On November 12, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported their partner Taiho Oncology, Inc. completed a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations.

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The submission was made under the FDA’s Real-Time Oncology Review (RTOR) program, which allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. The completed application will undergo the standard review period with the FDA, and, if accepted, a Prescription Drug User Fee Act (PDUFA) target action date will be assigned.

The NDA is based on the Phase 3 REZILIENT3 trial, which met its primary endpoint at an interim analysis, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) for zipalertinib plus chemotherapy versus chemotherapy alone. These results were presented in a Presidential Symposium at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC).

Cullinan Therapeutics is eligible to receive $30 million and $100 million in milestone payments upon second-line and first-line U.S. regulatory approvals, respectively.

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Cullinan Oncology, NOV 12, 2026, View Source [SID1234674717])

On November 12, 2026 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a genome engineering company developing genetic medicines for diseases that today demand a lifetime of treatment, reported financial results for the third quarter 2026 ended September 30, 2026, and provided a business update.

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« Since September, our teams have been fully committed to our new in vivo gene editing chapter, and the expanded preclinical data we presented at ESGCT for .HEAL-101 reinforce our conviction » said André Choulika, Ph.D., Co-founder and Chief Executive Officer of Cellectis. « After a single administration, .HEAL-101 edited the human APOC3 gene at rates of up to 70% in a humanized liver model, with editing restricted to the liver, and consistently reduced triglycerides by 76% in a disease model. These results support the continued development of .HEAL-101, and the initiation of an investigator-initiated trial in China is on track with the goal of delivering first clinical data for .HEAL-101 in the second half of 2027.

In Vivo Gene Editing Pipeline

.HEAL-101 – In vivo base editing of APOC3 for severe hypertriglyceridemia (sHTG)

Expanded preclinical data presented in a poster at the European Society of Gene and Cell Therapy (ESGCT) 2026 Congress support the potential of .HEAL-101 to achieve efficient and specific APOC3 editing after a single administration:

In vitro: ~90% mean APOC3 editing in a human hepatic cell line, with no DNA double-strand breaks at the target site.

In vivo: in a normolipidemic humanized liver mouse model, a single intravenous dose of .HEAL-101 (LNP-mRNA) edited human APOC3 at a mean rate of ~65%, reaching up to 70%.

Disease model: in a hypertriglyceridemic human APOC3 transgenic mouse model, .HEAL-101 reduced APOC3 by 67% ± 12% and triglycerides by 75% ± 11% (mean ± standard deviation).

Liver-restricted activity: editing was detected in the liver, with no significant activity in the other tissues analyzed.
The initiation of the Phase 1 investigator-initiated trial (IIT) in China is on track, with preliminary clinical data expected in the second half of 2027.

.HEAL-201 – In vivo epigenetic editing of PCSK9 for severe hypercholesterolemia (sHC)

Preclinical data support the potential of .HEAL-201 to durably silence PCSK9 without altering the DNA sequence:

In vitro: in a human hepatic cell line, PCSK9 TALE epigenetic modulator (TALEM) mRNA achieved high on-site epigenetic editing (mean >90%), resulting in a deep and stable reduction of PCSK9 transcript levels and PCSK9 secretion, with no off-site changes in gene or protein expression detected.
In vivo: intravenous injection of PCSK9 TALEM mRNA LNPs reduced mean plasma PCSK9 levels by more than 90% in a liver-humanized mouse model.
Cellectis plans to initiate a Phase 1 IIT in China, with preliminary clinical data expected in the first half of 2028.

Strategic Transformation Update

Cellectis continues to execute the strategic transformation announced on September 14, 2026, to become an in vivo gene editing company. As part of this transformation, Cellectis’ discontinuation of the lasme-cel and eti-cel clinical programs is proceeding as planned: enrollment has stopped, site close-out activities are underway, and treated patients will continue to be monitored in accordance with protocol-specified follow-up requirements.

The realignment of the Company’s operating model is ongoing. In connection with this initiative, the Company currently expects its global headcount to be reduced by up to 70% from its pre-transition level over the course of 2026 and 2027, subject to the completion of the applicable French works council consultation process and the compliance with applicable French and U.S. labor law requirements.

Partnerships

AstraZeneca – Joint Research and Collaboration Agreement

Activities are continuing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.

Servier (through its sublicensee Allogene) – Anti-CD19 CAR-T

In November 2026, Allogene announced that cema-cel is being evaluated in ALPHA3, the first pivotal, randomized trial in LBCL designed to assess whether minimal residual disease (MRD)-guided treatment following first-line therapy can delay or prevent clinical relapse, and that it continues to anticipate its next clinical update in mid-2027, with trial enrollment expected to be completed by year-end 2027.

Cema-cel is a product candidate licensed to Servier under the License, Development and Commercialization Agreement signed by and between les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and Cellectis (the "Servier Agreement") and sublicensed by Servier to Allogene in certain territories.

Iovance

In November 2026, Iovance announced that a Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL (tumor infiltrating lymphocyte) therapy, is enrolling patients with previously treated metastatic melanoma and mNSCLC (non-squamous metastatic non-small-cell lung cancer). IOV-4001 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the TME (tumor microenvironment).

Financial Results

Cash, cash equivalent and fixed-term deposits: As of September 30, 2026, Cellectis had $149 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current and non-current financial assets. When the Company’s realignment is fully implemented as planned, the Company believes that its existing cash and cash equivalents, together with fixed-term bank deposits, will be sufficient to fund its operations into the second half of 2028.

This compares to $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2025. The $62 million change was primarily driven by payments to suppliers of $37.9 million, payroll-related payments (salaries, bonuses and social charges) totaling $37.5 million, lease liability payments of $7.3 million, repayments of $4.0 million under the "PGE" loan and capital expenditures of $1.9 million, partially offset by $21.4 million of cash received from customers and $5.4 million of interest received from our financial and cash-equivalent investments.

We currently foresee focusing our cash spending at Cellectis primarily in supporting the development of our pipeline of product candidates, including .HEAL-101, .HEAL-201, potential new product candidates, and one-off restructuring costs.

Revenues and Other Income: Consolidated revenues and other income were $19.9 million for the nine-month period ended September 30, 2026, compared to $67.4 million for the nine-month period ended September 30, 2025. The $47.5 million decrease between the nine-month periods ended September 30, 2025 and 2026 was primarily attributable to a $47.8 million decrease in revenues mainly driven by the level of activities performed under the Research Plans of the AstraZeneca Joint Research Collaboration Agreement in the nine-month period of 2026. It was partially offset by a $0.3 million increase, which was mainly attributable to a higher research tax credit resulting from increased eligible R&D expenses.

R&D Expenses: Consolidated R&D expenses were $108.8 million for the nine-month period ended September 30, 2026, compared to $69.1 million for the nine-month period ended September 30, 2025. The $39.7 million increase was primarily driven by a $34.9 million impact from the strategic transformation announced in September 2026, including a $26.6 million one-off impairment loss, $6.2 million of termination benefits and $2.1 million of costs related to the close-out of the lasme-cel and eti-cel programs. Excluding the above impacts, research and development expenses increased by $4.8 million during the nine-month period ended September 30, 2026 compared with the same period in 2025, primarily driven by (i) a $1.4 million increase in non-cash stock-based compensation expense associated with awards granted in 2026, reflecting higher grant-date fair value due to an increase in the underlying share price, and (ii) a $2.1 million increase in purchases and external expenses, mainly attributable to higher clinical development costs related to the lasme-cel and eti-cel studies incurred prior to the strategic transformation announced in September 2026, as well as the .HEAL-101 and .HEAL-201 programs.

SG&A Expenses: Consolidated SG&A expenses were $17.5 million for the nine-month period ended September 30, 2026, compared to $15.0 million for the nine-month period ended September 30, 2025. The $2.5 million increase was primarily driven by a $1.1 million impact from the strategic transformation announced in September 2026, including $0.9 million of termination benefits related to the Group’s restructuring plan in the United States and France, and a $0.3 million impairment loss on our facility assets. Excluding the above impacts, selling, general and administrative expenses increased by $1.4 million, mainly due to higher stock-based compensation expense resulting from awards granted in 2026, whose grant-date fair value increased due to a higher underlying share price and to a slight increase in purchases and external expenses.

Net financial gain (loss): The consolidated net financial gain for the nine-month period ended September 30, 2026 was $5.2 million, compared to a $25.6 million net financial loss for the nine-month period ended September 30, 2025. The $30.8 million difference reflects a $10.8 million increase in financial income and a $20.0 million decrease in financial expenses.

The $10.8 million increase in financial income was primarily attributable to (i) a $14.3 million increase in non-cash gains recognized from fair value measurements, mainly reflecting a $15.1 million gain from the fair value measurement of the Tranche A, B and C warrants issued to the European Investment Bank ("EIB") during the period, compared with a $5.8 million fair value loss in the same period in 2025, partially offset by (ii) a $2.7 million decrease in interest income earned on cash, cash equivalents and financial assets, and (iii) a $1.0 million decrease in foreign exchange gains.

The $20 million decrease in financial expenses was primarily attributable to (i) a $23.7 million decrease in foreign exchange losses, mainly resulting from the appreciation of the US dollar against the euro, (ii) a $5.9 million decrease in losses from fair value measurements, as Tranche A, B and C warrants issued to the EIB generated a fair value gain during the period, partly offset by (iii) the recognition of a $9.4 million Expected Credit Loss (ECL) allowance on the financial guaranty contract with Cibus’ landlord.

Net Loss Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $101.1 million (or a $1.00 net loss per share) for the nine-month period ended September 30, 2026, compared to a $41.3 million net loss (or a $0.41 net loss per share) for the nine-month period ended September 30, 2025. The $59.8 million increase in net loss was mainly due to (i) a $90.5 million increase in operating loss, partly offset by (ii) a $30.8 million improvement in net financial result, from a net financial loss of $25.6 million as of September 30, 2025 to a net financial gain of $5.2 million as of September 30, 2026.

Adjusted Net Loss Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $95.2 million (or a $0.95 net loss per share) for the nine-month period ended September 30, 2026, compared to a net loss of $37.4 million (or a $0.37 net loss per share) for the nine-month period ended September 30, 2025.

The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board ("IFRS").

Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

(Press release, Cellectis, NOV 12, 2026, View Source [SID1234674716])

On November 12, 2026 Guardant Health, Inc. ("Guardant Health") (Nasdaq: GH), a leading precision oncology company, reported the pricing of its offering of $500 million aggregate principal amount of 0% convertible senior notes due 2032 (the "notes") in a private offering (the "offering") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The issuance and sale of the notes are scheduled to settle on November 16, 2026, subject to customary closing conditions. Guardant Health also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $50.0 million aggregate principal amount of notes.

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The notes will be senior, unsecured obligations of Guardant Health. The notes will not bear regular interest, and the principal amount of the notes will not accrete. The notes will mature on May 15, 2032, unless earlier converted, redeemed or repurchased by Guardant Health. Before February 15, 2032, noteholders will have the right to convert all or any portion of their notes only in certain circumstances. From and after February 15, 2032 until the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at any time at their election. Guardant Health will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Guardant Health’s election. The initial conversion rate is 4.7858 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $208.95 per share of common stock, and will be subject to customary anti-dilution adjustments. The initial conversion price represents a premium of approximately 35.0% above the last reported sale price of $154.78 per share of Guardant Health’s common stock on November 11, 2026.

Except as described in the second succeeding sentence with respect to a cleanup redemption, the notes will not be redeemable at Guardant Health’s election at any time before November 20, 2029. The notes will be redeemable, in whole or in part, for cash at Guardant Health’s option at any time, and from time to time, on a redemption date on or after November 20, 2029 and on or before the 25th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Guardant Health’s common stock exceeds 130% of the conversion price for a specified period of time (each, a "provisional redemption"). In addition, Guardant Health may redeem for cash all, but not less than all, of the notes at any time on or before the 25th scheduled trading day immediately before the maturity date if the aggregate principal amount of the notes outstanding at the time Guardant Health sends the related redemption notice is less than $50.0 million and the notes are freely tradable as of the date Guardant Health sends the related redemption notice (each, a "cleanup redemption"). The redemption price for any provisional redemption or cleanup redemption, as applicable, will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid special interest and additional interest, if any, to, but excluding, the redemption date.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then, subject to limited exceptions, noteholders may require Guardant Health to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid special interest and additional interest, if any, to, but excluding, the applicable fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date of the notes or if Guardant Health delivers a notice of redemption, Guardant Health will, in certain circumstances, increase the conversion rate of the notes for a noteholder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption during the related redemption period, as the case may be.

Guardant Health estimates that the net proceeds from the offering will be approximately $489.3 million (or approximately $538.3 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses. Assuming the initial purchasers exercise their option to purchase additional notes in full and the entry into the additional capped call transactions, Guardant Health expects to use approximately $501.7 million of the net proceeds to repurchase for cash approximately $395.2 aggregate principal amount of its 0% convertible senior notes due 2027 (the "2027 notes") in the note repurchase transactions described below and Guardant Health intends to use the remaining net proceeds, plus cash on hand, to fund the $51.7 million cost of entering into the capped call transactions described below. This press release is not an offer to repurchase any 2027 notes and the offering is not contingent upon the repurchase of any 2027 notes.

In connection with the pricing of the notes, Guardant Health entered into privately negotiated capped call transactions with certain financial institutions (the "option counterparties"). The capped call transactions cover, subject to customary adjustments, the number of shares of common stock initially underlying the notes. The capped call transactions are expected generally to reduce potential dilution to Guardant Health’s common stock upon conversion of the notes or at Guardant Health’s election (subject to certain conditions) offset any cash payments Guardant Health is required to make in excess of the aggregate principal amount of converted notes, as the case may be, with such reduction or offset subject to a cap. The cap price of the capped call transactions is initially $309.5600, which represents a premium of 100.0% above the last reported sale price of Guardant Health’s common stock of $154.78 per share on November 11, 2026, and is subject to certain adjustments under the terms of the capped call transactions.

Assuming the initial purchasers exercise their option to purchase additional notes in full, Guardant Health expects to use approximately $501.7 million of the net proceeds to repurchase for cash approximately $395.2 aggregate principal amount of the 2027 notes in privately negotiated transactions (each, a "note repurchase transaction") entered into concurrently with the pricing of the offering through one of the initial purchasers or its affiliate, as Guardant Health’s agent.

Guardant Health has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to purchase shares of Guardant Health’s common stock and/or enter into various derivative transactions with respect to Guardant Health’s common stock concurrently with or shortly after the pricing of the notes. Further, in connection with any note repurchase transaction, Guardant Health expects that holders of the 2027 notes who agreed to have their 2027 notes repurchased and who have hedged their equity price risk with respect to such 2027 notes (the "hedged holders") will, concurrently with, or shortly after, the pricing of the notes, unwind all or part of their hedge positions by buying Guardant Health’s common stock and/or entering into or unwinding various derivative transactions with respect to Guardant Health’s common stock. The amount of Guardant Health’s common stock that may be purchased by the hedged holders or in connection with such derivative transactions may be substantial in relation to the historic average daily trading volume of Guardant Health’s common stock. These activities by the option counterparties and the hedged holders could increase (or reduce the size of any decrease in) the market price of Guardant Health’s common stock, including concurrently with the pricing of the notes, which could have resulted in a higher effective conversion price of the notes. Guardant Health cannot predict the magnitude of any such market activity or the overall effect it would have on the trading price of the notes or Guardant Health’s common stock.

In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Guardant Health’s common stock and/or purchasing or selling Guardant Health’s common stock or other securities of Guardant Health in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 25 trading day period beginning on the 26th scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Guardant Health’s common stock or the notes, which could affect a noteholder’s ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares and value of the consideration that a noteholder will receive upon conversion of the notes.

In addition, if any such capped call transaction fails to become effective, whether or not the offering of the notes is completed, the option counterparty party thereto may unwind its hedge positions with respect to Guardant Health’s common stock, which could adversely affect the value of Guardant Health’s common stock and, if the notes have been issued, the value of the notes.

The notes sold in the offering were only offered to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A promulgated under the Securities Act by means of a private offering memorandum. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release is not an offer to sell nor a solicitation of an offer to buy any of the securities being offered in the offering or any shares of common stock issuable upon conversion of the notes, nor shall it constitute an offer, solicitation or sale of any securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

(Press release, Guardant Health, NOV 12, 2026, View Source [SID1234674715])

On November 12, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer, reported the pricing of its underwritten public offering of 15,000,000 shares of its common stock at a price to the public of $10.00 per share. The gross proceeds to Vir Biotechnology from the offering are expected to be $150 million, before deducting underwriting discounts and commissions and offering expenses. In addition, Vir Biotechnology has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering are being sold by Vir Biotechnology. Closing of the offering is expected to occur on November 16, 2026, subject to customary closing conditions.

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Leerink Partners, Morgan Stanley and Evercore ISI are acting as bookrunning managers for the offering. Raymond James is acting as co-manager for the offering.

The shares described above are being offered pursuant to a registration statement that was filed with the U.S. Securities and Exchange Commission (the SEC) on November 12, 2026 and became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on November 12, 2026. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Vir Biotechnology, NOV 12, 2026, View Source [SID1234674714])

On November 12, 2026 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 325+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported an update on the status of its intellectual property portfolio. The portfolio now includes 170 issued patents and has grown to more than 325 patents issued and pending worldwide. This solidifies its position as the world leader in intellectual property surrounding the therapeutic use of fibroblasts.

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Fibroblasts are the most common cells in connective tissue, and for most of the history of medicine they were treated as a background structural cell. FibroBiologics was founded on a different view – the cell that repairs the body can be developed into a therapeutic. Leadership in intellectual property is what allows the company to act on that view over the long term. A broad patent position allows FibroBiologics to pursue many diseases from one platform and give partners clear and durable rights on which to build.

The portfolio has been built steadily since FibroBiologics was founded in 2021. Issued patents have grown from 124 on December 31, 2025, to 170 today. Patents granted in 2026 include U.S. patents covering wound healing, type 1 diabetes, osteoporosis, cachexia, and degenerative disc disease, and European patents covering methods of enhancing fibroblast therapeutic activity and fibroblast delivery of tumor inhibitory agents.

Coverage and strength of the portfolio include:

Issued patents and pending applications cover the use of fibroblasts and fibroblast-derived materials across multiple clinical pathways, including degenerative disc disease, cartilage and joint repair, osteoporosis, wound healing, multiple sclerosis, psoriasis, lupus, type 1 diabetes, cachexia, and cancer. Additional patent families address immune function, regeneration of the thymus and spleen, skin, and human longevity.

The portfolio protects how fibroblast therapies are made as well as what they treat. Manufacturing and platform coverage includes methods of enhancing and augmenting fibroblast therapeutic activity, preparation of three-dimensional fibroblast spheroids, automated generation of core-shell spheroids, generation of multipotent cells from donor tissue, gene modification, surface marker modification to direct cells to specific tissues and organs, fibroblast conditioned media, organoids, and oral delivery systems.

The portfolio spans more than 50 patent families, with more than 150 applications still pending. Recent filings include injectable thymus organoids, three-dimensional cell aggregates that produce and secrete therapeutic peptides, and orally delivered fibroblast therapeutics.
"When the first application in this portfolio was filed, fibroblasts were not on anyone’s list of promising cell therapies," said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. "We thought they should be, so we kept inventing, discovering, and filing…one idea at a time. Today we have 170 issued patents and more than 325 issued and pending. That is the largest position in the world for the therapeutic use of fibroblasts. I want to be clear about why that matters. Patents are not the goal. Patients are the goal. What a portfolio like this gives us is the ability to keep investing in hard problems, and to bring in partners who want to build with us. We are optimistic, and the future is exciting for this cell."

"Every patent in this portfolio started as a question at the bench," said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. "How do you grow fibroblasts in three dimensions to strengthen their therapeutic activity? How do you produce spheroids consistently and at scale? How do you direct a cell to the tissue that needs it? The answers became inventions, and the inventions now protect both our therapies and the methods we use to make them. That pairing is important. Covering what a cell therapy does has value, and covering how it is made reliably is what allows it to reach patients. Our scientists are still asking new questions, and I expect the portfolio to keep growing with the science."

About the Technology

Fibroblasts are the most common cell type found in connective tissue and play a central role in tissue repair. They are abundant, can be isolated from donor tissue, and expand readily in culture, which makes them practical to manufacture as a cell therapy. FibroBiologics develops fibroblasts as cultured cells and as three-dimensional spheroids, together with fibroblast-derived materials such as conditioned media and extracellular vesicles. The company’s patented approaches apply this platform to chronic diseases, with the goal of repairing tissue, modulating the immune system, and delivering therapeutic agents where they are needed.

(Press release, FibroBiologics, NOV 12, 2026, View Source [SID1234674713])