Theralase(R) Completes Enrollment in Bladder Cancer Clinical Study

On February 2, 2026 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that it has successfully completed its targeted milestone of enrolling and treating 90 patients in a multi-center Phase II clinical study for bladder cancer.

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The Phase II clinical study has a primary endpoint of efficacy, a secondary endpoint of duration of response and a tertiary endpoint of safety, in evaluating light-activated Ruvidar in the treatment of patients diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) ("Study II").

The enrollment and treatment of 90 patients achieves the Company’s statistical analysis plan and represents a significant step forward in evaluating a statistically and clinically significant dataset in support of a Health Canada and FDA regulatory approval. In accordance with the clinical protocol, Theralase will enroll and treat any additional patients, who are in or pending screening.

Pending Health Canada and FDA regulatory approval, light-activated Ruvidar represents a potentially transformative, bladder-sparing treatment option for patients with limited alternatives, addressing a significant unmet need in high-risk NMIBC.

Clinical data generated to date continues to demonstrate a strong efficacy, duration of response and favorable safety profile, with a majority of patients achieving durable responses with a single treatment.

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase, stated, "I am pleased that Theralase has completed enrollment of 90 patients in its Phase II registrational clinical study for bladder cancer. This accomplishment allows the Company to complete this study in 2026 and prepare for Health Canada and FDA regulatory approval submissions."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase, added,
"Enrolling and treating 90 patients in our Phase II registration clinical study represents a significant milestone for the Company. With the targeted enrollment now completed, we can focus on compilation of the clinical data for Health Canada and FDA regulatory approval. 2026 will be a pivotal year for the Company as we complete our bladder cancer study, embark on a combinational clinical study for bladder cancer and launch numerous Phase I/II adaptive clinical studies for brain, lung, muscle invasive bladder, pancreatic and colorectal cancers."

About Study II:
Study II utilizes the therapeutic dose of the small molecule Ruvidar, which has been light-activated by the TLC-3200 Medical Laser System. Study II will enroll and treat 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.

About NMIBC
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.1 In the United States, bladder cancer is the sixth most common cancer,2 fourth among men,3 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.3 Historically, 75% of bladder cancer presents as NMIBC.4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.5 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).6

About Ruvidar:
Ruvidar is a small molecule activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of cancer, bacteria and viruses.

(Press release, Theralase, FEB 2, 2026, View Source [SID1234662400])

Twist Bioscience Reports Fiscal First Quarter 2026 Financial Results

On February 2, 2026 Twist Bioscience Corporation (NASDAQ: TWST), a mid-cap growth and value biotech company, reported financial results and business highlights for the first quarter ended December 31, 2025.

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"We’re continuing to build on the momentum we established in fiscal 2025, starting the new fiscal year with our twelfth consecutive quarter of growth. Revenue of $103.7 million exceeded guidance and increased 17% compared to the first quarter of 2025," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "As we continue through the year and beyond, we remain focused on driving toward profitability with consistent revenue growth, gross margins above 50% and disciplined spending to invest in scalable, sustainable growth opportunities while serving more customers, launching more products and expanding our addressable markets."

See "Non-GAAP Information" below for a discussion of the measure adjusted EBITDA.

FISCAL 2026 FIRST QUARTER FINANCIAL RESULTS

•Revenue: Total revenues for the first quarter of fiscal 2026 grew 17% to $103.7 million compared to $88.7 million for the same period of fiscal 2025.
◦DNA Synthesis and Protein Solutions revenue grew 27% to $51.1 million for the first quarter of fiscal 2026 compared to $40.1 million for the same period of fiscal 2025.
◦NGS Applications revenue grew 8% to $52.6 million for the first quarter of fiscal 2026 compared to $48.6 million for the same period of fiscal 2025. Excluding one large customer transitioning an assay from research to commercial, NGS Applications grew 18%.
•Cost of Revenues: Cost of revenues for the first quarter of fiscal 2026 increased to $49.7 million compared to $45.9 million for the same period of fiscal 2025.
•Gross Margin: Gross margin for the first quarter of fiscal 2026 increased to 52.0% compared to 48.3% for the same period of fiscal 2025.

•Research and Development Expenses: Research and development expenses for the first quarter of fiscal 2026 decreased to $17.1 million compared to $21.3 million for the same period of fiscal 2025.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of fiscal 2026 were $69.7 million compared to $56.2 million for the same period of fiscal 2025.
•Net Loss: Net loss for the first quarter of fiscal 2026 decreased to $30.5 million, or $0.50 per share, compared to $31.6 million, or $0.53 per share, for the same period of fiscal 2025.
•Adjusted EBITDA: Adjusted EBITDA for the first quarter of fiscal 2026 was $(13.4) million compared to $(16.3) million for the same period of fiscal 2025. See the table included in this release for a reconciliation between our adjusted EBITDA and net loss attributable to common stockholders, the most directly comparable GAAP financial measure.
•Cash Position: As of December 31, 2025, the company had approximately $198 million in cash, cash equivalents and short-term investments.

Recent Highlights:

•Shipped products to approximately 2,538 customers in the first quarter of fiscal 2026, versus approximately 2,376 in the same period of fiscal 2025.
•Physically shipped approximately 271,000 genes in the first quarter of fiscal 2026, compared with approximately 205,000 in the same period of fiscal 2025; additional >50,000 genes manufactured for data characterization
•Launched research-grade Plasmid DNA Preps designed to support the advancement of pharmaceutical and biotech customers’ pre-clinical studies.

Fiscal 2026 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2026. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2026, Twist expects:

•Total revenue in the range of $435 million to $440 million, growth of 16% at the midpoint, compared to prior guidance of $425 to $435 million. We expect the revenue increase versus prior guidance to be generally balanced across DSPS and NGS
•Gross margin to be above 52% for fiscal 2026

For the second quarter, Twist expects:

•Total revenue of approximately $107 million to $108 million, growth of approximately 16% percent year over year at the midpoint, with sequential growth driven by key NGS accounts

For the fourth quarter, Twist expects:

•To achieve adjusted EBITDA breakeven for the fourth quarter of fiscal 2026

Non-GAAP Information

This release includes EBITDA and adjusted EBITDA, which are non-GAAP financial measures, for the periods presented. EBITDA is defined as net loss adjusted to exclude interest income, income tax expense and depreciation and amortization. Adjusted EBITDA is defined as net loss adjusted to exclude interest income, income tax expense, depreciation and amortization, other income/expense, net, and stock-based compensation expense. These non-GAAP measures are not in accordance with, or an alternative for, measures prepared in accordance with generally accepted accounting principles (GAAP) and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. We believe that these non-GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. However, non-GAAP information is not superior to financial measures calculated in accordance with GAAP, is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. A reconciliation table of the most comparable GAAP financial measure to the non-GAAP financial measures is included at the end of this press release.

A reconciliation of adjusted EBITDA for the fourth quarter of fiscal 2026 to a corresponding GAAP financial guidance measure is not available on a forward-looking basis because the Company does not provide guidance on GAAP net loss and is not able to present the various reconciling cash and non-cash items between GAAP net loss and adjusted EBITDA without unreasonable effort. In particular, stock-based compensation expense is impacted by the Company’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which is difficult to predict and is subject to change. The actual amount of these expenses during the fourth quarter of fiscal 2026 will have a significant impact on Twist’s future GAAP financial results.

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 8:00 a.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The conference call will be webcast live through the Investor Relations section under the "Company" tab at www.twistbioscience.com. Those parties interested in participating via telephone must register on the Company’s Investor Relations website or by clicking here. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that can be used to access the call. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The webcast replay will be available for two weeks.

(Press release, Twist Bioscience, FEB 2, 2026, View Source [SID1234662401])

vTv Therapeutics Amends License Agreement with Newsoara Biopharma Co. Ltd. for PDE4 inhibitor, HPP737

On February 2, 2026 vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development of cadisegliatin, a novel, potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes ("T1D"), reported that it has expanded its license agreement with Newsoara Biopharma Co. Ltd. ("Newsoara") to provide Newsoara with global rights to the Company’s PDE4 inhibitor, HPP737. Pursuant to the amended license agreement, Newsoara has obtained an exclusive, worldwide license to develop and commercialize Company’s PDE4 inhibitor, HPP737, in exchange for an upfront payment and potential future milestone payments and royalties on net sales.

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"We are pleased to expand our license with Newsoara to allow the further development and commercialization of HPP737 globally. The amendment strengthens our balance sheet with the upfront payment of $20 million and underscores the intrinsic value of our deep pipeline of differentiated therapeutic assets," said Paul Sekhri, Chairman, President and CEO of vTv Therapeutics. "As we continue to advance cadisegliatin in our ongoing Phase 3 CATT1 trial, our wholly owned pipeline provides shareholders with another significant source of potential value creation. We remain opportunistic in exploring potential collaborations for advancing these exciting drug candidates."

In addition to the upfront payment of $20 million, the amended license with Newsoara includes future development milestones of up to approximately $50 million, future sales milestones of up to $65 million, and tiered royalties based on sales.

"Over the last several years, vTv and Newsoara have enjoyed a productive and collaborative relationship, and this exciting expansion of the relationship will help accelerate the clinical development of our highly differentiated and potential best-in-class PDE4 inhibitor, HPP737," said Rich Nelson, Executive Vice President, Chief Business Officer of vTv Therapeutics. "Alliance management is a major strategic priority for vTv, and our strong relationship with Newsoara demonstrates this commitment and our mutual desire to advance new and innovative therapies for inflammation-mediated disease."

"We are pleased to expand our collaboration with vTv and secure global rights to HPP737, a highly differentiated oral PDE4 inhibitor with the potential to address unmet needs in inflammation-mediated disease," said Dr. Benny Li, Chief Executive Officer of Newsoara. "With this expanded license, we plan to leverage our development and commercialization capabilities to advance HPP737’s progress and, if approved, bring it to patients worldwide."

HPP737, a selective phosphodiesterase type 4 (PDE4) inhibitor, has shown therapeutic activity in several animal models of inflammation. In phase 1 studies, HPP737 was well tolerated with little or no gastrointestinal distress. Preclinical and clinical data suggest that HPP737 may be able to expand the therapeutic use for this target, which has been limited by the side-effects of currently available PDE4 inhibitors.

About HPP737

HPP737 is a novel, potent, and selective phosphodiesterase type 4 (PDE4) inhibitor in development for the treatment of psoriasis. HPP737 has shown potent inhibition of interleukin-23 (IL-23) and tumor necrosis factor alpha (TNF-α) production in vitro and in vivo, as well as therapeutic activity in several animal models of inflammation. In addition, HPP737 showed target engagement ex vivo. PDE4 inhibitors increase intracellular cyclic adenosine monophosphate (AMP) levels, resulting in broad anti-inflammatory effects. However, the therapeutic potential of PDE4 inhibitors has historically been limited by dose-limiting adverse events, including nausea and emesis. Preclinical and clinical data to date suggest HPP737 may avoid some of the gastrointestinal side effects (e.g., nausea, vomiting, diarrhea) commonly associated with other PDE4 inhibitors.

About Cadisegliatin

Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase activator being investigated in the US as a potential first-in-class oral adjunctive treatment for type 1 diabetes (T1D). In non-clinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).

Cadisegliatin is under investigation, and the safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.

(Press release, vTv Therapeutics, FEB 2, 2026, View Source [SID1234662403])

Cycle Pharmaceuticals Announces Extension of Applied Therapeutics Tender Offer

On January 30, 2026 Cycle Group Holdings Limited ("Cycle" or "Parent") reported that AT2B, Inc., a Delaware corporation ("Purchaser") and indirect wholly owned subsidiary of Cycle, has extended the expiration date of its tender offer to purchase all of the outstanding shares of common stock, par value $0.0001 per share of Applied Therapeutics, Inc., a Delaware corporation ("Applied") for (i) $0.088 per share, net to the seller in cash, without interest, plus (ii) one non-tradeable contingent value right per share.

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The offer, which was previously scheduled to expire at one minute following 11:59 p.m., Eastern time, on January 29, 2026 is extended until one minute following 11:59 p.m., Eastern time, on February 2, 2026.

Equiniti Trust Company, LLC, the depositary for the offer, has advised Cycle that, as of 11:59 p.m., Eastern time, on January 29, 2026, approximately 75,895,437 shares (which include 2,429,370 shares subject to guaranteed delivery) have been validly tendered and not properly withdrawn pursuant to the offer, representing approximately 49.21% of the outstanding shares of Applied. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to this extension.

The offer is being made pursuant to the terms and conditions described in the offer to purchase, filed on December 29, 2025 (together with any amendments and supplements hereto), copies of which are attached to the tender offer statement on Schedule TO filed by Cycle and Purchaser with the US Securities and Exchange Commission, as amended.

The offer is conditioned upon the fulfilment of certain conditions described in Section 15—"Conditions to the Offer" of the offer to purchase, including, but not limited to, the tender of a majority of the then-outstanding shares of Applied’s common stock.

MacKenzie Partners, Inc. is acting as information agent for the offer. Requests for documents and questions regarding the offer may be directed to MacKenzie Partners, Inc by telephone, toll-free at 1-800-322-288. Bankers and Brokers may call at 212-929-5500.

(Press release, Cycle Pharmaceuticals, JAN 30, 2026, View Source [SID1234662375])

Adicet Bio to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026

On January 30, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 being held from February 11-12, 2026 in New York.

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Details of the event are as follows:
Date: Thursday, February 12, 2026
Time: 2:00p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

(Press release, Adicet Bio, JAN 30, 2026, View Source [SID1234662376])