1stOncology™: Cancer Intelligence Service – Page 220 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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])

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.

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])

Artera Enrolls First Patient in DIRECT-AI Registry, Marking Milestone in Real-World Evidence Generation for AI-Powered Prostate Cancer Care

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.

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])

Sarah Cannon Research Institute and Merck Collaborate to Expand Access to Oncology Clinical Trials

On August 13, 2026 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a strategic collaboration with Merck, known as MSD outside the United States and Canada, to utilize SCRI’s Accelero delivery model designed to expand patient access to oncology clinical trials at community-based sites across the U.S.

The oncology clinical research landscape is rapidly evolving, as study designs become more complex, patient eligibility criteria more precise, and the heightened urgency to bring breakthrough science to patients faster continues to grow. These dynamics require modern clinical trial delivery models that are more efficient, data-enabled, and accessible for patients in community settings. SCRI and Merck are working together to address the challenges by advancing a scalable approach to oncology trial execution.

"At Merck, we are focused on advancing research to better understand cancer and potential therapeutic approaches. By leveraging the Accelero delivery model, we have the potential to reach patients faster, reduce protocol complexity, and make oncology clinical studies more accessible in the communities where patients live," said Jennifer Coppola, Associate Vice President and Regional Head for Global Clinical Trial Operations of North America at Merck Research Laboratories.

Through Accelero, SCRI uses a streamlined operating model to improve the speed and efficiency of oncology drug development. SCRI works closely with its physician network and industry partners to identify specific challenges and tailor fit-for-purpose solutions, including EHR-to-EDC data transfer across portfolios, accelerated site start-up and increased enrollment on high-priority studies. With select industry partners, Accelero has delivered site activations up to 50 percent faster than traditional operations, enrollment rates 19 percent higher than the 7 percent national average, and 95 percent fewer data changes than traditional clinical research coordinator data entry processes.1

"Merck has helped shape the modern era of cancer treatment, and we share a commitment to advance the next generation of cancer medicines through innovative approaches," said Dee Anna Smith, Chief Executive Officer of SCRI. "Together, we are committed to accelerating trial delivery, reduce operational friction, and bring research to patients."

(Press release, Sarah Cannon Research Institute, AUG 13, 2026, View Source [SID1234670088])

Nektar Therapeutics Announces Second Quarter 2026 Financial Results

On August 13, 2026 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, reported financial results for the second quarter ended June 30, 2026.

Cash and investments in marketable securities on June 30, 2026, were $1,023.4 million as compared to $245.8 million on December 31, 2025.

"This year continues to be a transformative year for Nektar as we advance our lead program, rezpegaldesleukin, into Phase 3 clinical trials," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We initiated the first Phase 3 ZENITH AD trials in atopic dermatitis in July, and we plan to start a single registrational Phase 3 study in alopecia areata in early 2027. Our Phase 3 program establishes a clear path to the first BLA submission for rezpegaldesleukin in 2029. With its novel T-reg mechanism, rezpegaldesleukin is uniquely positioned to provide benefit for patients across a number of chronic autoimmune conditions. Importantly, our financial position is strong with over one billion dollars in cash and investments at the end of the quarter, and a cash runway that extends into the third quarter of 2028, past the initial Phase 3 data readouts expected in mid-2028."

Revenue in the second quarter of 2026 was $10.1 million as compared to $11.2 million in the second quarter of 2025. Revenue for the first half of 2026 was $21.0 million as compared to $21.6 million in the first half of 2025.

Total operating costs and expenses in the second quarter of 2026 were $52.5 million as compared to $47.4 million in the second quarter of 2025. Total operating costs and expenses were $102.4 million for both the first half of 2026 and first half of 2025. Operating expenses for the second quarter and first half of 2026 reflect an increase in R&D expenses, offset by a decrease in G&A expenses.

R&D expense in the second quarter of 2026 was $39.1 million as compared to $29.9 million for the second quarter of 2025. R&D expense in the first half of 2026 was $74.8 million as compared to $60.4 million for the first half of 2025. R&D expense increased primarily due to the commencement of activities to support the Phase 3 ZENITH AD program in atopic dermatitis as well as manufacturing activities associated with rezpegaldesleukin.

G&A expense was $12.8 million in the second quarter of 2026 as compared to $17.1 million in the second quarter of 2025. G&A expense was $26.2 million in the first half of 2026 as compared to $41.4 million in the first half of 2025. G&A expense decreased primarily due to a decrease in legal expenses.

Our non-cash loss from our equity method investment in Gannet BioChem was $0.3 million in the second quarter of 2026, as compared to $2.4 million in the second quarter of 2025. The non-cash loss from the equity method investment was $2.1 million in the first half of 2026, as compared to $6.8 million in the first half of 2025.

Net loss for the second quarter of 2026 was $40.6 million or $1.23 basic and diluted net loss per share as compared to net loss of $41.6 million or $2.95 basic and diluted loss per share in the second quarter of 2025. Net loss in the first half of 2026 was $85.5 million or $2.96 basic and diluted net loss per share as compared to a net loss of $92.5 million or $6.57 basic and diluted loss per share in the first half of 2025.

Second Quarter 2026 Business Highlights

In July 2026, Nektar announced the initiation of the first two global registrational trials in the Phase 3 ZENITH AD program evaluating rezpegaldesleukin in moderate-to-severe atopic dermatitis. The program will include a total of three randomized, double-blind, placebo-controlled trials: ZENITH AD-1 and ZENITH AD-2 will enroll biologic and systemic JAK inhibitor treatment naive patients, and ZENITH AD-3 will enroll patients with prior biologic and/or systemic JAK inhibitor treatment experience.
In April 2026, Nektar completed an underwritten public offering of its common stock resulting in $373.8 million of gross proceeds.
In April 2026, Nektar announced positive 52-week topline results from the 16-week blinded treatment extension of the Phase 2b REZOLVE-AA study, demonstrating deepening of responses to rezpegaldesleukin in patients with severe-to-very-severe alopecia areata with continued twice-monthly dosing.
Upcoming Data Presentations at the 2026 European Academy of Dermatology and Venereology Congress:

Oral Presentation: "Rezpegaldesleukin Provides Durable and Deepening Improvements in the Signs and Symptoms of Atopic Dermatitis with Monthly and Quarterly Dosing: Results from the Phase 2b REZOLVE-AD Maintenance Part of Study"
Abstract No: AS-1732
Presenter: Dr. Thomas Bieber
Session Title: FC02.1B
Presentation Date and Time: Thursday, October 1st 10:25 – 10:35 CEST
Location: Hall N
Oral Presentation: "Rezpegaldesleukin, a Novel Regulatory T Cell-Inducing Biologic, Demonstrates Efficacy and Safety in Severe-to-Very-Severe Alopecia Areata: 52-Week Results from the Phase 2b REZOLVE-AA Study"
Abstract No: AS-1872
Presenter: Dr. David Rosmain
Session Title: FC04.1D
Presentation Date and Time: Thursday, October 1st 16:30 – 16:40 CEST
Location: Hall N
The presentations at EADV will be made available on Nektar’s website at View Source under Scientific Publications, following the formal presentation.

Conference Call to Discuss Second Quarter 2026 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, today, August 13, 2026.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through September 13, 2026.

To access the conference call, please pre-register here. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, AUG 13, 2026, View Source [SID1234670087])