertible Preferred Stock if requested by holders in accordance with their terms; Lifecore’s ability to raise additional capital for ongoing needs, including through equity financing, debt financing, collaborations, strategic alliances or licensing arrangements; the impact of macroeconomic events or circumstances on Lifecore’s operations and financial performance, including inflation, tariffs, interest rates, social unrest and global instability; the performance of Lifecore’s third-party suppliers; pharmaceutical industry market forces that may impact Lifecore’s customers’ success and continued demand for the products Lifecore produces for those customers; Lifecore’s ability to recruit or retain key scientific, technical, business development, and management personnel and Lifecore’s executive officers; Lifecore’s ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including current Good Manufacturing Practice, or cGMP; the outcome and cost of existing and any new litigation or regulatory proceedings; and other risk factors set forth from time to time in the company’s filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the Annual Report on Form 10-K for the year ended May 25, 2025 (the “2025 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Lifecore’s filings with the SEC, including the risk factors contained in the 2025 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, Lifecore does not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

Lifecore Biomedical, Inc. Contact Information:

Vida Strategic Partners
Stephanie Diaz (Investors & Media)
415-675-7401
sdiaz@vidasp.com

Ryan D. Lake (CFO)
Lifecore Biomedical
952-368-6244
ryan.lake@lifecore.com


FAQ

What did Lifecore (LFCR) agree to provide Indomo for the DT-001 program?

Lifecore will manufacture and supply engineering and clinical batches of DT-001 to Indomo. According to Lifecore, these batches will support planned studies aimed at preparing DT-001 for anticipated Phase 2 trials in 2026.

Does the Indomo ClearPen™ use an approved drug or a new formulation for acne?

Indomo pairs a modernized formulation of triamcinolone acetonide with the ClearPen™ for intradermal self-injection. According to Indomo, triamcinolone has over 50 years of clinical use and a well‑established safety profile.

When is DT-001 expected to reach Phase 2 clinical trials according to the companies?

The companies anticipate advancing DT-001 into Phase 2 clinical trials in 2026. According to Lifecore, current manufacturing work will produce batches to support studies that prepare the program for that Phase 2 timeline.

How does the Lifecore-Indomo agreement affect Lifecore (LFCR) business focus?

The agreement broadens Lifecore’s CDMO scope beyond ophthalmics into device-enabled injectables and autoinjector technologies. According to Lifecore, this work strengthens its position in rapidly growing autoinjector markets.

What market access problem is Indomo aiming to address with ClearPen and DT-001?

Indomo aims to increase access to intralesional corticosteroid treatment by enabling at-home administration with ClearPen. According to Indomo, only about 1 million people currently receive injections despite 50 million Americans affected by acne annually.

Will Lifecore’s work with Indomo include formulation activities for DT-001?

Yes, Lifecore previously provided formulation and process optimization and will now also produce engineering and clinical batches. According to Lifecore, this continues their collaboration to advance the DT-001 program.