On August 13, 2025 Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, a rapid and painless testing platform for cervical cancer detection based on its patented biophotonic technology, reported that it had enrolled enough patients to begin closing out the study and starting data analysis (Press release, Guided Therapeutics, AUG 13, 2025, View Source [SID1234655224]). Data analysis will consist of completing the ongoing external review of all biopsy samples, reviewing and entering data from the study case report forms and performing the statistical analysis pursuant to the study protocol. All four participating clinics have reached their minimum specified quotas resulting in a total of approximately 430 patients enrolled. Part of the pathology analysis is intended to determine the number of patients with and without disease to ensure a representative mix of disease types. Once this part of the analysis has been completed, all clinical sites will be closed out from enrolling additional patients and the clinical report will be filed with the FDA, expected later this year. Additionally, there have been no adverse events linked to the use of the LuViva device, further supporting FDA’s designation of LuViva as a non-significant risk device.

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"We want to thank all of physicians and staff at the clinical sites who made this study possible," said Mark Faupel, CEO of Guided Therapeutics. "As we move from the testing phase to the analysis phase of the study, we have met the Company’s primary 2025 objective. We are optimistic that we have conducted a successful study and look forward to the results of the statistical analyses."

On August 13, 2025 LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA," or the "Company"), a clinical-stage immuno-oncology company historically focused on its proprietary Gammabody bispecific gamma delta T cell engagers, reported financial results for the second quarter ended June 30, 2025 and provided a corporate update (Press release, Lava Therapeutics, AUG 13, 2025, View Source [SID1234655305]).

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"We are pleased to announce that LAVA has recently entered into a definitive agreement to be acquired by XOMA Royalty Corporation," said Steve Hurly, Chief Executive Officer of LAVA. "This deal is the outcome of a comprehensive and diligent strategic review process by management and our Board of Directors, conducted under the guidance of our legal and financial advisors, with the objective of maximizing value for our shareholders while supporting the sustained success of LAVA’s business. Our Board of Directors has unanimously determined that the deal is in the best interests of all of our shareholders and has approved the proposed acquisition."

Entry into Share Purchase Agreement; Tender Offer

On August 4, 2025, the Company announced that it has entered a definitive share purchase agreement (the "Purchase Agreement" and the transactions set forth in the Purchase Agreement, the "Transactions") with XOMA Royalty Corporation ("XOMA"), whereby XOMA will acquire all of the issued and outstanding common shares of the Company through a cash tender offer for (i) between $1.16 and $1.24 per share in cash, consisting of (A) $1.16 per share, plus (B) an additional amount of up to $0.08 per share, plus (ii) a non-transferable contingent value right per share representing the right to receive potential contingent cash payments following the closing related to the Company’s two partnered assets as well as its unpartnered programs. Pursuant and subject to the terms of the Purchase Agreement, XOMA will commence a tender offer by August 15, 2025 to acquire all of the Company’s outstanding common shares. The closing of the Transactions is subject to customary closing conditions and is expected to close in the fourth quarter of 2025.

Discontinued LAVA-1266 Program

On August 4, 2025, the Company announced its plans to discontinue its Phase 1 clinical trial of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome, and initiate the wind-down of the LAVA-1266 program.

Updates Regarding Partnered Programs

Johnson & Johnson (J&J) Partnered Program (JNJ-89853413) – Phase 1 Trial (NCT06618001)

Designed to target CD33 and gamma delta T cells with a bispecific gamma delta T cell engager

· Key Indications: relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS)

· Current Status: J&J is enrolling patients in a Phase 1, open label, multi-center trial, currently underway in Canada and Spain. The trial includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with R/R AML or R/R higher risk type of MDS

Pfizer Partnered Program (PF08046052) – Phase 1 Trial (NCT05983133)

Potential first-in-class epidermal growth factor receptor (EGFR) and bispecific gamma delta T cell receptor-targeted therapy

· Key Indications: advanced solid tumors

· Current Status: Pfizer is enrolling patients in a Phase 1 open label, multi-center trial, currently underway in the US and UK. The trial is intended to evaluate PF08046052 in approximately 290 subjects

Second Quarter 2025 Financial Results

· As of June 30, 2025, LAVA had cash, cash equivalents, and short-term investments of $56.2 million, compared to cash, cash equivalents, and short-term investments of $76.6 million as of December 31, 2024.

· Revenue from contracts with customers was zero for the quarters ended June 30, 2025 and 2024, respectively, and zero and $7.0 million for the six months ended June 30, 2025 and 2024, respectively. Revenue of $7.0 million received in the six months ended June 30, 2024 was comprised of a $7.0 million payment from Pfizer related to the achievement of a clinical milestone.

· Research and development expenses were $4.7 million and $6.0 million for the quarters ended June 30, 2025 and 2024, respectively, and $8.9 million and $11.6 million for the six months ended June 30, 2025 and 2024, respectively. The decrease in both periods was primarily due to a reduction in headcount related to restructuring activities and resulting decrease in research and development activity, with lower preclinical and clinical expenses due to the discontinuation of the LAVA-1207 program and a reduction in the estimated remaining clinical trial activities, partially offset by activities for LAVA-1266 occurring in the quarter ended June 30, 2025.

· General and administrative expenses were $2.6 million and $3.4 million for each of the quarters ended June 30, 2025 and 2024, respectively and $6.0 million and $6.8 million for the six months ended June 30, 2025 and 2024, respectively. The decrease reflected in both periods was due to lower headcount and an overall streamlining of administrative and operating costs related to the Company’s restructuring activities, partially offset by increased professional and consultant fees related to the Company’s transition to US GAAP reporting as well as increased severance payments related to the Company’s restructuring action in February 2025.

· Other income (expense), net was a $1.3 million other expense, net and $1.2 million other income, net for the quarters ended June 30, 2025 and 2024, respectively, with other income, net of $3.1 million and $2.7 million for the six months ended June 30, 2025 and 2024, respectively. For the three months ended June 30, 2025 and 2024, the decrease is primarily due to foreign exchange loss, due to fluctuations in the US dollar currency rate compared to the Euro, as well as lower interest rates for cash held in money market accounts, partially offset by lower interest expense incurred as the Company’s outstanding innovation credit from Rijksdienst voor Ondernemend Nederland (RVO) was forgiven in March 2025. Forgiveness of the RVO credit balance also increased other income, net for the six months ended June 30, 2025.

· Net loss was $8.6 million and $8.3 million for the quarters ended June 30, 2025 and 2024, respectively, or $0.32 and $0.31 net loss per share, respectively, and $12.1 million and $8.9 million, or $0.45 or $0.33 net loss per share, for the six months ended June 30, 2025 and 2024, respectively.

On August 12, 2025 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy (Press release, Merck & Co, AUG 12, 2025, View Source [SID1234655107]). In this study, KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to surgery (radical cystectomy) alone.

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"Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen any treatment advance beyond surgery and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed," said Dr. Christof Vulsteke, MD, PhD, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. "The KEYNOTE-905 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet need."

The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer (previously Seagen) and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer. The trial is continuing to evaluate the secondary EFS, OS, and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature.

"There is a real and pressing need for more effective options for patients with bladder cancer who are ineligible for cisplatin-based treatment," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "The compelling survival results observed in this study reinforce the potential of combining KEYTRUDA with an antibody-drug conjugate to help address a significant unmet need in this vulnerable population."

The safety profile of KEYTRUDA plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide and will present the data at an upcoming medical meeting.

KEYTRUDA plus Padcev is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA as monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

Five additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Three of these studies are in MIBC including KEYNOTE-866 (NCT03924856), KEYNOTE-992 (NCT04241185) and KEYNOTE-B15 (NCT04700124), which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas. KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 (NCT03711032) trial, and as adjuvant treatment in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma KEYNOTE-123 (NCT03244384).

About KEYNOTE-905/EV-303

KEYNOTE-905, also known as EV-303, is an open-label, randomized, multi-arm, controlled, Phase 3 trial (ClinicalTrials.gov, NCT03924895) evaluating perioperative KEYTRUDA, with or without Padcev, versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. The trial enrolled 595 patients who were randomized to receive either:

Arm A: Three cycles of preoperative KEYTRUDA, followed by surgery to remove the bladder (radical cystectomy), followed by 14 cycles of postoperative KEYTRUDA;
Arm B: Surgery alone;
Arm C: Three cycles of preoperative KEYTRUDA plus enfortumab vedotin, followed by surgery to remove the bladder (radical cystectomy), followed postoperatively by six cycles of KEYTRUDA plus enfortumab vedotin and then eight cycles of KEYTRUDA alone.
The primary objective of this trial was to compare EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. The key secondary objectives were to compare OS and difference in pCR rate between arm C and arm B, as well as EFS, OS and the difference in pCR rate between arm A and arm B. The study remains ongoing to test hypotheses between arm A and arm B.

About bladder cancer

Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases. The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

On August 12, 2025 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the second quarter of 2025 and provided an update on recent company developments (Press release, Inovio, AUG 12, 2025, View Source [SID1234655145]).

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"With device DV testing complete, we remain on track to submit our BLA for INO-3107 in the second half of this year, with the goal of having FDA acceptance of the file by year end. Utilizing our breakthrough therapy designation, we’ve requested rolling submission and expect to be able to immediately provide the clinical and non-clinical modules for review, while we complete work on the device-related sections and update our Investigational New Drug (IND) Application for our confirmatory trial," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease. I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INOVIO completed the DV testing for the CELLECTRA 5PSP device and requested in July 2025 that the FDA allow it to begin submitting its BLA on a rolling basis based on the Breakthrough Therapy designation previously granted to INO-3107. INOVIO anticipates completing its submission over the next several months and requesting a priority review. FDA inspection of INOVIO as clinical sponsor of the Phase 1/2 trial was successfully completed. The company is working on the device-related sections for its BLA and updating its active IND so it can begin enrolling patients into its placebo-controlled, randomized confirmatory trial, which will include 100 patients and be conducted at approximately 20 sites across the United States.

Data from a retrospective study (RRP-002) investigating the long-term clinical efficacy of patients treated with INO-3107 have been published in a peer-reviewed journal, The Laryngoscope. The data demonstrate that INO-3107 provided significant clinical benefit to RRP patients, as measured by reduction in surgery, that continued to improve in years two and three following initial treatment. Highlights from the paper include:

Patients experiencing a 50-100% reduction in surgeries (Overall Response Rate) increased from 72% at the end of the initial 12-month Phase 1/2 trial (Year 1) to 86% at the end of the second 12-month period (Year 2)
Patients experiencing a Complete Response (CR – 0 surgeries per year) increased from 28% for Year 1 to 50% for Year 2
Mean number of surgeries was reduced from 4.1 in the pre-treatment period (the 52 weeks prior to beginning treatment with INO-3107) to 1.7 for Year 1 to 0.9 for Year 2
Partial data into the third 12-month period (Year 3 – median follow up 2.8 years following initial treatment) continued the trend of improvement and a reduced number of surgeries
INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns identified
Next Generation DNA Medicine Candidates
INOVIO presented data on its next generation DNA medicine technology at the Orphan Drug Summit in July. Data included key insights from an ongoing Phase 1 proof-of-concept trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19 (preprint of manuscript available on Research Square) as well as an overview of DNA-encoded protein technology (DPROT) that targets long-term protein expression and aims to address some of the shortcomings of conventional therapeutic protein replacement treatments.

Upcoming Presentations
INOVIO will present data on INO-3107 and other promising DNA medicine candidates at the following upcoming events:

American Academy of Otolaryngology – October 10-13
World Vaccine Congress Europe – October 13-16
European Society for Medical Oncology – October 17-21
37th International Papillomavirus Society Conference – October 23-26
World Orphan Drug Congress – October 27-29
ISV Congress – October 28-30
General Corporate
INOVIO remains focused on financial discipline and directing resources to support the INO-3107 program. The company strengthened its balance sheet with an underwritten public offering of common stock and warrants in July 2025. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $22.5 million.

Second Quarter 2025 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2025, decreased to $14.5 million from $23.1 million for the same period in 2024. The decrease was primarily the result of lower drug manufacturing, clinical study and other expenses related to INO-3107, and lower contract labor, among other variances.
General and Administrative (G&A) Expenses: G&A expenses decreased to $8.6 million for the three months ended June 30, 2025, from $10.2 million for the same period in 2024. The decrease was primarily related to a decrease in employee and consultant stock-based compensation, lower outside services and lower contract labor, among other variances.
Total Operating Expenses: Total operating expenses decreased to $23.1 million for the three months ended June 30, 2025, from $33.3 million for the same period in 2024.
Net Loss: Net loss for the three months ended June 30, 2025, decreased to $23.5 million, or $0.61 per basic and diluted share, from a net loss of $32.2 million, or $1.19 per basic and diluted share, for the three months ended June 30, 2024.
Shares Outstanding: As of June 30, 2025, INOVIO had 36.7 million common shares outstanding and 51.7 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, including pre-funded warrants and stock options, restricted stock units and convertible preferred stock.
Cash, Cash Equivalents and Short-term Investments: As of June 30, 2025, cash, cash equivalents and short-term investments were $47.5 million (excluding net proceeds from the July 2025 offering of $22.5 million), compared to $94.1 million as of December 31, 2024.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended June 30, 2025, which can be accessed at: View Source

Cash Guidance

INOVIO estimates its current cash, cash equivalents and short-term investments balances, including the net proceeds from the July 2025 offering, will support the company’s operations into the second quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the third quarter of 2025. These projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On August 12, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through artificial intelligence (AI)-powered drug discovery and NanoPalm Ltd., a Saudi-based biotechnology company pioneering advanced patterned lipid nanoparticle (pLNP) delivery systems, reported the signing of a non-binding Letter of Intent (LOI) (Press release, Rakovina Therapeutics, AUG 12, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-and-nanopalm-ltd-sign-letter-of-intent-to-form-joint-venture-leveraging-al-discovered-oncology-therapies-and-novel-lipid-nanoparticle-delivery-technologies [SID1234655206]). The LOI outlines the intention to form a joint venture to co-develop novel small-molecule oncology therapeutics, beginning with loading Rakovina’s dual-function PARP-HDAC inhibitor, kt3283, into Nano Palm’s pLNP technology.

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The collaboration brings together two novel platforms: Rakovina’s proprietary Al-enabled drug discovery engine, powered by an exclusive license to the proprietary Deep Docking platform, is capable of rapidly screening billions of molecules against validated cancer targets and predicting drug-like characteristics in silico, and NanoPalm’s next-generation self-targeting pLNP delivery system, Al-designed to enhance the precision and efficacy of therapeutic delivery. Promising candidates discovered through Rakovina’s platform and formulated with Nanopalm’s pLNP technology will be validated through Rakovina’s in-house pharmacology, toxicology, and in vivo models, creating a seamless path from in silico modeling to formulation to preclinical proof of concept.

kt-3283, the initial development candidate under the proposed joint venture, is a potent small-molecule inhibitor that simultaneously targets PARP and HDAC – two critical cancer survival pathways. Preclinical studies have demonstrated that kt-3283 induces DNA damage, disrupts cell-cycle progression, and produces enhanced cytotoxicity compared to currently approved PARP and HDAC inhibitors. The compound has shown particularly strong activity in Ewing sarcoma, breast, and ovarian cancer models, with data presented at major oncology conferences and published in a peer-reviewed journal.

NanoPalm’s pLNP technology, originally developed for gene therapy, uses Al-assisted formulation design and tunable shape & surface characteristics to improve tissue specificity, intracellular delivery, and systemic tolerability. This collaboration represents an initial oncology application of NanoPalm’s proprietary platform to small-molecule therapeutics, offering the potential to significantly enhance kt-3283’s therapeutic index and tumor-specific delivery. NanoPalm’s pLNP platform has been validated in multiple preclinical gene therapy programs, demonstrating superior delivery precision and biodistribution compared to conventional LNPs.

NanoPalm’s technology is differentiated by its Al-assisted design and modular architecture, enabling tunable surface properties and selective cellular uptake. Originally developed for gene therapy applications, this collaboration represents NanoPalm’s strategic entry into the oncology field.

"This collaboration brings together complementary expertise in drug discovery and delivery technologies," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "kt-3283 represents the first of what we believe could be multiple novel therapeutics that emerge from this alliance, offering a robust pipeline for development and future commercialization."

"We are excited to partner with Rakovina Therapeutics to bring our precision pLNP delivery technology into oncology for the first time," said Dr. Ali Alhasan, Founder and CEO of NanoPalm. "Our platform is uniquely suited to improve the delivery profile of small-molecule therapies, and the synergy with Rakovina’s innovative discovery capabilities creates an opportunity for the potential joint venture to pursue worldwide development and commercialization opportunities within Saudi Arabia as its operational hub to develop transformative treatments for patients with cancer. This aligns with the Kingdom’s National Biotechnology Strategy, leveraging the local fertile ground for innovating and accelerating local biotech development."

Once finalized, the joint venture will initially focus on advancing kt-3283 through late preclinical development and early clinical studies while evaluating additional Al-derived drug candidates for inclusion in the development pipeline. The partners also plan to explore global licensing and strategic commercialization opportunities as the pipeline matures.

Defined Responsibilities and Global Scope

Under the proposed joint venture:

Rakovina will contribute kt-3283 drug substance and additional select Al-discovered small-molecule drug candidates, along with supporting in vitro and in vivo validation, pharmacology, toxicology, CMC data, and regulatory expertise.
NanoPalm will contribute its proprietary pLNP platform, biomanufacturing capabilities, delivery science expertise, and preclinical and clinical support infrastructure in Saudi Arabia.
Joint development activities will be coordinated under a mutually agreed governance structure, with initial preclinical validation conducted in Rakovina’s research facilities at the University of British Columbia and manufacturing and biodistribution studies conducted by NanoPalm in Saudi Arabia.
The partners will co-fund the joint venture, pursue third-party investment and non-dilutive grant opportunities, and share equally in ownership, risk, and upside.
Global Reach and Strategic Alignment

The joint venture will be domiciled in Saudi Arabia, with a worldwide development and commercialization mandate. This JV will be the first pLNP-oncology-focused biotech co-founded in Saudi Arabia integrating locally developed nanomedicine with global drug discovery platforms. Development activities will be aligned with international regulatory standards, including those of the FDA, SFDA, and EMA. The parties have committed to a non-exclusive collaboration model, with exclusivity defined for programs combining Rakovina’s compounds with NanoPalm’s delivery technology in oncology and other mutually agreed indications.

Intellectual property arising from the collaboration will be jointly owned, with background IP and technology improvements retained by their respective inventors. Each party will non-exclusively license its IP to the JV for the purpose of fulfilling the venture’s objectives.