Whitehawk Therapeutics to Participate in 2026 Stifel Virtual Targeted Oncology Forum

On May 15, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported Dave Lennon, PhD, President and CEO, will participate in a virtual fireside chat as part of the 2026 Stifel Virtual Targeted Oncology Forum on Tuesday, May 19, 2026, at 3 PM ET.

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A live webcast of the event can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, MAY 15, 2026, View Source [SID1234665795])

Purple Biotech Reports First Quarter 2026 Financial Results and Business Highlights

On May 15, 2026 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, reported financial results for the three months ended March 31, 2026 and provided an update on recent business progress.

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"We continue to advance the CAPTN-3 platform as a core value driver," said Gil Efron, Purple Biotech CEO. "New patient-derived tumor data, generated with our collaborators at Mount Sinai, further supports IM1240’s differentiated tri-specific design and its potential to overcome tumor immune evasion and resistance in difficult-to-treat solid tumors. Importantly, the data continues to support the contribution of the NKG2A arm, which enhanced anti-tumor activity across tested samples and improved the therapeutic index. In parallel, our newly formed Scientific Advisory Board and collaboration with Converge Bio provide important scientific and computational expertise as we seek to expand the broader potential of CAPTN-3. Over the remainder of 2026, we plan to build on this momentum by generating additional efficacy evidence across potential indications and advancing new tri-specific antibody combinations."

Q1 2026 and Recent Clinical & Corporate Highlights:

Generated new patient-derived tumor data supporting IM1240’s differentiated mechanism and anti-tumor activity

● Data generated in the lab of Amir Horowitz, PhD, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, demonstrated that all tested patient-derived tumor samples responded to IM1240 treatment.

● IM1240 demonstrated activity across treatment-resistant samples, including PD-1 or PD-1/ chemo resistant head and neck squamous cell carcinoma metastatic lymph nodes and enfortumab vedotin + PD-1-resistant muscle-invasive bladder cancer.

● Data further supports the contribution of IM1240’s NKG2A arm, which significantly enhanced anti-tumor activity across tested samples and improved the therapeutic index.

● In a patient-derived non-small cell lung cancer (NSCLC) biopsy, IM1240 induced mature tertiary lymphoid structures (TLS) associated with effective anti-tumor immune response and favorable prognosis, corresponding with observed anti-tumor efficacy.

Established Scientific Advisory Board to support CAPTN-3 development

● Formed a CAPTN-3 Scientific Advisory Board (SAB) composed of experts in T-cell engager development, NK and T cell biology, translational science, and clinical oncology.

● The SAB is expected to provide strategic guidance as the Company advances IM1240 toward clinical development and continues to evaluate broader development opportunities for the CAPTN-3 platform.

Expanded collaboration with Converge Bio to apply generative AI to tri-specific antibody development

● The collaboration leverages Converge Bio’s proprietary generative AI platform to support the design and optimization of novel tri-specific antibodies for oncology.

● The AI-driven strategy is intended to accelerate discovery timelines, improve candidate quality and developability, and expand CAPTN-3’s potential across additional high-value solid tumor targets and resistance mechanisms.

Advancing IM1240 and IM1305 pre-clinical development toward first-in-human studies in 2027

● IM1240 remains the Company’s lead development priority, with IM1305, targeting TROP2, continuing to support the broader platform opportunity.

● Following the prior announcement that further development of CM24 and NT219 would require partnering or additional investment, the Company has redirected resources toward CAPTN-3 as its core development priority.

Financial Results for the Three Months Ended March 31, 2026

Research and Development Expenses were $1.2 million for the three months ended March 31, 2026, reflecting an increase of $0.5 million, from $0.8 million in the same period of 2025. The increase was primarily driven by higher chemistry, manufacturing, and controls (CMC) development activities related to the CAPTN-3 platform.

General and Administrative Expenses were $1.0 million for the three months ended March 31, 2026, compared to $0.6 million in the same period of 2025, representing an increase of $0.4 million, mainly due to higher payroll expenses as well as increased professional services and related expenses.

Adjusted Operating Loss (as reconciled below) was $2.1 million for the three months ended March 31, 2026, compared to $1.3 million in the same period of 2025, reflecting an increase of $0.8 million, primarily attributable to the higher operating expenses described above.

Finance Income, Net was $2.2 million for the three months ended March 31, 2026, compared to $1.0 million in the same period of 2025, reflecting an increase of $1.2 million, mainly due to non-cash warrant-related income due to changes in fair value measurement.

Net Loss was $0.1 million for the three months ended March 31, 2026, compared to a net loss of $0.5 million in the same period of 2025. The decrease in net loss was mainly driven by finance income, net, primarily resulting from changes in the fair value of warrants, partially offset by higher operating expenses.

Adjusted Net Loss (as reconciled below) for the three months ended March 31, 2026, was $2.1 million, an increase of $0.8 million, compared to $1.3 million in the same period of 2025, mainly reflecting financial income related to changes in the fair value of financial instruments.

As of March 31, 2026, Purple Biotech had cash and cash equivalents and short-term deposits of $6.4 million, which is expected to provide the Company with a cash runway into 2027.

Non-IFRS Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust for non-cash share-based compensation expenses, and adjusted net loss also adjusts for finance income from financial instruments. The Company’s management and board of directors utilize these non-IFRS financial measures to evaluate the Company’s performance. The Company provides these non-IFRS measures of the Company’s performance to investors because management believes that these non-IFRS financial measures, when viewed with the Company’s results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-IFRS measures are not measures of financial performance under IFRS and, accordingly, should not be considered in isolation or as alternatives to IFRS measures as indicators of operating performance. Further, these non-IFRS measures should not be considered measures of the Company’s liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release.

(Press release, Purple Biotech, MAY 15, 2026, View Source [SID1234665776])

Racura Oncology Announces Positive Safety Review Committee Recommendation in ongoing CPACS Clinical Trial

On May 15, 2026 Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, reported that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients.

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Following its review, the SRC recommended that the study continue, noting no safety concerns in patients treated with 40mg/m2 of RC220 as monotherapy, or 40mg/m2 of RC220 in combination with 60mg/m2 of doxorubicin, in the first patient cohort of this groundbreaking trial.

"The SRC’s unanimous recommendation to proceed with the trial, along with the absence of any safety concerns, represents an important milestone for this clinical program," said Daniel Tillett, CEO of Racura Oncology. "These findings support the continued advancement of RC220 into the next cohorts of this study. We wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial."

Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m2 RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test.

The Company has received the SRC’s formal written recommendation and has promptly notified the clinical trial sites to initiate enrolment in Cohort 2, as patients present and meet the eligibility criteria.

About Cardioprotection and Anticancer Synergy (CPACS) Trial

The CPACS Phase 1 solid tumor clinical trial is exploring the preclinical discovery that RC220 can provide protection from anthracycline cardiotoxicity while improving the anticancer activity of anthracyclines. Stage 1 of the trial is using ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics, and maximum tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to 33 patients using a Bayesian design. The effects on a range of clinical biomarkers, including a blood-based measure of the cardioprotective mechanism of action of RC220, are also being explored in the study.

After interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in Stage 2 for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. This open-label trial is being conducted across multiple sites in Australia, Hong Kong, and South Korea.

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC.

(Press release, Racura Oncology, MAY 15, 2026, View Source [SID1234665796])

Biogen Completes Acquisition of Apellis Pharmaceuticals

On May 14, 2026 Biogen Inc. (Nasdaq: BIIB) reported the successful completion of the acquisition of Apellis Pharmaceuticals, Inc. (Nasdaq: APLS). Apellis, a leader in advancing treatments for serious, complement-driven diseases, is now a wholly owned subsidiary of Biogen.

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The acquisition adds two best-in-class commercialized products, EMPAVELI and SYFOVRE, significantly bolstering Biogen’s near-term growth outlook and accelerating the Company’s expansion into nephrology. Together, the products recorded $689 million in net product revenue in 2025. This transaction will strengthen Biogen’s revenue and EPS growth potential by being accretive to Biogen’s Non-GAAP diluted EPS in 2027 and is expected to materially increase Biogen’s non-GAAP EPS compound annual growth rate (CAGR) through the end of the decade. Updated financial guidance will be provided in conjunction with the Q2 earnings report in July.

Apellis also brings an established nephrology commercial and medical infrastructure to accelerate Biogen’s launch readiness for felzartamab, with a first Phase 3 readout in antibody-mediated rejection in kidney transplant patients anticipated in the first half of 2027.

Biogen’s tender offer, to acquire all of the outstanding shares of Apellis common stock for $41 per share in cash and one contractual, non-transferable contingent value right per share representing the right to receive contingent cash payments of up to an aggregate of $4 in cash upon the achievement of certain annual global net sales thresholds for SYFOVRE, expired one minute after 11:59 p.m., Eastern Time, on May 13, 2026. Equiniti Trust Company, LLC, the depositary for the tender offer, has advised Biogen that approximately 105,687,831 shares were validly tendered and not validly withdrawn in the tender offer, representing approximately 82.4% of the total outstanding shares as of the expiration time. All conditions to the tender offer having been satisfied or waived on May 14, 2026, Aspen Purchaser Sub, Inc. (Aspen), a wholly owned subsidiary of Biogen, accepted for payment all shares that were validly tendered and not validly withdrawn pursuant to the tender offer.

Following the consummation of the tender offer, Aspen merged with and into Apellis in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Apellis shareholders, with Apellis continuing as the surviving corporation of the merger and a wholly owned subsidiary of Biogen. In connection with the merger, the shares that were not tendered in the tender offer were acquired by Biogen and converted into the right to receive the offer price. In connection with the completion of the transaction, the Apellis shares ceased trading on Nasdaq.

About SYFOVRE (pegcetacoplan injection)

SYFOVRE (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA) secondary to AMD. By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States and Australia for the treatment of GA secondary to age-related macular degeneration.

About Geographic Atrophy

Geographic atrophy is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroys the retinal cells responsible for vision. Vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. While rates of progression vary between patients, on average, it takes 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3

About EMPAVELI/Aspaveli (pegcetacoplan)

EMPAVELI (Aspaveli in the EU) (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age or older, to reduce proteinuria. EMPAVELI/Aspaveli is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and for the treatment of C3G and primary IC-MPGN in the European Union and other countries globally. EMPAVELI is being evaluated for the treatment of additional rare diseases. Sobi has commercial rights to EMPAVELI/Aspaveli outside the U.S.

About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring lifelong dialysis therapy or a burdensome kidney transplant.4-6 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.7

About Paroxysmal Nocturnal Hemoglobinuria (PNH)

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired, rare, chronic, and potentially life-threatening blood disease that is associated with persistently low (below normal) hemoglobin levels, thrombosis, and debilitating symptoms. PNH can appear at any age and in any race or gender, and is most often diagnosed in people in their early 30s.8,9

U.S. Important Safety Information for SYFOVRE (pegcetacoplan injection)

CONTRAINDICATIONS


SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred.

WARNINGS AND PRECAUTIONS


Endophthalmitis and Retinal Detachments


Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. •
Retinal Vasculitis and/or Retinal Vascular Occlusion


Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.


Neovascular Age-related Macular Degeneration (AMD)


In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.


Intraocular Inflammation


In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.


Increased Intraocular Pressure


Acute increase in intraocular pressure may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

ADVERSE REACTIONS


Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Please see full Prescribing Information for more information.

U.S. Important Safety Information for EMPAVELI (pegcetacoplan)

BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.


Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.


Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.

CONTRAINDICATIONS


Hypersensitivity to pegcetacoplan or to any of the excipients


For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B

WARNINGS AND PRECAUTIONS

Serious Infections Caused by Encapsulated Bacteria

EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.

Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.

Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.

EMPAVELI is available only through a restricted program under a REMS.EMPAVELI REMS

EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following:

Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.

Further information is available at www.empavelirems.com or 1-888-343-7073.

Infusion-Related Reactions

Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.

Monitoring Paroxysmal Nocturnal Hemoglobinuria (PNH) Manifestations after Discontinuation of EMPAVELI

After discontinuing treatment with EMPAVELI, closely monitor for signs and symptoms of hemolysis, identified by elevated Lactate Dehydrogenase (LDH) levels along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other reactions. If hemolysis, including elevated LDH, occurs after discontinuation of EMPAVELI, consider restarting treatment with EMPAVELI.

Interference with Laboratory Tests

There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.

ADVERSE REACTIONS

Most common adverse reactions in adult patients with PNH (incidence ≥10%) were injection site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash.

Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) (incidence ≥10%) were injection-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.

USE IN SPECIFIC POPULATIONS

Females of Reproductive Potential

EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.

(Press release, Biogen, MAY 14, 2026, View Source [SID1234665697])

SANGAMO THERAPEUTICS REPORTS RECENT BUSINESS HIGHLIGHTS AND
FIRST QUARTER 2026 FINANCIAL RESULTS

On May 14, 2026 Sangamo Therapeutics, Inc. (OTCQB Venture Market: SGMO), a genomic medicine company, reported recent business highlights and first quarter 2026 financial results.

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"During the first quarter, we advanced our rolling BLA submission for ST-920 and continued to progress our differentiated neurology pipeline," said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. "We remain focused on executing against our regulatory and clinical priorities while pursuing opportunities to secure additional funding and support the long-term potential of our pipeline."

Recent Business Highlights

Corporate Updates
•Transitioned to trading on the OTCQB Venture Market, operated by OTC Markets Group, following the receipt of a delisting determination from The Nasdaq Capital Market due to non-compliance with Nasdaq’s minimum bid requirements. Sangamo intends to appeal the delisting determination at a hearing before Nasdaq, scheduled for June 9, 2026.
•Sangamo’s common stock began trading on the OTCQB Venture Market on May 5, 2026, under the same trading symbol, SGMO.
Fabry Disease
•The rolling submission to the FDA of a BLA seeking approval of isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease under an Accelerated Approval pathway, remains in progress.
•The preclinical and clinical modules have been submitted to the FDA for review. In addition, the antibody assay companion diagnostic, which is designed to screen patients for eligibility with isaralgagene civaparvovec, has been submitted to, and accepted by, the FDA’s Center for Devices and Radiological Health (CDRH), seeking Premarket Approval (PMA).
•Isaralgagene civaparvovec has a clear pathway to accelerated approval from the FDA, using mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study. The FDA has recently affirmed to us that two-year eGFR data may serve as confirmatory evidence for traditional approval.
•In February, presented detailed data from the registrational Phase 1/2 STAAR study via four platform and poster presentations at the 22nd Annual WORLDSymposiumTM in San Diego, California.
•Sangamo is advancing the Chemistry, Manufacturing and Controls (CMC) module, ahead of completion of the rolling BLA submission for isaralgagene civaparvovec, expected as early as the summer of 2026, subject to the ability to secure adequate additional funding, while continuing business development discussions for a potential Fabry commercialization agreement.

Core Neurology Pipeline
Chronic Neuropathic Pain – ST-503
•Six sites have been activated in the Phase 1/2 STAND study evaluating ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.
•In March, a manuscript was published in Science Translational Medicine detailing the preclinical safety and pharmacology of ST-503 in human neurons, mice and nonhuman primates.
Prion Disease – ST-506
•Clinical Trial Application (CTA) enabling activities are in progress for ST-506, an investigational epigenetic regulator for the treatment of prion disease, leveraging STAC-BBB, Sangamo’s novel proprietary neurotropic adeno-associated virus (AAV) capsid.
•Held productive interaction with the MHRA, including alignment on diagnostic testing, analytical validation and nonclinical safety matters.
•The Good Laboratory Practice (GLP) toxicology study has been completed and analysis is ongoing.
29th ASGCT (Free ASGCT Whitepaper) Annual Meeting
•Participated in the 29th ASGCT (Free ASGCT Whitepaper) Annual Meeting, May 11-15, 2026, in Boston, MA, to present the progression of Sangamo’s neurology pipeline, including advances in zinc finger epigenetic regulation and developments in modular integrase technology. These presentations can be found on Sangamo’s website, in the Presentations section.
First Quarter 2026 Financial Results
Consolidated net loss for the first quarter ended March 31, 2026 was $31.0 million, or $0.08 per share, compared to a consolidated net loss of $30.6 million, or $0.14 per share, for the same period in 2025.
Revenues
Revenues for the first quarter ended March 31, 2026 were $1.4 million, compared to $6.4 million for the same period in 2025.
The decrease of $5.0 million in revenues was primarily attributable to $5.0 million in revenue relating to our collaboration agreement with Pfizer Inc. upon transfer of a specified sublicense in 2025, and a decrease of $0.8 million in revenue relating to our license agreement with Sigma-Aldrich Corporation. These decreases were partially offset by $0.5 million in revenue relating to our license agreement with Miltenyi Biotec B.V. & Co. KG.
GAAP and Non-GAAP Operating Expenses
(In millions)
Three Months Ended
March 31,
2026 2025
Research and development $ 26.6 $ 26.0
General and administrative 6.8 10.1
Total operating expenses 33.4 36.1
Depreciation and amortization (0.7) (1.0)
Stock-based compensation (1.0) (2.6)
Non-GAAP operating expenses $ 31.7 $ 32.5

Total operating expenses on a GAAP basis for the quarter ended March 31, 2026 were $33.4 million, compared to $36.1 million for the same period in 2025. Non-GAAP operating expenses, which exclude depreciation and amortization, and stock-based compensation expense, for the quarter ended March 31, 2026 were $31.7 million, compared to $32.5 million for the same period in 2025.
The decrease in total operating expenses on a GAAP basis was primarily driven by lower compensation and other personnel costs, mainly due to changes in variable compensation and lower headcount, and lower facilities and infrastructure-related expenses. These decreases were partially offset by an increase in manufacturing expenses, primarily due to BLA readiness activities for our Fabry disease program.

Cash and Cash Equivalents
As of March 31, 2026, we had cash and cash equivalents of $27.6 million, compared to cash and cash equivalents of $20.9 million as of December 31, 2025. Based on our current operating plan, including the implementation of potential additional cost reduction measures, we estimate that our cash and cash equivalents as of March 31, 2026, will be sufficient to fund our planned operations into the third quarter of 2026.
Financial Guidance for 2026
•On a GAAP basis, we expect total operating expenses in the range of approximately $110 million to $130 million in 2026, which includes estimated non-cash stock-based compensation expense, and depreciation and amortization.
•We expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $8 million, and estimated depreciation and amortization of approximately $2 million, in the range of approximately $100 million to $120 million in 2026.
•This financial guidance is subject to our ability to secure adequate additional funding for our current operating plan.
Conference Call
The Sangamo management team will hold a corporate call to further discuss program and financial updates on Thursday, May 14, at 4:30pm Eastern Time.
Participants should register for, and access, the call using this link. While not required, it is recommended you join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided or to use the dial-out option to connect their phone instantly.
An updated corporate presentation is available in the Investors and Media section under Presentations.
The link to access the live webcast can also be found on the Sangamo website in the Investors and Media section under Events. A replay will be available following the conference call, accessible at the same link.

(Press release, Sangamo Therapeutics, MAY 14, 2026, View Source [SID1234665714])