On September 21, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported the next clinical development steps for MaaT034, the first functionally-selected, co-cultured microbial ecosystem from the Company’s innovative donor-independent MET-C platform, to be evaluated in combination with PD-(L)1 inhibitors in advanced solid tumors.

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The MET-C platform combines rational candidate design, artificial intelligence-enabled computational tools for functional feature selection and unique co-culture technology to produce functionally selected microbial ecosystems at an industrial scale. MaaT034 is the first candidate to emerge from this platform and is specifically designed with the objective of optimizing intestinal microbiome functions and to support antitumor immune responses in combination with immune checkpoint inhibitors.

MaaT Pharma has scheduled a Pre-IND CMC-focused meeting with the FDA in October 2026, the next regulatory milestone toward clinical development of MaaT034. The program’s progression toward clinical development is based on a series of preclinical findings presented at the AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper) Annual Meetings1.

MaaT034 is expected to be developed in combination with PD-(L)1 inhibitors in selected advanced solid tumors, including second-line NSCLC and refractory advanced melanoma, as well as in other solid tumors characterized by significant unmet medical needs and limited treatment options. By modulating the gut microbiome, MaaT034 is designed to help restore anti-tumor immunity and sensitivity to PD-(L)1 inhibitors, with the aim of overcoming acquired resistance and improving outcomes beyond current standard of care benchmarks.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding, MaaT Pharma could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships with pharmaceutical companies.

(Press release, MaaT Pharma, SEP 21, 2026, View Source [SID1234670971])

On September 21, 2026 Kian Immune Cell Co. reported that it hosted a lively scientific discussion that brought together researchers, students, and colleagues for an exchange the company describes as genuine scientific thinking in action.

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Zohreh Mirlavasani shared insights on dendritic cell (DC) vaccines and explored how artificial intelligence could improve their development and therapeutic efficacy. Students and colleagues from the Royan Cancer Stem Cell Group engaged actively throughout the session, raising thoughtful questions and driving a wide-ranging scientific brainstorm.

The discussion converged on one of the most compelling questions in cancer immunotherapy today: which holds greater potential for treating cancer — mRNA vaccines or DC vaccines? No simple answer emerged, and the conversation reflected the depth and fast-evolving nature of the field. Kian Immune Cell Co. looks forward to continuing this dialogue and invites the broader scientific community to share their perspectives.

(Press release, Kian Immune Cell, SEP 21, 2026, View Source [SID1234670970])

On September 21, 2026 GT Biopharma, Inc. (the "Company") reported to have entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with the purchasers identified therein (collectively, the "Original Purchasers") providing for the issuance and sale to the Original 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 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").

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On September 18, 2026, the Company and the requisite Original Purchasers entered into the First Amendment to Securities Purchase Agreement (the "First Amendment to Securities Purchase Agreement") with a new purchaser (the "New Purchaser," and together with the Original Purchasers, the "Purchasers") to increase the number of shares of Preferred Stock issuable under the Securities Purchase Agreement, as amended, to 8,611.111 shares of Preferred Stock, and thereby increase the accompanying Warrants, with an aggregate stated value of $8,611,111.11, for an aggregate purchase price of $7,750,000, on the same terms and conditions as previously disclosed.

Pursuant to the First Amendment to Securities Purchase Agreement, each Purchaser may elect to purchase shares of Preferred Stock with an aggregate stated value of up to $34,675,615 (the "Greenshoe Rights") for an aggregate purchase price of $31,208,054, subject to adjustments, as further described in the Securities Purchase Agreement, as amended. 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.

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

As previously disclosed, on September 14, 2026, the Company and the Original 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 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, as amended, 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. On September 18, 2026, the New Purchaser executed a joinder agreement to the Registration Rights Agreement on the same terms and conditions (the "Joinder").

Certificate of Increase to Certificate of Designations of Preferences, Rights and Limitations of Series M Convertible Preferred Stock

As previously disclosed, on September 14, 2026, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series M 10% Convertible Preferred Stock with the Secretary of State of the State of Delaware (the "Certificate of Designations").

On September 18, 2026, the Company filed with the Secretary of State of the State of Delaware a Certificate of Increase (the "Certificate of Increase") increasing the shares of the Preferred Stock as designated in the Certificate of Designations from 41,778 shares to 43,287 shares.

The foregoing descriptions of the Certificate of Increase, First Amendment to Securities Purchase Agreement and Joinder do not purport to be complete and are qualified in their entirety by reference to the full text of such documents, copies of which are attached as Exhibits 3.1, 10.1 and 10.2 to this Current Report on Form 8-K, which are incorporated herein by reference.

(Filing, GT Biopharma, SEP 21, 2026, View Source [SID1234670969])

On September 21, 2026 AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK company, and Quimilza (imsidolimab) with Vanda, reported financial results for the second quarter and transitional fiscal year ended June 30, 2026, and provided a business update.

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"Jemperli continues to demonstrate robust year-over-year growth with major catalysts within the next 6 months including further sales acceleration ex-US, anticipated FDA approval of Jemperli in monotherapy in dMMR/MSI-H neoadjuvant rectal cancer, as well as a judgement expected in our litigation with GSK and Tesaro," said Daniel Faga, president and chief executive officer. "In addition to Jemperli, we anticipate FDA approval of Quimilza in GPP in December 2026."

GSK Jemperli Financial Collaboration

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GSK announced strong commercial performance for Jemperli
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$331 million (£248 million) in global net sales for the three months ended June 30, 2026, representing 26% year-over-year growth1
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$644 million (£480 million) in global net sales for the six months ended June 30, 2026, representing 34% year-over-year growth1
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Anaptys continues to expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak monotherapy sales guidance of > $2.7 billion2
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Anaptys estimates Sagard will have accrued ~$301 million in royalties and sales milestones through Q2 2026 and anticipates paydown of the remaining ~$299 million non-recourse debt monetization in the second half of 2027
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Jemperli development and regulatory updates include:
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AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
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In July 2026, GSK announced positive interim results from the trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months (cCR12) with no detectable signs of cancer for at least one year
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The FDA has assigned a PDUFA action date of February 2027
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Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025; eligible for an expedited review which could result in an earlier FDA decision
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GSK to present first results from the AZUR-1 trial as a late-breaking abstract at ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain on Oct. 25, 2026
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AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer
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Data expected in 2028
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AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer
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Primary completion date in Q4 2026
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JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 CPS≥1) post chemoradiation
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Data expected in 2028
Vanda Quimilza (imsidolimab) Financial Collaboration

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FDA target action date (PDUFA) of Dec. 12, 2026, for Quimilza in generalized pustular psoriasis (GPP)
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In August 2026, Vanda announced it received Orphan Designation from the European Commission for imsidolimab for the treatment of GPP
GSK and Tesaro Litigation Update

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The trial was held before the Delaware Chancery Court from July 14-17, 2026
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The Court has requested the parties submit post-trial briefs in advance of a post-trial hearing, which has been scheduled for October 20, 2026
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Anaptys filed its opening post-trial brief on August 21, 2026, GSK and Tesaro will file their answering post-trial brief on or before September 25, 2026, and Anaptys will file its reply post-trial brief on or before October 9, 2026
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Anaptys is seeking reversion of Jemperli rights as a remedy; the Company anticipates a judgement in Q4 2026 or Q1 2027
Second Quarter Financial Results

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The separation of AnaptysBio and First Tracks Biotherapeutics was completed on April 20, 2026. Beginning in the second quarter of 2026, AnaptysBio reclassified historical First Tracks Biotherapeutics, Inc. related assets, liabilities and expenses as discontinued operations.
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On May 18, 2026, Anaptys changed its fiscal year-end from December 31 to June 30. The Company will begin to file quarterly reports based on the new fiscal year beginning with the quarter ending September 30, 2026.
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As of June 30, 2026, Anaptys has not repurchased any shares under its $100 million Stock Repurchase Plan, which will expire on December 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock.
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Cash, cash equivalents and investments totaled $164.1 million as of June 30, 2026, compared to $211.6 million as of December 31, 2025, for a decrease of $47.5 million due primarily to $72.9 million for operating activities offset by $25.4 million received from stock option exercises.
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Collaboration revenue was $27.5 million and $53.0 million for the three and six months ended June 30, 2026, compared to $22.3 million and $50.0 million for the three and six months ended June 30, 2025. The increase is primarily due to Jemperli royalties increasing 25% and 34% for the three and six months ended June 30, 2026, offset by $9.7 million in revenue recognized for the Vanda license agreement for the three month and six months ended June 30, 2025.
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General and administrative expenses were $16.0 million and $23.4 million for the three and six months ended June 30, 2026, compared to $4.0 million and $8.3 million for the three and six months ended June 30, 2025. The
increase was due primarily to legal costs for the separation of the company and the GSK and Tesaro lawsuit and non-cash stock compensation.
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Research and development expenses from continuing operations were a negative $2.7 million for the six months ended June 30, 2026, compared to a negative $1.7 million six months ended June 30, 2025. The negative balance for the six months ended June 30, 2026, was primarily due adjustments related to the closeout of clinical contracts reducing expenses incurred prior to the separation.
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Benefit for income taxes for continuing operations was $181.5 million for the six months ended June 30, 2026. The benefit recognized was primarily due to the release of the valuation allowance on deferred tax assets due to the anticipated usage of deferred tax assets in the future due to the separation from First Tracks Biotherapeutics.
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Net income from continuing operations was $177.3 million and $176.4 million for the three and six months ended June 30, 2026, or a basic net income per share of $6.06 and $6.09, compared to a net income from continuing operations of $5.7 million and $16.6 million for the three and six months ended June 30, 2025, or a basic net income per share of $0.20 and $0.56.

(Press release, AnaptysBio, SEP 21, 2026, View Source [SID1234670968])

On September 21, 2026 Alligator Bioscience AB ("Alligator Bioscience" or the "Company"), reported the preliminary outcome of the rights issue of units that was announced on 23 July 2026 (the "Rights Issue"). The preliminary outcome indicates that the Rights Issue has been subscribed to approximately 17.1 percent with and without exercise of unit rights, of which approximately 16.7 percent were subscribed for by exercise of unit rights and approximately 0.5 percent were subscribed for without exercise of unit rights. The preliminary outcome thus indicates that guarantee commitments will be utilized with approximately 29.7 percent of the Rights Issue. Based on the preliminary outcome, Alligator Bioscience will initially receive SEK 58.8 million from the Rights Issue before issue costs and repayment of bridge loans.

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The subscription period in the Rights Issue ended on 18 September 2026. The Rights Issue comprised a maximum of 3,140,534,240 units whereof each unit consists of two (2) ordinary shares, one (1) warrant series TO 15 and one (1) warrant series TO 16. The preliminary outcome indicates that subscriptions with and without exercise of unit rights amount to a total of 538,108,763 units, corresponding to approximately 17.1 percent of the Rights Issue. The Rights Issue is thus subscribed below the guaranteed level and guarantee commitments will need to be utilized with approximately 29.7 percent of the Rights Issue, corresponding to a total of 931,891,237 units.

The final outcome of the Rights Issue is expected to be announced on 22 September 2026.

Advisers
APREA Partners AB acts as financial adviser in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.

(Press release, Alligator Bioscience, SEP 21, 2026, View Source [SID1234670967])