KIROMIC BIOPHARMA INC - KRBP STOCK NEWS

Kiromic BioPharma (OTCQB: KRBP) has reached a settlement agreement with the SEC regarding an investigation into the non-disclosure of FDA clinical holds by former management. The investigation concerned IND applications for ALEXIS-PRO-1 (Procel™) and ALEXIS-ISO-1 (Isocel™) filed in May 2021. Due to the company's self-reporting, prompt remediation, and cooperation, the SEC decided not to impose civil penalties, and there are no ongoing obligations related to the settlement.

Kiromic BioPharma (OTCQB: KRBP) reports favorable ongoing clinical results from its Deltacel-01 Phase 1 trial, evaluating Deltacel™ (KB-GDT-01) in stage 4 metastatic non-small cell lung cancer (NSCLC) patients. Key highlights:

• Patient 4: Maintained stable disease with a 5.3% tumor size reduction at 6-month follow-up
• Patient 6: Demonstrated stable disease with no new lesions at 2-month follow-up
• Median progression-free survival (PFS) increased to 6 months
• Median follow-up duration for all patients is 7.7 months

These results support Deltacel's potential to delay disease progression in advanced lung cancer patients and validate the therapeutic potential of gamma-delta T cells in advanced cancer treatment.

Kiromic BioPharma (OTCQB: KRBP) reports favorable 10-month follow-up results for the first patient in its Deltacel-01 Phase 1 clinical trial. The trial evaluates Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in stage 4 metastatic non-small cell lung cancer patients who failed standard therapies. Key findings include:

• 27% tumor size reduction compared to pre-treatment
• No new disease sites identified
• 10-month progression-free survival (PFS)
• No reported adverse events

These results follow earlier observations of 20% tumor reduction at eight months and 13% at six months post-treatment. The patient is being treated at Beverly Hills Cancer Center. Kiromic's CEO and the trial's Principal Investigator expressed optimism about Deltacel's potential as a safe and effective treatment for late-stage cancers.

Kiromic BioPharma (OTCQB: KRBP) has activated the University of Arizona Cancer Center (UACC) as the fifth clinical trial site for its ongoing Phase 1 Deltacel-01 trial. The trial is evaluating Deltacel™ (KB-GDT-01), Kiromic's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

UACC is one of 57 NCI-Designated Comprehensive Cancer Centers in the U.S. Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as Principal Investigator at the site. The site initiation visit has been completed, and patient enrollment is expected to begin in the coming weeks.

Kiromic BioPharma (OTCQB: KRBP) has received unanimous approval from the Safety Monitoring Committee (SMC) to advance its Deltacel-01 clinical trial into the expansion phase. The trial is evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed standard therapies.

The SMC's recommendation follows a favorable review of safety data from the first two cohorts, including the 40-day follow-up of the sixth patient, which showed a positive safety and tolerability profile with no dose-limiting toxicities. The expansion phase will enroll approximately nine patients, with screening expected to begin later this month. This phase aims to further assess Deltacel's effectiveness in treating solid tumors.

Kiromic BioPharma (OTCQB: KRBP) has received Fast Track designation from the FDA for Deltacel™ (KB-GDT-01), its allogeneic, off-the-shelf, Gamma Delta T-cell therapy. This designation is for Deltacel in combination with low-dose radiation therapy for treating metastatic non-small cell lung cancer (NSCLC) patients who have progressed on at least two lines of standard therapy.

The Fast Track status allows for more frequent FDA communication, potential priority review, and rolling submission of applications. Deltacel is currently in a Phase 1 study (Deltacel-01) for stage 4 NSCLC patients who failed standard therapies. Recent data from this trial has shown a favorable safety profile and preliminary clinical efficacy. Kiromic plans to activate a fifth clinical trial site on August 30th.

Kiromic BioPharma (OTCQB: KRBP) has reported interim results for Part 1 of its Deltacel-01 Phase 1 clinical trial, evaluating Deltacel™ (KB-GDT-01) in stage 4 metastatic non-small cell lung cancer (NSCLC) patients. Key findings include:

- Progression-Free Survival (PFS) ranging from 2 to 8 months, with an average of 4.8 months for five evaluated patients
- No dose limiting toxicities (DLTs) reported for patients completing full therapy
- One patient withdrawn due to unrelated adverse event
- Sixth and final patient in Part 1 started treatment on August 6th

The company is on track to initiate Part 2 of the Deltacel-01 trial in September, with early safety and tolerability outcomes expected in September and efficacy results in early October.

Kiromic BioPharma (OTCQB: KRBP) has reported favorable eight-month follow-up results from the first patient in its Deltacel-01 Phase 1 clinical trial. The trial is evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf, Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed standard therapies.

Key findings include:

• 20% tumor size reduction at eight months post-treatment
• No new tumor lesions detected
• Eight-month progression-free survival
• Improvement from 13% reduction at six months post-treatment

The patient is being treated at the Beverly Hills Cancer Center. Kiromic expects to report additional follow-up results from the fourth and fifth patients in August.

Kiromic BioPharma (OTCQB: KRBP) is advancing its Deltacel-01 Phase 1 clinical trial to the Expansion Phase following a positive assessment from the Safety Monitoring Committee. The trial evaluates Deltacel™, an allogeneic, off-the-shelf, Gamma Delta T-cell therapy for stage 4 metastatic non-small cell lung cancer patients who have failed standard therapies. The company plans to begin enrolling patients in the Expansion Phase in September, adding nine more patients to the trial.

The fifth patient in Deltacel-01 completed their 30-day visit with a favorable safety profile and no dose-limiting toxicities. Kiromic expects to report early efficacy data from this patient's two-month follow-up in August. The trial's progress marks a significant milestone in validating Kiromic's innovative gamma delta approach to cancer treatment.