On August 21, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Chemomab, AUG 21, 2024, View Source [SID1234646028]).

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"This past period has been an exciting time of transformation for Chemomab. The positive results of the Phase 2 SPRING trial represent a major milestone for the company and clearly establish clinical proof-of-concept for CM-101 in primary sclerosing cholangitis (PSC) and potentially other fibrotic diseases," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "CM-101 achieved the primary and key secondary endpoints in the trial and is the first therapy to demonstrate broad, clinically relevant effects on the three main components of PSC. This is also the first PSC trial to show, after just 15 weeks of treatment, a statistically significant reduction in liver stiffness, a widely used and well validated measure for assessing disease progression in PSC."

"We believe these results provide strong support for advancing CM-101 to a Phase 3 PSC trial, which we are in the process of planning and will be discussing with the FDA during the End-of-Phase 2 meeting targeted for later this year. We anticipate two milestones early in 2025 – additional data from the open label extension portion of the SPRING trial and finalization of the PSC Phase 3 design reflecting our discussions with the FDA. Based on recent developments in related indications, we are optimistic that an accelerated approval design incorporating surrogate biomarkers may be feasible for CM-101."

Dr. Mor continued, "We were pleased to welcome existing and major new investors, including OrbiMed, HBM Partners and Sphera, who participated in our successful $10 million PIPE financing. The proceeds generated by this financing will enable us to achieve our upcoming milestones in early 2025 and fund the operations of the company through the beginning of 2026."

Dr. Mor concluded, "As a first-in-class molecule with a promising novel target relevant to multiple fibro-inflammatory diseases, CM-101 has long been of interest to potential biopharma partners. As expected, the positive data reported from the Phase 2 SPRING trial provides us opportunities to further advance the optimal path forward for CM-101, including potentially partnering to accelerate timelines for CM-101 development in PSC and other indications."

Second Quarter 2024 and Recent Updates

On July 30, 2024, Chemomab announced the closing of a private placement that resulted in gross proceeds of approximately $10 million. Existing investors such as OrbiMed and new investors including HBM Partners and Sphera Biotech Master Fund participated in the financing, which extends the company’s cash runway through early 2026.

On July 25, 2024, Chemomab reported topline results from the CM-101 Phase 2 SPRING trial in patients with PSC. CM-101 met the primary study endpoint, demonstrating a favorable safety profile over the 15-week treatment period. CM-101-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including assessments of changes from baseline relative to placebo at Week 15 in liver stiffness; in liver fibrosis biomarkers, including the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; in total bilirubin and liver function tests; in pruritis (itch) and in markers of inflammation. Dose-dependent responses were observed for multiple disease-related biomarkers. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the higher 20 mg/kg dose of CM-101 and in the prespecified subgroup of PSC patients with moderate/advanced disease. The open label extension portion of the Phase 2 SPRING trial is continuing, with results expected to be reported in early 2025.

On June 18, 2024, Chemomab announced new scientific publications reinforcing the clinical potential of CM-101 in PSC. A proteomic analysis of patient samples further confirmed that the company’s novel CCL24 target is associated with disease severity and progression in PSC.

On June 6, 2024, Chemomab participated in multiple data presentations at EASL 2024 and a Gordon Research Conference supporting the clinical potential of CM-101 as a novel treatment for PSC. The findings support CM-101’s mode of action in liver fibrosis and could help in characterizing its anti-fibrotic drug effects and potentially serve as a translational tool in future PSC clinical trials.

On April 18, 2024, Chemomab announced a new peer-reviewed publication reinforcing the clinical association of its novel CCL24 target with disease severity and mortality in patients with systemic sclerosis.

On April 10, 2024, Chemomab hosted an expert PSC webinar featuring Christopher Bowlus, MD, of UC Davis Health; Ricky Safer, founder and CEO of PSC Partners Seeking a Cure and Massimo Pinzani, MD, PhD, of the UCL Institute for Liver and Digestive Health and UPMC ISMETT.
Second Quarter 2024 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $12.8 million as of June 30, 2024, compared to $19.9 million as of December 31, 2023. On July 30, 2024, Chemomab successfully closed a $10 million private investment.

Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the second quarter of 2024, compared to $5.0 million for the second quarter of 2023. The decrease in R&D expenses in the second quarter of 2024 compared to the second quarter of 2023 primarily resulted from the completion of the double-blinded portion of the company’s CM-101 Phase 2 PSC trial.

General and Administrative (G&A) Expenses: G&A expenses were $0.8 million for the second quarter of 2024, compared to $3.2 million for the second quarter of 2023. The decrease in G&A expenses primarily reflected reductions in headcount, consulting fees and other cost savings.

Net Loss: Net loss was $3.6 million, or a net loss of approximately $0.01 per basic and diluted ordinary share for the second quarter of 2024, compared to $8.0 million, or a net loss of approximately $0.04 per basic and diluted ordinary share for the second quarter of 2023. The weighted average number of ordinary shares outstanding, basic and diluted, was 286,080,133 (equal to approximately 14.3 million ADSs) for the second quarter of 2024.

Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30, 2024, together with the additional funds of approximately $10 million raised in July 2024, will enable the Company to fund its operations through the beginning of 2026.

Number of issued and outstanding shares: Following completion of its July 2024 financing, the Company had 18,508,057 ADSs (representing 370,161,140 ordinary shares) issued and outstanding and 25,121,231 ADSs (representing 502,424,620 ordinary shares) outstanding on a fully diluted basis.

On August 21, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial (Press release, Bristol-Myers Squibb, AUG 21, 2024, View Source [SID1234646027]). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025.

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"HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option. With the number of individuals diagnosed with HCC in the United States increasing over the last decade, new treatment options are urgently needed," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. " Opdivo plus Yervoy showed superior survival benefit compared to other available treatment options, and we look forward to working with the FDA to advance our application to potentially bring a new first-line treatment option to patients."

The filing was based on the results from the Phase 3 CheckMate -9DW study in which the combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to investigator’s choice of lenvatinib or sorafenib. The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC, and these results support the combination becoming a potential new treatment option in the first-line setting. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Results were presented at the 2024 American Society of Oncology (ASCO ) Annual Meeting .

Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 CheckMate -9DW clinical trial.

About CheckMate -9DW

CheckMate -9DW is a Phase 3 randomized, open-label trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.

668 patients were randomized to receive Opdivo plus Yervoy ( Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg for a maximum duration of 2 years) infusion, or single agent lenvatinib or sorafenib as oral capsules in the control arm. The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.

About Hepatocellular Carcinoma

Liver cancer is the third most frequent cause of cancer death worldwide. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 75%-85% of all liver cancers. HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.

Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.

On August 21, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update from the Company’s ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company’s ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML) (Press release, Bio-Path Holdings, AUG 21, 2024, View Source [SID1234646026]).

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"These positive responses mark a significant milestone for Bio-Path as they suggest our DNAbilize platform technology has the potential to produce multiple drug candidates capable of targetspecific protein inhibition for over-expressed, disease-causing gene products," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "We were thrilled to see that our first patient treated with the higher dose (90 mg/m2) in our Phase 1/1b study of BP1001-A has shown tumor regression and stable disease. We believe this is significant, particularly considering the heavily pretreated and fragile patient population involved."

"This elderly female patient with gynecologic cancer had previously been treated with multiple lines of chemotherapy along with multiple surgeries for her disease, and only now is showing positive clinical results with BP1001-A treatment. Importantly, we are not seeing the onerous side effects typically seen in patients with advanced solid tumors being treated with standard frontline therapies," continued Mr. Nielsen.

"In addition, we observed extended treatment durability in two elderly patients in our Phase 2 triple combination study of prexigebersen, venetoclax and decitabine in AML patients. These ongoing positive outcomes underscore the potential for prexigebersen to treat fragile AML patients for extended periods. We are particularly pleased with these results, as AML patients are typically unable to tolerate intensive chemotherapy and thus experience very poor clinical outcomes," concluded Mr. Nielsen.

Bio-Path’s DNAbilize Technology Platform – Bio-Path’s DNAbilize platform is a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. Bio-Path believes this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, DNAbilize delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, the Company’s DNAbilize drug candidates have demonstrated a promising safety and efficacy profile. Bio-Path currently has four DNAbilize drug product candidates in development.

Solid Tumor Patient Response in Second, Higher Dose Cohort – Bio-Path’s first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through six cycles of treatment. Moreover, it appears that these positive outcomes may have contributed to allow her to continue with rigorous exercise and improved quality of life.

The dose finding portion of the Phase 1/1b trial is comprised of BP1001-A monotherapy with no accompanying chemotherapy. This clinical trial of BP1001-A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m2 and began enrollment in the higher dose cohort of 90 mg/m2. The Phase 1b portion of the study is expected to commence after completion of three planned BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer

AML Patients Demonstrate Extended Treatment Durability – During the Company’s recent pause for an interim analysis of results for Bio-Path’s Phase 2 clinical trial treating AML patients, attention focused on two elderly patients who demonstrated continued treatment durability. The first patient is an elderly female who has received 16 cycles of treatment over 21 months and continues in complete remission. The second patient is an elderly male who is completing his twelfth cycle of treatment over fourteen months and continues in complete remission. The clinical trial investigator treating these two patients indicated that they are both doing very well on treatment. Both patients are being treated with the triple combination of prexigebersen, decitabine and venetoclax.

On August 21, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in the following investor conferences in September (Press release, Bicycle Therapeutics, AUG 21, 2024, View Source [SID1234646025]):

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Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, Sept. 4; fireside chat at 8:30 a.m. ET
2024 Cantor Global Healthcare Conference on Wednesday, Sept. 18; fireside chat at 11:30 a.m. ET

Live webcasts of the fireside chats will be accessible in the Investor section of the company’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available following the fireside chat dates.

On August 21, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported its unaudited financial results for the second quarter of 2024 (Press release, Nykode Therapeutics, AUG 21, 2024, View Source [SID1234646011]).

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The financial report can be accessed in the Investors section of the company’s website: View Source The company will host a webcast presentation at 4 p.m. CET / 10 a.m. ET.

A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website and on the following link: View Source;tp_key=dff7ea87a1