OPKO Health Expands Strategic Relationship with HealthCare Royalty Through $125 Million Notes Issuance Secured by Mazdutide Royalty Interests

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])

bioAffinity Technologies Announces Pricing of $4M Private Placement Offering Priced At-the-Market Under Nasdaq Rules

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])

Pyxis Oncology Reports Second Quarter 2026 Financial Results and Advances MICVO Toward Key 2026 Clinical Milestones

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])

Zentalis Pharmaceuticals Announces Pricing of Underwritten Public Offering

On August 13, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) ("Zentalis" or the "Company"), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, reported the pricing of an underwritten public offering of 23,000,000 shares of its common stock at a public offering price of $3.50 per share. The total gross proceeds to the Company from the offering are expected to be approximately $80.5 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company. All of the common stock is being offered by the Company. The offering is expected to close on August 17, 2026, subject to customary closing conditions. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 3,450,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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The Company intends to use the net proceeds from the offering, together with the Company’s existing cash, cash equivalents and marketable securities, to fund clinical trials, preclinical studies, regulatory filings, manufacturing and the Company’s companion diagnostic in support of its programs, as well as for pre-commercial activities, capital expenditures, working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities and Oppenheimer & Co. are acting as joint bookrunners for the offering. H.C. Wainwright & Co. is acting as a passive bookrunner for the offering. Rodman & Renshaw LLC is acting as a manager for the offering.

The securities described above are being offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 2025, and became effective on April 4, 2025. This offering is being made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A final prospectus supplement related to the offering (including the accompanying prospectus) will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement related to the offering and the accompanying prospectus may be obtained, when available, by visiting the SEC’s website or by contacting: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

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

(Press release, Zentalis Pharmaceuticals, AUG 13, 2026, View Source [SID1234670091])

Baylink Biosciences Announces FDA Clearance of IND Application for BLB101, a Novel CLDN6/CLDN9 Dual-Targeting ADC for Advanced Solid Tumors

On August 13, 2026 Baylink Biosciences, Inc. ("Baylink"), a biotechnology company focused on developing next-generation antibody-drug conjugates (ADCs) for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BLB101, a novel CLDN6/CLDN9 dual-targeting ADC for the treatment of patients with advanced solid tumors.

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BLB101 is Baylink’s lead ADC program and is designed to selectively deliver the highly potent topoisomerase I inhibitor Exatecan to tumor cells expressing CLDN6 and/or CLDN9. The molecule incorporates Baylink’s proprietary BL001 hydrophilic cleavable linker. It uses cysteine-maleimide conjugation approach with a drug-to-antibody ratio (DAR) of 8.

"FDA clearance of the BLB101 IND is an important milestone for Baylink and validates the progress of our ADC development platform," said Alice Chen, CSO of Baylink Biosciences. "BLB101 represents our differentiated approach to ADC development, combining dual CLDN6/CLDN9 targeting, a TOP1 inhibitor payload that is insensitive to efflux pump, and our proprietary hydrophilic linker technology. We look forward to advancing BLB101 into clinical development and evaluating its potential to provide a new treatment option for patients with advanced solid tumors."

Designed for Broader Tumor Targeting

CLDN6 is a tight-junction protein with highly restricted expression in most normal adult tissues and aberrant expression in some solid tumors. CLDN9, a closely related Claudin family member, is also expressed in a range of solid tumors and may provide complementary tumor coverage.

BLB101 incorporates Baylink’s proprietary 2D5S antibody, which binds both CLDN6 and CLDN9. This dual-targeting strategy is designed to expand the potential patient population and address tumor heterogeneity associated with expression of individual tumor antigens.

Preclinical studies have demonstrated specific binding to CLDN6 and CLDN9, internalization of BLB101 into target-positive tumor cells, and potent cytotoxic activity in relevant tumor models.

Exatecan Payload and Proprietary BL001 Linker

BLB101 uses Exatecan, a highly potent Topoisomerase I inhibitor that is insensitive to efflux pump, as its cytotoxic payload. Following internalization and intracellular processing of the ADC, Exatecan is released and induces DNA damage through stabilization of the TOP1-DNA cleavage complex, ultimately leading to tumor cell death.

Baylink’s proprietary BL001 linker was designed to improve the overall physicochemical properties and stability of high-DAR ADCs while supporting efficient intracellular payload release. BL001 incorporates hydrophilic structural elements and a cleavable Val-Ala sequence and supports a high drug-to-antibody ratio of 8. BL001 linker was also designed to reduce non-specific internalization by non-cancer cells which is expected to further reduce side effects.

Advancing Toward Clinical Proof of Concept

Baylink has completed key preclinical, CMC, and IND-enabling activities for BLB101, including GLP toxicology studies, pharmacokinetic and toxicokinetic characterization, analytical development, drug substance and drug product manufacturing, formulation development, and stability studies.

The FDA clearance of the BLB101 IND enables Baylink to initiate clinical development of BLB101 in patients with advanced solid tumors.

"The IND clearance is the result of the tremendous effort of the Baylink team," said Patrick Zweider-McKay, MD/PhD, Baylink’s Clinical Advisor. "We are excited to bring this program into the clinic and generate clinical data that will help determine the therapeutic potential of CLDN6/CLDN9 dual targeting."

(Press release, Baylink Biosciences, AUG 13, 2026, View Source [SID1234670159])