On May 13, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"Our TUSCANY clinical trial of tuspetinib in combination with venetoclax (VEN) and azacitidine (AZA) for frontline treatment of newly diagnosed acute myeloid leukemia (AML) continues to deliver robust safety and response data, and we’re pleased that an update of our TUS+VEN+AZA triplet clinical data has been selected for an oral presentation at the upcoming EHA (Free EHA Whitepaper)2026 Congress in June," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Likewise, we are pleased that the expected acquisition of the Company by Hanmi Pharmaceutical will allow the continued development of tuspetinib for AML patients in need of a well-tolerated and broadly active therapy to treat those with even the most adverse of mutation profiles, including those with TP53-mutated disease."

Key Corporate Highlights

Update on Acquisition of Aptose by Hanmi Pharmaceutical – On April 30, 2026, Aptose announced that the closing of the previously announced arrangement (the "Arrangement") with Hanmi Pharmaceutical Co. Ltd. ("Hanmi") and HS North America Ltd., a wholly owned subsidiary of Hanmi (together with Hanmi, the "Hanmi Purchasers"), has been delayed as certain Korean regulatory approvals pertaining to the Arrangement remain under way (press release here). The parties do not anticipate that the regulatory reviews will prevent closing and continue to work toward completing the Arrangement that they target for the month of May. The Company will provide a further update when available.

Under the terms of the Arrangement Agreement, Aptose shareholders, other than the Hanmi Purchasers and their respective affiliates that hold any common shares of Aptose (the "Common Shares"), receive C$2.41 in cash per Common Share, which represents a premium of 28% over Aptose’s 30-day VWAP of C$1.88 on the Toronto Stock Exchange (TSX) at the date of the execution of the Arrangement Agreement.
Aptose Clinical Data to be Presented at EHA (Free EHA Whitepaper) in Oral Presentation – Data from Aptose’s Phase 1/2 TUSCANY trial in newly diagnosed patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) has been selected for oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026), being held June 11-14, 2026, in Stockholm, Sweden. The TUS+VEN+AZA triplet is being developed as a safe and mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. As reported prior, the first two dose cohorts at 40 mg of TUS or 80 mg of TUS in the TUS+VEN+AZA triplet, demonstrated safety, complete remissions, and MRD negativity across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients. The oral presentation at EHA (Free EHA Whitepaper) will include updated data at the 80 mg and 120mg dose levels, as well as new data from the 160 mg dose of TUS, updated safety, complete remissions, minimal residual disease (MRD) and other clinical findings with a longer duration of follow up.

EHA session title: s446 Novel treatments in AML

Presentation title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy

Live session date & time: June 14, 2026 (11:00 – 12:15 CEST)
Aptose Returns Luxeptinib License Rights to CGI – Aptose and CGI Invites Co., Ltd. ("CGI") have entered into a Termination of License Agreement relating to the exclusive license originally granted to Aptose under a 2016 agreement (updated in 2018) whereby Aptose returned the license rights to CG-806 to CGI. Under the license agreement, Aptose held exclusive rights from CGI to develop and commercialize the compound CG-806, also known as luxeptinib (LUX).

FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Three Months Ended
March 31,
2026 2025
Operating expenses:
Research and development $ 3,621 $ 2,364
General and administrative 3,561 3,097
Total operating expenses 7,182 5,461
Total other expenses, net (452 ) (82 )
Net loss $ (7,634 ) $ (5,543 )
Net loss per common share, basic and diluted $ (2.99 ) $ (2.61 )

Weighted average number of common shares outstanding, basic and diluted 2,552,429 2,126,287


Net loss for the three months ended March 31, 2026 of $7.6 million increased $2.1 million as compared with a net loss of $5.5 million for the comparable period in 2025.

Aptose Biosciences Inc.
Balance Sheet Data
(unaudited)
($ in thousands)

March 31, December 31,
2026 2025
Cash and restricted cash $ 4,105 $ 4,096

Working capital (5,084 ) (2,860 )
Total assets 10,723 10,012
Long-term liabilities 34,156 27,873
Accumulated deficit (574,069 ) (566,435 )

Shareholders’ deficit (34,672 ) (27,167 )

Total cash and restricted cash as of March 31, 2026 was $4.1 million. The Company does not have sufficient cash to fund operations and relies on advances made by Hanmi to fund operations. The Company is actively deploying cost reduction efforts to extend cash runway.

As of May 8, 2026, there were 2,552,429 Common Shares issued and outstanding. In addition, there were 37,083 Common Shares issuable upon the exercise of outstanding stock options and 1,139,085 Common Shares issuable upon the exercise of outstanding warrants.

RESEARCH AND DEVELOPMENT EXPENSES

Research and development expenses for the three months ended March 31, 2026 and 2025 were as follows:

    Three Months Ended
    March 31,
(in thousands)   2026   2025

Program costs – Tuspetinib $ 2,880 $ 1,479
Program costs – Luxeptinib (5 ) 98
Personnel-related expenses 695 646
Stock-based compensation 51 141
Total $ 3,621 $ 2,364

Research and development expenses increased by $1.2 million to $3.6 million for the three months ended March 31, 2026 as compared to $2.4 million for the comparable period in 2025. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following activities:

Program costs for tuspetinib increased by $1.4 million to $2.9 million for the three months ended March 31, 2026 compared to $1.5 million for the comparable period in 2025. The higher program costs for tuspetinib in the current period are attributable to increased costs associated with the TUSCANY study as we continue the advancement of tuspetinib.

Program costs for luxeptinib decreased by approximately $0.1 million during the three months ended March 31, 2026 compared to the comparable period in 2025 due to a decrease in clinical trial costs as the trial is being wound down.

Personnel-related expenses remained relatively consistent during the three months ended March 31, 2026 compared to the comparable period in 2025 as headcount for research and development personnel remained consistent between periods.

Stock-based compensation decreased by $0.1 million for the three months ended March 31, 2026 compared to the comparable period in 2025. This decrease was primarily due to stock options forfeited and/or vested in prior periods that are no longer being expensed resulting in lower expense in the current period.

(Press release, Aptose Biosciences, MAY 13, 2026, View Source [SID1234665632])

On May 13, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported the successful completion of process tech transfer and product introduction to Thermo Fisher Scientific, the world leader in serving science, for IBTROZI (taletrectinib) to treat advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.

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"Our commitment to unencumbered access to IBTROZI for appropriate patients with ROS1+ NSCLC starts at the manufacturing stage, where we work to ensure that our collaborators and processes deliver critical medicine with high quality," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We are pleased to collaborate with Thermo Fisher, a leading contract manufacturer of pharmaceuticals, to bring IBTROZI manufacturing closer to the patients we serve."

Jennifer Cannon, President, Commercial Operations, Pharma Services at Thermo Fisher added, "We are pleased that Nuvation Bio has selected us for their final drug product manufacturing of IBTROZI in the United States. Our collaboration with Nuvation Bio builds on our commitment to work with both biotech and pharmaceutical companies alike to help ensure the availability and access to innovative treatments that address significant unmet medical needs for patients."

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com. 

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.

(Press release, Nuvation Bio, MAY 13, 2026, View Source [SID1234665648])

On May 13, 2026 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the first quarter ended March 31, 2026 and provided an update on recent company developments.

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"We remain focused on advancing INO-3107 toward its target PDUFA date to ensure that every RRP patient has access to therapeutic options that work for them to reduce the need for surgery. We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease, and that INO-3107 has the potential to become the preferred product by patients and their physicians, if approved, based on clinical results, tolerability data and the simplicity of its patient-centric treatment regimen that does not require additional surgeries during the dosing window," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "While the BLA for INO-3107 is under active review, we continue to advance our commercial readiness plans in anticipation of a 2026 approval, as well as leverage the power of partnerships to advance other promising candidates in our pipeline."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INO-3107 is INOVIO’s lead product candidate. It has been developed as a potential treatment for RRP, a rare and debilitating disease of the respiratory tract caused by infection with HPV-6 and/or HPV-11. In December 2025, the FDA accepted for review the company’s BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026. Since then, the BLA has been under active review by the FDA, including the recent completion of the mid-cycle review meeting. INOVIO is focused on advancing INO-3107 through the regulatory process and working with the FDA as they complete their review of the BLA, including addressing the potential review issue they noted in their file acceptance letter regarding eligibility for review under the accelerated approval program. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. As a part of communications about the mid-cycle review, the FDA has reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program.

INOVIO continues to engage with the RRP community, including presenting data from our Phase 1/2 trial of INO-3107 at the Combined Otolaryngology Spring Meeting (COSM), the premier educational and technology forum for the specialists who treat RRP. INOVIO will also be presenting at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Conference.

In anticipation of a potential approval in 2026, INOVIO continues to advance commercial readiness plans, including incorporating key learnings from the launch of a competitor’s recently approved RRP product. INOVIO believes INO-3107 has a positively differentiated product profile. INOVIO plans to commercialize INO-3107 itself in the U.S., with the support of a contract sales organization, and has engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB.

INO-5412
In March 2026, INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of glioblastoma (GBM). The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. This novel combination builds on INOVIO’s previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.

Next-Generation DNA Medicine Candidates
INOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb) and DNA-Encoded Protein (DPROT) programs at several recent scientific conferences. Based on positive preclinical data on Factor VIII production for Hemophilia A, INOVIO is developing additional DPROT indications in the rare disease space, including Fabry disease and Hypophosphatasia (HPP), and is in discussions with potential partners to accelerate development of this promising platform.

General Corporate
INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $16.0 million.

First Quarter 2026 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2026 decreased to $14.1 million from $16.1 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower expensed inventory, among other variances.
General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended March 31, 2026 from $9.0 million for the same period in 2025.
Total Operating Expenses: Total operating expenses decreased to $21.9 million for the three months ended March 31, 2026 from $25.1 million for the same period in 2025.
Net Loss: INOVIO’s net loss for the three months ended March 31, 2026 was $19.7 million, or $0.28 per basic and diluted share, compared to a net loss of $19.7 million, or $0.51 per basic and diluted share, for the three months ended March 31, 2025.
Cash, Cash Equivalents and Short-term Investments: As of March 31, 2026, cash, cash equivalents and short-term investments were $37.7 million (excluding net proceeds from the April 2026 offering of $16.0 million), compared to $58.5 million as of December 31, 2025.
Cash Guidance
INOVIO estimates that current cash, cash equivalents and short-term investments balances will support operations into the first quarter of 2027, beyond the target PDUFA date for INO-3107. This projection includes the net proceeds of $16.0 million from the public offering in April 2026, as well as an operational net cash burn estimate of approximately $18 million for the second quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

(Press release, Inovio, MAY 13, 2026, View Source [SID1234665633])

On May 13, 2026 Whitehawk Therapeutics, Inc. (the "Company" or "Whitehawk") (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 that it has entered into a securities purchase agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $87.5 million, before deducting placement agent fees and other private placement expenses.

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The PIPE financing includes participation from existing investors including Avoro Capital, QVT, Coastlands Capital, KVP Capital, ADAR1 Capital Management, Acuta Capital Partners, StemPoint Capital LP, Invus, as well as members of the Company’s executive team.

Pursuant to the terms of the securities purchase agreement, Whitehawk is selling an aggregate of (i) 4,330,866 shares of its common stock ("Common Stock") at a purchase price of $3.92 per share, and (ii) pre-funded warrants ("Pre-Funded Warrants") to purchase 17,991,021 shares of common stock at a purchase price of $3.9199 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.0001 per share. The PIPE financing is expected to close on May 14, 2026, subject to the satisfaction of customary closing conditions.

Whitehawk intends to use the net proceeds from the PIPE financing, together with its existing cash, cash equivalents and marketable securities, for working capital and general corporate purposes, including advancing its ADC pipeline and related development activities. Proceeds from the PIPE financing, together with the Company’s existing cash, cash equivalents and marketable securities, is expected to extend the Company’s cash runway into the second half of 2028.

Jefferies and Leerink Partners are acting as lead placement agents for the PIPE financing. Oppenheimer & Co., Citizens Capital Markets and Jones are also acting as placement agents for the PIPE financing.

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

The offer and sale of securities of Whitehawk described above are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and/or applicable state or other jurisdictions’ securities laws.

(Press release, Whitehawk Therapeutics, MAY 13, 2026, View Source [SID1234665649])

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.

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"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])