Chugai Announces 2026 2nd Quarter Results

On July 24, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the second quarter of fiscal year 2026.

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Core revenue of ¥663.3 billion (+14.7%), core operating profit of ¥329.1 billion (+21.0%), and core net income of ¥238.4 billion (+23.2%) were achieved (all changes year-on-year)
Strong growth in domestic and overseas sales, combined with a significant increase in other revenue driven by one-time income, and royalty income related to Hemlibra and NEMLUVIO, resulted in increased revenue and profit year-on-year
Achieved eight regulatory filings in Japan during the first half of the year, progressing steadily toward achieving the highest number of filings ever planned
R&D activities progressed steadily across both early- and late-stage development, including Chugai-originated projects
For NXT007, which is expected to become a next-generation growth driver, two Phase III studies were initiated
For AQUA07, the third macrocyclic peptide project, entry into the clinical stage was achieved, with dosing in a Phase I study in ALK-positive non-small cell lung cancer expected to start shortly
For Enspryng, developed using Chugai’s proprietary antibody engineering technologies, the U.S. FDA accepted the regulatory application for thyroid eye disease (TED) and granted Priority Review designation
Regarding products out-licensed to third parties, global market penetration of Chugai-originated new products advanced
Export sales and royalty income from NEMLUVIO (nemolizumab), a humanized anti-human IL-31 receptor A monoclonal antibody out-licensed to Galderma, drove revenue growth
As for Foundayo (orforglipron), an oral GLP-1 receptor agonist out-licensed to Eli Lilly, prescriptions were driven in the U.S. primarily by GLP-1 naïve patients, and the oral anti-obesity drug market is expanding. Chugai commenced recognition of royalty income from the product in the second quarter
Refer to the information below for details on the financial results:

Quarterly Reports / Finance Reports

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Presentation Materials

In addition to Chugai’s business and financial performance, these materials provide updates on our research and development pipeline. Videos and transcripts (including Q&A) will be made available at a later date.

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[2026 Second Quarter Results]

Core results (Billion JPY)
2026

Jan-Jun

2025

Jan-Jun

% change
Revenue

663.3

578.5 +14.7%
Domestic sales 237.9 223.3 +6.5%
Overseas sales 328.6 288.1 +14.1%
Other revenue 96.8 67.0 +44.5%
Operating profit 329.1 272.0 +21.0%
Net income 238.4 193.5 +23.2%

(Press release, Chugai, JUL 24, 2026, View Source [SID1234669414])

Sprint Bioscience Signs Agreement with Lilly TuneLab to Accelerate Drug Development

On August 13, 2026 Sprint Bioscience reported that the company has entered into an agreement with Lilly TuneLab, a collaborative, AI-driven drug discovery platform created by Eli Lilly and Company (Lilly). By joining TuneLab, Sprint Bioscience intends to strengthen and accelerate the development of its portfolio through access to advanced artificial intelligence (AI) and machine learning (ML) models.

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Sprint Bioscience will use Lilly TuneLab to further strengthen its capabilities in AI and ML. Through TuneLab, the company will gain access to predictive models for drug development that have been trained on decades of Lilly’s own research data. These models will complement Sprint Bioscience’s fragment-based drug design platform and established workflows with advanced AI tools that enable more data-driven decisions early in the development process. This is expected to increase both the speed and precision of the company’s preclinical programs.

TuneLab offers models in areas such as safety, pharmacokinetics, and early-stage development decisions for both small molecules and biologics. Through federated learning, participating companies can benefit from continuous improvements to the models without having to share or expose their own data.

"We are very excited to gain access to the TuneLab platform. The combination of our fragment-based approach and advanced AI models offers great opportunities to further improve the efficiency and pace of development of our programs," says Johan Emilsson, CEO of Sprint Bioscience.

(Press release, Sprint Bioscience, JUL 23, 2026, View Source [SID1234670072])

Scancell and Neuphoria Therapeutics Announce Merger Agreement and Financing

On July 23, 2026 Scancell Holdings plc (AIM: SCLP) ("Scancell") and Neuphoria Therapeutics Inc. (Nasdaq: NEUP) ("Neuphoria") reported an all-share merger in which Scancell will acquire Neuphoria. Upon completion of the Transaction, the combined company plans to operate under the name Scancell and will apply to trade on Nasdaq under the symbol "SCLT".

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Alongside the Merger, Scancell expects to secure up to $89 million of financing through a combination of equity and debt. It has secured commitments from new and existing shareholders for a Private Placement of $39.1 million (c.£29.2 million) and intends to launch today a UK Placing to raise approximately $12.0 million (c.£9.0 million) and a Retail Offer to raise up to $3.0 million (c.£2.3 million). In addition, Scancell has entered into a non-binding term sheet with certain funds and accounts managed by BlackRock for Debt Financing of up to $25 million (c.£18.7 million). Completion of the Merger is also expected to provide the combined company with a minimum of $10 million (c.£7.5 million) of additional cash as a result of Neuphoria’s cash balances.

The Transaction has been unanimously approved by the Board of Directors of each company. Completion of the Transaction is conditional upon approval by shareholders of both companies.

Unless otherwise stated, defined terms are included in the Appendix.

Strategic Rationale for the Merger and Financing

Scancell’s lead asset, iSCIB1+, has a defined regulatory path with fast-track designation from the US Food and Drug Administration and continues to demonstrate a potent and durable efficacy of 77 per cent Progression Free Survival at 22 months, in combination with ipilimumab and nivolumab, with expected further Progression Free Survival and Overall Survival data from the Phase 2 SCOPE study to be released in the next 12 months.

On the basis of this dataset, a Nasdaq listing unlocks access to US investors and the broader US life sciences sector. The equity and debt financing will provide the required capital to conduct the registrational Phase 3 study for iSCIB1+ through key clinical milestones, including the Phase 3 iSCIB1+ primary readout (H2 2028) and is expected to extend the Group’s cash runway into 2029.

Commenting on the announcement, Scancell’s Chief Executive Officer, Dr Phil L’Huillier, said:

"This transaction will establish Scancell on Nasdaq and enables access to US investors and the broader US life sciences sector for the capital we need to execute the registrational Phase 3 study for iSCIB1+ in advanced melanoma. We believe the compelling data from our Phase 2 SCOPE study demonstrating benefit to patients across multiple clinical endpoints warrants pressing forward to evaluate the product in a registrational randomized study. We strongly believe this transaction creates meaningful near- and long-term value for shareholders of both companies."

Commenting on the announcement, Neuphoria’s Chairman, Alan Fisher, said:

"We believe this transaction offers Neuphoria stockholders a compelling opportunity to participate in the future value creation of Scancell’s differentiated oncology pipeline, while preserving potential upside from Neuphoria’s partnered assets through the CVRs."

About the Transaction

Together, the Merger, Private Placement, Debt Financing and Nasdaq Listing are the "US Listing Transactions". The UK Placing and Retail Offer are the "UK Financing Transactions" and when taken together with the Private Placement and the Debt Financing, constitute the "Financing". All together form the "Transaction".

All-share Merger: The share consideration for the Merger consists of 20,414,065 ADSs (representing an aggregate of 204,140,654 Consideration Shares) which are expected to represent approximately 13.7 per cent. of Scancell’s enlarged issued Ordinary Share capital following Completion (the "Completion Ordinary Share Capital")2;
Contingent Value Rights (CVRs): Neuphoria stockholders will also receive contingent value rights representing the right to receive future conditional cash payments (if any) based on the achievement of certain milestones relating to Neuphoria’s partnered assets, any monetisation of certain of Neuphoria’s intellectual property rights and upon receipt of payment of an Australian R&D tax credit in respect of the year ended 30 June 2026;
Financing: subject to completion of the US Listing Transactions (expected to occur in late Q4 2026), the Group is expected to have a pro forma net cash balance of approximately $79.1 million (£59.2 million) (before transaction costs), taking into account the proceeds of the Financing and inclusive of the closing cash in Neuphoria:
Private Placement: Private Placement to raise $39.1 million (£29.2 million) through the issue of 324,190,865 new Ordinary Shares (including Ordinary Shares to be represented by ADSs) and Non-Voting Ordinary Shares. Placement Price of $0.1205 (£0.09) per ADS, Ordinary Share or Non-Voting Ordinary Share;3
UK Placing and Retail Offer: UK Placing to raise approximately $12.0 million (c.£9.0 million) and a Retail Offer to raise up to approximately a further $3.0 million (c.£2.3 million) at 9 pence per Ordinary Share, being the GBP equivalent of the Placement Price, neither being conditional on the US Listing Transactions; and
Debt Financing: non-binding term sheet entered into with certain funds and accounts managed by BlackRock for up to $25 million (c.£18.7 million) of new Debt Financing.
Scancell shareholders, together with the investors in the Private Placement, the UK Placing and the Retail Offer, are expected to own approximately 86.3 per cent. of the Completion Ordinary Share Capital and approximately 88.9 per cent. of the total outstanding issued share capital of Scancell including Ordinary Shares and the Non-Voting Ordinary Shares (together the "Completion Total Share Capital"). Neuphoria stockholders are expected to own approximately 13.7 per cent. of the Completion Ordinary Share Capital and 11.1 per cent. of the Completion Total Share Capital.

The US Listing Transactions are all inter-conditional and are expected to complete concurrently in late Q4 2026 subject to customary closing conditions. These include, among others, approval of the required shareholder resolutions at a general meeting of Scancell’s shareholders (the "EGM"), approval of the Merger at a special meeting of Neuphoria’s stockholders, the listing of the Scancell ADSs on Nasdaq (which is subject to Nasdaq listing process and SEC review) and the submission of the application for the admission to trading of the Consideration Shares on AIM. Further details are set out below.

To ensure the ADS price aligns with US market expectations, it is expected that each ADS will initially represent ten (10) Consolidated Ordinary Shares. Additionally, Scancell plans a 10:1 share consolidation, subject to Scancell shareholder approval (the "Share Consolidation"), to occur before closing of the US Listing Transactions.

Principal Terms of the Merger, Financing and associated transactions

1) Merger

Exchange Ratio and Merger Consideration

Pursuant to the terms of the Merger Agreement, each share of Neuphoria common stock outstanding immediately prior to the Effective Time will be converted into the right to receive:

a number of Scancell ADSs equal to the Exchange Ratio of 37.77199; and
a CVR representing the right to receive potential cash payments relating to Neuphoria’s partnered assets, any monetisation of certain of Neuphoria’s intellectual property rights and upon receipt of payment of an Australian R&D tax credit in respect of the year ended 30 June 2026.
The Exchange Ratio represents the number of Scancell ADSs that will be received by Neuphoria stockholders per Neuphoria share of common stock. Closing is conditional upon Neuphoria’s net cash at 31 December 2026 or at Completion, if earlier, being at least $10 million.

Based on current assumptions, it is anticipated that 204,140,654 Consideration Shares (represented by 20,414,065 ADSs at the ADS Ratio) will be issued to Neuphoria stockholders.

Upon Completion, Neuphoria will become an indirect wholly owned subsidiary of Scancell.

Other than in relation to de-minimis maintenance and enforcement costs relating to agreements to maintain Neuphoria’s intellectual property, Scancell does not intend to develop Neuphoria’s non-partnered assets and the Group will focus on the development of Scancell’s lead asset iSCIB1+ and Scancell’s other pipeline opportunities.

Contingent Value Rights (CVRs)

Each Neuphoria stockholder will also receive a CVR for each share of Neuphoria common stock held immediately prior to Completion, representing the right to receive a pro rata share of 100 per cent. of net proceeds received by Scancell: (i) under its research collaboration and licence agreement with Merck Sharp & Dohme Corp. for a period of 15 years from Completion; (ii) under the Participants Agreement and associated CRC Commercialisation License Agreements (including the existing licence agreement with Pfizer relating to KAT6), for a period of 15 years from Completion; (iii) pursuant to any monetisation of certain of Neuphoria’s intellectual property rights within the applicable timeframe as set out in the CVR Agreement; and (iv) in respect of an Australian R&D tax credit of Neuphoria in respect of the year ended 30 June 2026. The CVRs will be non-transferable and will not be listed.

Conditions and Termination Rights

Completion also requires: (i) Neuphoria stockholder approval of the Merger; (ii) Scancell shareholder approval of the requisite EGM resolutions; (iii) effectiveness of the Form F-4 Registration Statement; (iv) the listing of the Scancell ADSs on Nasdaq (which is subject to the Nasdaq listing process and SEC review); (v) an application having been made for the admission to trading of the Private Placement Ordinary Shares and Consideration Shares on AIM following closing; (vi) securing a minimum of $75 million (c.£56 million) through the Financing; and (vii) the Subscription Agreements being in full force and effect.

The Merger Agreement may be terminated prior to Completion by mutual consent, or by either party if (i) a governmental authority has permanently restrained or prohibited the Merger; (ii) the requisite shareholder approvals are not obtained; (iii) the other party has breached its representations, warranties, covenants or agreements such that the relevant closing conditions would not be satisfied; or (iv) the Merger has not completed by 28 February 2027 (the "End Date"). The End Date may be extended by a further 60 days if the SEC has not by the End Date declared the F-4 Registration Statement effective. Scancell may also terminate the Merger Agreement if the Neuphoria board changes or proposes to change its recommendation, fails to reaffirm it following a request from Scancell in certain circumstances, or Neuphoria materially breaches its non-solicitation obligations, in each case prior to the obtaining of Neuphoria stockholder approval. If the Merger Agreement is terminated because the requisite approval of either Scancell or Neuphoria is not obtained, the relevant party is required to reimburse the other party’s aggregate fees and expenses incurred in connection with the Transaction.

Voting and Support Agreements and Lock-Up Agreements

Scancell has obtained customary agreements to support the transactions contemplated by the Merger Agreement and vote in favour of the resolutions to be proposed at the EGM from Scancell’s directors and certain shareholders in respect of holdings totalling, in aggregate, 443,249,106 Ordinary Shares, representing approximately 42.7 per cent. of Scancell’s existing Ordinary Shares as of the date of this announcement (prior to completion of the UK Placing and the Retail Offer). Neuphoria has also obtained customary agreements to support and vote in favour of the transactions contemplated by the Merger Agreement from certain of its directors and officers in respect of holdings totalling, in aggregate, 10,453 Neuphoria shares of common stock, representing less than 1 per cent. of Neuphoria’s outstanding shares of common stock.

The Directors and certain shareholders of Scancell and Neuphoria will also enter into lock-up agreements at Completion, pursuant to which, subject to specified exceptions, they will accept certain restrictions on transfers of Ordinary Shares (or other securities) they beneficially hold for the 180-day period following Completion.

Leerink Partners is acting as financial advisor to Scancell in connection with the Merger. H.C. Wainwright & Co. and WG Partners LLP are acting as financial advisors to Neuphoria in connection with the Merger.

2) Private Placement

Concurrently with signing the Merger Agreement, Scancell has entered into the Private Placement by executing Subscription Agreements with certain existing and new accredited investors. The Private Placement is expected to raise approximately $39.1 million (c.£29.2 million). Subscribers in the Private Placement can elect to receive Ordinary Shares (including Ordinary Shares represented by ADSs) or Non-Voting Ordinary Shares at the Placement Price. The Placement Price is subject to pro rata adjustment upon the Share Consolidation becoming effective and for the final ADS Ratio. The Private Placement is expected to result in the issue of up to 279,377,587 new Ordinary Shares and 44,813,278 Non-Voting Shares (excluding the impact of the proposed Share Consolidation).

The closing of the Private Placement is conditional upon the passing of certain resolutions at the EGM, the closing of the Merger and the Nasdaq Listing and is also subject to customary closing conditions.

Leerink Partners TD Cowen and H.C. Wainwright & Co. are acting as placement agents for the Private Placement.

3) UK Placing and Retail Offer

Scancell intends to raise approximately $12.0 million (c.£9.0 million) through the placing of new Ordinary Shares via an accelerated bookbuild process with select new and existing UK institutional investors of Scancell at 9 pence per Ordinary Share, being the GBP equivalent of the Placement Price.

Scancell also intends to launch the Retail Offer at 9 pence per Ordinary Share, to raise up to approximately a further $3.0 million (c.£2.3 million) in order to allow existing shareholders of Scancell and new qualifying UK retail investors to participate in the Financing. The Retail Offer will be conducted via the Winterflood Retail Access Platform ("WRAP").

Separate announcements regarding the launch of (i) the UK Placing; and (ii) the launch of the Retail Offer, including their respective terms, will be made shortly.

Neither the UK Placing nor the Retail Offer are conditional on the US Listing Transactions and both will be completed within Scancell’s existing share capital authorities.

Panmure Liberum Limited is acting as sole placement agent for the UK Placing and as joint Corporate Broker to Scancell. WG Partners LLP is acting as joint Corporate Broker to Scancell.

4) Debt Financing

Scancell has signed a non-binding term sheet for secured interest-bearing debt facilities of up to $25 million (the "Debt Financing") to be provided by certain funds and accounts managed by BlackRock, to be drawn in four tranches through December 2027. A portion may convert into equity at the Placement Price. The lender would receive warrants pro rata to drawdowns, which are expected to represent a single digit percentage of borrowed amounts and to carry an exercise price equal to the Placement Price.

Subject to due diligence and binding agreement, Scancell expects to draw the first tranche of $7 million prior to completion of the US Listing Transactions. Scancell expects to have the ability to draw down a further tranche on or around completion of the US Listing Transactions and could draw down further tranches if additional conditions are met. Each tranche is expected to have an initial interest-only period, followed by repayments of the principal and interest.

The Debt Financing is subject to shareholder approval at the EGM.

A further announcement will be made upon finalisation of the Debt Financing, which is expected to be during Q3 2026.

5) Non-Voting Ordinary Shares

The Redmile Funds have agreed to the conversion of all of the outstanding CLNs issued by Scancell to the Redmile Funds into (at the Redmile Funds’ election) 15,986,515 restricted ADSs and/or a new class of non-voting ordinary shares in the capital of Scancell ("Non-Voting Ordinary Shares") representing 159,865,155 Ordinary Shares (subject to adjustment of the conversion price under the CLNs for the dilutive impact of the Financing and exclusive of any payment of accrued interest under the CLNs in shares), subject to passing of the requisite resolutions at the EGM and immediately following Completion ("CLN Conversion"). It is also proposed that, subject to passing of the requisite resolutions at the EGM, a number of the existing Ordinary Shares held by the Redmile Funds will be re-designated as Non-Voting Ordinary Shares (the "Redmile Funds Redesignation") such that, following Completion, the Redmile Funds will hold no more than 9.99 per cent. of the voting share capital of Scancell.2

The Non-Voting Ordinary Shares will rank pari passu with Scancell’s existing Ordinary Shares in all respects (including economic rights) save that they will carry no voting rights. The Non-Voting Ordinary Shares will not be admitted to trading on AIM.

Further details of the CLN Conversion, the Redmile Funds’ Redesignation and the Non-Voting Ordinary Shares will be included in the Circular.

6) Related Party Transactions

The Redmile Funds, which currently hold 28.6 per cent. of Scancell’s Ordinary Shares, have conditionally agreed to subscribe for 44,813,278 Non-Voting Ordinary Shares as part of the Private Placement. Upon the CLN Conversion and the Redmile Funds Redesignation described above, the Redmile Funds are expected to hold up to 147,777,048 Ordinary Shares representing 9.9 per cent. of the expected Completion Ordinary Share Capital and, together with the 354,089,750 Non-Voting Ordinary Shares, 27.1 per cent. in aggregate of the Completion Total Share Capital. The Transaction will not result in the Redmile Funds being interested in shares carrying 30 per cent. or more of the voting rights of Scancell.

Vulpes, which currently holds 13.8 per cent. of Scancell’s Ordinary Shares, has agreed to conditionally subscribe for 9,128,630 ADSs pursuant to the Private Placement at the Placement Price (representing 91,286,307 Ordinary Shares), such that upon Completion, Vulpes is expected to beneficially own 234,823,344 Ordinary Shares (including through ADSs) representing approximately 15.7 per cent. of the expected Completion Ordinary Share Capital and 12.7 per cent. of the Completion Total Share Capital.

Dr Phil L’Huillier has agreed to subscribe for 24,896 ADSs pursuant to the Private Placement at the Placement Price, such that upon completion of the Transaction, he is expected to hold 248,962 Ordinary Shares representing 0.02 per cent. of the expected Completion Ordinary Share Capital and 0.01 per cent. of the Completion Total Share Capital.

The Redmile Funds, Vulpes and Dr Phil L’Huillier are each related parties under Rule 13 of the AIM Rules (as substantial shareholders or, in Dr Phil L’Huillier’s case, as CEO of Scancell and as a participant in the Private Placement). The CLN Conversion, the Redmile Funds Redesignation and the related parties’ participation in the Private Placement together constitute the "Related Party Transactions".

Dr Jean-Michel Cosséry, Professor Lindy Durrant, Susan Clement Davies, and Dr Ursula Ney, being the Directors independent of the Related Party Transactions, having consulted with Scancell’s nominated adviser, Panmure Liberum, consider the terms of the Related Party Transactions to be fair and reasonable insofar as Scancell’s shareholders are concerned.

7) Shareholder Circular, Notice of EGM and Certain Other Information

Subject to announcement of the results of the UK Placing and the Retail Offer, application will be made to the London Stock Exchange for admission to trading on AIM of the UK Placing Shares and the Retail Offer Shares to trading on AIM with Admission expected to be on or around 28 July 2026.

Application is expected to be made at the time of Completion to the London Stock Exchange for the Consideration Shares and the Private Placement Ordinary Shares to be admitted to trading on AIM which is expected to occur in late Q4 2026. Further updates as to timing will be made in due course.

Scancell expects to publish the Circular in connection with the EGM in due course, a further announcement will be made at the time of publication.

Scancell also expects to file with the SEC a Registration Statement on Form F-4, which will include a proxy statement of Neuphoria that also constitutes a prospectus of Scancell under SEC filing rules.

The Merger constitutes a substantial transaction for Scancell for the purposes of Rule 12 of the AIM Rules. Accordingly, Scancell has disclosed certain information in relation to Schedule Four of the AIM Rules under the section "About Neuphoria" below.

Following Completion, it is anticipated that the Group will enter into a new service contract with a current director of Neuphoria, who will join the board of Scancell as a new non-executive director. The terms of this service contract are subject to completion of the requisite AIM due diligence and verification checks. A further announcement will be made regarding the appointment in due course.

(Press release, Scancell, JUL 23, 2026, View Source [SID1234669412])

20/20 BioLabs Announces Standstill Agreement with Streeterville Capital Regarding Series E Convertible Preferred Stock

On July 23, 2026 20/20 BioLabs, Inc. (Nasdaq: AIDX) (the "Company"), an early market entrant in AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, reported that it has entered into a standstill agreement (the "Agreement") with Streeterville Capital, LLC ("Streeterville") relating to the Company’s outstanding Series E Convertible Preferred Stock (the "Series E Preferred Stock"). The Agreement became effective on July 16, 2026.

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Under the terms of the Agreement, during the 120-day period beginning on the date of the Agreement, Streeterville has agreed not to convert any shares of Series E Preferred Stock into shares of the Company’s common stock unless, on a given trading day, the common stock trades at a price at least 10% above the "Minimum Price" (as defined under Nasdaq Rule 5635) (the "Standstill") provided that the Standstill shall terminate immediately upon the occurrence of any breach of the Agreement or any Event of Default (as defined in the Certificate of Designation for the Series E Preferred Stock). The Agreement temporarily limits potential dilution from conversions of the Series E Preferred Stock while preserving the existing rights and obligations of both parties under the related transaction documents.

Upon expiration or termination of the Standstill, Streeterville may resume converting shares of the Series E Preferred Stock in accordance with the terms of the applicable transaction documents. Except as expressly provided in the Agreement, the Series E Preferred Stock and all related transaction documents remain in full force and effect.

Additional information regarding the Agreement will be included in a Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission.

(Press release, 20/20 GeneSystems, JUL 23, 2026, View Source [SID1234669411])

HCW Biologics Reaches Milestones for Its Proprietary Tetravalent Second-Generation T-Cell Engager Program On Track To Initiate Clinical Trials in First Half 2027

On July 23, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics"), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases promoted by chronic inflammation, focusing on autoimmune disorders and other inflammatory diseases, cancer and senescence-associated dysplasia, reported that it has requested a Type B (pre-IND application) meeting with the U.S. 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.

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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.

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 antigen selection, limited efficacy in solid tumors, tolerability and safety concerns, and require a complex manufacturing process. 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 it may be able to overcome the limitations of earlier-generation TCEs.

Currently, the U.S. FDA and other regulatory agencies have approved eight TCEs to be used to treat 12 indications. Even with a very limited number of approved indications, approved TCEs generate multi-billion-dollar annual sales. The level of interest for this area from major pharmaceutical companies remains strong over many years, as indicated by the large number of high-value partnerships formed with innovative biotechnology companies developing second-generation TCEs. These partnerships have likely been driven by TCE’s potential in both oncology and autoimmune diseases.

Dr. Hing C. Wong, the Company’s Founder and CEO, stated, "We are pleased to have reached this important milestone in the development of HCW11-018b and look forward to discussing our proposed clinical trial designs, nonclinical testing programs, and CMC data with the FDA. HCW11-018b exhibits remarkable anti-tumor activities with high tolerability in animal models. We discovered that it can penetrate into the tumor microenvironment with potent and antigen-specific anti-pancreatic cancer activities."

Dr. Wong continued, "We believe we have established a robust, streamlined, and cost-efficient manufacturing process capable of producing high-quality cGMP material to support HCW11-018b in clinical development and potential future commercialization. Our manufacturing process is based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody needed for the affinity purification process. The monoclonal antibody is currently being manufactured under GMP standards using a top-tier CDMO."

About HCW11-018b:

HCW11-108b is designed to treat a wide spectrum of solid tumors with enhanced anti-tumor activities and tolerability. HCW Biologics has identified HCW11-018b as the lead candidate in its Tetravalent T-Cell Engager Program, known as the "Big BiTE." The unique structure of the Big BiTE combines a tumor-associated tissue factor-targeting BiTE with IL-15 immune stimulation, in addition to a TGF-β trap to address immunosuppression in the tumor microenvironment. HCW11-018b was created using the Company’s proprietary TRBC drug development platform, without using the Fc fusion technology commonly found in bi-specific or tri-specific fusion molecules. In extensive preclinical studies, HCW11-018b demonstrated that it induces robust, sustained, antigen-specific tumor killing, enhances CD8⁺ T-cell activation, survival, and effector functions and promotes tumor infiltration into solid tumors. Further, HCW11-018b demonstrated in preclinical studies that it does not trigger cytokine release syndrome, a major concern of using BiTEs, when used in its therapeutic dose range.

(Press release, HCW Biologics, JUL 23, 2026, View Source [SID1234669410])