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Precigen Reports First Quarter 2026 Financial Results and Business Updates

On May 13, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported first quarter 2026 financial results and business updates.

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"We are thrilled with the strength of the PAPZIMEOS launch and the pace of revenue growth as we drive broad commercial success across the US and work toward expanded market opportunities in additional geographies and the pediatric patient population," said Helen Sabzevari, PhD, President and CEO of Precigen. "Looking ahead, we are excited to advance the next chapter of our AdenoVerse platform through the continued development of PRGN-2009 in HPV-associated cancers, and look forward to sharing more details on our broader pipeline progress later this year. We are also proud to once again collaborate with the Recurrent Respiratory Papillomatosis Foundation in recognizing RRP Awareness Day for the third consecutive year on June 11, reflecting our deep and long-standing commitment to the RRP community. This year’s event carries particular significance as adult patients now have access to an approved treatment, PAPZIMEOS, for the first time in the more than 100-year history of this disease."

"We are encouraged by the strong progress we are seeing as PAPZIMEOS continues to gain traction, with approximately 400 patients currently enrolled in the PAPZIMEOS patient hub, of which a noteworthy 25% are from the community setting," said Phil Tennant, Chief Commercial Officer of Precigen. "We are focused on converting hub enrollment into treated patients, and we look forward to building on this progress in the second quarter and beyond as more sites become activated, the impact of the permanent J-code takes hold, and our targeted site support helps deliver a seamless journey to treatment."

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS: First-line Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first treatment that addresses the root cause of RRP.

· National prescribing growth: PAPZIMEOS is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment. Building on strong community practice demand, the Company’s target footprint has been expanded beyond the initial list, with increased engagement across community practices reflecting the broad interest seen since the full deployment of the PAPZIMEOS field team in September 2025.

· Patient hub enrollment: Enrollment in Precigen’s patient hub reached approximately 400 registered patients, reflecting robust and growing demand from both patients and physicians. Notably, 25% of hub-enrolled patients are from the community setting, underscoring the broad reach of PAPZIMEOS beyond academic and major centers and reinforcing that PAPZIMEOS can be effectively integrated into routine clinical practice beyond major centers. Beyond hub enrollment, the Company’s field teams continue to identify additional patients outside the hub, further underscoring the breadth of unmet need and commercial opportunity in the RRP community.

· Positive payer coverage: PAPZIMEOS has private health plan coverage spanning approximately 215 million US lives, including the significant majority of leading insurers. With additional coverage under Medicare and Medicaid, PAPZIMEOS is accessible to an estimated 297 million US lives, or over 90% of insured lives in the US, reflecting broad and growing payer support for the therapy.

· Permanent J-code accelerating site activations and patient access: Effective April 1, 2026, the Centers for Medicare and Medicaid Services assigned a permanent J-code (J3404) to PAPZIMEOS, and early indicators suggest this is already streamlining site activations. J-codes are standardized reimbursement codes that enable healthcare providers to bill government and commercial insurers for physician-administered therapies, and the permanent J-code designation is expected to further simplify claims processing and facilitate broader patient access across both medical centers and community practices.

· PAPZIMEOS recommended as standard of care first-line treatment: In January 2026, an expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line treatment for adults with RRP in the US.

· Upcoming ASCO (Free ASCO Whitepaper) clinical presentation: The Company will present updated durability of response data at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from May 29 to June 2, 2026, with a presentation titled "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial."

· Strong presence at key medical and scientific meetings: At AAO-HNSF 2025, SITC (Free SITC Whitepaper) 2025, EUROGIN 2026, and COSM 2026, the Company presented long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease’s significant clinical, economic, and human impact.

· Redosing study enrolling patients: The Company’s open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).

· MAA under review by the EMA: Following submission in November 2025, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP was validated by the European Medicines Agency and is under review. PAPZIMEOS was granted orphan drug designation by the European Commission.

· RRP Awareness Day 2026: For the third consecutive year, Precigen will collaborate with the Recurrent Respiratory Papillomatosis Foundation to co-host RRP Awareness Day on June 11. The annual initiative is dedicated to educating the public and medical community about RRP by amplifying the voices of patients, caregivers, advocates, and the healthcare community supporting them.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
· A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
· The Company plans to highlight progress across its AdenoVerse portfolio, including an update on PRGN-2009, by end of year.

FINANCIAL HIGHLIGHTS

"We are pleased with the launch performance of PAPZIMEOS, recognizing $21.6 million of net revenue in the first full quarter of its launch. In the second quarter of 2026, we are seeing continued strength in revenue growth from PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "As of March 31, 2026, the Company’s cash, cash equivalents, and investments totaled $56.7 million, which based on payment terms, did not include any collection of PAPZIMEOS related accounts receivable since launch of approximately $25.7 million. Based on our current revenue outlook and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026. Our forecasted expenditures include additional investments to progress both clinical and pre-clinical assets."

First Quarter 2026 Financial Results Compared to Prior Year Period

Total revenues increased by $21.9 million compared to the three months ended March 31, 2025. The significant increase in total revenues for the three months ended March 31, 2026 was due to the ramp up of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Revenues related to the sale of PAPZIMEOS for the three months ended March 31, 2026 were $21.6 million. No PAPZIMEOS sales were recorded for the three months ended March 31, 2025, as the product had not yet been approved.

R&D expenses decreased by $4.8 million compared to the three months ended March 31, 2025, primarily due to the change in the accounting treatment of manufacturing costs as a result of the FDA approval of PAPZIMEOS.

Selling, general, and administrative (SG&A) expenses increased by $8.7 million compared to the three months ended March 31, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025.

Total other expense, net, decreased by $29.6 million compared to the three months ended March 31, 2025. This change was primarily attributable to the absence of a $32.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $2.9 million in interest expenses related to long term debt that originated in the third quarter of 2025.

Net loss was $7.9 million, or $0.02 per basic and diluted share, for three months ended March 31, 2026, compared to a net loss of $54.2 million, or $0.18 per basic and diluted share, for the three months ended March 31, 2025.

(Press release, Precigen, MAY 13, 2026, View Source [SID1234665638])

PDS Biotech Reports First Quarter 2026 Financial Results and Provides Clinical Programs and Corporate Update

On May 13, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported business and clinical programs update and announced financial results for the quarter ended March 31, 2026.

"During the first quarter, we made meaningful clinical and regulatory progress across our clinical pipeline," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "We work towards restarting enrollment in the amended VERSATILE-003 Phase 3 trial. With regards to PDS01ADC, we have completed enrollment in the metastatic colorectal cancer trial, and the advanced castration resistant prostate cancer trial continues to recruit well".

Dr. Bedu-Addo continued: "We believe the progress achieved during the quarter reflects the continued advancement and maturation of our clinical portfolio. We remain focused on advancing potentially differentiated immunotherapy candidates designed to address significant unmet medical needs for patients with difficult-to-treat cancers".

Clinical and Corporate Update

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Amended VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.

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Announced publication of positive clinical and immunological biomarker data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) trial evaluating PDS01ADC, the Company’s tumor-targeted IL-12 immunocytokine. The results, published in the March issue of Journal of Clinical Oncology (JCO) Oncology Advances, included:

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Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)

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24-month survival rate approximately 85%; in the parallel trial without PDS01ADC, the 24-month survival rate was approximately 40%

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Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months

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Presented encouraging early results from an NCI-led trial investigating PDS01ADC at the AACR (Free AACR Whitepaper) special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline.

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Strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

First Quarter 2026 Financial Results

Reported net loss for the quarter ended March 31, 2026, was approximately $7.3 million, or $0.13 per basic and diluted share, compared to a net loss of $8.5 million, or $0.21 per basic and diluted share for the quarter ended March 31, 2025.

Research and development expenses for the quarter ended March 31, 2026, were $3.5 million, compared to $5.8 million for the quarter ended March 31, 2025. The decrease was primarily due to lower clinical and manufacturing costs.

General and administrative expenses for the year ended March 31, 2026, were $3.1 million, compared to $3.3 million for the year ended March 31, 2025. The decrease was primarily due to lower professional fees.

Total operating expenses for the year ended March 31, 2026, were $6.5 million compared to $9.1 million for the quarter ended March 31, 2025.

Net interest expense was $0.8 million for the quarter ended March 31, 2026, compared to $0.6 million for the quarter ended March 31, 2025.

The Company’s cash balance as of March 31, 2026, was $21.7 million.

Conference Call Details

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Date: May 13, 2026

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Time: 8:00 a.m. Eastern Time

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Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)

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Conference I.D.: 13760368

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Webcast: Click Here

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CallMeTM: Click Here (available 15 minutes prior to the call)

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

(Press release, PDS Biotechnology, MAY 13, 2026, View Source [SID1234665637])

Omeros Corporation Reports First Quarter 2026 Financial Results

On May 13, 2026 Omeros Corporation (Nasdaq: OMER) reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2026, which include:

First Quarter and Recent Highlights

● In January 2026, we launched YARTEMLEA in the U.S. market. During the quarter, gross product sales were $11.1 million and associated net sales, after deduction of wholesaler distribution fees and chargebacks, were $9.9 million.

● Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share, for the first quarter of 2025.

● First quarter results include a $73.1 million non-cash gain associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 unsecured convertible notes (the "2029 Notes"). Excluding the non-cash change in our embedded derivatives, non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share.

● At March 31, 2026, we had $135.3 million of cash and short-term investments. This balance includes the February 2026 repayment at maturity of the remaining $17.1 million aggregate principal amount of our 2026 unsecured convertible notes (the "2026 Notes"). Following that repayment, our only remaining debt outstanding is $70.8 million aggregate principal amount of our 2029 Notes, which mature in June 2029.

● In April, the U.S. Centers for Medicare & Medicaid Services ("CMS") assigned a permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA. This simplifies billing and reimbursement across payors. The J-code becomes effective on July 1, 2026. Also in April, CMS, in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-On Payment ("NTAP") for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost, innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP expected to be effective October 1, 2026.

"The launch of YARTEMLEA has changed the trajectory of Omeros, both operationally and financially," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We are seeing strong early adoption across transplant centers, expanding formulary access, favorable reimbursement support, and growing physician experience with the first and only approved treatment for TA-TMA. At the same time, our Novo Nordisk transaction has strengthened our balance sheet and accelerated advancement of our pipeline, including next-generation MASP-2 programs, OncotoX-AML, OMS527 for cocaine use disorder under NIDA funding, and our T-CAT platform targeting multidrug-resistant pathogens. The progress achieved this quarter further demonstrates the strength of our science and the value we are creating across Omeros."

Recent Developments

● YARTEMLEA and our other MASP-2 inhibitor programs

o A marketing authorization application ("MAA") for YARTEMLEA for the treatment of TA-TMA is currently under review by the European Medicines Agency ("EMA") with a decision expected in mid-2026. If approved, the MAA authorizes the product to be marketed in all EU member states and European Economic Area countries.

o We are assessing opportunities for YARTEMLEA across indications involving lectin pathway activation, including acute respiratory distress syndrome (ARDS), sickle cell disease, acute kidney injury, solid organ transplant-related TMA, and delayed graft function.

o In parallel, we are finalizing selection of an indication for a Phase 2 clinical program for OMS1029, our long-acting antibody targeting MASP-2. In our MASP-2 small-molecule inhibitor program, we have selected a drug development candidate and are advancing to IND-enabling studies.

● OMS527 for the treatment of addiction — cocaine use disorder program funded by the National Institute on Drug Abuse ("NIDA")

o We are developing, at NIDA’s request, our lead orally administered phosphodiesterase 7 ("PDE7") inhibitor for the treatment of cocaine use disorder. Preclinical studies, designed with NIDA toxicologists, were completed and showed no drug-interaction or safety issues, supporting the scheduled in-patient human study of OMS527 in cocaine users.

o Following FDA’s request for additional nonclinical information and a subsequent meeting with FDA to discuss that request, we are working with FDA to streamline the path to initiate the in-patient clinical trial, targeted for initiation by year-end 2026.

● Oncology platform — OncotoX-AML

o We continue to progress preclinical studies within our novel oncology program. The lead indication for development is acute myeloid leukemia ("AML"), an aggressive and highly fatal bone marrow and blood cancer. We have completed selection of a drug development candidate in the OncotoX-AML program, and IND-enabling studies are underway.

o OncotoX-AML shows broad application across AML regardless of genetic mutation, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients. In human tumor-bearing animal and in vitro human AML cell-line studies, our AML therapeutic candidate has demonstrated superior efficacy to current AML standard of care treatments.

o In February 2026, we announced the successful completion of our initial study in nonhuman primates evaluating the efficacy and safety of OncotoX-AML. Administration of only one course of OncotoX-AML treatment to immunocompetent primates demonstrated the desired pharmacologic response, selectively reducing myeloid progenitor cells, which can mutate and lead to AML, by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values.

● Targeted Complement Activating Therapy ("T-CAT") platform

o Our T-CAT platform is a new class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on multidrug-resistant organisms ("MDROs"), one of the most critical unmet needs in medicine.

o Data from our T-CAT platform were recently featured in a podium presentation at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases.

o The seminal manuscript describing our T-CAT technology was accepted for publication in Science Translational Medicine.

Financial Results

Commercial distribution and sales of YARTEMLEA commenced in January 2026. Gross product sales for the three months ended March 31, 2026 were $11.1 million, with net sales of $9.9 million. Revenue for the period reflects sales of YARTEMLEA to U.S. wholesalers.

Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share for the first quarter of 2025.

The change in fair value of financial instruments as shown in our statement of operations and comprehensive income (loss) reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net gain on the change in the fair value of our financial instruments, which is non-cash, our non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share.

At March 31, 2026, we had $135.3 million of cash and short-term investments. Upon their maturity in February 2026, we repaid the remaining $17.1 million outstanding principal balance of our 2026 Notes and currently have only $70.8 million aggregate principal amount outstanding of our 2029 Notes, which mature in June 2029.

Total operating expenses for the three months ended March 31, 2026 were $27.3 million compared to $35.0 million for the three months ended March 31, 2025. The $7.7 million decrease was primarily due to reduced OMS906-related research and development work as a result of the zaltenibart asset sale and licensing agreement with Novo Nordisk in November 2025.

Interest expense increased $2.2 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The increase primarily relates to interest incurred on the 2029 Notes and, to a lesser extent, a non-cash remeasurement charge taken on our OMIDRIA royalty obligation in the prior year, offset by decreased interest incurred on our 2026 Notes, which were repaid in February 2026.

Interest and other income was $1.5 million for the three months ended March 31, 2026 compared to $1.1 million for the three months ended March 31, 2025 due to holding higher cash and investment balances in the current period.

Net income from discontinued operations, net of tax, was $4.8 million, or $0.07 per share, for the three months ended March 31, 2026 compared to $4.1 million, or $0.07 per share, in the prior year period.

During the three months ended March 31, 2026, we repurchased and retired approximately 0.4 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $4.2 million.

Conference Call Details

Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.

For online access to the live webcast of the conference call, please register at the following URL View Source or go to Omeros’ website at View Source

A replay of the call will be made accessible online for 90 days at View Source

(Press release, Omeros, MAY 13, 2026, View Source [SID1234665636])

Moleculin Announces Imminent MIRACLE Trial Unblinding as Blinded Data Continue to Significantly Outperform Historical Benchmarks

On May 13, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that it is approaching the first unblinding of data from its pivotal Phase 2B/3 "MIRACLE" trial evaluating Annamycin in combination with cytarabine for the treatment of subjects that have been relapsed or refractory to their primary line of treatment for acute myeloid leukemia (R/R AML). The trial incorporates two arms of Annamycin at different doses plus cytarabine compared to the control arm of cytarabine plus a placebo. The Company continues to expect this unblinding to occur prior to June 30, 2026, as previously communicated.

The Company also reported that preliminary blinded efficacy data for the 45 subjects continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results compare favorably to historical CR rates from two major trials of approximately 17-18% observed with cytarabine alone in similar patient populations. Cytarabine is a currently approved standard of care for second line treatment of AML. Based on preliminary data, the median age for subjects enrolled is in the mid-60’s, with over 30% entering the trial after becoming relapsed from or refractory (R/R) to a prior venetoclax regimen as first line therapy, which is considered a particularly challenging patient group. As of May 1st, a total of 56 subjects have been recruited in the MIRACLE trial to date keeping the Company on track to recruit the 90th subject in Part A in Q3 2026.

"The data coming from MIRACLE is encouraging" said Walter Klemp, Chairman and CEO of Moleculin. "For decades, cytarabine monotherapy regimens, although one of the current standards of care, have set a relatively low bar in relapsed or refractory AML, with historical complete remission rates hovering around 17-18% in previously referenced clinical trials. With our trial comparing two arms of Annamycin in combination with cytarabine compared to cytarabine with a placebo, we are looking forward to the opportunity of showing Annamycin is additive to cytarabine alone in a head to head trial. Against this backdrop, the data emerging from MIRACLE highlight what could be a substantial advancement, suggesting that we may finally be moving beyond the limitations that have defined standard-of-care outcomes."

MIRACLE Trial Progress and Next Steps

The MIRACLE study (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a Phase 2B/3, global multi-center, randomized, double-blind, placebo-controlled, adaptive designed clinical trial whereby data from the 2B (Part A) portion will be combined with the Phase 3 (Part B) portion for purposes of measuring its primary efficacy endpoint. Part A of the MIRACLE trial is designed to evaluate the effectiveness of Annamycin in two dosing arms (190 mg/m² and 230 mg/m²) in combination with cytarabine (also referred to as Ara-C) as compared to a control arm of cytarabine plus placebo. The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data of the three arms at 45 subjects in Part A, in addition to the conclusion of Part A (at 90 total subjects). The first early unblinding should yield approximately 30 subjects treated with Annamycin (190 mg/m2 and 230 mg/m2) in combination with cytarabine and 15 subjects treated with just cytarabine plus placebo. The MIRACLE trial is being offered only to AML patients who have had a single prior induction therapy (2nd line patients or 2L) including subjects that were treated with a Venetoclax regimen.

The unblinding of the first 45 subjects is on track to occur in late Q2 2026, as the data are subject to final data entry and audit. The second group of 45 subjects in Part A are expected to be fully recruited in the third quarter of 2026 with unblinding expected late in the second half of 2026. Recruitment of the second group of 45 subjects in Part A will continue uninterrupted while the first 45 subjects with efficacy are being unblinded. Unblinding for the full 90 subjects in Part A may require more time than for the first 45 as it involves more data to support the transition from Part A to Part B.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU can be found on euclinicaltrials.eu and the reference identifier is 2024-518359-47-00.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Annamycin also benefits from composition of matter patent protection through 2040 with the potential to extend that protection as far as 2045. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

(Press release, Moleculin, MAY 13, 2026, View Source [SID1234665635])

MacroGenics Reports First Quarter 2026 Financial Results and Highlights Business Transformation

On May 13, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended March 31, 2026, and highlighted its recent corporate progress.

"We are very pleased to report a strong start to the year, building on the momentum generated in 2025. These results reflect our team’s disciplined execution of a strategy designed to sharpen our focus, maximize the value of our pipeline, and strengthen our financial position. As part of this effort, we recently announced the sale of our GMP manufacturing operations to Bora Pharmaceuticals and the monetization of additional ZYNYZ royalties with Sagard Healthcare Partners. Subject to the closing of the manufacturing operations divestiture, these transactions are expected to provide significant non-dilutive capital to support growth opportunities in 2026 and beyond," said Eric Risser, President and CEO of MacroGenics. "We look forward to providing multiple updates during the remainder of the year, including key programmatic milestones for MGC026, MGC028, and MGC030. We believe our increased focus on discovering and developing breakthrough medicines has the potential to enhance patients’ lives while creating meaningful value for our shareholders."

Focus and Realignment Across Our Business

MacroGenics recently took a series of significant steps designed to focus resources on the Company’s innovative oncology programs. These steps include:

Divestiture of Manufacturing Operations. As announced earlier this week, MacroGenics entered into a definitive agreement with Bora Pharmaceuticals Co., Ltd. and Bora Biologics USA, LLC (collectively, Bora) to sell its manufacturing operations, inclusive of drug substance manufacturing, development and quality services. Subject to customary closing conditions, MacroGenics is expected to receive an upfront payment of $122.5 million, before transaction fees and expenses. As part of this transaction, MacroGenics’ headquarters and warehouse sites in Maryland will transfer to Bora. The transaction is expected to close in the third quarter of this year. At closing, MacroGenics will enter into a supply agreement with Bora to support development and production of clinical drug substance for current and future pipeline programs. The Company has historically leveraged both internal manufacturing capabilities as well as those of external contract manufacturing partners. Through this transaction, the Company will transition to a fully outsourced model, which is expected to provide increased flexibility and cost advantages.

Expanded ZYNYZ Royalty Monetization. Earlier this month, MacroGenics announced that it had entered into an amended royalty purchase agreement with Sagard Healthcare Partners (Sagard) in exchange for a revised capped royalty interest in future global net sales of ZYNYZ. MacroGenics received a $60.0 million cash payment from Sagard with the potential to receive an additional milestone, based on 2026 ZYNYZ sales performance, of up to $20.0 million.

Corporate Restructuring. As part of the manufacturing divestiture transaction, approximately 140 employees are expected to transfer to Bora. With some additional reductions across the company, MacroGenics is expected to have approximately 135 employees at closing, enabling a more agile organization that is focused on the research and clinical development of novel therapeutics.

Advancement of Innovative Pipeline

MacroGenics is developing potential best-in-class or first-in-class antibody-drug conjugates (ADCs) and T-cell engagers (TCEs). MacroGenics’ two clinical-stage ADC programs, MGC026 and MGC028, continue to demonstrate acceptable safety profiles to date, with no observations of interstitial lung disease, as well as evidence of anti-tumor activity by Response Evaluation Criteria in Solid Tumors (RECIST).

MGC026 is a novel ADC that targets B7-H3, which is overexpressed in multiple solid tumors. The Company completed enrollment of the dose escalation portion of a Phase 1 study in late 2025 and is currently enrolling patients in the dose expansion portion of the study in selected solid tumor indications. The Company anticipates reporting initial MGC026 clinical data in mid-2026.

MGC028 is a first-in-class ADC that targets ADAM9, which is overexpressed in multiple solid tumors. MGC028 is currently being evaluated in the dose escalation portion of a Phase 1 study in patients with advanced solid tumors. The Company anticipates reporting initial MGC028 clinical data in the second half of 2026.

MGC030 is a first-in-class preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for the third quarter of 2026.

Future Pipeline. MacroGenics is advancing additional preclinical programs that incorporate proprietary platforms for next-generation TCEs and ADCs with novel payloads. The company expects to nominate two additional product candidates by the end of 2026.

Lorigerlimab Update

MacroGenics continues its LINNET Phase 2 monotherapy study of lorigerlimab, a PD-1 × CTLA-4 bispecific DART molecule, in patients with gynecological cancers.

As of a data cut-off on May 7, 2026, 17 patients with clear cell gynecologic cancer (CCGC) were treated at 6 mg/kg every three weeks (Q3W). Of the 16 evaluable patients with CCGC, 4 (25%) had objective responses, including 4 with confirmed partial responses (PR), of which 1 patient subsequently had an unconfirmed complete response (CR). Of the 17 CCGC patients evaluable for safety, Grade ≥3 treatment-related adverse events (TRAEs) occurred in 8 patients (47%) and 2 patients (12%) discontinued treatment due to AEs. No treatment-related fatalities were reported in these patients.

Going forward, MacroGenics intends to enroll an additional 20 CCGC patients at a lower dose of 3 mg/kg Q3W, which was selected based on pharmacokinetic and pharmacodynamic modeling, with the goal of improving safety while maintaining clinical benefit. The Company anticipates completing enrollment of these 20 patients by year-end 2026 and reporting updated study results in the first half of 2027.

Based on an assessment of results from the high-grade serous and platinum-resistant ovarian cancer (PROC) cohort of the LINNET study, the predetermined response rate was not achieved, and the Company no longer intends to pursue development in this indication.

Current Partnerships

MacroGenics maintains partnerships with Incyte Corporation, Sanofi, and Gilead Sciences, which span multiple commercial, clinical and preclinical programs. These include ZYNYZ (retifanlimab-dlwr), TZIELD (teplizumab-mzwv), and MGD024, a clinical-stage CD123 × CD3 bispecific DART molecule. Across these collaborations, the Company remains eligible to receive up to approximately $2.5 billion in aggregate future milestones, in addition to royalties on partnered products.

First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of March 31, 2026, was $154.2 million, compared to $189.9 million as of December 31, 2025. The balance as of March 31, 2026, did not include the $60.0 million received from Sagard earlier this month. In addition, the Company is expected to receive $122.5 million proceeds from Bora, less related transaction fees and expenses, in connection with the manufacturing operations divestiture, which is expected to close in the third quarter of this year, subject to customary closing conditions.

Revenue: Total revenue was $20.8 million for the quarter ended March 31, 2026, compared to $13.2 million for the quarter ended March 31, 2025. The increase was due to higher contract manufacturing revenue from higher production volume for external clients and royalty revenue recognized from higher sales of ZYNYZ, offset by decreased collaborative revenue.

Cost of Manufacturing Services: Cost of manufacturing services was $9.5 million for the quarter ended March 31, 2026, compared to $5.4 million for the quarter ended March 31, 2025. The increase was due to increased production for external clients.

R&D Expenses: Research and development expenses were $35.0 million for the quarter ended March 31, 2026, compared to $39.7 million for the quarter ended March 31, 2025. The decrease is primarily due to the discontinuation of further development of vobramitamab duocarmazine. This was partially offset by increased development costs related to MGC028 and the preclinical TCE programs.

G&A Expenses: General and administrative expenses were $9.7 million for the quarter ended March 31, 2026, compared to $10.7 million for the quarter ended March 31, 2025.

Net Loss: Net loss was $36.8 million for the quarter ended March 31, 2026, compared to $41.0 million for the quarter ended March 31, 2025.
Shares Outstanding: Shares of common stock outstanding as of March 31, 2026, were 63,560,068.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $154.2 million as of March 31, 2026, in addition to projected and anticipated future payments from partners, including $60.0 million received from Sagard earlier this month plus anticipated sale proceeds of $122.5 million, less related transaction fees and expenses, from Bora related to divestiture of the Company’s manufacturing operations, is expected to support its cash runway through 2028.

(Press release, MacroGenics, MAY 13, 2026, View Source [SID1234665634])