On August 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 June 30, 2026, and highlighted its recent corporate and pipeline progress.

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"Our team delivered strong second-quarter execution: advancing our strategic priorities, strengthening our financial position, and sharpening our focus to accelerate the development of life-changing medicines for patients," said Eric Risser, President and Chief Executive Officer of MacroGenics. "With a significantly stronger financial foundation, we are well-positioned to advance our pipeline and deliver a catalyst-rich period ahead."

Advancement of Innovative Pipeline
MacroGenics is developing a portfolio of investigational agents, including both topoisomerase I inhibitor-based antibody-drug conjugates (ADCs) and T-cell engagers (TCEs).

•MGC026 is a novel ADC targeting B7-H3, a protein expressed across the tumor microenvironment, including tumor-associated stroma and vasculature. The dose-escalation portion of the ongoing Phase 1 study has been completed after evaluating doses ranging from 1 mg/kg to 9 mg/kg every three weeks (Q3W). A dose of 7.5 mg/kg Q3W is being further evaluated in four tumor-specific cohorts, including squamous cell carcinoma of the head and neck (SCCHN), endometrial cancer, melanoma and soft tissue sarcoma. MGC026 recently achieved an important milestone, with the SCCHN cohort meeting the pre-specified response threshold to advance into Stage 2. Interim results from the Phase 1 study have been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress in October.

•MGC028 is a first-in-class ADC targeting ADAM9, a protein that is overexpressed in multiple solid tumors. The dose escalation study of MGC028 is ongoing and the Company anticipates providing an update with preliminary clinical results in late 2026.

•MGC030 is a first-in-class ADC targeting an undisclosed antigen expressed across several solid tumors. The Company’s Investigational New Drug (IND) application was submitted ahead of schedule and cleared by the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. The Company plans to commence a Phase 1 dose escalation study in the third quarter of 2026.

•Lorigerlimab is a PD-1 × CTLA-4 bispecific DART molecule being evaluated in patients with advanced gynecologic cancers. MacroGenics continues the Phase 2 LINNET study of lorigerlimab, with the interim data accepted for poster presentation at the ESMO (Free ESMO Whitepaper) 2026 Congress. The Company is enrolling 20 additional patients with clear cell gynecologic cancer (CCGC) at a dose of 3 mg/kg Q3W and anticipates reporting updated study results in the first half of 2027.

Future Pipeline

MacroGenics is advancing multiple preclinical programs that incorporate proprietary platforms for next-generation TCEs and ADCs. Following completion of preclinical proof-of-concept studies and preliminary toxicology in non-human primates, the Company recently nominated MGD032, a novel next-generation TCE against an undisclosed target. This molecule is now advancing in IND-enabling studies.

Partnership Updates

MacroGenics maintains partnerships with Incyte Corporation, Sanofi and Gilead Sciences, Inc. spanning multiple commercial, clinical and preclinical programs. Through these collaborations, the Company remains eligible to receive up to approximately $2.4 billion in aggregate future milestone payments, in addition to potential royalties on net product sales.

On August 11, the Company announced that Gilead had exercised its option to license a preclinical bispecific program under the companies’ 2022 collaboration agreement. This option exercise triggers a $10.0 million payment to MacroGenics. The Company remains eligible to earn additional milestones and royalties based on net product sales.

Corporate Update

Corporate Restructuring and Divestiture of Manufacturing Operations. In July, MacroGenics announced the completion of the sale of its GMP drug substance manufacturing operations to Bora Pharmaceuticals Co., Ltd. and Bora Biologics USA, LLC (collectively, Bora) for a previously disclosed base purchase price of $122.5 million. At closing, the Company received $119.6 million in cash consideration, reflecting adjustments for net working capital and indebtedness, before transaction fees and expenses. Approximately 140 previous MacroGenics employees were hired by Bora and, together with a concurrent restructuring, MacroGenics’ workforce is anticipated to be reduced to approximately 140 employees by year-end. As part of the transaction, MacroGenics entered into a supply agreement with Bora to support process development and drug substance production for the Company’s internal pipeline. MacroGenics’ transition to a fully-outsourced manufacturing model and a leaner organization is expected to enable greater focus on the advancement of its novel therapeutics pipeline, while providing increased flexibility and cost effectiveness.

Second Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026, were $173.3 million, compared with $189.9 million as of December 31, 2025. The balance as of June 30, 2026, included $60.0 million received from Sagard Healthcare Partners related to the monetization of ZYNYZ royalties. During the quarter, the Company also earned a $24.5 million regulatory milestone from Sanofi related to a U.S. approval of TZIELD, with payment expected in the third quarter of 2026. Subsequent to June 30, 2026, MacroGenics received cash consideration of $119.6 million from Bora in connection with the completed sale of the Company’s GMP manufacturing operations. In addition, in August, the Company achieved a $10.0 million milestone pursuant to Gilead’s exercise of its option to obtain an exclusive license for a preclinical bispecific program under the companies’ 2022 collaboration agreement. The Company’s pro forma cash, cash equivalents and marketable securities as of June 30, 2026, including net proceeds from Bora, Sanofi and Gilead, totaled $327 million.

•Revenue: Total revenue was $32.8 million for the quarter ended June 30, 2026, compared with $6.9 million for the quarter ended June 30, 2025. The increase was primarily due to achievement of the $24.5 million regulatory milestone from Sanofi related to U.S. approval of TZIELD.

•R&D Expenses: Research and development expenses were $38.8 million for the quarter ended June 30, 2026, compared with $40.8 million for the quarter ended June 30, 2025. The decrease was primarily due to decreased costs related to lorigerlimab and discontinued programs, partially offset by increased trial costs related to MGC026 and MGC028.

•G&A Expenses: General and administrative expenses were $7.9 million for the quarter ended June 30, 2026, compared with $9.3 million for the quarter ended June 30, 2025. The decrease was primarily due to lower personnel-related costs, including stock-based compensation expense.
•Net Income (Loss): Net income was $19.5 million for the quarter ended June 30, 2026, compared with net loss of $36.3 million for the quarter ended June 30, 2025. Net income for the quarter ended June 30, 2026,, reflects income from discontinued operations of $89.2 million related to the sale of the Company’s GMP manufacturing operations to Bora, and a $52.8 million non-cash loss on the extinguishment of the ZYNYZ royalty monetization liability.
•Shares Outstanding: Shares of common stock outstanding as of June 30, 2026, were 63,645,711.
•Cash Runway Guidance: MacroGenics anticipates that its pro forma cash, cash equivalents and marketable securities of $327 million as of June 30, 2026, plus other projected future payments from partners, will support the Company’s cash runway through 2028.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
June 30, 2026 December 31, 2025
(unaudited)
Cash, cash equivalents and marketable securities $ 173,305 $ 189,913
Total assets 345,409 256,846
Deferred revenue 55,503 56,779
Total stockholders’ equity 42,873 55,591

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(Amounts in thousands, except share and per share data)
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Revenues:
Collaborative and other agreements $ 25,488 $ 5,558 $ 26,058 $ 12,157
Royalty revenue 7,344 1,311 13,495 1,754
Total revenues 32,832 6,869 39,553 13,911
Costs and expenses:
Research and development 38,780 40,791 73,754 80,489
General and administrative 7,904 9,302 17,614 20,020
Total costs and expenses 46,684 50,093 91,368 100,509
Loss from operations (13,852) (43,224) (51,815) (86,598)
Loss on extinguishment of royalty monetization liability (52,762) — (52,762) —
Interest and other income 1,368 1,414 2,922 3,093
Interest and other expense (4,396) (802) (9,285) (894)
Loss before income taxes (69,642) (42,612) (110,940) (84,399)
Income tax provision — 105 — 105
Net loss from continuing operations (69,642) (42,717) (110,940) (84,504)
Net income from discontinued operations, net of taxes 89,157 6,466 93,681 7,217
Net income (loss) 19,515 (36,251) (17,259) (77,287)
Other comprehensive income (loss):
Unrealized gain (loss) on investments 12 (6) (47) (12)
Comprehensive income (loss) $ 19,527 $ (36,257) $ (17,306) $ (77,299)
Net income (loss) per common share – basic
Net loss from continuing operations $ (1.10) $ (0.67) $ (1.75) $ (1.34)
Net income from discontinued operations 1.40 0.10 1.47 0.11
Net income (loss) per share – basic $ 0.31 $ (0.57) $ (0.27) $ (1.23)
Net income (loss) per common share – diluted
Net loss from continuing operations $ (1.10) $ (0.67) $ (1.75) $ (1.34)
Net income from discontinued operations 1.40 0.10 1.47 0.11
Net income (loss) per share – diluted $ 0.31 $ (0.57) $ (0.27) $ (1.23)
Weighted average common shares outstanding
Basic and diluted 63,594,453 63,136,057 63,522,516 63,051,207

(Press release, MacroGenics, AUG 13, 2026, View Source [SID1234670068])

On August 13, 2026 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the enrollment of the first patient in its DIRECT-AI registry study, marking the beginning of real-world prospective evidence generation for the first nationwide registry evaluating the clinical utility of an AI-powered prostate cancer test. The first patient was enrolled at The Urology Place, a leading independent urology practice in San Antonio, TX, recognized for its commitment to advancing innovation in prostate cancer care.

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Building on extensive clinical validation of the ArteraAI Prostate Test, the enrollment of the first patient marks the next phase in evaluating how the test influences treatment discussions, shared decision-making, and long-term outcomes for patients with localized prostate cancer.

The non-interventional observational registry follows patients receiving the ArteraAI Prostate Test as part of their standard care, without requiring additional procedures. Data collected from participating clinical sites across the United States will provide insights into how AI-powered prognostic and predictive information is used in clinical decision-making, including the impact of results on shifts in treatment choices and physician confidence.

"As clinicians, we’re constantly evaluating whether new technologies truly change the way we care for patients or provide meaningful value beyond existing approaches," said Naveen Kella, M.D., Founder and Director of The Urology Place. "DIRECT-AI allows us to better understand how AI-powered insights are incorporated into routine clinical practice and how they support more informed conversations. We’re proud to contribute to generating this evidence, as it is an important step toward advancing more personalized prostate cancer care."

Prostate cancer treatment decisions are highly individualized and can depend on multiple factors, including disease characteristics, patient preferences, age, clinical comorbidities, and the potential benefits and risks of different approaches. As treatment options continue to evolve, generating evidence on how new tools perform in real-world settings is essential to understanding their clinical utility. In addition, real-world evidence from DIRECT-AI may help inform subsequent health economic and cost-effectiveness analyses by providing insights into how AI-guided treatment decisions change patterns of care and healthcare resource utilization.

"Clinical validation demonstrates a test’s performance; clinical utility helps us understand its impact in real-world care," said Calvin Chao, MD, Vice President of Medical Science at Artera. "DIRECT-AI reflects Artera’s commitment to generating evidence that can inform how AI-powered tools are integrated into oncology practice and help shape the future of precision medicine."

(Press release, Artera, AUG 13, 2026, View Source [SID1234670089])

On August 13, 2026 OPKO Health, Inc. (NASDAQ: OPK) reported the expansion of its financing relationship with HealthCare Royalty, a business of KKR (HCRx), through the issuance of an additional $125 million aggregate principal amount of senior secured notes. The newly issued notes are secured by OPKO’s royalty interests arising under its mazdutide license agreement with Eli Lilly and Company and mature in 2044, consistent with the maturity of OPKO’s existing HCRx notes issued under the original financing arrangement.

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The transaction provides OPKO with additional non-dilutive capital while preserving significant long-term participation in the value of the mazdutide franchise. Total payments under the expanded financing structure are capped at 1.5 times the amount funded, after which OPKO retains future royalty economics associated with the financed stream. The structure is intended to unlock immediate value from an emerging royalty stream while maintaining OPKO’s participation in long-term royalty growth.

"This transaction with HCRx further demonstrates our ability to leverage high-quality royalty assets to create non-dilutive financing alternatives for our shareholders," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "Mazdutide represents a promising opportunity in China within our partnered product portfolio. By financing a portion of these future royalty interests on attractive terms, we strengthen our balance sheet while retaining meaningful long-term upside."

The product is being commercialized in China by Innovent Biologics, and OPKO receives royalties on commercial sales pursuant to its licensing arrangement with Eli Lilly and Company. OPKO recorded its initial mazdutide royalty revenue during 2025 following commercial launch activities in China.

"We are pleased to further expand our partnership with OPKO," said Clarke Futch, Chairman and CEO of HealthCare Royalty. "OPKO has assembled a unique portfolio of royalty-generating assets, and mazdutide represents an attractive opportunity to invest in a high growth segment in China. We believe this transaction provides a compelling outcome for both organizations and further demonstrates the strength of our relationship."

About HealthCare Royalty

HealthCare Royalty ("HCRx") is a leading royalty acquisition company founded in 2006 that is majority owned by KKR & Co. Inc. (NYSE: KKR). Over two decades, the HCRx team has developed a strong track record of investing in commercial-stage and near-commercial-stage biopharmaceutical assets, committing $7+ billion in over 110 biopharmaceutical products. With offices in New York, Stamford, San Francisco, Boston, London and Miami, HCRx continues to advance biopharmaceutical innovation by providing innovative capital solutions to counterparties. For more information, visit View Source . HEALTHCARE ROYALTY, HEALTHCARE ROYALTY PARTNERS and HCRx are registered trademarks of HealthCare Royalty Management, LLC.

(Press release, Opko Health, AUG 13, 2026, View Source [SID1234670069])

On August 13, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, reported that it has entered into a securities purchase agreement with an institutional investor to sell 8,462,027 shares of common stock (or pre-funded warrants in lieu thereof), together with two warrants to purchase up to an aggregate 16,924,054 shares of common stock, in a private placement offering priced at-the-market under Nasdaq rules. The combined effective offering price for each share of common stock (or pre-funded warrant) and accompanying two warrants to be issued is $0.4727. The combined effective offering price for each pre-funded warrant and accompanying two warrants to be issued is $0.4657. The pre-funded warrants will have an exercise price of $0.007 per share of common stock and the warrants will have an exercise price of $0.4727 per share, will be exercisable following stockholder approval, and will expire five years from the date of issuance.

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The gross proceeds to the Company from the offering are estimated to be approximately $4.0 million before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about August 14, 2026, subject to the satisfaction of customary closing conditions.

WallachBeth Capital LLC is acting as the sole placement agent in connection with the offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities 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 such applicable state securities laws. The Company will provide customary registration rights for the shares of common stock underlying the warrants, subject to the terms of the definitive transaction documents.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, BioAffinity Technologies, AUG 13, 2026, View Source [SID1234670090])

On August 13, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended June 30, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development programs.

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"The second quarter was marked by continued execution across the MICVO program and a financing that strengthened our balance sheet and extended our cash runway into the second quarter of 2027," said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "The additional capital gives us greater flexibility to incorporate longer patient follow-up and planned analyses into our next clinical updates. We expect to report updated monotherapy data in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) this fall, followed by updated first-line combination data with pembrolizumab in the fourth quarter. We remain focused on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer, regardless of HPV status or prior therapy."

Pipeline & Corporate Updates

•
Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in Fall 2026. The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, together with detailed analyses of the dose cap impact on safety, tolerability, efficacy and initial durability.
•
The Company completed target enrollment in the Phase 1 Part 2 monotherapy dose expansion study in the first quarter of 2026.
•
The ongoing MICVO Phase 1 monotherapy study is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025, supporting MICVO’s broad potential to address a significant unmet need for patients regardless of HPV status or prior therapy.
•
The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post-platinum and anti-PD-(L)1-experienced patients (Arm 1) and post-EGFRi and anti-PD-(L)1-experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20.
•
In December 2025, a dose cap was implemented for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation. The Fall 2026 monotherapy disclosure will remain focused on patients treated at or below the dose cap.
•
Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in the fourth quarter of 2026.

•
The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.
•
In June 2026, Pyxis Oncology announced up to $114 million of private placement financing with new and existing healthcare-focused investors to advance MICVO through key clinical milestones.
•
On July 2, 2026, the Company completed the private placement which resulted in upfront gross proceeds of approximately $50 million, before deducting placement agent fees and offering expenses, and anticipates up to an additional approximately $64 million of gross proceeds, before placement agent fees, if the accompanying warrants are exercised in full for cash.
•
The upfront proceeds from the private placement, together with existing cash, extended the Company’s cash runway into the second quarter of 2027. The additional capital from the private placement provides flexibility to continue patient follow-up and allow the data to mature following completion of enrollment of the 2L+ R/M HNSCC study.

Second Quarter 2026 Financial Results

•
As of June 30, 2026, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $34.5 million. Additionally, on July 2, 2026, the Company completed the private placement which resulted in upfront gross proceeds of approximately $50 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent fees and offering expenses. The Company believes that its cash and cash equivalents, including restricted cash, and short-term investments as of June 30, 2026, along with the upfront proceeds from the private placement, will be sufficient to fund its operations into the second quarter of 2027.
•
Research and development expenses were $16.1 million for the quarter ended June 30, 2026, compared to $17.1 million for the quarter ended June 30, 2025. The decrease was primarily due to a $3.5 million increase in clinical trial related expenses related to monotherapy and combination therapy of MICVO, $1.1 million increase in preclinical studies, offset by a reduction of $4.7 million in manufacturing costs.
•
General and administrative expenses were $9.9 million for the quarter ended June 30, 2026, compared to $5.4 million for the quarter ended June 30, 2025. The increase was primarily due to an increase in severance costs and higher stock-based compensation.
•
Net loss was $25.3 million, or ($0.40) per common share, for the quarter ended June 30, 2026, compared to $18.4 million, or ($0.30) per common share, for the quarter ended June 30, 2025. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended June 30, 2026 was $19.8 million, compared to a net loss of $15.3 million for the quarter ended June 30, 2025.
•
As of August 12, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 83,408,050.

(Press release, Pyxis Oncology, AUG 13, 2026, View Source [SID1234670070])