On August 9, 2023 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 115.9 million in the second quarter of 2023 (Q2 2022: NOK 99.9 million), and an EBITDA of NOK 23.4 million (NOK 1.4 million) (Press release, PhotoCure, AUG 9, 2023, View Source;utm_medium=email_campaign&utm_campaign=newsletter [SID1234634003]). The Company reiterates its 2023 annual guidance of new Saphira blue light tower installations in the U.S. expected in the range of 65 to 75, anticipated consolidated product revenue growth above 20%, and positive EBITDA excluding business development spending.

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"In the second quarter of 2023, Hexvix/Cysview revenue increased 16% year over year driven by higher unit sales in the U.S., price increases and foreign exchange. We generated over NOK 23 million in EBITDA, including a positive contribution from our commercial business and a milestone payment from Asieris related to the clinical development of Cevira. During the second quarter, we delivered 4% sequential unit sales growth in North America and 6% in Europe, demonstrating continued positive traction in the region," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 144.3 million in the second quarter of 2023 (NOK 100.6 million), and an EBITDA* of NOK 23.4 million (NOK 1.4 million). Hexvix/Cysview revenues ended at NOK 115.9 million in the quarter (Q2 2022: NOK 99.9 million), and the total group revenues includes a milestone payment related to the development of Cevira by Asieris of NOK 26.9 million. The EBIT was NOK 16.8 million (NOK -4.6 million), and the cash balance at the end of the period was NOK 258.9 million. Photocure paid off the balance of its term debt during the second quarter of 2023.

At the end of the second quarter of 2023, the total installed base of rigid blue light cystoscopes (BLC) in the U.S. was 327, an increase of 21% or 56 towers since the same period in 2022. These figures do not include the 69 flexible cystoscopy towers that were installed in the U.S. as of December 31, 2022. In early 2023, Karl Storz announced that it will no longer sell flexible BLC equipment for use in the surveillance setting and will cease servicing existing units when the availability of replacement parts has been exhausted, anticipated in late 2023. Despite Karl Storz’ decision to discontinue its flexible BLC equipment, surveillance of bladder cancer patients with flexible BLC remains a strategic priority for Photocure, and the Company plans to pursue initiatives to restore this specialized equipment in the U.S. and in international markets.

"Offsetting the loss in flexible BLC equipment, the installed base of rigid blue light capital equipment expanded once again, with 13 new Saphira towers installed in Q2. Eight new placements and five upgrades were installed prior to Karl Storz’s recent promotional discount program which went into effect in July and shifted the timing of some tower installations into the third quarter. In July alone, 40 quotes were issued for new Saphira systems, and so far in Q3, 12 purchase orders have been received. We believe that this momentum will result in a strong second half of the year for new tower placements," Schneider adds.

Photocure reiterates its guidance for 2023 and continues to expect new Saphira blue light tower installations in the range of 65 to 75, consolidated product revenue growth above 20%, and positive EBITDA excluding business development spending.

"I remain confident in Photocure’s future and our ability to bring Hexvix/Cysview to more patients and establish Blue Light Cystoscopy as standard of care. The new technology cycle of high-definition blue light equipment from multiple manufacturers is expected to significantly increase the use of Hexvix/Cysview. We continue to await information from Karl Storz and the FDA regarding the Citizen’s Petition to re-classify BLC as a Class 2 device, which we believe will enable additional equipment manufacturers to enter the U.S. market and build critical mass behind BLC. Given our prior success in creating and accelerating the use of BLC in the large untapped bladder cancer surveillance market, we are pursuing a strategy to reintroduce the technology in the near to intermediate future. For the remainder of the year, we will focus on driving sales in the rigid cystoscopy setting, and we look forward to several milestone events including the anticipated Phase 3 results for Hexvix in China and Cevira with our partner Asieris," Schneider concludes.

Photocure also announced today that Jan H. Egberts, M.D. has decided to step down from his position as Chairperson of the Company’s Board of Directors due to increased time commitments to his personal companies. Dr. Egberts will leave the Board in September 2023, and the Nomination Committee has initiated a search for a new Chairperson.

Robert Blatt, Chair of Photocure’s Nomination Committee, said, "I would like to express my gratitude to Jan, who has made important contributions to Photocure during his more than six years as Chairperson of the Board. His dedication and medical experience will be missed".

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the second quarter and first half 2023 financial report on page 23.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20230809_1

The presentation is scheduled to conclude at 14:45 CEST.

On August 8, 2023 Bayer reported its Half-Year Financial Report 2023 (Presentation, Bayer, AUG 8, 2023, View Source [SID1234634657]).

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On August 08, 2023 ADC Therapeutics reported financial results for the second quarter 2023 and provided business updates (Press release, ADC Therapeutics, AUG 8, 2023, View Source [SID1234634577]).

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"We continue to focus on unlocking potential value from multiple ongoing initiatives over the next 12 months," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "During the second quarter, we executed on our corporate and capital allocation strategy that streamlined our processes and prioritized our nearer-term clinical catalysts. We implemented the new commercial go-to-market model, enhanced investment in key pipeline programs, delivered organizational efficiencies and strengthened our capital resources. Our ongoing clinical trials of ZYNLONTA in earlier lines and combinations, as well as our earlier-stage pipeline programs, are expected to deliver key milestones in 2024. We look forward to keeping you updated on our progress."

Recent Highlights and Developments

ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA generated net sales of $19.2 million in the second quarter of 2023, representing an 11% increase over the second quarter of 2022. The growth was partially offset by higher gross-to-net sales deductions due to the new Medicare Part B discarded drug policy effective January 1, 2023 and Group Purchasing Organization (GPO) contracting. Compared to the prior quarter, net sales increased 1.3% and volume increased 3.4%.
The Company’s partner Sobi completed the first European commercial sale of ZYNLONTA with the launch in Germany in the second quarter of 2023. The first commercial sale in the European Union triggered a $75 million milestone payment to the Company from HealthCare Royalty Partners under the royalty purchase agreement.
The Biologics License Application (BLA) for ZYNLONTA submitted by Overland ADCT BioPharma was accepted for filing by the China National Medical Products Administration (NMPA) seeking an indication for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The BLA has been granted priority review by the NMPA.
During the second quarter, the Company’s partner Mitsubishi Tanabe Pharma Corporation (MTPC) initiated the Phase 1/2 bridging study for ZYNLONTA in Japan.
The Company announced its plan to discontinue the Phase 2 LOTIS-9 trial studying ZYNLONTA in combination with rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trial for new patient enrollment but will allow patients already on therapy who are deriving clinical benefit to remain on therapy after being reconsented. Following completion of treatment of any reconsenting patients, the Company will conduct the necessary steps to terminate the trial.
The LOTIS-5 Independent Data Monitoring Committee (IDMC) reviewed unblinded data at a regularly scheduled meeting in late July and noted that the study should proceed as planned. They also recognized that the LOTIS-9 and LOTIS-5 trials target very different patient populations.
Pipeline

ADCT-601 (targeting AXL): Dose escalation is progressing in the Phase 1b trial, and the maximum tolerated dose has not yet been reached. The trial has been amended to focus on patients with non-small cell lung cancer (NSCLC) and patients with sarcoma. The immunohistochemistry (IHC) assay is under final validation.
ADCT-901 (targeting KAAG1): The Phase 1 study protocol amendment to explore different dosing schedules has been finalized and submitted to the FDA and will be submitted shortly to the regulatory authorities in Europe. Once approved by the Institutional Review Board (IRB), the Company plans to advance to the next dosing level. The IHC assay is under final validation.
ADCT-602 (targeting CD22): Dose expansion in the Phase 1 trial in collaboration with MD Anderson Cancer Center is progressing and additional clinical trial sites have been selected.
Guidance
The Company maintains the following guidance based on its current business plan:

ZYNLONTA FY 2023 net product sales expected to grow by a double-digit percentage year-over-year. This includes a gross-to-net increase as compared to 2022 of:
Approximately 2 to 3 percentage points related to Group Purchasing Organization (GPO) contracting
Mid to high single-digit percentage points resulting from the Infrastructure Investment and Jobs Act’s requirement for manufacturers of certain single-source drugs separately paid for under Medicare Part B and marketed in single-dose containers to provide annual refunds for discarded drug, effective January 1, 2023
Continued decrease in total operating expenses expected in 2023 and 2024 as compared to 2022 as a result of the implementation of the new corporate strategy
Expected cash runway to the middle of 2025
Upcoming Expected Milestones

ZYNLONTA

Grow ZYNLONTA net sales by a double-digit percentage year-over-year and achieve commercial brand profitability in 2023
Updated data from safety lead-in portion of Phase 3 LOTIS-5 study in 2H 2023
Complete enrollment of the LOTIS-5 study in 2024
Initial safety and efficacy data from the LOTIS-7 study in 2024
Pipeline

ADCT-901 (targeting KAAG1)

Initial data from Phase 1 study in 1H 2024
ADCT-601 (targeting AXL)

Initial data from Phase 1 study in 1H 2024
ADCT-602 (targeting CD22)

Additional data from Phase 1 study in 1H 2024
Second Quarter 2023 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $347.5 million as of June 30, 2023, compared to $326.4 million as of December 31, 2022. In June 2023, the Company received a $75.0 million milestone payment from Healthcare Royalty Partners, triggered by the first EU commercial sale. The Company expects its cash runway to extend into the middle of 2025.

Product Revenues

Net product revenues were $19.2 million for the quarter ended June 30, 2023, compared to $17.3 million for the same quarter in 2022. Net product revenues are for U.S. sales of ZYNLONTA. The increase of $1.9 million for the quarter was primarily due to higher sales volume, partially offset by higher gross-to-net deductions.

Research and Development (R&D) Expenses

R&D expenses were $31.9 million for the quarter ended June 30, 2023, compared to $48.5 million for the same quarter in 2022. R&D expenses decreased due to less investment in Cami (camidanlumab tesirine) due to the completion of the Phase 2 study in 2022 and the Company’s decision to seek a partner to progress the program, as well as less investment in other development programs. R&D expenses in the second quarter of 2023 also decreased due to lower share-based compensation expense as a result of fluctuations in the share price, voluntary terminations and the reduction in workforce implemented in May 2023 creating organizational efficiencies. These efficiencies allowed the Company to enhance investments in prioritized portfolio programs.

Selling and Marketing (S&M) Expenses

S&M expenses were $14.5 million for the quarter ended June 30, 2023, compared to $17.7 million for the same quarter in 2022. The decrease in S&M expenses for the quarter was primarily due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with voluntary terminations and the commercial realignment implemented in the second quarter.

General & Administrative Expenses

G&A expenses were $11.4 million for the quarter ended June 30, 2023, compared to $18.2 million for the same quarter in 2022. G&A expenses decreased during the second quarter of 2023 primarily due to lower share-based compensation expense due to fluctuations in the share price, transition of a board member, voluntary terminations and the workforce reduction implemented in May 2023.

Net Loss and Adjusted Net Loss

Net loss was $47.1 million, or a net loss of $0.58 per basic and diluted share, for the quarter ended June 30, 2023. This compares to a net loss of $64.4 million, or a net loss of $0.84 per basic and diluted share, for the same quarter in 2022.

Adjusted net loss was $30.3 million, or an adjusted net loss of $0.37 per basic and diluted share, for the quarter ended June 30, 2023. This compares to an adjusted net loss of $56.3 million, or an adjusted net loss of $0.73 per basic and diluted share, for the same quarter in 2022.

The decrease in net loss and adjusted net loss for the quarter ended June 30, 2023, as compared to the same quarter in 2022, was attributable to lower R&D expenses and higher product revenues during the second quarter of 2023. The decrease in net loss was also attributable to lower share-based compensation expense, partially offset by other financial expense arising from a cumulative catch-up adjustment associated with the valuation of the deferred royalty obligation with Healthcare Royalty Partners recognized in the second quarter of 2023 and from changes in the fair value of our convertible loan derivatives, which was recognized in the second quarter of 2022.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On August 8, 2023 Evotec (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that its partner STORM Therapeutics Ltd. ("STORM"), a clinical stage biotechnology company focused on discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, will be presenting the discovery of its lead clinical candidate, STC-15, at the American Chemical Society (ACS) Fall 2023 Conference (Press release, Evotec, AUG 8, 2023, View Source [SID1234634071]). STC-15, an orally bioavailable and highly selective METTL3 inhibitor, was co-designed and developed through a collaboration between STORM and Evotec.

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The presentation entitled "Discovery of STC-15, an orally bioavailable, highly selective METTL3 inhibitor for the treatment of AML and solid tumours: The first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development" will detail the company’s discovery efforts in optimising novel chemistries and the identification of STC-15 for evaluation in clinical studies.

The first-in-class clinical candidate was discovered with the support from Evotec’s fully integrated small molecule drug discovery and development platform including biomarker support enabling the rapid development of STC-15 from high-throughput screening to candidate nomination in less than three years. Evotec and STORM originally entered a strategic partnership in 2016 which was extended into an integrated drug discovery and development alliance in 2017, with the focus on new small molecule RNA epigenetic drugs for oncology and other diseases. Following the selection of STC-15 as a first-in-class development candidate in 2020, the seamless integration from project initiation to IND, using Evotec’s INDiGO platform, led to the entry of STC-15 into clinical development in 2022.

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: "We are delighted to have been partners in the successful discovery and development of STC-15. Our ongoing drug discovery collaboration with STORM, focused on the exploration of a novel class of RNA modulating enzymes, stands as a testament to the effectiveness of our joint efforts. By supporting STORM with our industry-leading drug discovery science and expertise, we are confident in our collective ability to pave the way for delivering high quality, innovative and transformative drug candidates to patients in need."

For further information, please follow this link to the press release from STORM.

On August 8, 2023 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, MAIA Biotechnology, AUG 8, 2023, View Source [SID1234634017]).

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"We recently reached an important milestone in the THIO-101 phase 2 trial, with our first patients dosed in the trial crossing the 1 year mark since starting therapy with THIO followed by an immune checkpoint inhibitor, without any additional cancer treatment. These positive preliminary results align well with our preclinical data and supported a faster pace of enrollment in the last quarter in Europe as we continue to activate more sites," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "In addition to THIO, we have 3 proprietary home-grown telomere-targeting molecules patented which further expands our options to treat several cancer indications. For the second half of the year, we look forward to continue evolving in the Part B randomized efficacy/dose selection of THIO-101."

Corporate Highlights

Reported second broad provisional patent application, nominating MAIA-2021-029 as the third new molecular candidate in MAIA’s Telomere-Targeting Molecule Program: MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell intrinsic telomerase activity and cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.

Announced updates in enrollment in THIO-101 Phase 2 clinical trial: As of July 2023, announced that 35 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO.

Reported positive updates on preliminary survival data for THIO-101: As of July 2023, the first 2 patients dosed with THIO continue to be alive for approximately 12.2 and 11.5 months respectively, from treatment initiation. They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.

Reported updates on disease control rates for THIO-101 Phase 2 trial for advanced Non-Small Cell Lung Cancer: As of July 2023, out of the first 11 patients with post-baseline scans, 82% (9 patients) met the disease control primary endpoint (defined as a complete response, partial response, or stable disease per RECIST 1.1) at first response assessment. In similar heavily treated NSCLC patients, typical disease control rates (DCR) are in the 25-35% range. All patients enrolled had previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC. No new safety analysis was conducted at the time.

Second Quarter 2023 Financial Results

Cash Position: The Company had cash totaling approximately $9.1 million as of June 30, 2023, compared to $8.2 million in cash as of June 30, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended June 30, 2023, compared to approximately $2.1 million for quarter ended June 30, 2022. The increase was primarily related to an increase in scientific research expenses of approximately $0.44 million, an increase in payroll and bonus expenses of approximately $0.20 million related to the increased headcount of additional research and development employees, an increase in stock-based compensation costs of approximately $0.06 million and an increase of approximately $0.03 million in other expenses offset by a decrease in Clinical and Scientific research expenses of approximately $0.21 million due to less THIO-101 trial start-up fees, and a decrease in consulting of approximately $0.04 million.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.0 million for the quarter ended June 30, 2023, compared to approximately $1.3 million for the quarter ended June 30, 2022. The increase for the quarter was primarily due to an increase in other expenses of approximately $0.73 million related to the costs of operating as a public company, and an increase in payroll expense of approximately $0.13 million, offset by a decrease in stock-based compensation of approximately $0.02 million and professional fees of approximately $0.09 million.

Other Income (Expense): Other income was approximately $0.14 million for the quarter ended June 30, 2023, and other income for the quarter ended June 30, 2022 was approximately $0.14 million. The quarterly activity included a gain from the change in the fair value of the warrant liability of approximately $0.10 million offset by a reduction in the Australia research and development incentives of approximately $0.10 million and an increase in interest expense of approximately $0.002 million.

Net Income (Loss): Net loss was approximately $4.5 million for the quarter ended June 30, 2023, as compared to net loss of approximately $3.3 million for the quarter ended June 30, 2022.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in sequential combination an anti-PD1 therapy, allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.