Chemomab Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update

On August 12, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Chemomab, AUG 12, 2022, View Source [SID1234618210]).

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"We continued to make good progress on multiple fronts in the second quarter," said Dale Pfost, PhD, Chairman and Chief Executive Officer of Chemomab. "We advanced our clinical programs for CM-101, our first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target at the confluence of fibrosis and inflammation; we added to our intellectual property portfolio for CM-101; we presented important new data at major scientific meetings; and we added several highly experienced staff essential to progressing our scientific and clinical priorities."

Dr. Pfost continued, "Congratulations to our research team for gaining issuance of a new U.S patent covering the use of CM-101 in liver diseases such as primary sclerosing cholangitis (PSC), thereby further extending our proprietary protection for disease targets involving hepatic and cholestatic conditions. I am also very pleased at how active our researchers and consultants have been in the past few months educating their scientific and medical peers by presenting data on CCL24 and CM-101 at major international scientific meetings. We recently added several outstanding research and clinical experts to our team to help ensure rapid advancement of our preclinical and clinical programs. In addition, we added a new director, Jill Quigley, JD, who brings a wealth of biotechnology strategic and operational expertise to our board. These are exciting times for our company, and I look forward to reporting more details on our progress in the coming months."

Clinical Update:

Phase 2 Liver Fibrosis Trial in NASH patients

Chemomab concluded the treatment phase of its randomized, placebo-controlled Phase 2 liver fibrosis trial that included a total of 23 NASH patients, with patients in the active arm receiving 5mg/kg of CM-101 delivered subcutaneously in 8 doses administered once every two weeks. This sets the stage for a planned topline study read-out before year-end. Importantly, these data represent the first read-out of CM-101’s activity in patients with established liver disease. The main study outcome is safety and tolerability. Additionally, based on the encouraging signs of activity observed in the CM-101 Phase 1b study in patients with non-alcoholic fatty liver disease, the company believes that evaluations of similar secondary outcomes in this patient population with more severe liver fibrosis and inflammation could be informative, and may provide useful insights in support of the overall CM-101 clinical development program. The trial results should also generate the pharmacokinetic and tolerability data needed to inform next steps in the development of the subcutaneous formulation of CM-101.

Phase 2 Trial in Primary Sclerosing Cholangitis patients

Chemomab previously indicated its intention to increase its efforts in the rare disease primary sclerosing cholangitis, or PSC, including expanding the size and scope of the ongoing randomized, placebo-controlled Phase 2 trial. The company is adding an open label extension and a dose finding component intended to better inform selection of the optimal dose of CM-101 to advance into late development. These revisions have been finalized and global regulatory filings supporting the trial expansion have been initiated, while new sites in Europe and the U.S. continue to open. The company plans to enroll a total of 93 patients: 25 patients in each of the three dosing cohorts, which include the current 10mg/kg dose along with a lower 5 mg/kg dose and a higher 20mg/kg dose. Another 18 patients are receiving placebo. All outcome measures in the trial, including evaluations of serum ALP levels, serum biological markers, and Fibroscan, remain unchanged, except that the primary outcome now is safety. Consistent with this change, the study is not formally powered to assess efficacy. However, cohort sizes sufficient to detect, with expected variability, a clinically relevant improvement in serum ALP levels (defined as change from baseline), which is a key secondary outcome for studies in PSC, have been maintained. A blinded interim Drug Monitoring Committee safety review of the current cohort is planned for late this year, and Chemomab anticipates reporting topline data from the trial in the second half of 2024.

Phase 2 Trial in Systemic Sclerosis patients

Chemomab has made significant progress in delineating the design of its upcoming Phase 2 trial in systemic sclerosis, or SSc, working closely with a number of top systemic sclerosis experts. The company aims to establish biological proof of concept on clinically relevant aspects of this complex disease, focusing on CM-101’s potential activity in modifying the skin, lung and vascular pathophysiology observed in SSc patients. Plans to launch the trial by the end of this year remain on track. A special webcast to provide details on the final trial design is planned in the next several months.

Recent Highlights:

Awarded U.S. Patent No.11365246, "Anti CCL24 (eotaxin 2) Antibodies for Use in the Treatment of Hepatic Disease," a new method of use patent that covers the use of CM-101 and other anti-CCL24 antibodies and binding fragments in the treatment of a range of fibro-inflammatory liver diseases, including primary sclerosing cholangitis and other cholestatic-related disorders. The new patent extends Chemomab’s intellectual property protection for CM-101 in the U.S. for another three years through at least 2038, with additional extensions possible.
At a poster presentation at the EULAR European Congress of Rheumatology (June 1-4, Copenhagen, DK), Chemomab collaborator Professor Francesco Del Galdo of the University of Leeds presented a poster further supporting the role of CCL24 as a therapeutic target for systemic sclerosis. This study, which examined the role of CCL24 in longitudinal cohorts of diffuse cutaneous SSc patients, reported elevated serum levels of CCL24 in these patients and showed that high circulating CCL24 levels were correlated with disease activity and worse prognosis, as reflected by high fibrotic activity and deterioration of lung function over time.
In an oral presentation at the 2022 EASL International Liver Congress (June 22-26, London, UK), Chemomab researchers presented data from a preclinical PSC model that used advanced technologies to reveal unique liver macrophage subpopulations as the major source of CCL24 production in the area of the bile duct that is damaged in PSC. Chemomab scientists also demonstrated in this model that treatment with CM-101 interfered with core PSC disease pathways in a way that is potentially associated with therapeutic activity.
At the first international Extracellular Matrix Pharmacology Conference (June 23-25, Copenhagen DK), Chemomab researchers presented a poster that included both preclinical and early clinical data demonstrating that CM-101 attenuates biomarkers associated with extracellular matrix (ECM) expression. ECM expression is involved in PSC pathophysiology and is closely related to CM-101’s mechanism of action. Importantly, this dataset supports the company’s efforts to translate findings on preclinical biomarkers associated with ECM remodeling in the liver to the use of similar serum biomarkers in patients in its clinical trials.
Appointed Jill M. Quigley, JD, to the Chemomab board of directors. Ms. Quigley brings more than 20 years of biotechnology industry leadership experience encompassing executive management, corporate operations, legal affairs, financings, and board membership. Previously Ms. Quigley was Chief Operating Officer at Passage Bio.
Appointed Ilan Vaknin, PhD, MBA, as Vice President of Research & Development. Dr. Vaknin brings Chemomab more than 20 years of biotechnology drug discovery and development experience in immunology, translational research, antibody development and manufacturing, and bioassay development, including more than a decade in senior science roles at Compugen, Ltd.
Appointed Christina Crater, MD, as Vice President of Clinical Development. Dr. Crater brings Chemomab an extensive background in medical affairs and clinical trial design and execution, across a broad range of therapeutic indications. She has served as medical monitor, safety physician, therapeutic expert and study director in all phases of clinical development. Dr. Crater’s experience spans pharmaceutical firms including Bristol-Myers Squibb, as well as major clinical research organizations including PRA Health Sciences and PAREXEL International.
Presented at the JMP Securities Life Sciences and HC Wainwright Global Investment Conferences. Recorded webcasts from these events can be accessed at Chemomab’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
Second Quarter 2022 Financial Highlights

Cash Position: Cash, cash equivalents and bank deposits were $51.8 million as of June 30, 2022, compared to $57.5 million at March 31, 2022. The company currently expects its runway to last through the end of 2023, consistent with the update provided last quarter.
Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the quarter ended June 30, 2022, compared to $1.3 million for the same quarter in 2021. The increase in R&D expense quarter-over-quarter primarily reflects the ramp-up in activities supporting the company’s clinical programs for CM-101.
General and Administrative (G&A) Expenses: G&A expenses were $3.3 million for the quarter ended June 30, 2022, compared to $1.5 million for the same quarter in 2021. The increase in cash G&A in the second quarter partly reflects key additions to the senior management team, as well as a non-cash charge for previously disclosed equity-based compensation plus a provision accrued for a potential tax liability, the majority of which arises from transactions that took place prior to the company’s reverse merger in March 2021.
Net Loss: Net loss was $6.2 million, or a net loss of approximately $0.03 cents per basic and diluted ordinary share, for the second quarter of 2022, compared to $2.8 million, or a net loss of approximately $0.01 per basic and diluted ordinary share, for the quarter ended June 30, 2021. The weighted average number of Ordinary Shares outstanding, basic and diluted were 228,173,276 (equal to 11,408,664 ADS’s) for the quarter ended June 30, 2022.
For further details on Chemomab’s financial results for the quarter ended June 30, 2022, refer to the Form 10-Q, which will be filed with the SEC today, August 12, 2022.

Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, August 12, 2022

Chemomab management will host a webcast and conference call today, Friday, August 12, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13730646. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call. The webcast link is also available on the company’s website at View Source

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

Chemomab Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update

On August 12, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Anchiano Therapeutics, AUG 12, 2022, View Source [SID1234618209]).

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"We continued to make good progress on multiple fronts in the second quarter," said Dale Pfost, PhD, Chairman and Chief Executive Officer of Chemomab. "We advanced our clinical programs for CM-101, our first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target at the confluence of fibrosis and inflammation; we added to our intellectual property portfolio for CM-101; we presented important new data at major scientific meetings; and we added several highly experienced staff essential to progressing our scientific and clinical priorities."

Dr. Pfost continued, "Congratulations to our research team for gaining issuance of a new U.S patent covering the use of CM-101 in liver diseases such as primary sclerosing cholangitis (PSC), thereby further extending our proprietary protection for disease targets involving hepatic and cholestatic conditions. I am also very pleased at how active our researchers and consultants have been in the past few months educating their scientific and medical peers by presenting data on CCL24 and CM-101 at major international scientific meetings. We recently added several outstanding research and clinical experts to our team to help ensure rapid advancement of our preclinical and clinical programs. In addition, we added a new director, Jill Quigley, JD, who brings a wealth of biotechnology strategic and operational expertise to our board. These are exciting times for our company, and I look forward to reporting more details on our progress in the coming months."

Clinical Update:

Phase 2 Liver Fibrosis Trial in NASH patients

Chemomab concluded the treatment phase of its randomized, placebo-controlled Phase 2 liver fibrosis trial that included a total of 23 NASH patients, with patients in the active arm receiving 5mg/kg of CM-101 delivered subcutaneously in 8 doses administered once every two weeks. This sets the stage for a planned topline study read-out before year-end. Importantly, these data represent the first read-out of CM-101’s activity in patients with established liver disease. The main study outcome is safety and tolerability. Additionally, based on the encouraging signs of activity observed in the CM-101 Phase 1b study in patients with non-alcoholic fatty liver disease, the company believes that evaluations of similar secondary outcomes in this patient population with more severe liver fibrosis and inflammation could be informative, and may provide useful insights in support of the overall CM-101 clinical development program. The trial results should also generate the pharmacokinetic and tolerability data needed to inform next steps in the development of the subcutaneous formulation of CM-101.

Phase 2 Trial in Primary Sclerosing Cholangitis patients

Chemomab previously indicated its intention to increase its efforts in the rare disease primary sclerosing cholangitis, or PSC, including expanding the size and scope of the ongoing randomized, placebo-controlled Phase 2 trial. The company is adding an open label extension and a dose finding component intended to better inform selection of the optimal dose of CM-101 to advance into late development. These revisions have been finalized and global regulatory filings supporting the trial expansion have been initiated, while new sites in Europe and the U.S. continue to open. The company plans to enroll a total of 93 patients: 25 patients in each of the three dosing cohorts, which include the current 10mg/kg dose along with a lower 5 mg/kg dose and a higher 20mg/kg dose. Another 18 patients are receiving placebo. All outcome measures in the trial, including evaluations of serum ALP levels, serum biological markers, and Fibroscan, remain unchanged, except that the primary outcome now is safety. Consistent with this change, the study is not formally powered to assess efficacy. However, cohort sizes sufficient to detect, with expected variability, a clinically relevant improvement in serum ALP levels (defined as change from baseline), which is a key secondary outcome for studies in PSC, have been maintained. A blinded interim Drug Monitoring Committee safety review of the current cohort is planned for late this year, and Chemomab anticipates reporting topline data from the trial in the second half of 2024.

Phase 2 Trial in Systemic Sclerosis patients

Chemomab has made significant progress in delineating the design of its upcoming Phase 2 trial in systemic sclerosis, or SSc, working closely with a number of top systemic sclerosis experts. The company aims to establish biological proof of concept on clinically relevant aspects of this complex disease, focusing on CM-101’s potential activity in modifying the skin, lung and vascular pathophysiology observed in SSc patients. Plans to launch the trial by the end of this year remain on track. A special webcast to provide details on the final trial design is planned in the next several months.

Recent Highlights:

Awarded U.S. Patent No.11365246, "Anti CCL24 (eotaxin 2) Antibodies for Use in the Treatment of Hepatic Disease," a new method of use patent that covers the use of CM-101 and other anti-CCL24 antibodies and binding fragments in the treatment of a range of fibro-inflammatory liver diseases, including primary sclerosing cholangitis and other cholestatic-related disorders. The new patent extends Chemomab’s intellectual property protection for CM-101 in the U.S. for another three years through at least 2038, with additional extensions possible.
At a poster presentation at the EULAR European Congress of Rheumatology (June 1-4, Copenhagen, DK), Chemomab collaborator Professor Francesco Del Galdo of the University of Leeds presented a poster further supporting the role of CCL24 as a therapeutic target for systemic sclerosis. This study, which examined the role of CCL24 in longitudinal cohorts of diffuse cutaneous SSc patients, reported elevated serum levels of CCL24 in these patients and showed that high circulating CCL24 levels were correlated with disease activity and worse prognosis, as reflected by high fibrotic activity and deterioration of lung function over time.
In an oral presentation at the 2022 EASL International Liver Congress (June 22-26, London, UK), Chemomab researchers presented data from a preclinical PSC model that used advanced technologies to reveal unique liver macrophage subpopulations as the major source of CCL24 production in the area of the bile duct that is damaged in PSC. Chemomab scientists also demonstrated in this model that treatment with CM-101 interfered with core PSC disease pathways in a way that is potentially associated with therapeutic activity.
At the first international Extracellular Matrix Pharmacology Conference (June 23-25, Copenhagen DK), Chemomab researchers presented a poster that included both preclinical and early clinical data demonstrating that CM-101 attenuates biomarkers associated with extracellular matrix (ECM) expression. ECM expression is involved in PSC pathophysiology and is closely related to CM-101’s mechanism of action. Importantly, this dataset supports the company’s efforts to translate findings on preclinical biomarkers associated with ECM remodeling in the liver to the use of similar serum biomarkers in patients in its clinical trials.
Appointed Jill M. Quigley, JD, to the Chemomab board of directors. Ms. Quigley brings more than 20 years of biotechnology industry leadership experience encompassing executive management, corporate operations, legal affairs, financings, and board membership. Previously Ms. Quigley was Chief Operating Officer at Passage Bio.
Appointed Ilan Vaknin, PhD, MBA, as Vice President of Research & Development. Dr. Vaknin brings Chemomab more than 20 years of biotechnology drug discovery and development experience in immunology, translational research, antibody development and manufacturing, and bioassay development, including more than a decade in senior science roles at Compugen, Ltd.
Appointed Christina Crater, MD, as Vice President of Clinical Development. Dr. Crater brings Chemomab an extensive background in medical affairs and clinical trial design and execution, across a broad range of therapeutic indications. She has served as medical monitor, safety physician, therapeutic expert and study director in all phases of clinical development. Dr. Crater’s experience spans pharmaceutical firms including Bristol-Myers Squibb, as well as major clinical research organizations including PRA Health Sciences and PAREXEL International.
Presented at the JMP Securities Life Sciences and HC Wainwright Global Investment Conferences. Recorded webcasts from these events can be accessed at Chemomab’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
Second Quarter 2022 Financial Highlights

Cash Position: Cash, cash equivalents and bank deposits were $51.8 million as of June 30, 2022, compared to $57.5 million at March 31, 2022. The company currently expects its runway to last through the end of 2023, consistent with the update provided last quarter.
Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the quarter ended June 30, 2022, compared to $1.3 million for the same quarter in 2021. The increase in R&D expense quarter-over-quarter primarily reflects the ramp-up in activities supporting the company’s clinical programs for CM-101.
General and Administrative (G&A) Expenses: G&A expenses were $3.3 million for the quarter ended June 30, 2022, compared to $1.5 million for the same quarter in 2021. The increase in cash G&A in the second quarter partly reflects key additions to the senior management team, as well as a non-cash charge for previously disclosed equity-based compensation plus a provision accrued for a potential tax liability, the majority of which arises from transactions that took place prior to the company’s reverse merger in March 2021.
Net Loss: Net loss was $6.2 million, or a net loss of approximately $0.03 cents per basic and diluted ordinary share, for the second quarter of 2022, compared to $2.8 million, or a net loss of approximately $0.01 per basic and diluted ordinary share, for the quarter ended June 30, 2021. The weighted average number of Ordinary Shares outstanding, basic and diluted were 228,173,276 (equal to 11,408,664 ADS’s) for the quarter ended June 30, 2022.
For further details on Chemomab’s financial results for the quarter ended June 30, 2022, refer to the Form 10-Q, which will be filed with the SEC today, August 12, 2022.

Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, August 12, 2022

Chemomab management will host a webcast and conference call today, Friday, August 12, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13730646. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call. The webcast link is also available on the company’s website at View Source

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

InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Marginal Zone Lymphoma in China

On August 12, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL) (Press release, InnoCare Pharma, AUG 12, 2022, View Source [SID1234618171]).

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Professor Jun Zhu of the Beijing Cancer Hospital said, "As the principal investigator, I am happy to see the treatment of R/R MZL patients with orelabrutinib reached the preset primary endpoint and showed sustainable efficacy at the dose of 150 mg QD. Orelabrutinib was well tolerated with a safety profile in the patients with MZL. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and we do hope that orelabrutinib can fill the gap in this therapeutic area. "

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: " MZL is a common type of non-Hodgkin’s lymphoma (NHL), accounting for about 7-10% of all NHL1. The incidence is higher in the elderly population, especially those over 80 years old. Current treatment options for R/R MZL are quite limited. Orelabrutinib is expected to be the first BTK inhibitor to be approved for R/R MZL in China. We hope orelabrutinib will benefit MZL patients who are in urgent need of innovative treatment as soon as possible."

On December 25, 2020, orelabrutinib received approval from NMPA in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list. In March 2022, the NMPA accepted a supplemental New Drug Application for orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia.

About Marginal Zone Lymphoma

Marginal zone lymphoma (MZL) is a common B-cell non-Hodgkin’s lymphoma (B-NHL), accounting for about 7-10% of all NHLs. Its incidence rate ranked third after diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). According to WHO classification, MZL can be divided into three subtypes: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT), nodal MZL (NMZL), and splenic MZL (SMZL). Although MZL is an indolent lymphoma, it is still an incurable malignant tumor based on the existing treatment options, and the prognosis of R/R MZL patients is even worse. At present, there is no consensus standard of care in clinical practice, and the therapies for R/R MZL patients are limited. As no effective targeted drug has been approved for the treatment of R/R MZL in China, there is an urgent unmet medical need for patients with R/R MZL.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

Blue Water Vaccines Announces Closing of $10 Million Private Placement Priced At-the-Market Under Nasdaq Rules

On August 11, 2022 Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), a biopharmaceutical company developing transformational vaccines to address significant global health challenges, reported the closing of its previously announced private placement of 3,683,280 shares of common stock (or common stock equivalents in lieu thereof) to several healthcare-focused institutional investors, that was priced at-the-market under Nasdaq rules (Press release, Onconetix, AUG 11, 2022, View Source [SID1234641110]). The Company also issued to investors unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 4,972,428 shares of common stock. The purchase price for one share of common stock (or common stock equivalent) and one investment option was $2.715. The investment options have an exercise price of $2.546 per share, are exercisable immediately upon issuance, and have a term equal to five years.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from the private placement were approximately $10 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the private placement for the research and development of its pipeline as well as for working capital and other general corporate purposes. The Company’s current cash position including the gross proceeds from this private placement is approximately $30.3 million.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with investors, BWV has agreed to file a resale registration statement covering the securities described above within thirty days of August 9, 2022.

In addition, the investors in the private placement agreed to cancel preferred investment options to purchase up to an aggregate of 1,180,812 shares of the Company’s common stock issued in April 2022.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Molecure announces filing of Clinical Trial Application with Polish regulator for OATD-02, a novel dual arginase inhibitor being developed for the treatment of cancer

On August 11, 2022 Molecure S.A. ("Molecure": WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, reported it has filed a Clinical Trial Application (CTA) for OATD-02 with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Press release, Molecure, AUG 11, 2022, View Source [SID1234640064]). The Company plans to conduct a Phase I clinical trial with OATD-02 in patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma.

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The Phase I trial is expected to be an open-label, multi-center, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study is expected to start in the fourth quarter of 2022, subject to regulatory approval.

Marcin Szumowski, Molecure CEO commented, "Today’s CTA filing represents a significant milestone in the development of OATD-02, potentially the first dual arginase inhibitor to enter the clinic. We have already seen promising pre-clinical data that shows OATD-02 has significant anti-cancer activity with potential to improve treatment outcomes in a broad range of solid tumors. Subject to regulatory approval we look forward to advancing OATD-02 into clinical development later this year."

The clinical part of the development of the OATD-02 compound is carried out within the framework of the project: pre-clinical and clinical development of arginase inhibitor for application in anti-cancer immunotherapy (POIR.01.01.01-00-0415/17), cofinanced by the European Union in the framework of European Funds Smart Growth and European Regional Development Fund.

About OATD-02 (oncology)

OATD-02 is being developed as a potential new therapeutic for a range of solid tumors. It is the first and only dual acting, highly potent arginase inhibitor in development for the treatment of cancer, involved in both tumor immunity and metabolism. Arginase 1 (ARG1) and Arginase 2 (ARG2) are validated targets that have been found on a variety of tumor types where their increased activity correlates with more advanced disease and worse clinical prognosis due to diminished arginine levels.