On May 11, 2023 CytoAgents, Inc., a clinical-stage biotechnology company developing a safe, effective treatment for Cytokine Release Syndrome (CRS), reported that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) (Press release, CytoAgents, MAY 11, 2023, View Source [SID1234631499]). This clearance enables the initiation of a U.S. Phase 1b/2a clinical trial under its Investigational New Drug (IND) application for the therapeutic, CTO1681, to treat CRS in lymphoma patients receiving CAR T-Cell Therapy. This is an area of great unmet medical need as the majority of patients undergoing CAR T treatment for their cancer experience CRS and associated neurotoxicity.

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"We are thrilled to advance CTO1681 into the clinic and excited about how our novel therapeutic will potentially prevent and/or treat CRS," said Teresa Whalen, RPh, CEO of CytoAgents. "The FDA’s clearance to advance our clinical program for CTO1681 in the U.S. is another important milestone for our company."

CytoAgents is developing innovative pharmaceutical products to treat life-threatening conditions, diseases and disorders associated with CRS. Commonly referred to as cytokine storm, CRS is caused by excessive cytokine production and can be triggered by a range of diseases and treatments. Certain advanced immunotherapies in the oncology space such as CAR T-Cell and Bispecific Antibody Therapies suffer from high incidence of associated CRS. The condition can be lethal and requires hospitalization for adequate control in nearly all cases. The company expects that effective CRS management will support greater accessibility to and broader adoption of these highly effective therapies in the clinic.

Building on this news, the company also announced the initial closing of its second equity round of financing. "CytoAgents has a clear path forward and a team ready to execute," says Brian Shanahan, Managing Partner, PCG Capital. "We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients."

CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

On May 11, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical leader in cell cycle checkpoint control developing innovative medicines based on cancer cell biology, reported its first quarter financial results and provided a business update (Press release, Cyclacel, MAY 11, 2023, View Source [SID1234631498]).

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"We are on track to deliver on key readouts this year. For fadraciclib, our oral CDK2/9 inhibitor, we plan to report pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation stage of our 065-101 study followed by initial clinical activity data from the Phase 2 proof of concept (PoC) stage. We also expect to report PK, PD, safety and activity data from the dose escalation part of our 140-101 Phase 1/2 study of plogosertib, our oral PLK1 inhibitor," said Spiro Rombotis, President and Chief Executive Officer. "Data collected to date suggest that fadraciclib and plogosertib are differentiated from other molecules in their respective classes. Furthermore, the receipt of $4.7 million in non-dilutive capital from the R&D tax credit along with existing resources supports our ongoing clinical programs."

"Both clinical programs with fadraciclib and plogosertib are progressing well and are approaching important data readouts," said Mark Kirschbaum, M.D., Chief Medical Officer. "In 065-101, we are currently recruiting patients at dose level 6A of fadraciclib with the aim of optimizing the recommended Phase 2 dosing schedule before opening the PoC stage. Our Phase 2 clinical sites are ready to enroll patients with the tumor types that appear to be most sensitive to fadraciclib treatment. With plogosertib we are recruiting patients at dose level 4. After observing unexpected efficacy at lower dose levels with three patients on treatment for three to eight cycles, we are investigating the biological rationale for this effect and how we could exploit these findings in subsequent studies. We remain enthusiastic about our clinical stage pipeline and look forward to presenting emerging data from these two programs during the year."

Key Upcoming Milestones for 2023

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
· Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2023, pro forma cash and cash equivalents totaled $16.1 million, including the $4.7 million of United Kingdom research & development tax credits received after the end of the quarter. Cash and cash equivalents as of March 31, 2023 was $11.4 million, compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $6.9 million for the three months ended March 31, 2023 compared to $6.8 million for the same period of 2022. The Company estimates that its available cash will fund currently planned programs into the first quarter of 2024.

Research and development (R&D) expenses were $5.7 million for the three months ended March 31, 2023, as compared to $5.0 million for the same period in 2022. R&D expenses relating to fadraciclib were $4.1 million for the three months ended March 31, 2023, as compared to $3.6 million for the same period in 2022 due to increased non-clinical expenditures. R&D expenses related to plogosertib were $1.4 million for the three months ended March 31, 2023, as compared to $1.1 million for the same period in 2022 due to clinical trial costs associated with the progression of the Phase 1/2 study.

General and administrative expenses for the three months ended March 31, 2023 and 2022, remained relatively flat at $1.6 million.

Total other income, net, for the three months ended March 31, 2023, was $0.2 million compared to an income of $1.3 million for the same period of the previous year. The decrease of $1.1 million for the three months ended March 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months ended March 31, 2023 were $1.3 million compared to $1.1 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended March 31, 2023, was $5.8 million, compared to $4.1 million for the same period in 2022.

Conference call information:

US/Canada call: (800) 274-8461 / international call: (203) 518-9783

US/Canada archive: (800) 839-6975 / international archive: (402) 220-6061

Code for live and archived conference call is CYCCQ123. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 11, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2023 (Press release, Cullinan Oncology, MAY 11, 2023, View Source [SID1234631497]).

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"We made important progress in the first quarter of this year and believe that 2023 will be a transformational year for Cullinan Oncology," said Nadim Ahmed, Chief Executive Officer of Cullinan. "Consistent with our guidance on reporting first clinical data from two of our ongoing Phase 1 studies by mid-year, preliminary safety data for CLN-049 were published in abstract form today as part of the 2023 EHA (Free EHA Whitepaper) Congress and first clinical data for CLN-619 will be presented during a poster session at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. Additionally, enrollment in the zipalertinib pivotal study will now continue at the 100mg BID dose only. We also continue to progress our diverse pipeline: both CLN-978 and CLN-617 received FDA clearance of IND applications in the first quarter, which will allow us to initiate first-in-human studies this year. Finally, we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications. Together, these achievements position us well with six programs in the clinic this year as we work toward our mission of creating new standards of care for patients with cancer."

Portfolio Highlights

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Zipalertinib: Enrollment will continue solely at the 100 mg BID dose level in the pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy.

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Further enrollment in the 150mg BID cohort was recently discontinued based upon recommendation of the safety review committee.

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CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

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Preliminary safety data from an ongoing first in human study were published in abstract form as part of the 2023 EHA (Free EHA Whitepaper) Congress.
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Cytokine production and low-grade clinical cytokine release syndrome (CRS) consistent with the postulated mechanism of action were observed at the initial dose levels in the now completed single ascending dose study using IV administration.

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Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.

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CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis by both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both a monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
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First clinical data will be presented during a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting on June 3, 2023.

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New preclinical data on the anti-tumor mechanism of CLN-619 were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.

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CLN-418: CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor-associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues. Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors, with initial clinical data expected in 2024.

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In February, Cullinan Oncology licensed the exclusive U.S. development and commercial rights to CLN-418 from Harbour Biomed for an upfront fee of $25 million, with the potential for up to an additional $148 million in development and regulatory milestones and up to $415 million in sales-based milestones, as well as tiered royalties on potential U.S. commercial sales.

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CLN-978: CLN-978 is a novel CD19xCD3 bispecific therapeutic with extended serum half-life and robust potency against target cells expressing low levels of CD19.

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Cullinan received FDA clearance of its IND application for CLN-978 in January and anticipates initiating a Phase 1 clinical study in 2023.

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CLN-617: CLN-617 is a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection.

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Cullinan received FDA clearance of its IND application for CLN-617 in March and anticipates initiating a Phase 1 clinical study in 2023.

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New preclinical data highlighting the therapeutic potential of CLN-617 was presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.

First Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $503.5 million as of March 31, 2023. This balance reflects the $25 million upfront payment to Harbour Biomed upon the execution of the licensing agreement for CLN-418. Cullinan expects its cash resources to provide runway into 2026 based on its current operating plan.

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R&D Expenses: Research and development (R&D) expenses were $52.1 million for the first quarter of 2023, compared to $21.3 million for the fourth quarter of 2022. R&D expenses for the first quarter of 2023 and fourth quarter of 2022 included $3.1 million and $2.9 million of equity-based compensation expenses, respectively. Excluding the impact of equity-based compensation expenses, the increase in R&D expenses was primarily related to the upfront payment to Harbour Biomed upon the execution of the licensing agreement for CLN-418, and higher clinical and clinical supply costs driven by the advancement and expansion of our pipeline.

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G&A Expenses: General and administrative (G&A) expenses were $10.7 million for the first quarter of 2023, compared to $11.3 million for the fourth quarter of 2022. G&A expenses in the first quarter of 2023 and fourth quarter of 2022 included $4.2 million and $4.6 of equity-based compensation expenses, respectively. The decrease in G&A expenses, excluding equity-based compensation, was primarily driven by a decrease in professional fees.

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Net Loss: Net loss (before items attributable to noncontrolling interest) for the first quarter of 2023 was $58.1 million, compared with net loss of $27.1 million for the fourth quarter of 2022. Net losses included the items described above, partially offset by interest income of $4.5 million and $3.4 million in the first quarter of 2023 and fourth quarter of 2022, respectively, and an income tax benefit of $1.9 million in the fourth quarter of 2022.

On May 11, 2023 ChromaDex Corp. (NASDAQ:CDXC), a global bioscience company dedicated to healthy aging, reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Brianna Gerber, reported that it will be participating in the Lytham Partners Spring 2023 Investor Conference (Press release, ChromaDex, MAY 11, 2023, View Source [SID1234631496]).

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Mr. Fried and Mrs. Gerber will be participating in virtual one-on-one meetings throughout the event on Thursday, May 18, 2023.

To arrange a meeting with the ChromaDex management team, please contact Lytham Partners at 1×[email protected], or register online by clicking the link here: ChromaDex Investor Meetings – Lytham Partners.

For additional information on ChromaDex, visit www.chromadex.com.

On May 11, 2023 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported its financial and operating results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Chemomab, MAY 11, 2023, View Source [SID1234631495]).

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"I am pleased to report that we have continued to make good progress on multiple fronts since our last quarterly update," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "In January we reported encouraging top-line results from our CM-101 Phase 2 liver fibrosis trial in nonalcoholic steatohepatitis (NASH) patients. In this study CM-101 appeared safe and demonstrated improvement across multiple disease-related fibrotic and inflammatory biomarkers. In our view, these data have been generally well-received by opinion leaders and potential partners. Importantly, these results also are consistent with the encouraging biomarker changes that were observed in two earlier CM-101 clinical trials and reinforce our optimism about CM-101’s potential as a treatment for fibro-inflammatory diseases."

Dr. Pfost continued, "We continue to make good progress in advancing our CM-101 Phase 2 clinical program in primary sclerosing cholangitis (PSC). We have opened additional clinical sites, added an open label extension and enhanced our patient outreach activities, supporting our goal of reporting top-line data in the second half of next year."

"Turning to systemic sclerosis (SSc), earlier this year we reported that our Investigational New Drug (IND) submission for our CM-101 Phase 2 trial was cleared by the FDA. We have been working diligently to prepare for the start of this proof-of-concept trial and we are on track to open our initial U.S. sites around mid-year. We expect to report data from this trial in the latter part of 2024. We also are supporting our clinical programs with an active schedule of scientific presentations at major medical meetings in the U.S. and Europe, and we anticipate several scientific publications in respected journals going forward. These activities aim to build knowledge about, and interest in, our unique approach to fibro-inflammatory diseases among researchers and opinion leaders."

"Since our last call, we have also added two exceptional senior executives—our Chief Medical Officer, Dr. Matt Frankel, and our Vice President of Corporate Development and Strategy, Dr. Mitch Jones. Matt brings us a wealth of global clinical and medical affairs experience, along with his track record in helping to bring numerous drugs to market. Mitch is an MD/PhD with a rich combination of science and business skills that make him uniquely well qualified to lead the corporate development function at Chemomab."

"I am also pleased to announce that today we are extending our estimated cash runway by another quarter through the first half of 2024," said Dr. Pfost. "We accomplished this extension while maintaining the resources needed to advance our two clinical programs towards our expected data read-outs in the second half of 2024. In conclusion, we believe that CM-101 has the potential to make a difference in deadly diseases with few current treatment options and we are committed to staying laser-focused on assessing its potential."

Clinical Update

Reported Top-line Results from CM-101 Phase 2 Liver Fibrosis Trial in NASH Patients

Top-line results were reported in January demonstrating that CM-101 met its primary endpoint of safety and tolerability and showed positive activity across multiple liver fibrosis biomarkers and physiologic assessments. These results provide insights supporting the overall CM-101 clinical development program as well as pharmacokinetic and tolerability data needed to inform next steps in the development of the current subcutaneous formulation of CM-101.

Advanced Phase 2 Trial in PSC Patients

Late last year, the independent Drug Monitoring Committee for the PSC trial reviewed CM-101 safety data and cleared the addition of a planned higher dose arm to the trial. In recent months Chemomab has opened additional clinical trial sites and implemented a protocol amendment adding the higher dose cohort and an open label extension. Currently Chemomab believes it is on track to report top-line data from the double-blind portion of this trial in the second half of 2024.

Received FDA IND Clearance for CM-101 Phase 2 Trial in SSc Patients

Following the recent IND clearance, Chemomab is finalizing plans to open the Phase 2 SSc trial to patient enrollment by mid-year. The study will be conducted at multiple sites in the U.S., Europe and Israel. It aims to confirm the critical role of CCL24 in SSc and to establish biological and clinical proof-of-concept for CM-101 in patients with SSc. The study is designed to generate additional information about disease mechanisms and to enable more informed decisions about future patient stratification strategies and the selection of endpoints for registrational studies. An initial data read-out is planned for the second half of 2024.

First Quarter 2023 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $32.8 million as of March 31, 2023, compared to $39.9 million at December 31, 2022.
Research and Development (R&D) Expenses: R&D expenses were $6.9 million for the quarter ended March 31, 2023, compared to $2.7 million for the same quarter in 2022. The increase was primarily due to increased clinical and preclinical activities.
General and Administrative (G&A) Expenses: G&A expenses were $2.2 million for the quarter ended March 31, 2023, compared to $2.6 million for the same quarter in 2022.
Net Loss: Net loss was $8.8 million, or a net loss of approximately $0.04 per basic and diluted ordinary share for the first quarter of 2023, compared to $5.1 million, or a net loss of approximately $0.02 per basic and diluted ordinary share for the quarter ended March 31, 2022. The weighted average number of ordinary shares outstanding, basic and diluted, was 220,996,240 (equal to approximately 11 million ADSs) for the quarter ended March 31, 2023.
For further details on the company’s financial results for the quarter ended March 31, 2023, please refer to the company’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission today.

Conference Call and Webcast

Chemomab management will host a conference call for investors today, Thursday, May 11, 2023, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions.

Click this Webcast link to access the live webcast or replay. The live webcast and replay can also be accessed at the News & Events section of the Investors page on the Chemomab website at investors.chemomab.com/events.

To access the conference call via telephone, shareholders and other interested parties can dial
+1 (877) 407-9208 (in the U.S.) or +1 (201) 493-6784 (outside the U.S., including Israel) and enter passcode 3735393. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call.

Or click on Call meTM starting 15 minutes before the scheduled start time for instant telephone access without having to wait for an operator.

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.