On April 30, 2025 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)-powered drug discovery reported the financial results for its fourth quarter and fiscal year ending December 31, 2024 and provided a corporate update (Press release, Rakovina Therapeutics, APR 30, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-inc-announces-2024-financial-results-and-provides-corporate-update [SID1234652392]).

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2024 Highlights and Recent Developments

On April 29, 2025, we announced the intention to appoint Yevgeniy Meshcherekov and David Kideckel to the Company’s board of directors, subject to receiving approval from the TSX Venture Exchange. The Company also announces that Michael Liggett has retired from the Board. Subject to TSXV approval, Mr. Meshcherekov will replace Mr. Liggett as the chair of the audit committee of the Board
On April 28 & 29, 2025, we presented pre-clinical data related to the development of our kt-2000 and kt-5000 programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. These data demonstrate that select candidates derived from our AI collaborations may meet our target product profile for a PARP-1 selective lead candidate (kt-2000) and for an ATR-inhibitor (kt-5000).
On March 12, 2025, we announced that we had received the first synthesized batch of AI-generated ATR inhibitor compounds developed in collaboration with Variational AI.
On January 30, 2025, we announced the listing of common shares on the Frankfurt Stock Exchange (FSE) under the ticker symbol "7J0".
On January 13, 2025, we announced the successful achievement of a shortlist of AI-generated molecules targeting ATR (Ataxia Telangiectasia and Rad3-related protein) with specific designs for central nervous system (CNS) penetration.
On January 6, 2025, we announced the receipt of initial synthesized drug candidates: AI-generated PARP-inhibitor compounds for in vitro and in vivo validation in our laboratories.
On December 13, 2024, we announced the closing of an oversubscribed $3.0 million private placement offering (the "Private Placement"). The Private Placement consists of 50,000,000 units (the "Units") at a price of $0.06 per Unit. Each Unit consists of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share of the Company for a period of 24 months from the date of issue at a price of $0.10 per Common Share. Rakovina retains the right to accelerate the Warrant exercise period if, upon written notice to the holder, the 20-day volume-weighted average price of its Common Shares exceeds $0.30.
On November 22, 2024, we delivered a poster presentation highlighting initial results of our Deep Docking and generative Artificial Intelligence (AI) PARP-inhibitor program at the Neuro-Oncology Annual Meeting in Houston, Texas.
On October 25, 2024, we presented our research on kt-3283, our lead small-molecule bifunctional inhibitor of PARP and HDAC enzymes at the 36th EORTC-NCI-AARC Symposium in Barcelona, Spain.
On October 23, 2024, we announced the receipt of initial results from the Company’s Deep Docking AI partnership following the evaluation of billions of molecular structures. This process resulted in a short-list of drug candidates that have been optimized to a specific target-product profile.
On September 17, 2024, we announced a research collaboration with Variational AI to employ the proprietary Enki AI platform to identify and develop novel small-molecule therapies against select DDR kinase targets for the treatment of cancer.
On July 26, 2024, we announced the final closing of an over-subscribed non-brokered private placement financing of units priced at $0.10 per unit with each unit consisting of one common share and one common share purchase warrant with an exercise price of $0.20 per warrant and a term of three years for gross proceeds to the Company of $2 million (the "2024 Private Placement"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.
On May 8, 2024, we announced the expansion of our collaborations with the University of British Columbia ("UBC") and our medicinal chemistry partner, Pharma Inventor Inc. to support the Company’s AI drug discovery initiatives.
On March 27, 2024, we announced a collaboration agreement with Dr. Artem Cherkasov granting Rakovina exclusive access to the proprietary Deep Docking AI Platform for DNA-damage response targets. We are using the Deep Docking platform to quickly analyze billions of molecular structures to evaluate their potential as targeted cancer drugs.
Summary Financial Results for the fourth quarter and year ended December 31, 2024

At December 31, 2024, the Company had positive working capital of approximately $321,442.

For the three- and twelve-months ending December 31, 2024, the Company reported a net loss of $1,483,988 and $4,072,618, respectively. Research and development operating expenses were $744,533 and $2,341,600 for the three and twelve months ended December 31, 2024, respectively. General and administrative expenses were $650,268 and $1,446,451 for the three- and twelve-months ending December 31, 2024, respectively. Total cash operating expenses related to research and development and general and administrative expenses for the three and twelve months ended December 31, 2024, were $3,165,554 and $1,243,517 respectively.

Selected Financial Information As at December 31, 2024 $
Cash & cash equivalents 1,312,743
Working capital 321,442
Intangible assets 3,977,473
Total Assets 6,240,920
Total liabilities 1,942,005
Deficit (14,997,929)
Total equity 4,298,915
Statements of net loss and comprehensive loss data: For the three months ended December 31, 2024 $ For the year ended December 31, 2024 $
Research & Development 744,533 2,341,600
General and administrative 650,268 1,446,451
Net loss and comprehensive loss (1,483,988) (2,612,925)
Basic and diluted income (loss) per share (0.01) (0.05)
Operating cash burn 1,243,517 3,165,554
Weighted average shares outstanding 100,089,471 82,549,477
Rakovina Therapeutics’ financial statements as filed with SEDAR can be accessed from the Company’s website at: View Source

On April 30, 2025 Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported that Brian Windsor, Ph.D., President and Chief Executive Officer, will present at The Citizens Life Sciences Conference 2025 on Thursday, May 8, 2025 at 12:00 p.m. EDT in New York, NY (Press release, Aileron Therapeutics, APR 30, 2025, View Source [SID1234652374]).

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A live webcast of the event can be accessed at View Source A replay of the webcast will be available for 90 days following the presentation.

On April 30, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported that a poster presentation titled "Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers" is being presented during the session "Liquid Biopsy: Circulating Nucleic Acids 4 / Predictive Biomarkers 1" at the Annual Meeting of the American Association of Cancer Research (AACR 2025) on Wednesday, April 30, 2025 (Press release, Purple Biotech, APR 30, 2025, View Source;id=347386&p=2372871&I=1206939-c7Z3G6f3m8 [SID1234652394]).

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"These statistically significant biomarker results, with up to a 90% reduction in risk of death over the control group, are highly encouraging and we believe warrant a biomarker-driven Phase 2b study," stated Purple Biotech CEO Gil Efron. "The new, previously unpublished data presented at AACR (Free AACR Whitepaper) demonstrate significant overall survival (OS) and progression-free survival (PFS) benefit for patients meeting the criteria of either serum CEACAM1 or tumor CEACAM1 biomarkers. With these final data reported, we believe CM24 could potentially be positioned as a therapy targeting CEACAM1 in cancers with large unmet needs."

At AACR (Free AACR Whitepaper) 2025, Purple Biotech presented final data from its randomized, controlled, open-label, multicenter Phase 2 study (NCT04731467), which established proof of concept in a biomarker-enriched subgroup of 31 patients with advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) who were post-first line therapy, and compared treatment with CM24 + nivolumab + Nal-IRI/5FU/LV against treatment with Nal-IRI/5FU/LV alone.

The following is a summary of the findings.

The combination of CM24, nivolumab and Nal-IRI/5FU/LV chemotherapy was well tolerated and demonstrated quantitative improvement in all efficacy parameters, including OS, PFS, objective response rate (ORR), disease control rate (DCR) and CA19-9, in previously treated PDAC patients.

Without consideration of biomarkers, a consistent improvement in the treatment arm compared to the control arm was observed, as follows:

Prolongation of 2.4 months in OS HR=0.81 (p-0.575) and prolongation of 1.9 months in PFS HR=0.75 (p=0.463) vs. control arm
Higher ORR in experimental arm vs control arm (25% vs 6.7%)
Higher DCR in experimental arm vs control arm (62.5% vs 46.7%)
Consistent and continuous decrease in CA19-9 was observed in experimental arm vs control arm increase
Biomarker results included the following:

A statistically significant benefit to patients with defined pre-treatment ranges of serum CEACAM1 or tumor CEACAM1 expression (H score) compared to the control arm (representing a subgroup of 52% of patients):

Subgroup analyses of 16/31 patients meeting the criteria of CEACAM1+Tumor cell H score 115-275 or serum CEACAM1 levels 6K-15K pg/mL
78% reduction in risk of death (HR 0.22, 95% CI 0.07-0.7, p=0.006) and 95% reduction in the risk of progression or death (HR 0.05, 95% CI 0.01-0.44, p=0.0003)
Prolongation of 3.7 months in OS and 2.9 months in PFS
Statistically significant results in patients with defined pre-treatment serum CEACAM1 or myeloperoxidase (MPO) levels (representing a subgroup of 80% of patients):

Subgroup analyses for 24/30 patients meeting the criteria of MPO levels 200-600 ng/mL or serum CEACAM1 levels 6K-15K pg/mL
61% reduction in risk of death (HR = 0.39, 95% CI 0.16-0.98, p=0.039) and 72% reduction in the risk of progression or death (HR=0.28, 95% CI 0.11-0.73, p=0.006)
Prolongation of 2.4 months in OS and 2.2 months in median PFS
A statistically significant benefit for CM24-nivolumab treatment in patients with high CEACAM1+Tumor cell H score and low PD-L1 CPS (representing a subgroup of 38% of patients):

Subgroup analyses of 10/26 patients meeting the criteria of high CEACAM1+Tumor cell H score 115 and Low CPS 1 (
90% reduction in risk of death (HR = 0.1, 95% CI 0.01-0.89, p=0.013) and 81% reduction in the risk of progression or death (HR = 0.19, 95% CI 0.04-1.02, p=0.033)
Prolongation of 4 months in OS and 2 months in PFS
"The identification of CEACAM1 as a potential biomarker, both in serum and at the tumor, corresponds with the multi-faceted function of CEACAM1, as part of the neutrophil extracellular trap (NET) structure affecting NET-related tumor immune evasion, metastasis and other cancer-associated complications, such as thrombosis, at the level of the whole body, as well as modulation of the tumor microenvironment (TME)," stated Purple Biotech VP of Research and Development, Dr. Hadas Reuveni. "Targeting CEACAM1 by CM24 suggests a potential new approach that may address tumor-associated mechanisms affecting the patient at the levels of the tumor, the TME and the whole body. The biomarker data accumulated in this clinical study may help us to direct the treatment of patients who might have a higher chance to benefit from the treatment and could expand our understanding of CEACAM1 and NETs in cancer biology."

Final conclusions from the study:

The combination of CM24, nivolumab, and Nal-IRI/5FU/LV chemotherapy was well tolerated and
demonstrated quantitative improvement in all efficacy parameters, including OS, PFS, ORR and CA19-9, in previously treated PDAC patients.

Based on post-hoc analyses – serum CEACAM1 and MPO, a NET marker, are demonstrated as potential predictive biomarkers for CM24-based therapy, consistent with its mechanism of action (MoA) in targeting CEACAM1 to modulate immune evasion and NET activities.
Results imply that both serum and tumor CEACAM1 levels are potential predictive biomarkers for CM24 based therapy, suggesting multifaceted MoA and the crosstalk of the tumor with the TME and the whole body.
Improved outcome in patients with high tumor CEACAM1 expression and low PD-L1 CPS further support the mechanistic rationale of the CM24/nivolumab combination and highlight its potential in disease settings where immuno-oncology is less effective.
"The design of the randomized trial enabled us to evaluate the benefit of CM24 and nivolumab in combination with standard of care chemotherapy and to analyze potential biomarker data to better prepare for the next study." stated Purple Biotech Head of Clinical and Regulatory Affairs, Dr. Michael Schickler. "We currently expect the design of the next Phase 2b study to include an additional group testing CM24 alone in combination with standard of care with patients selected based on the identified biomarkers, potentially in indications such as gastric and/or biliary tract cancer, in addition to PDAC."

The poster will be available at the Publication section on Purple Biotech’s website following its presentation at the conference.

On April 30, 2025 Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, reported that the first patient has been enrolled in the Phase 1 clinical trial of its drug candidate 177Lu-AKIR001 (Press release, Akiram Therapeutics, APR 30, 2025, View Source [SID1234652375]). The trial is being conducted at Karolinska University Hospital, which also acts as the study sponsor, and marks an important milestone in Akiram’s efforts to develop a new targeted treatment for difficult-to-treat cancers.

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This is the first-in-human trial with AKIR001 and aims to evaluate the drug’s safety, tolerability, and pharmacokinetic profile. The trial follows a dose-escalation design and targets patients with advanced, difficult-to-treat tumors.

Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6—a cancer marker associated with several aggressive tumor types—with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered directly to tumor cells while minimizing damage to surrounding healthy tissue.

The trial is enrolling patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer. It is expected to run for 18–24 months with patients recruited on a rolling basis. As the sponsor, Karolinska University Hospital is responsible for conducting the trial in accordance with applicable regulations and with patient safety as a top priority.

"The launch of the clinical trial with AKIR001 marks the beginning of a new chapter for Akiram. Our vision has always been to develop a treatment that can offer new opportunities for patients with difficult-to-treat cancers, where treatment options are often limited. Seeing our drug candidate now being evaluated in collaboration with Karolinska University Hospital—one of Europe’s leading cancer centers—is a major milestone and a strong motivator for our continued work," says Marika Nestor, CEO of Akiram Therapeutics.

"The enrollment of the first patient means that we have now initiated dose escalation and systematic evaluation of AKIR001’s safety and potential. This is an important first step in understanding how the drug behaves clinically and the potential role a CD44v6-targeted therapy could play in tumor types where treatment options today remain limited," says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.

The trial is registered at ClinicalTrials.gov: NCT06639191.

On April 30, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will participate in the BofA Securities 2025 Healthcare Conference. Company management will participate in a fireside chat on Wednesday, May 14, 2025, at 10:00 a.m. PT / 1:00 p.m. ET / 6:00 p.m. IST (Press release, Jazz Pharmaceuticals, APR 30, 2025, View Source [SID1234652395]).

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An audio webcast of the fireside chat will be available via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcast will be archived on the website for 30 days.