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Anaptys Announces Second Quarter and Transitional Fiscal Year 2026 Financial Results and Provides Business Update

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])

Alligator Bioscience announces preliminary outcome in rights issue

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.

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])

Telix and ITM Join Forces to Create a Radiopharmaceutical Powerhouse

On September 21, 2026 Telix reported it has signed a strategic agreement to lead a merger with ITM Isotope Technologies Munich SE ("ITM"), a global leader in radioisotope production and radiopharmaceutical development.

The merger will further strengthen Telix’s leadership as a vertically integrated radiopharmaceutical company with the capabilities required to develop, manufacture and deliver innovative treatments to patients globally. The combined organization will be uniquely positioned as a radiopharmaceutical industry leader, differentiated by a world-class scaled isotope manufacturing business with a validated global distribution network, a market-leading commercial precision medicine platform and the industry’s most extensive therapeutic radiopharmaceutical pipeline.

Founded in 2004, ITM is a private company with a leading commercial scale radioisotope manufacturing and global distribution network spanning over 65 countries. ITM is a key supplier of 177Lu and – with a compound annual growth rate (CAGR) of 40% from 2021 to 2025 – delivered annual revenue of US$273 million in 20252. This commercial momentum is underpinned by increasing global demand for TRT and radioisotopes for commercially approved products and assets under clinical development. The global nuclear medicine market is forecast to reach US$41 billion by 20343.

ITM’s late-stage novel pipeline is complementary to Telix and includes ITM-11 (177Lu-edotreotide), a differentiated somatostatin receptor (SSTR)-targeted treatment for GEP-NETs. ITM-11 has completed a successful Phase 3 trial (COMPETE, NCT03049189)4 and fully enrolled a second indication expansion Phase 3 study (COMPOSE, NCT04919226) with an interim analysis expected in H1 2027. If approved, ITM-11 has the potential to accelerate Telix’s entry into the commercial therapeutic market and expand its presence in neuroendocrine tumors, a commercially validated and clinically significant market for TRT.

The combined organization is expected to generate unaudited pro forma 2026 revenue and income exceeding US$1.3 billion5, based on management estimates. ITM’s radioisotope manufacturing business is profitable and generates cash flow. Continued growth from manufacturing, cost savings and further synergies and pipeline optimization are expected to support a positive EBITDA6 contribution in 20277 and onward. If approved by health regulators, the launch of ITM-11 is expected to drive further upside, with the potential to generate additional high-margin therapeutic revenue in the near term.

Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, said, "This merger positions Telix at the forefront of the consolidation that is occurring as the industry matures. ITM is the leader in radioisotope production, with deep scientific expertise and a track record of value-adding innovation. We have enjoyed a close working relationship with ITM for many years and there is strong management alignment for the rationale behind this transaction. By combining our complementary strengths, we will create a company with commercial scale, world-leading supply and the most exciting theranostic drug portfolio in the sector. Importantly, this combination further expands our late-stage therapeutic pipeline with two completed Phase 3 trials and deepens radioisotope security, while bringing together the mission critical capabilities needed to deliver radiopharmaceutical treatments to patients around the world."

ITM Chief Executive Officer, Dr. Andrew Cavey, added, "Joining two radiopharmaceutical pioneers creates a company with unmatched breadth and depth across the value chain, supported by deep expertise and talent. Our management teams have a track record of working together and a nuanced understanding of our respective commercial strengths and customer relationships. Together, we believe Telix and ITM will be uniquely positioned to capitalize on rapidly growing global demand for radiopharmaceuticals to the benefit of both Shareholders and patients."

Deal Terms

Under the terms of the agreement and subject to Shareholder approval, Telix will acquire 100% of the shares in ITM for US$1.65 billion upfront on a cash-free/debt-free basis expected as follows:

US$1.25 billion will be paid to the sellers in the form of 105.8 million Telix shares (priced at the 30-day trailing VWAP as of signing of US$11.841) and released to the sellers as Nasdaq-listed ADRs at the end of their respective escrow periods;
US$302 million of net debt will be assumed by Telix at closing; and
US$96 million of management equity rollover and transaction expenses payable by the sellers8; and in each case subject to closing adjustments.
Additional contingent consideration of up to US$700 million will become payable upon the achievement of specified regulatory approvals and sales milestones for ITM-11 as set out below:

Up to US$250 million upon U.S. Food and Drug Administration (FDA) approval of ITM-11 across three different indications:
US$100 million upon FDA approval for expected first indication in G1-G2 GEP-NETs no later than December 31, 2027;
US$100 million upon FDA approval for G2-G3 GEP-NETs indication no later than December 31, 2030; and
US$50 million upon FDA approval for Lung NETs indication no later than December 31, 2031; and
Up to US$450 million based on ITM-11 net global sales in FY 2030 in excess of US$150 million.
All milestone consideration will be payable in cash or Shares9 at Telix’s election10. Consideration paid to ITM Shareholders at closing is subject to financial adjustments at closing, indemnity holdbacks, and escrow (lockup) restrictions on the Shares issued at closing of up to 15 months which may be waived in limited part to allow the sellers to pay their tax and transaction expense liabilities.

Upon completion of the transaction, Telix Shareholders will own approximately 76.3% and ITM Shareholders will own approximately 23.7% of Telix shares on issue. The transaction has been approved by Telix’s Board of Directors and, as of signing, Shareholders holding over 90%11 of ITM’s Shares. The transaction is expected to close by the end of FY 2026 subject to Telix Shareholder approval as required under the ASX Listing Rules, regulatory approvals, and other customary closing conditions.

Refer to the Investor Presentation lodged today with the ASX for further information on the transaction.

A Notice of Meeting will be sent to Telix Shareholders for an extraordinary general meeting expected to be held in November 2026.

(Press release, Telix Pharmaceuticals, SEP 21, 2026, View Source [SID1234670964])

Antengene Announces First Patient Dosed in Pivotal Phase III CLINCH-3 Study of ATG-022

On September 20, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported that the first patient has been dosed in China in the pivotal Phase III CLINCH-3 study of ATG-022. ATG-022 is a CLDN18.2 antibody-drug conjugate (ADC) being evaluated for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma.

ATG-022 was previously granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This designation has facilitated efficient regulatory communications and supported the rapid advancement of the CLINCH-3 study. Initiated in China with the first patient dosed and planned for expansion into a multi-regional clinical trial (MRCT), the CLINCH-3 study is intended to generate robust clinical evidence to support a future marketing approval application for ATG-022 as monotherapy for CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma.

The CLINCH-3 study is led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH studies, which showed that ATG-022, as monotherapy, demonstrated a differentiated robust efficacy and well tolerated safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%), in the 1.8 mg/kg dose cohort, the recommended phase 2 dose (RP2D), the ORR was 46.7% (14/30) with confirmed ORR of 40% (12/30), the DCR was 86.7% (26/30), and the mOS had not yet been reached after a median follow‑up of 14.03 months. Among patients with low/ultra-low CLDN18.2 expression treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21) and the DCR was 52.4% (11/21). In addition, multiple patients achieved complete responses (CR). In terms of safety, compared with the data cutoff of December 25, 2025, the incidence of Grade ≥3 treatment‑related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. Despite more than six additional months of treatment exposure and follow‑up, the incidence of Grade ≥3 TRAEs remained broadly stable in the 1.8 mg/kg dose cohort. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma.

"The dosing of the first patient in CLINCH-3 marks an important step in the clinical evaluation of ATG-022." said Professor Lin Shen of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study. "Patients with advanced gastric or gastroesophageal junction adenocarcinoma continue to face substantial unmet medical needs, particularly after disease progression on existing therapies. The antitumor efficacies and manageable safety profile observed in the Phase I/II study demonstrate therapeutic potential, supporting advancement of ATG-022 into the pivotal Phase III clinical study. CLINCH-3 will provide important evidence regarding whether ATG-022 can improve clinical outcomes for patients with CLDN18.2+ disease. We look forward to conducting this study with scientific rigor and working closely with participating investigators and study centers."

Antengene will continue to advance the three complementary clinical development pathways planned for ATG‑022: CLINCH-3 provides a near-term registration pathway for ATG-022 monotherapy at the optimized RP2D 1.8 mg/kg dose in 3L+ gastric/GEJ cancer with CLDN18.2 IHC 2+ ≥ 20%, establishing ATG-022 in gastric cancer. CLINCH-2 is evaluating ATG-022 in 1L in combination with standard-of-care chemotherapy and anti-PD-1 therapy, targeting the broadest CLDN18.2-positive population starting from IHC 1+ ≥ 1%, with the goal of supporting 1L registration and unlocking the full potential of ATG-022 in gastric cancer. Meanwhile, the CLINCH basket trial is expanding ATG-022 beyond gastric cancer, with encouraging efficacy already observed in multiple non-gastric CLDN18.2-positive solid tumors. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world.

(Press release, Antengene, SEP 20, 2026, View Source [SID1234670965])

Alaunos Therapeutics, Inc. Announces Pricing of Registered Direct Offering priced at-the-market under Nasdaq rules

On September 18, 2026 Alaunos Therapeutics, Inc. (Nasdaq: TCRT) reported that it has entered into definitive agreements with institutional investors in a registered direct offering for the sale of 380,469 shares of its common stock and pre-funded warrants to purchase up to 386,654 shares of common stock at a price of $1.46 per share, for aggregate gross proceeds of approximately $1,120,000, before deducting placement agent fees and offering expenses. The offering was priced at-the-market under Nasdaq rules. The offering is expected to close on or about September 21, 2026, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering primarily for general working capital and corporate purposes.

Dawson James Securities, Inc. is acting as sole placement agent for the offering.

The securities will be offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-289748), including a base prospectus, initially filed with the U.S. Securities and Exchange Commission (the "SEC") on November 11, 2025 and became effective on December 1, 2025. The offering will be made only by means of a written prospectus. A prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of Dawson James Securities, Inc. 2700 N Military Trail, Suite 100, Boca Raton, FL, 33431 or by email at [email protected].

Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Alaunos Therapeutics, SEP 18, 2026, View Source [SID1234671031])