First pivotal cohort enrolled 300 subjects, with topline clinical data from 24-week primary endpoint on track for December 2026 releaseCompletion of enrollment in the second pivotal cohort evaluating 600 subjects across the PEAK and PINNACLE studies is expected in 4Q 2026, with topline clinical data release anticipated in 2Q 2027

PALO ALTO, Calif., Aug. 6, 2026 /PRNewswire/ — Kodiak Sciences Inc. (Nasdaq: KOD) today announced that it has completed enrollment of the first 300-patient cohort in its PEAK trial, supporting Pivotal Analysis 1 of the KSI-101 Phase 3 program in macular edema secondary to inflammation (“MESI”). Kodiak also reaffirmed its plan to release the topline data from Pivotal Analysis 1 in December 2026.

“We were pleased to complete this important enrollment milestone in early June , and we can now confidently plan for the topline data to be released in December 2026,” said Victor Perlroth, M.D., Chief Executive Officer of Kodiak. “Our data from the Phase 1b APEX study meaningfully increased our conviction in KSI-101’s potential to be a cornerstone therapy for MESI patients. The global registrational PEAK trial is the first pivotal test of that conviction, and we look forward to sharing topline data before the end of this year.”

“Pivotal Analysis 1 gives us the opportunity to evaluate KSI-101 in patients with more severe MESI across our global site footprint,” said J. Pablo Velazquez-Martin, M.D., Chief Medical Officer of Kodiak. “These are patients at high risk of losing meaningful vision, and the goal of treatment is not only to reduce inflammation but to dry the retina and improve vision without the toxicities and other limitations associated with today’s complex patchwork of systemic and ocular therapies. KSI-101 was designed for this clinical challenge, and we are grateful to the patients, investigators and study teams who have helped bring the program to this important milestone.”

“MESI encompasses a broad range of diseases resulting in a swollen macula and which are not attributable to other common causes of retinal edema such as wet AMD, diabetic macular edema and retinal vein occlusion. MESI represents a meaningful number of patients in my retina practice,” said David Eichenbaum, M.D., Director of Research at Retina Vitreous Associates of Florida and a principal investigator in the PEAK and PINNACLE clinical trials. “Many of these patients have experience with corticosteroid use and understand its limitations, including the risks of elevated intraocular pressure and cataract. I am encouraged by the data generated to date with KSI-101 in which the therapy appears to work well and to date is demonstrating a favorable safety profile. KSI-101 could open up treatment for MESI to many more patients and may meaningfully change the treatment paradigm for this diagnosis in retina practice in the years ahead. I’m thrilled to be on the leading edge of this program.”

About Macular Edema Secondary to Inflammation (MESI)

MESI is a heterogeneous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology of inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization).

Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. Existing therapies remain limited by side effects and tolerability, underscoring the need for safer and more effective treatment options. MESI represents a new macular edema market segment separate from the established anti-VEGF market.

About KSI-101

KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF for the treatment of MESI. Data from our dose-finding Phase 1b APEX study demonstrated robust anatomical and visual responses across MESI patients. More than half of patients achieved ≥15-letter gains in best corrected visual acuity, with additional benefit at higher dose levels. Rapid vision improvements and anatomical response were observed with 10-letter gains by Week 4 in top dose groups and OCT CST <325 microns achieved as early as Week 1 in top dose groups. Continued anatomical improvement was observed over time with >90% resolution of intraretinal (“IRF”) and subretinal fluid (“SRF”) by Week 8 and 20/25 Snellen visual acuity by Week 20. In top dose groups, ≥90% achieved complete absence of IRF and SRF, indicating retinal dryness and normalization of retinal architecture. KSI-101 also continued to be well tolerated with a favorable safety profile. The top two dose levels in APEX have been advanced into the Phase 3 pivotal studies, PEAK and PINNACLE. The PEAK and PINNACLE studies are actively enrolling.

About PEAK and PINNACLE

The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK and PINNACLE are identical in study design with key differences in patient population. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients.

Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN. The primary and key secondary endpoints will be evaluated at Week 24. PEAK and PINNACLE are now actively enrolling patients. Topline data readouts for Pivotal Analysis 1 (PEAK patients 1 – 300) and Pivotal Analysis 2 (PEAK patients 301 – 600 and PINNACLE patients 1 – 300) are expected in December 2026 and 2Q 2027, respectively.

About Kodiak Sciences Inc.

Kodiak Sciences (Nasdaq: KOD) is a pre-commercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a BLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD, and, together with KSI-501, is being explored in the BLA-facing Phase 3 DAYBREAK wet AMD study, with topline data expected in September 2026. Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI). Topline data for Pivotal Analysis 1 (PEAK) are expected in December 2026 and Pivotal Analysis 2 (PEAK+PINNACLE) in 2Q 2027.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding:  Kodiak’s plans to release topline data; Kodiak’s expectation regarding the timing of completion of enrollment in the PEAK and PINNACLE studies; Kodiak’s belief regarding KSI-101’s efficacy and safety profile based on data from the Phase 1b APEX study and in the PEAK and PINNACLE studies. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could,” “expect,” “plan,” “believe,” “intend,” “pursue,” “anticipate,” and other similar expressions, among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that data observed to date in the Phase 1b APEX study or in the ongoing PEAK and PINNACLE studies may not continue or persist, or may not be replicated in later analyses or in a larger or more diverse patient population; the risk that KSI-101 may not achieve the primary or key secondary endpoints in the PEAK or PINNACLE studies or may not do so on the anticipated timeline; the risk that cessation, modification, or delay of the PEAK or PINNACLE studies, or of Kodiak’s development of KSI-101 or any other product candidate, may occur; the risk that KSI-101 may not be successfully developed, approved, or commercialized; the risk that Kodiak’s research and development efforts and ability to advance product candidates into later stages of development may fail; adverse conditions in the general domestic and global economic markets, which may significantly impact Kodiak’s business and operations, including its clinical trial sites, as well as the business or operations of its manufacturers, contract research organizations, or other third parties with whom Kodiak conducts business; as well as the other risks identified in the section entitled “Risk Factors” in Kodiak’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Kodiak’s subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Kodiak undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on such forward-looking statements.

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SOURCE Kodiak Sciences Inc.

Q2 2026 Highlights:

Revenue of $215.2 millionGAAP Gross Margin of 42.4%, and Non-GAAP Gross Margin of 42.7%GAAP Operating Margin of 9.4% and Non-GAAP Operating Margin of 14.7%GAAP Diluted Earnings Per Share of $0.75, and Non-GAAP Diluted Earnings Per Share of $1.06

BEVERLY, Mass., Aug. 6, 2026 /PRNewswire/ — Axcelis Technologies, Inc. (Nasdaq: ACLS) today announced financial results for the second quarter ended June 30, 2026.

President and CEO Russell Low commented, “We executed well in the second quarter, delivering results that exceeded our forecasts driven by stronger system shipments and higher CS&I volume.” Low continued, “Demand in the Memory market remains robust, and we are also benefitting from positive momentum in our Power market. In General Mature, we are encouraged by improving engagement and utilization trends as customers respond to growing end-demand in data center, industrial and automotive segments. As a result, we now expect to deliver year-over-year revenue growth in 2026, with momentum carrying through to 2027. We are focused on satisfying the remaining conditions to complete our pending merger with Veeco and look forward to closing the transaction in the second half of 2026.”

Senior Vice President and Interim CFO David Ryzhik stated, “Axcelis delivered better than expected revenue and operating income in our second quarter, reflecting the attractive operating leverage in our business.” Ryzhik concluded, “With improving systems demand in our markets and continued strength in our CS&I aftermarket business, we anticipate that Axcelis’ financial performance will continue to improve over the balance of 2026.”

Business Outlook
For the third quarter ending September 30, 2026, Axcelis expects revenues of approximately $230 million, GAAP earnings per diluted share of approximately $0.76, and non-GAAP earnings per share of approximately $1.11.

Please refer to Third Quarter 2026 Outlook under the “Notes on our Non-GAAP Financial Information” section of this document for detail relating to the computation of non-GAAP earnings per diluted share as well as the Safe Harbor Statement section of this document.

Second Quarter 2026 Conference Call
The Company will host a call to discuss the results for the second quarter 2026 today at 8:30 a.m. ET. The call will be available via webcast that can be accessed through the Investors page of Axcelis’ website at www.axcelis.com, or by registering as a participant here:
https://register-conf.media-server.com/register/BIf61211144e3b4baeb4c13ba3b1f529fa
Webcast replays will be available for 30 days following the call.

Use of Non-GAAP Financial Results
This press release includes financial measures that are not presented in accordance with U.S. generally accepted accounting principles (“non-GAAP financial measures”). These non-GAAP financial measures include non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating income, non-GAAP operating margin, non-GAAP income tax provision, Adjusted EBITDA, non-GAAP net income, and non-GAAP diluted earnings per share, and reflect adjustments for the impact of share-based compensation expense, certain items related to restructuring and severance charges and any associated adjustments and transaction and integration costs associated with the merger agreement with Veeco Instruments announced on October 1, 2025.

Reconciliations of these non-GAAP financial measures to the most directly comparable financial measures calculated and presented in accordance with GAAP are provided in the financial tables included in this release.

For further information regarding these non-GAAP financial measures, please refer to the tables presenting reconciliations of our non-GAAP results to our GAAP results and the “Notes on Our Non-GAAP Financial Information” at the end of this press release.

Safe Harbor Statement
This press release contains, and the conference call will contain, forward-looking statements under the Private Securities Litigation Reform Act safe harbor provisions. These statements, which include our expectations for spending in our industry and guidance for future financial performance, are based on management’s current expectations and should be viewed with caution. They are subject to various risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are outside the control of the Company, including that customer decisions to place orders or our product shipments may not occur when we expect, that orders may not be converted to revenue in any particular quarter, or at all, whether demand will continue for the semiconductor equipment we produce or, if not, whether we can successfully meet changing market requirements, and whether we will be able to maintain continuity of business relationships with and purchases by major customers. Increased competitive pressure on sales and pricing, increases in material and other production costs that cannot be recouped in product pricing and instability caused by changing global economic, political or financial conditions, including with respect to the imposition of tariffs on our products or components of our products, could also cause actual results to differ materially from those in our forward-looking statements. These risks and other risk factors relating to Axcelis are described more fully in the most recent Form 10-K filed by Axcelis and in other documents filed from time to time with the Securities and Exchange Commission.

About Axcelis
Axcelis (Nasdaq: ACLS), headquartered in Beverly, Mass., has been providing innovative, high-productivity solutions for the semiconductor industry for over 45 years. Axcelis is dedicated to developing enabling process applications through the design, manufacture and complete life cycle support of ion implantation systems, one of the most critical and enabling steps in the IC manufacturing process. Learn more about Axcelis at www.axcelis.com.

CONTACTS:

Investor Relations Contact:
David Ryzhik
Senior Vice President and Interim CFO
Telephone: (978) 787-2352
Email: David.Ryzhik@axcelis.com

Press/Media Relations Contact:
Maureen Hart
Senior Director, Corporate & Marketing Communications
Telephone: (978) 787-4266
Email: Maureen.Hart@axcelis.com

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SOURCE Axcelis Technologies, Inc.

California law now bars “the AI acted on its own” as a defense. AICtrlNet’s answer: the “person of record” as a software feature, MIT-licensed at the core.

NAPERVILLE, Ill., Aug. 6, 2026 /PRNewswire/ — The question of who pays when an AI agent misbehaves stopped being hypothetical this year. California’s AB 316 bars companies that developed, modified, or used an AI system from arguing it acted autonomously. The European Union’s revised Product Liability Directive treats firms that modify or brand an AI system as its manufacturer. And insurers, using Verisk’s generative-AI exclusion forms, are writing AI incidents out of general-liability renewals. As NYU’s Haran Segram wrote in The Wall Street Journal this week, the exposure “sits on nobody’s books.”

Bodaty LLC’s answer has been in production since June: AICtrlNet, the open source platform for Governed AI Orchestration. Every consequential action an AI takes through AICtrlNet — a customer email, an invoice, a payment instruction — can be gated behind a named person’s approval, and every approval lands in a timestamped, tamper-evident audit record. The person of record is not a contract clause in AICtrlNet; it is how the software runs. The platform never moves money on its own.

“The 1979 IBM training rule said a computer must never make a management decision, because it can never be held accountable,” said Bobby Koritala, Bodaty’s founder and CEO, previously chief product officer at Infogix (acquired by Precisely), whose data-integrity products served many of the country’s largest banks and insurers. “That rule is becoming case law and insurance policy. Businesses don’t need braver AI. They need to answer ‘who approved that?’ in one query. We built software that makes that the default.”

AICtrlNet deploys anywhere — sovereign, air-gapped, or managed cloud — and is model-independent (Claude, OpenAI, Gemini, local open-weight runtimes). The MIT-licensed Community Edition is freely available at github.com/bodaty/aictrlnet-community; Business and Enterprise tiers are commercially available. HitLai, Bodaty’s small-business product, brings the same governance to SMB operations: AI does the work, your team approves what matters.

About Bodaty LLC: Bodaty is the holding company for AICtrlNet (aictrlnet.com), HitLai (hitlai.net), and the HitLai Institute, which hosts a one-day workshop September 23 in Naperville. “Governed AI Orchestration” is a trademark of Bodaty LLC.

View original content:https://www.prnewswire.com/news-releases/as-ai-agent-liability-lands-on-deployers-bodatys-open-source-aictrlnet-puts-a-named-human-on-every-consequential-ai-action-302844210.html

SOURCE Bodaty LLC