On August 14, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported financial results and provided an update on operational highlights for the second quarter ended June 30, 2026.

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"The second quarter was a highly productive period for Allarity. During the quarter, the USPTO granted the key U.S. patent covering our stenoparib-specific DRP companion diagnostic, providing exclusivity to develop stenoparib with its DRP into April 2042. This establishes a critical, long-term intellectual property foundation for stenoparib development and commercialization and reinforces our confidence in the long-term potential of our approach to pairing anticancer therapeutics with drug-specific companion diagnostics," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics.

"Subsequent to quarter-end, we also successfully completed our manufacturing campaign for stenoparib, securing drug supply in accordance with the more stringent standards required for late-stage clinical development. Completion of this campaign represents an important step as we prepare for a pivotal, registrational trial. We have also secured CLIA certification for our in-house laboratory, enabling us to do all of the necessary testing for the DRP in-house, which will further secure our ability to control and accelerate the advance of stenoparib toward FDA approval. I am particularly proud of these accomplishments as they position the company to drive stenoparib forward as rapidly as possible. Together with the presentation of our promising, durable Phase 2 clinical benefit data in advanced ovarian cancer patients at leading international oncology conferences, these achievements further strengthen the foundation for accelerating stenoparib toward FDA approval. Finally, I am pleased that we ended the quarter with almost $27 million in cash and restricted cash, providing us with the financial resources to continue the important work of advancing stenoparib."

Clinical and Drug Development Progress

Phase 3 manufacturing campaign milestone: During the second quarter, Allarity announced that its active pharmaceutical ingredient (API) manufacturing campaign for stenoparib was progressing in line with the planned timeline at its world-class contract development and manufacturing organization (CDMO). Subsequent to quarter-end, the campaign was successfully completed (July 2026), ahead of the originally planned completion by the third quarter of 2026. The campaign supports accelerating stenoparib toward FDA approval following its FDA Fast Track designation and was completed in anticipation of the generation of clinical benefit data from the ongoing Phase 2 trial in advanced ovarian cancer. All manufacturing-related payments were completed during the second quarter and are recorded as prepaid expenses, and no additional cash outlays for API manufacturing are anticipated.
Key U.S. patent granted for the stenoparib DRP companion diagnostic: The United States Patent and Trademark Office (USPTO) granted the key U.S. patent covering Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP) companion diagnostic, with a term extending into April 2042. The grant follows the USPTO’s Notice of Allowance announced in April 2026. The patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment, and affords commercial exclusivity protection for stenoparib when used in concert with the stenoparib DRP.
AACR 2026 data linking DRP to enhanced overall survival in ovarian cancer: At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (AACR 2026), Allarity presented Phase 2 clinical data showing extended overall survival benefit in advanced, platinum-resistant and refractory ovarian cancer patients, particularly in those patients whose tumors have the highest stenoparib DRP scores. These data reinforce the value of leveraging the DRP-based patient selection strategies to select patients most likely to benefit from stenoparib and to accelerate stenoparib’s advance to FDA approval.
AACR 2026 data highlighting stenoparib’s potential in colorectal cancer: In a second AACR (Free AACR Whitepaper) 2026 poster, the Company presented new findings demonstrating stenoparib’s mechanism of action—modulating the WNT/β-catenin signaling pathway and inhibiting the growth of human colorectal cancer cell lines at clinically relevant concentrations. The majority of colorectal cancers activate the WNT pathway, enabling cancer progression and metastatic spread. Accordingly, inhibition of the WNT pathway may provide an exciting new therapeutic option for colon and rectal cancers, which remain among the most prevalent and deadly cancers in the United States.
Poster presented at ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress: Allarity presented a Trial-in-Progress poster outlining the scientific background, study design, and clinical rationale for its ongoing Phase 2 trial evaluating stenoparib in patients with advanced platinum-resistant or platinum-ineligible ovarian cancer. The poster was presented by the study’s Principal Investigator, Kathleen N. Moore, M.D., an internationally recognized specialist in gynecologic oncology and a leading expert in advanced platinum-resistant and platinum-refractory ovarian cancer.
Ovarian cancer program continued under FDA Fast Track designation: Allarity continued enrollment in its Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The amended protocol is designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum-resistant patients and to accelerate the clinical development of stenoparib toward FDA approval.
SCLC combination trial continued enrollment: The Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC)—fully funded by the U.S. Department of Veterans Affairs (VA)—continued enrolling patients across multiple VA medical centers throughout the United States.
CLIA certification obtained: Allarity obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory in Hørsholm, Denmark. The FDA requires that biomarker testing used to select patients for registration trials be performed in a CLIA-certified laboratory environment. For the first time, Allarity is now able to perform its DRP testing in-house in a CLIA-certified environment to support U.S. clinical trials, including a registrational trial of stenoparib in advanced ovarian cancer. This is expected to reduce reliance on external laboratories, may shorten turnaround times and reduce costs. It also may position the Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified laboratory partner in Northern Europe for other companies seeking to conduct clinical trials in, or commercialize products for the U.S. market.
Corporate and Strategic Developments

Scientific visibility at Precision Medicine Forum Europe 2026: CEO Thomas Jensen presented at Precision Medicine Forum Europe 2026 in Stockholm, Sweden, discussing stenoparib’s dual mechanism of action and Allarity’s predictive biomarker, as well as the Company’s ongoing Phase 2 trials.
Second Quarter 2026 Financial Review

Results of Operations for the Three Months Ended June 30, 2026

Cash Position: As of June 30, 2026, cash and restricted cash totaled $26.9 million, compared to $14.7 million as of June 30, 2025. The Company used $2.6 million of cash in operating activities during the quarter.
R&D Expenses: Research and development (R&D) expenses were $1.3 million for the quarter ended June 30, 2026, compared to $2.3 million for the quarter ended June 30, 2025.
G&A Expenses: General and administrative (G&A) expenses were $1.3 million for the quarter ended June 30, 2026, compared to $1.8 million for the quarter ended June 30, 2025.
Total Comprehensive Loss: The total comprehensive loss attributable to common stockholders was $3.7 million for the quarter ended June 30, 2026, compared to $4.2 million for the quarter ended June 30, 2025. For the six months ended June 30, 2026, the loss was $6.5 million, compared to $7.2 million for the six months ended June 30, 2025.
About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers, especially drug-resistant cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, small cell lung cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has completed its first Phase 2 trial for stenoparib in advanced ovarian cancer patients. That trial showed promising and durable clinical benefit in ovarian cancer patients who had two or more lines of prior lines of therapy and recieved stenoparib twice daily. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in ovarian cancer in September 2025. These analyses are subject to change as follow-up matures. A new protocol was designed expressly to capitalize on this emerging clinical experience with stenoparib in platinum-resistant patients and began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum- resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites in the U.S.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which Allarity believes may be useful in all cancer types and is patented for dozens of anticancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, AUG 14, 2026, View Source [SID1234670140])

On August 14, 2026 Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal first quarter ended June 30, 2026 and provided a business update.

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On August 6, 2026, the Company announced the U.S. Food and Drug Administration (FDA) has approved TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1 antibody-based regimen. The Company has begun launch preparations in the U.S. and anticipates having product in the market within 60 days. Replimune also recently completed a $150 million financing to support commercial launch and the ongoing IGNYTE-3 confirmatory trial.

The Company also announced today the appointment of Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. Ms. DiNapoli brings more than 25 years of biopharmaceutical experience commercializing innovative oncology therapies and building high-performing commercial organizations. She joins Replimune after a seven-year tenure at Deciphera Pharmaceuticals. At Deciphera, she built the U.S. sales force, led the U.S. Commercial organization, and scaled infrastructure to drive launch execution as the company grew from a single product to a multi-product organization. Prior to Deciphera, Ms. DiNapoli spent 16 years at Genentech in commercial leadership roles spanning breast, lung, and colorectal cancer franchises as well as cancer immunotherapy, developing deep expertise in market access, lifecycle management, and cross-functional execution.

"The FDA’s approval of TUDRIQEV is a defining milestone for Replimune and, more importantly, for the patients facing advanced melanoma, where the need for safe and effective treatment options remains significant," said Sushil Patel, Ph.D., CEO of Replimune. "With this approval, we are now a fully integrated biotechnology company. We are completing the build out of our commercial infrastructure to enable a successful launch and bring TUDRIQEV to patients as quickly as possible."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

· IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint, expected to readout in 2030, is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

· REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027.

Financial Highlights

· Cash Position: As of June 30, 2026, cash, cash equivalents and short-term investments were $195.3 million, as compared to $268.9 million as of fiscal year ended March 31, 2026. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of June 30, 2026, in addition to the $141.0 million of net proceeds from the issuance of our common stock in August 2026, will enable us to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, which includes scale up for the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

· R&D Expenses: Research and development expenses were $49.3 million for the fiscal first quarter and $57.8 million for the fiscal first quarter ended June 30, 2025. This decrease was primarily due to a decrease in personnel related and other costs, as well as a decrease in direct research costs relating to the IGNYTE, ARTACUS and CERPASS studies. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026.

· S,G&A Expenses: Selling, general and administrative expenses were $19.0 million for the fiscal first quarter ended June 30, 2026, as compared to $32.6 million for the fiscal first quarter ended June 30, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026.

· Net Loss: Net loss was $69.8 million for the fiscal first quarter ended June 30, 2026 and $86.7 million for the fiscal first quarter ended June 30, 2025.

About TUDRIQEVTM (vusolimogene oderparepvec-wtpg)

TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R–) and human granulocyte macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the transporter associated with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV. TUDRIQEV preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R– expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote anti-tumor immune response.

INDICATION

TUDRIQEV is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Accidental exposure of TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients.

Herpetic infection or reactivation: Patients with suspected herpetic infections should contact their healthcare provider for assessment and antiviral treatment of the suspected herpetic infection as clinically warranted.

Injection procedure complications: Complications related to injection procedure have occurred, including hemorrhage, infection, and visceral injury. Patients should be monitored for signs and symptoms of visceral injury (eg, pneumothorax) during and after TUDRIQEV administration and managed according to clinical practice.

Immune-mediated events: In clinical studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo have been reported in patients treated with TUDRIQEV and nivolumab.

Adverse Reactions

Most common non-laboratory adverse reactions reported in more than 10% of patients were fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.

Serious adverse reactions occurring in >1% patients include pleural effusion (n=3), acute kidney injury (n=2), arthralgia (n=2), atrial fibrillation (n=2), atrial flutter (n=2), cancer pain (n=2), hypophysitis (n=2), immune-mediated enterocolitis (n=2), pyrexia (n=2), sepsis (n=2), urinary tract infection (n=2), and myocardial infarction (n=2). Serious adverse reactions leading to death include myocardial infarction (n=1) and multiple organ dysfunction (n=1).

Drug Interactions

Patients receiving systemic antiviral treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy.

Special Populations

Advise females and males of reproductive potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the last dose.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, AUG 14, 2026, View Source [SID1234670129])

On August 14, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported financial results for the second quarter ended June 30, 2026, and highlighted continued progress in its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (AML).

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Moleculin continues to advance the pivotal Phase 2/3 MIRACLE trial following positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A, which showed complete remission rates at least three times greater than the control arm. Enrollment remains on track to reach the 90-patient milestone in September with the data readout in the December 2026 to February 2027 timeframe. These data are expected to support selection of the optimal Annamycin dose and the planned initiation of Part B in the first half of 2027.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin, commented, "In addition to the positive interim MIRACLE results, we are just as excited by the feedback we are receiving from investigators about Annamycin and their enthusiasm for participating in the study. Their response reflects both the significant unmet need in relapsed or refractory AML and growing recognition of Annamycin’s potential, with its encouraging data generated to date and differentiated cardiac safety profile, to play an important role in the treatment landscape. As we advance toward the 90-patient milestone and next unblinded efficacy readout, this strong investigator engagement adds to our confidence in the program and the potential for Annamycin to meaningfully improve outcomes for patients."

Recent Highlights

Reported positive interim results from the Phase 2/3 MIRACLE trial, with both Annamycin treatment arms demonstrating complete remission (CR) rates at least three times higher than the control arm in patients with relapsed or refractory AML. The interim analysis demonstrated a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus cytarabine and 230 mg/m² plus cytarabine, over the cytarabine control arm. CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while composite complete remission (CRc) reached 50% and 57%, respectively, versus 29% for the control arm. The n=45 population contained 75.6% over 60 years of age, 55.6% 7+3 and 31.1% venetoclax regimens for first line (1L) therapies.
Announced independent market research indicating strong physician intent to prescribe Annamycin based on its potential efficacy, transplant-bridging potential and favorable cardiac safety profile.
Presented data at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrating no detectable cardiotoxicity with Annamycin despite cumulative exposure levels exceeding conventional anthracycline limits, further supporting its differentiated safety profile.
Chairman and Chief Executive Officer Walter Klemp discussed the positive preliminary MIRACLE interim results during a Virtual Investor "What This Means" segment, providing additional context on the Company’s clinical progress and anticipated next milestones.
Enrollment continued in Part A of the MIRACLE trial, with more than 80% of the planned 90 patients enrolled as of the interim analysis.
Cash on hand and cash equivalents as of June 30, 2026, together with $9.3 million in financing proceeds raised subsequent to the quarter, expected to support planned operations into the first quarter of 2027.
Clinical Development Update

Annamycin – MIRACLE Trial
Moleculin continues to advance the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, a pivotal adaptive-design Phase 2/3 study evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia.

During the second quarter, the Company reported positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the trial. Both Annamycin treatment arms demonstrated substantially higher complete remission rates than the control arm, while maintaining the encouraging safety profile previously observed in clinical studies. Activity in the MIRACLE trial continues to demonstrate no evidence of cardiotoxicity. The Company continues to enroll patients in Part A and expects to use these data to select the optimal dose for advancement into Part B.

Expected Milestones for the Annamycin Development Program

September 2026: Completion of enrollment in Part A of MIRACLE
December 2026 to February 2027 timeframe: MIRACLE – data unblinding for Part A 90 subjects completed
2H 2026: Atlantic Health pancreatic cancer clinical trial begins
1H 2027: MIRACLE – Start of Part B
2027: Begin 3rd line R/R AML subject trial
2027: Begin pediatric AML clinical study
2028: End recruitment of Part B
2028: Primary efficacy data for MIRACLE 2nd line subjects
2028: Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
2029: NDA submission complete
Additional Pipeline Programs

Moleculin continues to support development activities for WP1066 through investigator-sponsored and externally funded studies, while maintaining its focus on advancing Annamycin as the Company’s lead clinical program.

Second Quarter 2026 Financial Results

Research and development expenses were $5.5 million and $3.6 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $1.9 million is mainly related to the MIRACLE clinical trial of $1.1 million, additional nonclinical studies of $0.4 million, and $0.4 million in other research costs during the current quarter as compared to the prior year quarter.

General and administrative expenses for the quarter ended June 30, 2026 were approximately $2.1 million, compared with approximately $2.1 million for the same period in 2025.

As of June 30, 2026, the Company had cash and cash equivalents of approximately $7.3 million. Management believes that its cash on hand and cash equivalents as of June 30, 2026, together with $9.3 million in financing proceeds raised subsequent to the quarter, will support planned operations into the first quarter of 2027.

(Press release, Moleculin, AUG 14, 2026, View Source [SID1234670128])

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])