On August 14, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage AI-driven precision oncology company leveraging its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the second quarter ended June 30, 2026, and provided an update on its portfolio of AI-driven drug candidates and AI platforms.

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The second quarter of 2026 marked continued execution of Lantern’s strategy to translate its AI platform into differentiated clinical, regulatory, intellectual property, and commercial milestones. Emerging data from the HARMONIC trial indicated that LP-300’s progression-free survival benefit deepens with longer treatment duration in patients with EGFR exon 21 L858R-mutations, while the FDA reviewed key protocol amendments without objection. The European Medicines Agency (EMA) cleared an investigator-initiated Phase 1b/2 trial of LP-184 (zirdafulven) for biomarker-selected, advanced bladder cancer patients, and the U.S. Patent and Trademark Office issued a Notice of Allowance covering a three-gene patient-selection signature for LP-184. In August, Lantern established Open Medicine AI as a separate company and entered into board-approved commercial licensing agreements. Reflecting ongoing operating discipline, loss from operations declined approximately 25% year over year for the quarter.

"The emerging HARMONIC data point to a clear observation: L858R patients who stay on LP-300 longer do better," said Panna Sharma, President and Chief Executive Officer of Lantern Pharma. "A signal that strengthens with time should shape trial design, and that is exactly what our amended protocol does — concentrate enrollment where the benefit is deepest and extend treatment from six cycles to eight. The FDA reviewed those amendments without objection.

"The quarter also showed what our AI-enabled model produces: a Notice of Allowance on the patient-selection signature for LP-184, European clearance to administer that drug in a dual-biomarker-selected bladder cancer trial, and Open Medicine AI established as a separate company. We have advanced new programs from AI-derived insights to first-in-human clinical trials in roughly two to three years at approximately $2 to $3 million each. The industry norm to reach that same point is five to ten years and $25 to $100 million. That difference is not a marketing claim; it is our operating model."

With the establishment of Open Medicine AI, Lantern has two value-creation engines:

1. A clinical-stage, precision oncology drug development business advancing biomarker-guided therapies across solid tumors, blood cancers, and pediatric brain cancers; and

2. An AI platform business addressing the opportunity in AI-enabled drug discovery, the market for which is projected to exceed $10 billion by 2030, with oncology as its largest therapeutic segment.

Open Medicine AI: Establishment as a Separate Company

In August 2026, Lantern announced the formal creation of Open Medicine AI (OMAI) and the execution of commercial licensing agreements between OMAI and Lantern Pharma. The agreements, approved by the Lantern Pharma Board of Directors, were contemplated in the framework of the Company’s May 2026 registered direct financing and establish the commercial operating structure for the multi-agentic AI co-scientist platform previously launched as withZeta.ai. Under the agreements, OMAI licenses Lantern’s related models, data, algorithms, and other assets and personnel.

"Open Medicine AI is not a research project with a logo on it. It has board approval, executed licenses, a platform in production, paying subscription tiers, and two engineering centers. We believe that this is a great foundation from which to attract investors who can value AI and a technology-centric disruptive business separate from our portfolio of cancer drug-candidates," said Mr. Sharma, who is the Founder of Open Medicine AI and continues as President and Chief Executive Officer of Lantern Pharma. "Separating OMAI is intended to let each business be funded by the investors who understand it and valued on the metrics that apply to it."

OMAI is currently 100% owned by Lantern Pharma. OMAI intends to obtain additional funding in exchange for equity in OMAI, and the longer-term objective is for OMAI to become a newly listed company on a national stock exchange or market, with Lantern expecting to remain one of OMAI’s largest shareholders. As OMAI receives outside funding, additional operational and success incentives are expected to be put in place for the Open Medicine AI team.

Today OMAI is a wholly-owned subsidiary, and Lantern retains the ability to apply the platform across its clinical pipeline and preclinical assets, including LP-184, LP-284, and LP-300, and the separation does not alter the priority or expected timing of those programs, which remain the Company’s principal clinical value drivers.

OMAI will operate as a commercial software business through tiered subscriptions based on functionality and tool access, alongside enterprise agreements for organizations requiring broader deployment and integration with internal data and workflows. Target customers include biopharmaceutical and biotechnology R&D organizations, academic medical centers, life sciences investors, and disease foundations. The platform comprises coordinated specialist agents spanning medicinal chemistry, computational biology, clinical trial strategy, biomarkers and translational science, and clinical oncology. Development is anchored by AI Centers of Excellence in Dallas, Texas and Bengaluru, India, the latter established in the first quarter of 2026. In July 2026, the Company launched ZetaOmics, the computational-biology module of the platform — an autonomous "Computational Biologist" agent that designs an analysis, executes it independently on real biological data, defends its methodological choices, and returns publication-quality results with a queryable, exportable audit trail suited to regulated research.

Management will host a dedicated informational call and webcast in mid-September 2026 to discuss the Open-Medicine AI market opportunity, platform roadmap, and commercial model in greater detail. Details will be announced separately.

Clinical Pipeline Developments

Lantern’s AI-driven clinical pipeline encompasses multiple drug candidates across solid tumors, blood cancers, and pediatric oncology, with a combined estimated annual market potential exceeding $15 billion. The portfolio includes a Phase 2 clinical program (LP-300) in NSCLC focused on never-smokers and non-smokers with the EGFR exon 21 L858R mutation; Phase 1b/2 trial (LP-184) in precision, biomarker-defined advanced bladder cancer; and an ongoing Phase 1a program in hematologic malignancies and soft tissue sarcomas (LP-284). Additionally, through wholly-owned subsidiary Starlight Therapeutics, the Company has a planned Phase 1 pediatric CNS cancer trial and a planned Phase 1b trial in adult relapsed glioblastoma (GBM) in combination with spironolactone, both with STAR-001 (LP-184). Each program has been guided by the RADR platform’s AI-driven insights and capabilities which are aimed at compressing the cost and timeline of cancer drug development.

LP-300 HARMONIC Trial: Progression-Free Survival Benefit Deepens With Treatment Duration

In June 2026, Lantern reported emerging data from the ongoing Phase 2 HARMONIC trial (NCT05456256) of LP-300 in combination with carboplatin and pemetrexed as of the May 11, 2026 data cutoff. The data revealed a dose-duration relationship in which the progression-free survival benefit of LP-300 deepens with treatment duration, most pronounced in patients with the EGFR exon 21 L858R mutation.

● Progression-Free Survival: Median progression-free survival reached 8.9 months among L858R patients who completed six cycles of LP-300 (n=9, of whom three had not progressed at the time of analysis), compared with 8.4 months across the overall L858R cohort (n=16). The L858R subgroup corresponded to a hazard ratio of 0.37 (95% CI 0.15–0.89).

● Depth and Durability of Response: More than 70% of evaluable L858R patients experienced a reduction in target-lesion size, including a complete response and multiple partial responses among the deepest responders, with certain responses sustained beyond two years and a clinical benefit rate of 77%.

● Dose-Duration Relationship: Comparable safety profiles were observed across patients receiving four or six cycles of LP-300, with no evidence of increased adverse events with longer treatment duration. This trend is consistent with LP-300’s kinase inhibitory mechanism of action and provides supporting scientific rationale for extending the maximum number of treatment cycles from six to eight.

● Safety and Tolerability: No clinically meaningful toxicity was observed beyond that of carboplatin and pemetrexed alone. Lantern believes this profile compares favorably with amivantamab plus chemotherapy on a cross-trial basis and supports the extended treatment duration.

Preliminary multivariable Cox regression analyses incorporating race, gender, and TP53 mutation status confirmed L858R as an independent predictor of progression-free survival benefit. These data are exploratory and based on small patient cohorts. Following a successful outcome from its May 2026 Type C meeting request, at which the FDA raised no objections to key proposed amendments, the Company has implemented protocol changes that: (i) focus future enrollment on patients with the EGFR exon 21 L858R mutation, a subtype demonstrating lower sensitivity and inferior treatment outcomes with osimertinib-based therapy; (ii) increase the maximum number of LP-300 treatment cycles from six to eight; and (iii) discontinue enrollment into the control arm while migrating to a single-arm study design.

The HARMONIC trial will continue to enroll in the United States and in Taiwan, where more than 50% of lung cancer cases occur in never-smokers; targeted enrollment in Japan was completed in July 2025 across five clinical sites including the National Cancer Center Tokyo. The Company furnished its data presentation as an exhibit to a Current Report on Form 8-K and used the dataset in partnering and clinical discussions at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including potential global and regional licensing and co-development opportunities. Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics, representing a global market opportunity estimated at over $4 billion annually, with no therapies specifically approved for these patients.

LP-184 (zirdafulven): EMA Clearance for Biomarker-Selected Bladder Cancer Trial

In July 2026, the European Medicines Agency cleared an investigator-initiated Phase 1b/2 clinical trial of LP-184 (zirdafulven) in advanced, recurrent bladder cancer. The study will be conducted at Rigshospitalet in Copenhagen, Denmark’s national referral center for urologic cancers, with Professor Kristoffer Staal Rohrberg, MD, PhD, serving as Sponsor and Principal Investigator and Professor Helle Pappot, MD, DMSc, serving as Coordinating Investigator.

The open-label study is designed to enroll up to approximately 39 patients with advanced or metastatic urothelial carcinoma who have progressed on or are ineligible for current standard-of-care regimens, including patients treated after enfortumab vedotin plus pembrolizumab. It is among the first studies to prospectively select patients using a dual biomarker strategy, combining overexpression of the LP-184-activating enzyme PTGR1 with tumor DNA-damage repair deficiency. LP-184 will be administered on Days 1 and 8 of each 21-day cycle, with objective response rate by RECIST 1.1 as the primary endpoint.

Bladder cancer is among the ten most common cancers worldwide, with approximately 550,000 new cases diagnosed annually, and there is no FDA-approved therapy for nucleotide excision repair deficient tumors. Lantern is initially positioning LP-184 in a clinical trial where it will be used primarily in the third-line setting. This represents approximately 130,000 eligible patients globally each year and a potential market opportunity estimated by analysts at $3 billion or more by 2035.

LP-184 (zirdafulven): Expanded Patent Estate and Advancement in Triple-Negative Breast Cancer

In July 2026, the United States Patent and Trademark Office issued a Notice of Allowance for U.S. Patent Application No. 17/230,821, covering methods of selecting and treating patients with ovarian, primary liver, kidney, or thyroid cancer with LP-184 based on measured elevated expression of three genes — PTGR1, PTPN14, and ASPH — in a patient tumor sample. Lantern intends to continue expanding its patent portfolio through additional filings covering further indications and biomarker-guided applications of LP-184.

Lantern is preparing to initiate a Phase 1b/2 trial of LP-184 monotherapy in patients with relapsed or refractory advanced or metastatic triple-negative breast cancer (TNBC) whose tumors carry DNA damage repair alterations, homologous recombination deficiency, or genomic loss of heterozygosity. The study has been cleared by the FDA and is designed to enroll approximately 40 patients across two dose-level cohorts in Phase 1b to confirm the recommended Phase 2 dose, followed by a Simon two-stage Phase 2a assessment of preliminary objective response rate. LP-184 completed a 63-patient Phase 1a trial (NCT05933265) achieving all primary endpoints and establishing a recommended Phase 2 dose of 0.39 mg/kg, and has received Fast Track and Orphan Drug designations from the FDA across multiple indications including TNBC.

LP-284 and Starlight Therapeutics

LP-284 continues in an ongoing Phase 1 program in hematologic malignancies and adult soft tissue sarcomas, and holds FDA Orphan Drug Designations for soft tissue sarcomas, mantle cell lymphoma, and high-grade B-cell lymphomas, with composition of matter patents providing protection through 2039 in major medicine markets.

Starlight Therapeutics holds FDA clearance of the Investigational New Drug application for its planned Phase 1 pediatric CNS cancer trial of STAR-001 (LP-184) in Atypical Teratoid Rhabdoid Tumor (ATRT) and other rare pediatric cancers. STAR-001 holds Rare Pediatric Disease Designation and Orphan Drug Designation for ATRT, with additional designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors. Each Rare Pediatric Disease Designation independently qualifies for a potential FDA Priority Review Voucher upon potential approval and satisfaction of other program conditions; such vouchers have historically been sold or transferred in the range of $100 million to $150 million or more, representing a potentially meaningful source of non-dilutive value independent of the commercial potential of the underlying therapy. Starlight is also advancing plans for a Phase 1b trial of STAR-001 in adult patients with relapsed glioblastoma in combination with spironolactone, where preclinical studies have demonstrated meaningful synergy relative to either agent alone. Lantern and Starlight continue to explore partnership opportunities across both pediatric and adult CNS indications.

Financial Results for the Second Quarter Ended June 30, 2026

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $7.4 million as of June 30, 2026 (consisting of approximately $6.7 million in cash and cash equivalents and approximately $0.7 million in marketable securities), compared to approximately $10.1 million of cash, cash equivalents, and marketable securities as of December 31, 2025. Funding received during the second quarter consisted of approximately $4.4 million in gross proceeds from a registered direct offering that closed on May 14, 2026. The Company intends to pursue additional capital raises, collaborations and other opportunities to extend its operating runway.

Research and Development Expenses: R&D expenses were approximately $1.8 million for the three months ended June 30, 2026, compared to approximately $3.1 million for the three months ended June 30, 2025, a decrease of approximately $1.3 million or 42%. The decrease was primarily attributable to reductions of approximately $1.0 million in research studies and materials expenses relating to the conduct of our clinical trials and decreases of approximately $0.3 million in salaries and benefit expenses.

General and Administrative Expenses: G&A expenses were approximately $1.7 million for the three months ended June 30, 2026, compared to approximately $1.6 million for the three months ended June 30, 2025, an increase of approximately $0.13 million or 8%. The increase was primarily attributable to increases in business development and investor relations expenses of approximately $0.36 million and salaries and benefit expense increases of approximately $0.14 million, offset in part by decreases in other professional fees of approximately $0.35 million.

Operating Loss: Loss from operations was approximately $3.5 million for the three months ended June 30, 2026, compared to a loss from operations of approximately $4.7 million for the three months ended June 30, 2025, a decrease of approximately 25%.

Warrant Expense: In connection with the May 2026 offering, the Company issued investor warrants to purchase up to 2,135,923 shares of common stock at an exercise price of $2.27 per share, and placement agent warrants to purchase up to 106,796 shares of common stock at an exercise price of $2.575 per share. These warrants are accounted for as liabilities due to a settlement feature that may be triggered in the event of a fundamental transaction. During the three months ended June 30, 2026, the Company recorded an aggregate of approximately $3.6 million of expense related to these warrants. The principal component was non-cash expense arising from an increase in the fair value of the warrants, driven primarily by a substantial increase in the Company’s stock price between the May 14, 2026 warrant issuance date and June 30, 2026. Other components related to warrant expense were loss on issuance of the warrants and warrant issuance costs.

Net Loss: After including non-cash and other items relating to warrants, net loss was approximately $7.1 million (or $0.57 per share) for the three months ended June 30, 2026, compared to a net loss of approximately $4.3 million (or $0.40 per share) for the three months ended June 30, 2025. For the six months ended June 30, 2026, net loss was approximately $10.4 million (or $0.88 per share), compared to a net loss of approximately $8.9 million (or $0.82 per share) for the six months ended June 30, 2025.

"Our reported net loss went up largely because our stock price went up," said Mr. Sharma. "That is warrant accounting, not the operating business. A key number that shows how we actually run the company — loss from operations — fell approximately 25% in a quarter when we secured European clearance for a new precision oncology trial and established a separate AI software company."

Capitalization: As of June 30, 2026, the Company had 12,759,146 shares of common stock outstanding. On May 14, 2026, the Company closed a registered direct offering and concurrent private placement comprising 1,454,175 shares of common stock, pre-funded warrants to purchase up to 681,748 shares of common stock, investor warrants to purchase up to 2,135,923 shares of common stock at an exercise price of $2.27 per share, and placement agent warrants to purchase up to 106,796 shares of common stock at an exercise price of $2.575 per share. There was no activity under the Company’s ATM Sales Agreement during the three months ended June 30, 2026.

Additional detail is available in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission.

Conference Call Information

Lantern Pharma will host a conference call and webcast to discuss second quarter 2026 financial results and business updates on Friday, August 14, 2026 at 9:00 a.m. Eastern Time / 6:00 a.m. Pacific Time. To participate, please register at the Zoom webcast link: View Source

A replay will be available following the call in the investor relations section of Lantern’s website at ir.lanternpharma.com.

(Press release, Lantern Pharma, AUG 14, 2026, View Source [SID1234670127])

On August 14, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, reported financial results and recent business highlights for the three and six months ended June 30, 2026.

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On June 16, 2026, the Company announced its preliminary human data readout for the first two cohorts in a dose-escalating Phase 1 clinical study to evaluate HCW9302 as a monotherapy in patients with alopecia areata. HCW9302 is a fusion immunotherapeutic which is potentially a best-in-class IL-2-based treatment for autoimmune diseases. These preliminary findings support the Company’s belief that HCW9302 has the potential to activate and expand regulatory T (Treg) cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression or unwanted side effects caused by the activation of immune effector cells.

The Company remains on track for a full Phase 1 clinical data readout in the fourth quarter of 2026. Treatment of patients in the third dose cohort (i.e., eight (8) micrograms/kg body weight) is underway and evaluation of correlative study endpoints is ongoing. The Company has not reported any dose-limiting toxicities.

In the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three (3) micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool ("SALT") scores. These three participants, all with mild alopecia, showed a ≥25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. In addition, there were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. HCW9302 treatment did not increase blood eosinophil count, another serious side effect commonly associated with IL-2 therapy.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, "HCW9302 was selected as our lead product candidate for our autoimmune program because it has several unique features that differentiate it from other immunotherapeutic treatments for autoimmune disorders. Because our clinical study was designed to administer HCW9302 as a monotherapy, we feel confident of our findings and clear signals that indicate this drug has great potential. So far, our in-human clinical experience with HCW9302 is consistent with our preclinical results showing HCW9302’s effectiveness in alopecia areata and atopic dermatitis in relevant animal models."

Dr. Wong continued, "HCW9302 targets CD25 directly, which we believe demonstrates activation and expansion of regulatory T cells. It has preliminarily demonstrated it has an effect on alopecia areata, even when administered as monotherapy at a low dose. Our design does not use pegylation, so we avoid anti-PEG immune responses, which account for efficacy loss and can possibly cause severe allergic symptoms. With an eye toward the future commercialization of HCW9302 for the treatment of alopecia areata and other autoimmune disorders, we developed a manufacturing process for this drug that is a simple process capable of producing large quantities with consistent quality at a relatively low cost."

Business and Clinical Development Highlights

Commercial-Ready Molecules Used as Reagents

Since the second quarter of 2025, the AlloTera Therapeutics License (formerly the Wugen License) was in a one-year suspension period, which the Company agreed to at the request of AlloTera Therapeutics, Inc. ("AlloTera Therapeutics"). On May 21, 2026, the Company re-acquired the ex vivo rights to two commercial-ready molecules that had previously been licensed to AlloTera Therapeutics by exercising its right to terminate the AlloTera Therapeutics License Agreement according to the terms of the suspension letter agreement.

The Company is actively pursuing a corporate partner to commercialize HCW9206 and like molecules as reagents to support the production of cell-based immunotherapeutics, particularly CAR-T therapies. In collaboration with researchers at the Albert Einstein College of Medicine, the Company demonstrated and published in a scientific paper in Science Advances that replacing standard activation with HCW9206 during CAR-T cell manufacturing significantly increased the long-term persistence, functionality, and proportion of T memory stem cells in immunotherapies for cancer and HIV and potentially significantly lowers the production costs.

The market for reagents used in CAR-T therapy production is experiencing rapid expansion, driven by a projected increase in the global CAR-T cell therapy market, which is expected to grow from $4.0 billion in 2025 to over $15.0 billion by 2032. One of the impediments to growth is the manufacturing process, which is subject to delays and has difficult meeting target doses for commercial production.

Milestone for Company’s T-Cell Engager Program

The Company requested a Type B (pre-IND application) meeting with the U.S. Food and Drug Administration ("FDA") to discuss the development and regulatory strategy for its investigational lead product candidate, HCW11-018b, a tetravalent T-cell engager ("TCE") constructed with the Company’s proprietary TRBC drug development platform. The Company would like to reach agreement with FDA on requirements for a clinical study before we submit an IND application to evaluate HCW11-018b in cancer. This clinical trial is on track to initiate in the first half of 2027, provided we secured FDA authorization.

HCW11-018b is intended to treat solid tumors and is administered by subcutaneous injection. In preclinical studies, it has shown the ability to target tissue factor-expressing cancer cells and activate CD3-positive effector T cells, while simultaneously reducing immunosuppression in the tumor microenvironment. Immunosuppression in the tumor microenvironment can limit effector T-cell infiltration and antitumor activity in solid tumors, particularly in gynecologic and pancreatic cancers.

The Company believes that our robust, streamlined, and cost-efficient manufacturing process will produce high-quality cGMP material to support clinical development. Our manufacturing process for HCW11-018b is based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody needed for the affinity purification process. This monoclonal antibody will be manufactured under GMP standards using a top-tier CDMO.

TCEs have emerged as a potent therapeutic modality to treat cancer. First-generation TCEs represented a breakthrough in immunotherapy but they continue to face significant challenges, including limited antigen selection, poor efficacy in solid tumors, tolerability and safety concerns, and complex manufacturing processes. Extensive preclinical studies of HCW11-018b —including assessments of in vitro and in vivo potency, antigen specificity, pharmacokinetics, toxicity in nonhuman primates, and its therapeutic window — suggest that HCW11-018b may be able to overcome the limitations of earlier-generation TCEs.

$5.6 Million in Equity Financings

Pursuant to a May 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 71,174 shares of Common Stock, 403,322 Pre-Funded Warrants, and Common Warrants to purchase an aggregate of up to 474,496 shares of Common Stock for aggregate gross proceeds of approximately $4.0 million at the closing, before deducting fees payable to the placement agent and other offering expenses payable by the Company. The Investors included officers, directors and significant stockholders. Scott Garrett, Chairman of the Company’s Board of Directors, purchased $250,000 of securities, Hing C. Wong, the Company’s Founder and Chief Executive Officer, purchased $160,000 of securities, and Rebecca Byam, the Company’s Chief Financial Officer, purchased $20,000 of securities. Such purchases were made on the same terms and conditions as those offered to other investors. On June 18, 2026, the SEC declared effective a resale registration statement on Form S-1 (File No. 333-296577) covering the resale of shares of Common Stock and warrants issued in this private placement.

Pursuant to a July 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 218,862 shares of Common Stock, 400,000 Pre-Funded Warrants and Common Warrants to purchase an aggregate of 618,682 shares of Common Stock for aggregate proceeds of approximately $1.6 million at closing, before deducting offering fees. The Investors included officers and directors. Scott Garrett purchased $20,000 of securities, Hing C. Wong purchased $60,000 of securities, and Lee Flowers, the Company’s SVP Business Development, purchased $20,000 of securities. Under a Registration Rights Agreement, the Company is obligated to file a registration statement to register the securities sold in this offering within 15 business days from closing.

Second Quarter 2026 Financial Results

Revenues: Revenues for the three months ended June 30, 2025 and 2026 were $6,550 and $135,568, respectively. Revenues in the six months ended June 30, 2025 and 2026 were $11,615 and $6.7 million, respectively. In the three and six months ended June 30, 2026, the Company completed the closing of the exclusive, worldwide licensing agreement with Beijing Trimmune Biotech Co., Ltd. ("Trimmune") for the in vivo rights for HCW11-006 ("Trimmune License") and performed additional post-transfer services under the agreement.

Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2025 and 2026 were $1.2 million and $1.2 million, respectively, a decrease of $23,472, or 2%. The decrease was primarily due to decreases in salaries, benefits and related taxes and clinical trial expenses, partially offset by an increase in preclinical expenses with a focus on IND-enabling activities for the Company’s lead product T-Cell Engager candidate, HCW11-018b. R&D expenses for the six months ended June 30, 2025 and 2026 were $2.7 million and $2.5 million, respectively, a decrease of $244,236, or 9%. The decrease was primarily due to a decline in manufacturing and materials expenses, partially offset by increases in taxes and salaries, benefits and related expenses.

General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2025 and 2026 were $2.1 million and $1.9 million, respectively, a decrease of $225,646, or 11%. The decrease was primarily attributable to decreases of $242,073 in salaries and benefits related to a decline in stock-based compensation expense, $87,835 in accretion expense for the fixed bonus payable upon the maturity date of outstanding Secured Notes and a $79,518 decrease in insurance premiums, partially offset by increases in taxes and expenses related to financing activities. In May 2025, the Company restructured $7.4 million of debt related to the Secured Notes, and these Noteholders converted to equity. G&A expenses for the six months ended June 30, 2025 and 2026 were $4.3 million and $3.7 million, respectively, a decrease of $598,649, or 14%. The decrease was primarily attributable to decreases of $507,206 in salaries and benefits related to a decline in stock-based compensation expense and $346,482 in accretion expense for the fixed bonus payable upon maturity date of outstanding Secured Notes and a decrease of $175,343 in insurance premiums, partially offset by an increase in taxes and expenses related to financing activities.

Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration, net of insurance recoveries. In the six months ended June 30, 2025, the Company received a $2.0 million insurance recovery, partially offset by $403,049 of legal expenses. The Company anticipates it will continue to incur some expenses for the costs of remaining in compliance with the terms of the Settlement and Release Agreement from the Arbitration, primarily due to requirements for patents which are necessary to protect the Company’s exclusive, worldwide intellectual property rights held in perpetuity.

Nonoperating changes impacting net income (loss): The Company adopted the fair value method of accounting for its shares in AlloTera Therapeutics in the second quarter of 2025. As a result, in the three and six months ended June 30, 2025, the Company recognized a $1.7 million gain in both periods related to a change in the fair value for this investment. The Company recognized a warrant liability in connection with warrants with a contingent settlement provision which was resolved on June 15, 2026. As a result, these warrants were reclassified to permanent equity. In the three and six months ended June 30, 2026, the changes in the fair value of the warrant liability prior to reclassification were a loss of $2.4 million and $1.8 million, respectively. In addition, during the three and six months ended June 30, 2026, the Company settled a $1.7 million liability for $1.2 million, and as a result recognized a gain on extinguishment of a liability of $483,383 in both periods.

Net loss: Net loss for the three months ended June 30,2025 and 2026 was $1.9 million and $5.2 million, respectively. Net loss for the six months ended June 30, 2025 and 2026, was $4.1 million and $1.7 million, respectively.

Financial Guidance

As of June 30, 2026, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered future elements of our financing plan, especially business development programs. We have had early success in completing key elements of our multi-step financing plan; however, we cannot be assured that we will continue to have success with remaining elements of our plan.

On June 26, 2025, the Company announced that it received formal notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company is in compliance with Listing Rule 5550(b)(1) (the "Equity Rule"). On June 29, 2026, HCW Biologics Inc. (the "Company") received written notice form the Listing Qualifications Staff (the "Staff") of the Nasdaq Capital Market Nasdaq Stock Market LLC ("Nasdaq") that the Nasdaq Hearings Panel (the "Panel") found that the Company regained compliance with Listing Rule 5550(a)(2), the "Bid Price Rule," per the terms set forth in the Panel’s decision letter dated May 29, 2026, as amended. As indicated in the Panel’s decision letter, as amended, if the Company satisfies the remaining terms of the decision through September 22, 2026, the Panel also intends to impose a Discretionary Panel Monitor on the Company pursuant to Listing Rule 5815(d)(4)(A) for a one-year period from that date. On June 30, 2026, the Company effected a one-for-six reverse stock split.

(Press release, HCW Biologics, AUG 14, 2026, View Source [SID1234670126])

On August 14, 2026 Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) reported financial results for the second quarter and first half of 2026 and confirmed its updated full-year 2026 outlook.

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Dr. Christian Wojczewski, Chief Executive Officer of Evotec, said:

"While the first half of 2026 results reflect the challenging start to the year previously anticipated, we are seeing clear and encouraging signs that our actions are gaining traction. Commercial activity is improving across both segments, with strong growth in D&PD base net sales, increasing customer engagement and continued momentum at Just – Evotec Biologics. At the same time, Horizon is progressing according to plan, supporting greater focus, accountability and efficiency across the organization. While the financial benefits of these developments will take time to fully materialize, they represent important building blocks for recovery and the next phase of growth. We continue to see attractive opportunities across both segments and remain confident in the strength of our strategic partnership pipeline, with a significant portion of opportunities progressing through advanced discussions. Our continued investment in next-generation discovery capabilities, including our proteomics and transcriptomics platforms, strengthens our scientific differentiation, enhances the quality of our partner offerings and expands future opportunities for strategic collaborations."

Selected Business Highlights

Strategic Partnership Pipeline

Evotec maintains an active strategic partnership opportunity pipeline, supported by ongoing discussions across a broad range of therapeutic areas and modalities. The Company is actively advancing opportunities at various stages of evaluation, including a significant number in advanced due diligence and term sheet discussions. While Evotec remains confident in its ability to enter new strategic partnerships in 2026, the timing, complexity and revenue ramp-up associated with individual agreements remain inherently variable and are reflected in the Company’s updated full-year 2026 outlook.

As communicated in the outlook update on July 14, 2026, Evotec expects lower contributions from both existing and potential new strategic partnerships in 2026 than previously anticipated. Approximately 40% of the reduction in expected full-year 2026 revenue relative to the previous outlook reflects revised project phasing and milestone schedules for existing partnerships, with the associated revenues now expected to be recognized in 2027. Approximately 45% reflects lower-than-anticipated contributions from potential new strategic partnerships due to the timing of agreement execution and development activities. Approximately 15% is attributable to lower-than-expected revenue conversion against the Company’s internal ambition for accelerated sales-to-revenue conversion, with the associated revenues now also expected to shift into 2027.

Commercial Execution

Commercial execution remains a key focus area of the Horizon transformation and an important driver of Evotec’s path to recovery. Within the Horizon transformation, the Company has strengthened its commercial organization, sharpened customer focus and enhanced business development processes across both segments. These efforts are increasingly reflected in commercial indicators, including higher customer engagement, growing new business activity and improved sales effectiveness.

Commercial momentum across Evotec’s base CRO and CDMO businesses strengthened during the first half of 2026. In Drug Discovery & Preclinical Development (D&PD), net sales increased by more than 28% year-on-year, reflecting improved customer engagement and commercial execution. Just – Evotec Biologics continues to demonstrate positive operating momentum as well, supported by high-capacity utilization and expansion of its customer base.

Based on the typical conversion cycle between sales generation and revenue recognition, increased commercial activity in D&PD is expected to contribute increasingly to revenues from the fourth quarter of 2026 onwards.

Governance Update: Supervisory Board Transition

Camilla Macapili Languille has decided to step down from Evotec’s Supervisory Board effective August 7, 2026. Since her appointment in June 2022, she has served as an independent Supervisory Board member and as a member of the Audit & Compliance Committee. Following her departure, Supervisory Board member Wes Wheeler has been appointed by the Supervisory Board to the Audit & Compliance Committee. Evotec would like to thank Ms. Macapili Languille for her commitment and service.

The Supervisory Board has initiated the process to identify a successor and will focus on candidates with strong financial expertise to maintain the Supervisory Board’s balanced competency profile and committee composition.

Strategic Evaluation

The strategic evaluation announced in connection with the Company’s first quarter 2026 results on May 6, 2026, remains ongoing and continues alongside the implementation of the Horizon transformation program. Additional details regarding the review are available in the Company’s Q1 2026 results announcement.

Horizon Transformation

Horizon remains Evotec’s framework for the next phase of its transformation, focused on operational excellence, scientific leadership and commercial execution.

Since the launch of Horizon in March 2026, Evotec has continued to advance measures to streamline operations, increase agility and focus resources on areas with the clearest path to value. The updated full-year 2026 outlook does not change the strategic direction of Horizon or the timeline for its implementation.

Evotec remains on track to deliver approximately 20-30% of cost savings in 2026 as part of its previously announced objective of €75 million in annual run-rate savings by the end of 2027. Horizon measures implemented to date are delivering as planned, with first-half savings providing a foundation for achieving the expected 2026 savings contribution.

Financial Results

Claire Hinshelwood, Chief Financial Officer of Evotec, said:

"As previously announced, we confirm that our updated full-year outlook primarily reflects a revised view surrounding strategic partnership activities and milestone contributions in the second half of the year. The reduced contribution from these activities is expected to affect profitability disproportionately relative to revenues, reflecting their typically attractive economics and impact on overall capacity utilization. The current year continues to require disciplined execution and careful cash flow management. We remain focused on driving efficiency across the organization, increasing transparency around our business performance and strategic priorities and delivering on our Horizon objectives. Alongside ongoing cost and footprint optimization, we continue to invest in key strategic areas to support future growth opportunities while preserving financial flexibility."

Group Financials

For the second quarter of 2026, Group revenues amounted to €143.5 million (€146.3 million CER) compared to €171.2 million in the same period in 2025, representing a 16.2% decrease. Adjusted Group EBITDA was -€20.8 million (-€18.6 million CER), reflecting a decrease of 320.3% versus -€5.0 million in the same prior-year period, mainly driven by lower revenues.

For the six months ended June 30, 2026, Evotec generated Group revenues of €300.1 million (€313.2 million CER), a 19.2% decline versus €371.2 million in the first half of 2025. R&D expenses were managed in line with the Company’s focus on cost discipline, decreasing to €20.3 million (6.8% of total Group revenues) compared to €29.4 million in the prior year (7.9% of total Group revenues). Adjusted Group EBITDA decreased to -€42.7 million (-€37.4 million CER), down from -€1.9 million for H1 2025. The decrease was partially offset by lower cost of revenue as well as reduced R&D and SG&A expenses.

Evotec closed the second quarter of 2026 with a liquidity position of €465.6 million, reflecting a net cash position.

Segment Financials

Discovery and Preclinical Development (D&PD)

For the second quarter of 2026, revenues for Discovery & Preclinical Development amounted to €108.1 million (€109.5 million CER), representing a year-on-year decrease of 15.8%. Adjusted EBITDA for the quarter amounted to -€14.6 million (-€13.0 million CER), down from -€2.5 million in the second quarter of 2025.

For the first half of 2026, revenues totaled €228.1 million (€235.9 million CER), representing a year-on-year decrease of 15.3% compared with €269.0 million in the prior-year period, primarily driven by weak sales to revenue conversion across all business areas and softer-than-expected customer demand, reflecting the continued challenging market environment. Adjusted EBITDA for the segment was -€24.4 million (-€18.4 million CER), compared with -€9.3 million in the prior year, reflecting the reduced topline performance.

(Press release, Evotec, AUG 14, 2026, View Source [SID1234670125])

On August 14, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence, reported financial results for the second quarter ended June 30, 2026, and provided an overview of recent and upcoming business highlights.

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"Our team made substantial progress this quarter in advancing our integrated CNS oncology platform including a full repositioning and rebranding of the Company," said Marc H. Hedrick, M.D., M.B.A., Cerenome President and Chief Executive Officer. "For the remainder of the year, I expect the progress to accelerate across all verticals, highlighted by our buildout of the diagnostic commercial organization."

Q2 2026 AND RECENT HIGHLIGHTS

Corporate

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Rebranded from Plus Therapeutics, Inc. to Cerenome, Inc., effective August 3, 2026, with the Company’s common stock trading on the Nasdaq Capital Market under the ticker symbol "CNSY"

REYOBIQ Development

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Continued enrollment in the ReSPECT-LM multiple-dose clinical trial. As of June 30, 2026, approximately one-third of patients had been enrolled, with no dose-limiting toxicities observed to date, supporting the development of a recommended Phase 2 dose/dosing regimen by year-end
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Continued enrollment in the ReSPECT-GBM Phase 2 trial. Current enrollment rates indicate full enrollment in 2026 followed by a data readout and a subsequent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)
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Initial site activation of the ReSPECT-PBC pediatric brain cancer Phase 1 trial at Lurie Children’s Hospital. First dosing expected in the third quarter of 2026.
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Continued commercial-level manufacturing scale-up and supply chain enhancement for REYOBIQ drug supply

CNSide CSF Assay Platform

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Performed 232 CNSide cerebrospinal fluid tests during the first half of 2026 and continued to grow the number of ordering providers and institutions
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Achieved the 2026 corporate objective for contracted commercial payer coverage of 150 million covered lives by mid-year
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Received Medicare Provider Transaction Access Number and dedicated American Medical Association billing identifier for CNSide
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Partnered with Genomic Testing Cooperative to integrate next-generation sequencing into the CNSide platform
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Achieved College of American Pathology or CAP accreditation, the gold standard in laboratory quality assurance, for Cerenome’s CLIA laboratory in Houston, TX
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Partnered with Xifin, Inc., the market leader in artificial intelligence enabled revenue cycle management for diagnostic providers, to serve as our billing and clearinghouse partner

Data & Artificial Intelligence

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Partnered with Ephemeral Technologies to develop native artificial intelligence, a corporate operating system and data infrastructure designed to integrate therapeutic, diagnostic and bioinformatic data sets and to facilitate advanced data analytics and machine learning across Cerenome’s CNS oncology platform

SECOND QUARTER 2026 FINANCIAL RESULTS

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Cash, cash equivalents and investments were $8.6 million as of June 30, 2026 and December 31, 2025.

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Recognized $0.4 million in grant revenue from CPRIT for the advancement of REYOBIQ in LM in the second quarter of 2026, compared with $1.4 million in grant revenue from CPRIT for the same program in the second quarter of 2025
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Operating loss for the second quarter of 2026 was $9.1 million, compared with an operating loss of $1.5 million for the second quarter of 2025. The change primarily reflects expansion of CNSide commercial operations and continued funding of the REYOBIQ Phase 2 trial
•
Net loss for the second quarter of 2026 was $9.0 million, or $1.31 per basic share, compared with net income of $5.2 million, or $0.62 per basic share, for the second quarter of 2025, which included a $6.5 million change in fair value of derivative instruments

AFFIRMED ANTICIPATED MILESTONES AND OUTLOOK FOR 2026

The Company is affirming the milestone framework and outlook it provided when reporting full-year 2026 financial results, as follows:

REYOBIQ Clinical Program

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Define the optimal dose/dosing interval for REYOBIQ in Leptomeningeal Metastases
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Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma; data is expected in Q1 2027, followed by an End-of-Phase 2 meeting with the FDA
•
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
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Complete commercial manufacturing scale-up for REYOBIQ

CNSide Commercial Rollout

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Expand U.S. commercial payer coverage beyond 150 million covered lives
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Secure Medicare coverage and reimbursement
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Achieve an annualized run-rate of test orders exceeding 1,250
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Expand the CNSide assay platform to include a comprehensive portfolio of clinically relevant test for patients at risk for CNS cancers

About Leptomeningeal metastases (LM)

Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Cerenome, AUG 14, 2026, View Source [SID1234670124])

On August 14, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage biopharmaceutical company targeting transformative therapies for immune-mediated diseases, reported second quarter 2026 financial results as well as recent business highlights.

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"I am pleased with our progress this quarter, advancing our pipeline and strengthening our position for long-term growth," said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. "The CUE-221 license agreement augments our portfolio and opportunities and the higher expenditures this quarter reflect expected one-time non-cash items and payments related to the transaction. Combined with our recent CUE-221 IND submission, financing with high-quality investors, and strategic leadership additions, we believe we are well positioned for the next phase of execution. We look forward to anticipated CUE-221 Phase 2 data by the end of this quarter and remain on track to initiate a CUE-401 Phase 1 study by the end of the year."

Business, Financial and Leadership Highlights

Milestones
CUE-221

Recently submitted an IND to the FDA in food allergy applications
Phase 2 data readout in Chronic Spontaneous Urticaria anticipated by the end of the third quarter of 2026
CUE-401

Company anticipates submitting an IND to the FDA and initiating a Phase 1 clinical study by year-end 2026
Financial and Corporate

Completed a private placement for gross proceeds of $50 million primarily to support clinical development, pipeline advancement, and infrastructure growth
Leadership

Dr. Dominic Borie, Chief Medical Officer and Head of Research and Development, physician-scientist and immunology leader with deep expertise in immunology, joined Cue to help advance key clinical programs in allergic and autoimmune diseases
Mr. James M. Ahlers, Chief Financial Officer, a veteran biotechnology finance executive, joined Cue to help strengthen the Company’s financial leadership and the infrastructure needed to support execution of its corporate strategy
Second Quarter 2026 Financial Results
Second quarter revenue was $7.9 million, compared to $3.0 million in the second quarter of 2025. The increase in 2026 was due to revenue earned from the Boehringer Ingelheim collaboration and license agreement upon achievement of a preclinical milestone, triggered in the second quarter of 2026.

Research and development expenses were $49.0 million for the three months ended June 30, 2026, compared to $7.9 million in 2025. The increase primarily consisted of one-time cash payments of approximately $20.0 million, including the upfront payment to Ascendant and transaction-related costs. Additionally, approximately $20.0 million of expense was recognized as the fair value of warrants issued to Ascendant pursuant to the license agreement, with a corresponding credit to shareholders’ equity resulting in no net impact on stockholders’ equity.

General and administrative expenses were $46.6 million for the three months ended June 30, 2026, compared to $3.7 million in 2025. The increase was primarily attributable to one-time expenses incurred in connection with the Company’s strategic transformation, including approximately $23.0 million related to integration with a newly assembled, complementary management team and transaction-related costs, as well as approximately $19.7 million of non-cash stock-based compensation expense recognized during the quarter.

Other income and expense for the three months ended June 30, 2026, primarily comprised a net non-cash loss of $63.1 million related to the license agreement with Ascendant. As a result, a loss on issuance of liability-classified warrants was recognized, partially offset by a gain on the fair value measurement of warrants issued.

Net loss for the three months ended June 30, 2026 was $153.1 million, compared to $8.5 million in 2025. The increase was primarily due to one-time non-cash losses accounted for in other income, and one-time expenses related to the license agreement.

As of June 30, 2026, the Company had $17.4 million in cash and cash equivalents after incurring one-time cash outflows related to the license agreement. Subsequent to June 30, 2026, the Company completed a $50 million private placement financing.

(Press release, Cue Biopharma, AUG 14, 2026, View Source [SID1234670123])