On August 14, 2026 Tvardi Therapeutics, Inc. ("Tvardi" or the "Company") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the second quarter ended June 30, 2026, and provided a business update.

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Recent Developments

Reported topline results from the healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, confirming prodrug design, improved tolerability and pharmacodynamic evidence of STAT3 target engagement.
TTI-109 delivered TTI-101-equivalent exposure with improved tolerability and, across the active dose range, reductions in cellular and humoral immune populations known to correlate with UC disease severity.
Selected UC as the initial disease indication for TTI-109, based on its ability to modulate multiple pathogenic pathways downstream of STAT3 simultaneously.
In UC, STAT3 acts as a single convergent node downstream of multiple signaling pathways implicated in disease progression, integrating immune dysregulation, inflammation and tissue remodeling.
These findings are further supported by published clinical studies linking reductions in activated STAT3 with higher rates of clinical remission across multiple UC therapeutic classes.
UC represents a large, underserved market, with more than 1.25 million patients diagnosed in the U.S. and an addressable market of approximately $3 billion in the U.S. and $9 billion globally.
Announced that the Company will host a KOL webinar on the clinical potential of TTI-109 in UC featuring Randy Longman, MD, PhD (Weill Cornell Medicine) on August 19, 2026, at 11:00 a.m. ET.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "Since our last quarterly report, we have made significant progress in the clinical development of our STAT3 inhibitors. Regarding our next-generation STAT3 inhibitor, TTI-109, we were enthusiastic to see modulation of disease-relevant immune cell population even in healthy volunteers. We believe this bodes well for the development of TTI-109 in inflammatory and proliferative diseases, like UC."

Key Upcoming Milestones

August 19, 2026: KOL webinar with Randy Longman, M.D., Ph.D., on the UC treatment landscape and TTI-109. To register, please click here
4Q 2026: TTI-101 Phase 1b/2 HCC topline data
2027: Initiation of clinical trial of TTI-109 in UC, subject to clearance of Investigational New Drug (IND) application and additional funding
Second Quarter 2026 Financial Results

Research and development expenses for the three months ended June 30, 2026, were $4.0 million as compared to $5.8 million for the comparable period in 2025. The decrease was primarily driven by lower clinical costs associated with TTI-101, partially offset by higher development costs associated with TTI-109.

General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.1 million for the three months ended June 30, 2025. The decrease was primarily driven by lower professional fees, reflecting higher accounting and consulting costs in the comparable 2025 period associated with the Company’s April 2025 merger, partially offset by higher legal and investor relations costs associated with operating as a public company.

Net loss for the three months ended June 30, 2026, was $6.5 million, compared to net income of $4.2 million for the three months ended June 30, 2025. Net income in the prior-year period reflected a $12.7 million non-cash gain from the change in fair value of the Company’s convertible notes, which converted into common stock in connection with the Company’s merger with Cara Therapeutics in April 2025.

Basic and diluted net loss per share attributable to common shareholders for the three months ended June 30, 2026, were both $(0.69). Basic net income per share attributable to common shareholders for the three months ended June 30, 2025 was $0.51, and diluted net loss per share for the same period was $(1.00), reflecting the dilutive impact of the Company’s convertible notes prior to their conversion into common stock in April 2025.

Cash, cash equivalents and short-term investments as of June 30, 2026, were $15.8 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its existing cash, cash equivalents and short-term investments will be sufficient to fund operations, as currently planned, through the HCC topline readout into the third quarter of 2027. Advancing TTI-109 into UC and additional indications will require additional funding and IND clearance.

(Press release, Tvardi Therapeutics, AUG 14, 2026, View Source [SID1234670151])

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 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 13, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported VEPPANUTM (vepdegestrant) is now available by prescription in the United States for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), as detected by a U.S. Food and Drug Administration (FDA)-authorized test, with disease progression following at least one line of endocrine therapy.

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"The commercial launch of VEPPANU marks an important milestone for Rigel and, more importantly, for patients living with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. In a pivotal trial, VEPPANU was generally well tolerated and demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus fulvestrant in this patient population. As the first and only FDA-approved PROTAC, VEPPANU introduces a novel mechanism of action and represents an important new treatment option for healthcare providers to consider with their patients," said Raul Rodriguez, Rigel’s president and CEO. "Supported by our established oncology infrastructure, experienced commercial and medical affairs teams and comprehensive patient support programs, we are well positioned to execute a successful commercial launch of VEPPANU, allowing Rigel to deliver for patients while advancing our long-term growth strategy."

VEPPANU is the first and only FDA-approved PROteolysis TArgeting Chimera (PROTAC). PROTACs are a new class of heterobifunctional protein degraders designed to harness the body’s natural machinery to selectively degrade, rather than inhibit, disease-causing proteins. The recommended dosage of VEPPANU is 200 mg taken orally once daily. VEPPANU is immediately available through Rigel’s network of specialty distributors and specialty pharmacies in the United States and Puerto Rico at $29,400 per 30-day supply.

More information on how to order VEPPANU can be found at www.RIGELONECARE.com. For those who qualify, Rigel offers patient assistance programs for patients prescribed VEPPANU by their doctor. RIGEL ONECARE, the company’s comprehensive patient support center, can help patients and physicians as they navigate insurance coverage requirements and provide financial assistance when needed and if eligible, along with other support programs. To learn more, visit www.RIGELONECARE.com or contact RIGEL ONECARE at 833-RIGELOC (833-744-3562).

In May 2026, Rigel announced it entered into an exclusive, global license agreement with Arvinas, Inc. and Pfizer Inc. to develop, manufacture and commercialize VEPPANU.

About ER+/HER2-, ESR1-mutated Metastatic Breast Cancer
Breast cancer is the most common cancer in women in the United States, except for skin cancers.1 The estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) patient population represents the majority (70%) of breast cancer, where treatment with endocrine therapies (aromatase inhibitors) is the standard of care. While endocrine therapy remains a cornerstone of metastatic ER+/HER2- breast cancer treatment, up to 50% of patients treated with endocrine therapy and a CDK4/6 inhibitor acquire estrogen receptor 1 gene (ESR1) mutations, resulting in endocrine resistance and poor prognosis. Treatment options in second-line and later ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer setting include chemotherapy, selective estrogen receptor degraders (SERDs), and as of May 2026, vepdegestrant, the first and only FDA-approved oral PROteolysis TArgeting Chimera (PROTAC).

About VEPPANUTM (vepdegestrant)

INDICATION
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor–1 (ESR1)–mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
QTc Interval Prolongation
VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, VEPPANU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).

Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients.

The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.

Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage.
Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions.
Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval.

LACTATION
Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Click here for Important Safety Information and Full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

VEPPANU is a trademark and RIGEL ONECARE is a registered trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, AUG 13, 2026, View Source [SID1234670071])

On August 13, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported financial and operating results for the three months ended June 30, 2026, and reviewed recent business highlights.

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"Throughout the second quarter, Calidi continued to advance its RedTail platform and redefine the potential of oncolytic viruses and genetic medicine," said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. "We anticipate CLD-401, the lead drug candidate from our RedTail platform, entering the clinic during the first quarter of 2027. In addition, we have expanded what the RedTail platform can do with our new approach of in situ T-cell engagers."

Second Quarter 2026 and Recent Business Developments

In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs, and the FDA provided feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds upon the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.
Presented preclinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on CLD-501, the lead compound from Calidi’s in situ TCE approach. CLD-501 is a systemically delivered virotherapy designed to selectively target tumors and simultaneously enable the high-level in situ expression of a TROP-2 TCE and IL-15 superagonist (IL-15 SA). The Company also presented preclinical data on CLD-401, its lead program. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 SA, a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment, including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models.
Strengthened its Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders served as strategic advisor to Celgene’s Chief Medical Officer following Celgene’s acquisition of Juno, where she was Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb following its acquisition of Celgene. Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including Senior Vice President, Global Head of Clinical Operations and Industry Collaboration.
Reduced general and administrative expenses by $1.5 million, or 48%, in the second quarter of 2026 compared with the same period in 2025. The Company will continue its tight focus on expense management to ensure sufficient capital to advance its pipeline.
Second Quarter 2026 Financial Results

Calidi reported a net loss attributable to common stockholders of $4.2 million, or $2.94 per share, for the second quarter of 2026, compared with a net loss attributable to common stockholders of $5.7 million, or $31.75 per share, for the same period in 2025. Prior-period share and per-share amounts have been adjusted to reflect the Company’s 1-for-16 reverse stock split completed in July 2026.

Research and development expenses were $2.6 million for the second quarter of 2026, unchanged from the second quarter of 2025.

General and administrative expenses were $1.6 million for the second quarter of 2026, compared with $3.1 million for the comparable period in 2025.

The Company had $4.1 million in cash and $0.2 million in restricted cash as of June 30, 2026, compared with $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.

(Press release, Calidi Biotherapeutics, AUG 13, 2026, View Source [SID1234670092])