On September 14, 2026 GT Biopharma, Inc. (the "Company") entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with the purchasers identified therein (collectively, the "Purchasers") providing for the issuance and sale to the Purchasers of (i) up to 8,277.778 shares of the Company’s Series M 10% Convertible Preferred Stock (the "Preferred Stock"), (ii) warrants to purchase up to a number of shares of common stock of the Company (the "Common Stock") equal to 100% of the shares of the Company’s Common Stock issuable upon conversion of the shares of Preferred Stock (the "Common Warrants"), and (iii) warrants to purchase up to a number of shares of the Company’s Common Stock equal to the number of Greenshoe Conversion Shares (as defined in the Securities Purchase Agreement) issuable upon exercise of the Greenshoe Right (as defined below) (the "Vesting Warrants" and together with the Common Warrants, the "Warrants"), with an aggregate stated value of $8,277,778, for an aggregate purchase price of $7,450,000 (the "Offering").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the Securities Purchase Agreement, each Purchaser may elect to purchase shares of Preferred Stock with an aggregate stated value of up to $33,333,333 (the "Greenshoe Rights") for an aggregate purchase price of $30,000,000, subject to adjustments, as further described in the Securities Purchase Agreement. Each Purchaser is entitled to exercise its respective Greenshoe Rights for an amount of Preferred Stock equal to the ratio of such Purchaser’s original subscription amount to the original aggregate subscription amount of all Purchasers.

Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of Series M 10% Convertible Preferred Stock (the "Certificate of Designation"), and subject to certain ownership limitations, the Preferred Stock may be converted at any time at the option of the Purchasers into shares of the Company’s Common Stock at an initial conversion price of $6.10, subject to certain conditions, as further described in the Certificate of Designation. In addition, the holders of the Preferred Stock are entitled to receive cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10% per annum until September 13, 2027, increasing to 12% per annum thereafter, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance of the Preferred Stock and on each Conversion Date (as defined in the Certificate of Designation), with respect only to Preferred Stock being converted, in cash, shares of the Company’s Common Stock (subject to the Company’s satisfaction of the conditions set forth in the Certificate of Designation), or a combination thereof.

Pursuant to the Securities Purchase Agreement, each Purchaser will be issued (i) a Common Warrant, each to purchase up to a number of shares of the Company’s Common Stock equal to 100% of the Conversion Shares underlying the Preferred Shares issued to such Purchaser and (ii) a Vesting Warrant (the exercisability of which shall vest ratably from time to time in proportion to the Purchaser’s (or its permitted assigns’) exercise of such Purchaser’s Greenshoe Rights pursuant to Section 2.4 of the Securities Purchase Agreement), each to purchase up to a number of shares of the Company’s Common Stock equal to the number of Greenshoe Conversion Shares (as defined in the Securities Purchase Agreement) applicable to such Purchaser, in accordance with the Securities Purchase Agreement. The Common Warrants have an initial exercise price of $6.10 per share, are exercisable, subject to certain ownership limitations, immediately upon issuance and have a term of exercise equal to five years. The Vesting Warrants have an initial exercise price of $6.10 per share, are exercisable, subject to certain vesting and ownership limitations, and have a term of exercise equal to five years from the date that the applicable warrant shares vest.

The Preferred Shares and Warrants both have full ratchet price protection and are subject to other adjustments (including for reverse and forward splits, recapitalizations and similar transactions), as further described in the Certificate of Designation or the Warrants, as applicable. With respect to adjustments in connection with the exercise of Greenshoe Rights, in the first instance, there will not be a floor price; provided, however, if the Company receives written notice from The Nasdaq Stock Market that a floor price should be implemented, a floor price of $1.282 shall be set.

The securities in the Offering were offered privately pursuant to Rule 506(b) of Regulation D under the Securities Act of 1933, as amended.

Registration Rights Agreement

The Company and the Purchasers entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") covering the public resale of the shares of Common Stock issuable upon conversion of the Preferred Stock and upon exercise of the Warrants. The Company has agreed to file a registration statement within thirty (30) days after the initial closing and after each closing of the exercise of a Greenshoe Right in accordance with the Securities Purchase Agreement, to become effective no later than sixty (60) days after the Closing Date (as defined in the Securities Purchase Agreement) or each Trigger Date (as defined in the Registration Rights Agreement), or in the event of a "full review" by the SEC, ninety (90) days after the Closing Date or each Trigger Date. If these deadlines are not met, the Company will be liable for partial liquidated damages of 1.5% of the subscription amount paid by each Purchaser pursuant to the Securities Purchase Agreement. Further, if the Company fails to pay such liquidated damages within seven days from the date payable, the Company will pay interest thereon at the prime rate plus 12% to each holder of the registerable securities.

Voting Agreement

Pursuant to the Securities Purchase Agreement, the Company agreed to hold a meeting of its stockholders at the earliest practical date after the execution of the Securities Purchase Agreement for the purpose of (i) obtaining shareholder approval for the issuance, in the aggregate, of more than 19.99% of the number of shares of the Company’s Common Stock outstanding on the date of the initial closing ("Shareholder Approval") and (ii) obtaining such shareholder approval as may be required to effect any necessary increase in authorized shares of Common Stock if the number of Underlying Shares (as defined the Securities Purchase Agreement) is greater than the number of authorized shares of Common Stock. In connection with the required Shareholder Approval, all of the Company’s officers and directors (each a "Voting Agreement Party") entered into a voting agreement (the "Voting Agreement") pursuant to which each Voting Agreement Party agreed to vote all shares of voting stock over which the Voting Agreement Party has voting control in favor of any proposal presented to the stockholders of the Company seeking the Shareholder Approval.

Lock-Up Agreement

Pursuant to the Securities Purchase Agreement, the Company and its directors and officers entered into lockup agreements (the "Lockup Agreements"), pursuant to which each officer and director agreed not to sell or transfer any securities of the Company held by them for a period commencing on the date of the Lockup Agreement until thirty (30) days after the later of (i) the Effective Date (as defined in the Securities Purchase Agreement) and (ii) the date that Shareholder Approval is obtained and deemed effective, subject to limited exceptions.

The foregoing descriptions of the terms of the Certificate of Designation, form of Common Warrant, form of Vesting Warrant, Securities Purchase Agreement, Registration Rights Agreement, Voting Agreement and Lockup Agreement are not intended to be complete and are qualified in their entirety by reference to such exhibits, which are filed herewith as Exhibits 3.1, 4.1, 4.2, 10.1, 10.2, 10.3 and 10.4, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. Neither this current report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein.

(Filing, GT Biopharma, SEP 14, 2026, View Source [SID1234670862])

On September 14, 2026 Shanghai Allink Biotherapeutics Co.,Ltd ("Allink"), a clinical-stage biotechnology company dedicated to developing next-generation antibody-drug conjugates (ADCs) and multispecific antibodies for oncology and immunology, reported the presentation of initial data from the first-in-human Phase I clinical trial (NCT06707610) of ALK202, its internally discovered and potential best-in-class EGFR/c-MET bispecific ADC.The data were featured in a poster tour presentation (Abstract #PT2.01.03) on September 14, 2026, at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, South Korea.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study is led by Principal Investigator Professor Caicun Zhou of Shanghai East Hospital, Tongji University School of Medicine, with Professor Fei Zhou as first author, and is being conducted across multiple clinical sites in China, Australia and the United States.

Study Design and Patient Baseline

ALK202 is under investigation in an open-label, international, multicenter Phase I study in patients with advanced solid tumors refractory to standard therapy. The dose-escalation stage (Part A) evaluated ALK202 administered every three weeks (Q3W; 1.5–6.4 mg/kg) and on Days 1 and 8 of every three-week cycle (D1/D8 Q3W; 3.2–3.6 mg/kg). The dose-expansion stage (Part B) is further evaluating the safety and efficacy profile of selected doses (2.8 or 3.2 mg/kg D1/D8 Q3W) in patients with EGFR-mutant non-small cell lung cancer (NSCLC), EGFR wild-type c-MET–positive NSCLC, c-MET–positive colorectal cancer and other solid tumors.
At the June 24, 2026 data cutoff, 71 patients had received dosing. The enrolled group represented a heavily pretreated, refractory advanced population: the median age was 61 years (range, 33–80), 90% had metastatic disease and 82% had received two or more prior lines of therapy (including 54% with three or more).
Manageable Safety Profile
Safety analysis of the 71 patients showed that treatment-related adverse events (TRAEs) occurred in 96% of patients, with Grade ≥3 TRAEs in 31%. The most common adverse events were hematologic and gastrointestinal toxicities, which were generally manageable. Notably, EGFR target-associated toxicities were infrequent, with low rates of rash (4%) and pruritus (7%). Overall, the treatment demonstrated a favorable tolerability profile, only 3% of patients discontinued treatment due to TRAEs, and no treatment-related deaths or interstitial lung disease (ILD) events were reported.

Encouraging Efficacy Data
EGFR-mutant NSCLC population (n=20): The best objective response rate (ORR) was 40% and the disease control rate (DCR) was 85%. In the D1/D8 Q3W dose groups, the ORR reached 71% (5/7) .

c-MET–positive (IHC 2+/3+ ≥50%) solid tumor population (n=20): The ORR was 40% and the DCR was 95%. In the D1/D8 Q3W dose groups, the ORR reached 83% (5/6) .

"The Phase I data for ALK202 have demonstrated clear efficacy signals in patients with c-MET–positive solid tumors and EGFR-mutant NSCLC," said Dr. Hui Feng, Founder and Chief Executive Officer of Allink Biotherapeutics. "We will accelerate enrollment in the dose-expansion stage to further explore c-MET as a biomarker-driven population across EGFR wild-type NSCLC, colorectal cancer and additional solid tumors. At the same time, these monotherapy results in late-line NSCLC provide a stronger data foundation for advancing combination treatment strategies into first-line setting. We believe that, with its differentiated molecular design and growing body of international multicenter clinical evidence, ALK202 has the potential to become a best-in-class EGFR/c-MET bispecific ADC, bringing meaningful benefit to patients in China and around the world as early as possible."

About ALK202

ALK202 is Allink’s internally discovered first-in-class EGFR/c-MET bispecific antibody-drug conjugate, comprising the topoisomerase I inhibitor exatecan conjugated via a cleavable, highly hydrophilic linker. Its antitumor activity is mediated through multiple mechanisms: dual blockade of the EGFR and c-MET pathways, antibody-dependent cellular cytotoxicity (ADCC), targeted payload delivery, and a bystander killing effect. EGFR and c-MET are key oncogenic drivers and resistance-associated targets in NSCLC and multiple other solid tumors. ALK202 has the potential to offer a new treatment option for patients with EGFR-mutant NSCLC and solid tumors with high c-MET expression. A Phase I clinical study of ALK202 in advanced solid tumors (NCT06707610) is actively advancing, and a Phase II clinical study in lung cancer (NCT07603791) is also underway.

(Press release, Shanghai Allink Biotherapeutics, SEP 14, 2026, View Source [SID1234670857])

On September 14, 2026 Bionano Genomics, Inc. (Nasdaq: BNGO) reported three new independently authored, peer-reviewed publications demonstrating the clinical utility of OGM in high-risk hematologic malignancies — myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and therapy-related myeloid neoplasms (t-MN). The studies, published in Modern Pathology, the International Journal of Cancer, and npj Precision Oncology, reinforce a growing body of evidence that OGM can detect prognostically important structural genomic alterations that elude standard karyotyping, FISH, and targeted sequencing panels.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MD Anderson Cancer Center: Chromoanagenesis by OGM defines an ultra-high-risk MDS subset.

Researchers at The University of Texas MD Anderson Cancer Center, led by Guilin Tang, PhD, used OGM to study 332 samples from subjects with MDS, identifying chromoanagenesis (CAG), a catastrophic single-event genomic restructuring process, in 15.9% of cases overall and 17.6% of newly diagnosed subjects. The study, published in Modern Pathology (Wei et al., 2026), found that:

CAG-positive by OGM subjects had a median overall survival of just 9.9 months, significantly shorter than non-CAG subjects where median survival was not reached.
CAG by OGM showed the potential to confer prognostic information beyond existing risk-stratification systems, potentially enabling the identification of patients for early allogeneic transplantation or TP53-targeted clinical trials.

University of Oulu: Cryptic structural variants uncovered in "normal karyotype" AML.

A separate study from the University of Oulu and collaborators, led by Tuomo Mantere, PhD, used OGM to analyze 48 samples of cytogenetically normal AML (CN-AML) — a subgroup that appears unremarkable on standard karyotyping but is clinically heterogeneous. Published in the International Journal of Cancer (Turtinen et al., 2026), the study found that:

OGM detected clinically relevant structural variants or copy-neutral loss-of-heterozygosity in 46% of cases classified as "normal" by conventional karyotyping.
Recurrent alterations included KMT2A partial tandem duplications (10% of cases), RUNX1 disruptions, NF1 deletions, and a novel putative FOXP1:EYA2 fusion not previously reported in the literature.
Subjects with OGM-detected abnormalities had significantly worse overall survival than those without (p = 0.005).

Josep Carreras Leukaemia Research Institute: OGM refines risk in therapy-related neoplasms and younger MDS.

A multicenter Spanish study led by Mar Mallo, PhD, and Francesc Solé, PhD, at the Josep Carreras Leukaemia Research Institute in collaboration with a Spanish hospital network applied OGM to two clinically distinct: 48 subjects with therapy-related myeloid neoplasms (t-MN) and 65 subjects with younger-onset MDS (yMDS, age ≤60). Published in npj Precision Oncology (Mestre et al., 2026), the study found that:

OGM was interpretable in 100% of samples, including all 8 cases where conventional banding analysis (CBA) failed due to lack of dividing cells, and identified 134 additional genomic alterations.
OGM refined cytogenetic classification in 52.0% of karyotypically abnormal cases and detected clinically relevant structural alterations in 9.8% of cases with a normal karyotype, including reclassification of subjects into the therapeutically relevant MDS with isolated 5q- category.
OGM-defined genomic complexity was independently associated with overall survival; chromoanagenesis emerged as the strongest independent predictor of inferior survival in multivariable analysis (HR 9.26), exceeding even TP53 mutation status.
Integrating OGM findings into IPSS-R and IPSS-M scoring shifted 16.7% of t-MN and up to 12.8% of yMDS subjects into higher-risk prognostic categories, which could have implications for treatment planning, including identification of biallelic TP53 inactivation.

Key highlights across all three studies:

Three independent academic centers, spanning the U.S., Finland, and Spain, each show the potential for OGM to identify clinically actionable genomic complexity that conventional cytogenetic workups miss.
All three studies link OGM findings directly to overall and/or disease-specific survival.
Findings support a potential role for OGM in refining prognostication beyond IPSS-R/IPSS-M and ELN2022 classification systems, including in patients who otherwise appear lower-risk by standard testing, and in cases where conventional karyotyping fails outright due to lack of dividing cells.
Across all three cohorts, chromoanagenesis and TP53 disruption consistently emerge as markers of a biologically distinct, ultra-high-risk disease subset best captured by genome-wide structural variant detection.

"These three independent studies, spanning MDS, AML, and therapy-related myeloid neoplasms, all point to the same conclusion: a meaningful fraction of high-risk genomic complexity in myeloid malignancies is simply invisible to conventional karyotyping," said Al Luderer, PhD, chairman and interim chief executive officer of Bionano. "As OGM adoption continues to expand, we expect to see more of this kind of evidence connecting structural variant detection directly to potential patient outcomes and treatment decisions."

(Press release, Bionano Genomics, SEP 14, 2026, View Source [SID1234670855])

On September 14, 2026 Asimov, the company building an AI-native synthetic biology platform to advance therapeutic development, reported a cell line development partnership with Sidewinder Therapeutics, a biopharmaceutical company pioneering the development of next-generation bispecific ADCs (antibody-drug conjugates) for the treatment of cancer. As part of a broader collaboration across multiple products, Asimov successfully delivered a cell line for Sidewinder’s bispecific antibody candidate for solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to be partnering with Sidewinder Therapeutics to advance their novel bispecific, which represents a powerful approach to targeting and treating solid tumors," said Alec Nielsen, co-founder and CEO at Asimov. "Complex molecules such as Sidewinder’s 4-chain bispecific can be challenging to express, and achieving such high titers for this molecule is a testament to the strength of both our team and our CHO Edge System."

Asimov has worked closely with the Sidewinder team on a custom cell line development program for this 4-chain bispecific antibody. In order to achieve the required expression levels and quality attributes, Sidewinder relied on Asimov’s CHO Edge system, which combines a GS knock-out CHO host, hyperactive transposase, genetic parts library, and Kernel, Asimov’s AI-driven genetic design software.

"With a pipeline of first-in-class bispecific ADCs, we needed to find a cell line development partner with the technical capabilities required to deliver high expression levels while simultaneously achieving consistent product quality," said Eric Murphy, Ph.D., co-founder and CEO at Sidewinder. "The team at Asimov has exceeded expectations, and we’re excited to be progressing toward the clinic with such a high performing cell line."

(Press release, Sidewinder Therapeutics, SEP 14, 2026, View Source [SID1234670854])

On September 14, 2026 Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults1.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. The sBCC indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also furthers Biofrontera’s strategy of broadening the clinical utility of its Red-Light PDT platform. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera. Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor. This approval reflects years of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform." He added "We are planning an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027 with our existing commercial organization and installed lamp base. We believe the approval represents a further driver of long-term growth for our existing customers. It also gives new Dermatology practices a reason to purchase a RhodoLED lamp and begin to use Ameluz PDT, expanding our overall installed base." This new indication utilizes the same topical product (Ameluz) and the same red-light device as the Company’s AK indication, so our existing customers will be able to rapidly adopt this new treatment option.

Basal cell carcinoma (BCC) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according to the Skin Cancer Foundation. Published estimates suggest that the superficial subtype accounts for approximately 15%-20% of BCC cases, or an estimated 540,000 to 720,000 sBCC cases annually in the U.S.2. Superficial BCC lesions can be up to several cm in diameter and are frequently located on the trunk and extremities and often present as multiple lesions, for which non-surgical, tissue-sparing treatment options are limited.

The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle. This rigorous target was achieved in 66% of subjects treated with Ameluz PDT (95/145) compared with 5% of subjects treated with placebo-PDT (2/42). Histological clearance of the main target lesion was seen in 76% of Ameluz PDT treated patients versus 19% with Placebo-PDT, and 83% of Ameluz-treated subjects achieved complete clinical clearance of all target lesions compared with 21% for Placebo-PDT. The most common adverse reactions were application-site reactions consistent with the known safety profile of Ameluz PDT.

Dr. M. Shane Chapman, MBA, board certified dermatologist, Professor and Founding Chair, Department of Dermatology, Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, and a key contributor to the Phase 3 study added "For many patients with superficial basal cell carcinoma — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred — treatment options have been limited. This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office. As someone who has worked with PDT for many years, I see this as a meaningful expansion in the use of this treatment."

(Press release, Biofrontera, SEP 14, 2026, View Source [SID1234670853])