On May 10, 2022 Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Tuesday, May 17, 2022 at 8:30 a.m. ET to report financial results for the first quarter ended March 31, 2022 and to provide a business overview (Press release, Bio-Path Holdings, MAY 10, 2022, View Source [SID1234614170]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 9488426. A live audio webcast of the call will also be available on the Presentations section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On May 10, 2022 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported its financial results for the first quarter ended March 31, 2022, and recent business highlights (Press release, Achilles Therapeutics, MAY 10, 2022, View Source [SID1234614168]).

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"We recently dosed the first patient with our higher-dose cNeT therapy in the CHIRON clinical trial for the treatment of advanced non-small cell lung cancer (NSCLC) and began enrollment in Cohort B of the THETIS clinical trial evaluating cNeT in combination with a PD-1 checkpoint inhibitor for the treatment of metastatic malignant melanoma. We expect to report initial higher-dose monotherapy data from both CHIRON and THETIS as well as initial combination data from THETIS Cohort B in the second half of 2022," said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We also expanded our global footprint, including increased clinical manufacturing capacity in the United Kingdom and the United States, where we have established a US headquarters in Philadelphia that will house our first US R&D facility, to further support our clinical programs. Overall, our unique approach to targeting clonal neoantigens, differentiated ability to detect, quantify and track our cNeT products, and strong balance sheet continue to position us well to execute across our upcoming value-creating catalysts."

Business Highlights

Dosed the first patient with higher-dose (Process 2) cNeT monotherapy in the CHIRON clinical trial for advanced NSCLC.
Following a positive Independent Data Safety Monitoring Committee review, initiated enrollment of THETIS Cohort B to evaluate cNeT therapy in combination with a PD-1 checkpoint inhibitor for the treatment of metastatic malignant melanoma.
Strengthened the Board of Directors with the addition of independent member Bernhard Ehmer, MD.
Expanded global manufacturing by increasing capacity in the United Kingdom with a GMP license obtained for the Cell & Gene Therapy Catapult facility, and entered into a partnership agreement for clinical manufacturing in the United States with the Center for Breakthrough Medicines, a contract development and manufacturing organization in King of Prussia, Pennsylvania.
Hosted a key opinion leader webcast highlighting important data selected from the 31 posters and presentations on the TRACERx study presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
Financial Highlights

Cash and cash equivalents: Cash and cash equivalents were $236.9 million as of March 31, 2022, as compared to $266.3 million as of December 31, 2021. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations into the second half of 2024, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.
Research and development (R&D) expenses: R&D expenses were $13.0 million for the first quarter ended March 31, 2022, as compared to $8.9 million for the first quarter ended March 31, 2021. The increase was primarily driven by increased activity related to our ongoing clinical trials and overall R&D.
General and administrative (G&A) expenses: G&A expenses were $6.0 million for the first quarter ended March 31, 2022, as compared to $4.8 million for the first quarter ended March 31, 2021. The increase was primarily driven by fees associated with the Company’s public company obligations, and an increase in headcount and related personnel costs.
Net loss: Net loss for the first quarter ended March 31, 2022, was $17.4 million or $0.45 per share compared to $13.8 million, or $8.38 per share for the first quarter ended March 31, 2021.
2022 Milestones and Upcoming Events

Higher-dose Monotherapy: Report initial data from the higher-dose cohort of patients undergoing cNeT monotherapy for the treatment of NSCLC and melanoma in the second half of 2022.
cNeT Combination: Dose first melanoma patient with cNeT in combination with a PD-1 checkpoint inhibitor in Cohort B of the THETIS clinical trial and report initial data in the second half of 2022.
Manufacturing: Begin clinical cNeT production at the Cell & Gene Therapy Catapult facility in the second half of 2022.
Tumor Archiving Program: Initiate program in the second quarter of 2022.
Achilles will present at the following medical and investor conferences in May 2022. Additional details will be available in the Events & Presentations section of the Company’s website:

BofA Securities 2022 Healthcare Conference: May 9-13, 2022
H.C. Wainwright Global Investment Conference: May 23-26, 2022

On May 10, 2022 Harbour BioMed (the "Company", HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported the Company will release the progress of the next-generation anti-CTLA-4 antibody HBM4003 studies of monotherapy and combination therapy with anti-PD-1 antibody at 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on June 3-7 in Chicago (Press release, Harbour BioMed, MAY 10, 2022, View Source [SID1234614153]).

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Details for the presentations:

Abstract One

Title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors
Abstract number: 363712
Publication Format: Poster

Abstract Two:

Title: A Phase I Open-label Study to Evaluate the Safety, Tolerability, PK/PD and Anti-tumor Activity of HBM4003 in Combination with Toripalimab in Subjects with Advanced Melanoma and Other Solid Tumors
Abstract number: 368316
Publication Format: Abstract

"We are extremely pleased to announce the progress of HBM4003 studies at ASCO (Free ASCO Whitepaper) Annual Meeting 2022. HBM4003 has a remarkable safety and tolerability profile with encouraging anti-tumor efficacy. Given the high therapeutic promise of HBM4003, we are proceeding with multiple global phase Ib/IIa trials in solid tumors. We look forward to bringing this novel therapeutic to cancer patients worldwide." Said Dr. Humphrey Gardner, CMO of Harbour BioMed.

HBM4003 has demonstrated strong efficacy and excellent safety profile. It is believed that this product will have the potential to lead the development of next generation therapy of immuno-oncology, especially combination therapeutics. The Company will continue to be fully committed to advancing the global clinical development project of HBM4003, furthering its global innovation and development strategy in 2022.

Harbour BioMed is developing HBM4003 as part of its broad and innovative immuno-oncology pipeline to address significant unmet medical needs in many solid tumor indications.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 expressing Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combination therapy.

On May 10, 2022 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal second quarter ended March 31, 2022 (Press release, ESSA, MAY 10, 2022, View Source [SID1234614152]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"During this past quarter, we continued to dose patients in our Phase 1 monotherapy study of EPI-7386, a first-in-class N-terminal domain ("NTD") androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies," stated David Parkinson, M.D., President and CEO of ESSA. "We expect to present a clinical update on the monotherapy trial in the first half of 2022. In addition, several clinical collaborations are underway investigating the potential clinical benefit of EPI-7386 in combination with approved second-generation antiandrogens, including the Company-sponsored Phase 1/2 study of EPI-7386 in combination with enzalutamide in mCRPC patients who have not yet been treated with second-generation antiandrogen therapies."

Clinical and Corporate Highlights

EPI-7386 Monotherapy

The Company is currently dosing patients in the Phase 1a dose escalation study evaluating EPI-7386 as a monotherapy in patients with mCRPC. Patients are being dosed at 1,000 mg QD, 800 mg/day administered as 400 mg twice daily (BID) and 1200 mg/day administered as 600 mg BID.

The Company expects to provide a clinical update on the Phase 1a dose escalation study in the first half of 2022.

The Phase 1b study is expected to commence in the second half of 2022 and will confirm a recommended Phase 2 dose ("RP2D").
EPI-7386 Clinical Collaborations

In January 2022, the Company dosed the first patient in the Company-sponsored Phase 1/2 study of EPI-7386 in combination with Astellas Pharma Inc.’s and Pfizer Inc.’s enzalutamide in patients with mCRPC who have not been treated with second-generation antiandrogen therapies.

Janssen Research and Development LLC has initiated a Phase 1/2 trial of EPI-7386 in combination with apalutamide or abiraterone acetate plus prednisone in earlier line mCRPC patients.

The Bayer-led Phase 1/2 trial will evaluate EPI-7386 in combination with darolutamide in earlier line mCRPC patients.
Preclinical

On April 10, 2022 at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the Company presented preclinical data for its first generation of androgen receptor (AR) ANITen bAsed Chimera (ANITAC) (NTD) degraders showing orally bioavailable ANITAC degraders can eliminate full length, mutant and splice variant forms of AR that are expressed in castration-resistant prostate cancer (CRPC) patients, and that ANITAC degraders inhibit AR-dependent transcription and reduce viability of AR-dependent prostate cancer cells.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $10.9 million ($0.25 loss per common share based on 44,030,480 weighted average common shares outstanding) for the quarter ended March 31, 2022, compared to a net loss of $13.0 million ($0.36 loss per common share based on 36,484,041 weighted average common shares outstanding) for the quarter ended March 31, 2021. For the quarter ended March 31, 2022, this included non-cash share-based payments of $1.9 million compared to $2.7 million for the comparable period in 2021, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2022 were $7.6 million compared to $7.3 million for the quarter ended March 31, 2021 and included non-cash costs related to share-based payments ($1.1 million for the quarter ended March 31, 2022 compared to $791,969 for the quarter ended March 31, 2021). The increase in R&D expenditures for the first fiscal quarter ended March 31, 2022 was primarily related to clinical data analysis associated with the Phase 1a clinical study, as well as increased expenses related to intellectual property and salaries, as well as the non-cash share-based expenses.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2022 were $3.8 million compared to $4.6 million for the quarter ended March 31, 2021 and included non-cash costs related to share-based payments of $741,494 for the quarter ended March 31, 2022 compared to $1.9 million for the comparable period in 2021. The increased expenditure is the result of increased professional fees related to higher salaries and benefits, as well as the non-cash share-based payments.
Liquidity and Outstanding Share Capital
At March 31, 2022, the Company had available cash reserves and short-term investments of $181.0 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2024.

As of March 31, 2022, the Company had 44,059,700 common shares issued and outstanding.

In addition, as of March 31, 2022 there were 3,234,750 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted average exercise price of $49.69. There were 6,795,736 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.33 per common share.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase 1 clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of ESSA’s Investigational New Drug application and Health Canada acceptance. EPI-7386 is also being studied in earlier line mCRPC patients in Phase 1/2 trials in combination with enzalutamide, apalutamide and abiraterone acetate with prednisone. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

On May 10, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an immunology company, reported financial results for the first quarter of 2022 (Press release, Corbus Pharmaceuticals, MAY 10, 2022, View Source [SID1234614150]).

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Key Corporate and Program Updates:

Anti-integrin monoclonal antibodies (mAb) program targeting the inhibition of TGFβ is progressing on schedule.
CRB-601, an anti-αvβ8 mAb, is being developed as a potential treatment for solid tumors. Corbus presented the first preclinical data for CRB-601 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022. The poster can be viewed at: www.corbuspharma.com/AACRposter.
The most recent data from CRB-601 will be presented on May 11, 2022 at the New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). This new data demonstrates effects of CRB-601 in additional syngeneic animal models with increasing levels of resistance to check point inhibitors.
Across models explored to date, CRB-601 demonstrates an enhancement of anti-tumor activity when combined with anti PD-1 therapy compared to either single agent alone. This enhancement of efficacy is associated with tumor infiltration of proliferating CD4+ and CD8+ T cells in addition to NK cells and M1 macrophages.
Collectively, this data supports the hypothesis that blockade of local TGFb production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, potentially enhancing the benefit of PD-1 blockade.
IND-enabling activities for CRB-601 are ongoing and the program is on-schedule for an IND submission in the first half of 2023.

A lead candidate, CRB-913, has been selected for the CB1 inverse agonist program. In animal models of diet-induced obesity, CRB-913 induced weight loss and impacted multiple metabolic parameters, both as monotherapy and in combination with semaglutide and tirzepatide. Corbus is seeking partnerships to advance CRB-913 into clinical studies.

The National Institutes of Health sponsored Phase 2 study of lenabasum in systemic lupus erythematosus has completed its last patient visit and the clinical database has been locked. The Company is awaiting topline results. Corbus is pursuing potential partnerships to fund further development of lenabasum.

A detailed update on the Corbus pipeline can be found in the most recent Corporate Presentation available at: ir.corbuspharma.com/presentations
"We are executing our plan to transform Corbus into a company with a novel and diversified immuno-oncology pipeline. We’re excited about the first data to come out of our integrin program and for the opportunity to present it at scientific conferences. We look forward to entering the clinic in 2023," commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We are actively engaging in business development activities with the goal of expanding our immuno-oncology pipeline while monetizing our ECS assets through new partnerships."

Financial Results for First Quarter Ended March 31, 2022:

The Company reported a net loss of approximately $9.4 million, or a net loss per diluted share of $0.08, for the three months ended March 31, 2022, compared to a net loss of approximately $16 million, or a net loss per diluted share of $0.14, for the same period in 2021.

Operating expenses decreased by $7.5 million to approximately $8.5 million for the three months ended March 31, 2022, compared to $16 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.

As of March 31, 2022, the company has $86.8 million of cash and investments on hand which is expected to fund operations into the first quarter of 2024, based on the current planned expenditures.