On March 11, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and big data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases, reported business updates and financial results for its third quarter ending September 30, 2021 (Press release, Kiromic, MAR 11, 2022, View Source [SID1234609976]).

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"We believe that we made meaningful progress during the third quarter of 2021 with our corporate developments and with our chemical manufacturing and control manufacturing processes. We believe these developments will allow us to effectively address the FDA clinical hold comments, and will ensure that we are well positioned to advance our oncology cell therapy trial candidates. We were also able to recently complete an internal review associated with certain complaints that the Company received through its complaint hotline. The internal review was conducted by a Special Committee of our Board of Directors. The Company was precluded from filing its Form 10-Q in November 2021 pending completion of the internal review," stated Pietro Bersani, interim Chief Executive Officer of Kiromic BioPharma.

Mr. Bersani continued: "As a result of the internal review, we also appointed two new board members, Frank Tirelli and Karen Reeves, and appointed Michael Nagel as the chairperson of our board of directors. We also established a disclosure committee, which is charged with preparing and overseeing all corporate disclosures made by the Company in response to the ineffectiveness of our disclosure controls and procedures outlined in the Form 8-K filed on February 2, 2022. Accordingly, we anticipate providing more updates and increasing the frequency of our shareholder communications as we report on our progress and upcoming milestones."

Recent Business Highlights:

Surpassed 1.5 billion Data Points Powering Kiromic’s DIAMONDAI Platform for Drug Discovery and Development: The Company added approximately 300 million data points in 2021, representing a 25% increase from 2020. Kiromic’s growing machine learning platform is designed to identify new therapeutic opportunities, prioritizing T and B cell targets, and accelerate development. The increase was primarily driven by Clinical Proteomic Tumor Analysis Consortium ("CPTAC") and Blood Donor Artificial Intelligence analysis. CPTAC is a data portal serving as a centralized repository for the public dissemination of proteomic sequence datasets collected by CPTAC along with corresponding genomic sequence datasets. The National Cancer Institute’s CPTAC is a national effort to accelerate the understanding of the molecular basis of cancer through the application of large-scale proteome and genome analysis, or proteogenomics.
Completion of InSilico Solutions, LLC Acquisition: On July 26, 2021, we announced the completion of the Insilico Solutions, LLC acquisition. InSilico Solutions is a world-class bioinformatics and artificial intelligence (AI) innovator with long-standing collaborative relationships with its clients at University of Texas MD Anderson Cancer Center, Johns Hopkins School of Medicine, and the National Cancer Institute. With this acquisition, Kiromic expanded its team with experts in bioinformatics and AI to accelerate its AI-driven efforts identifying the optimal biomarkers for advanced immuno-oncology therapies like CAR-T cell therapy.
Closing of Public Offering: On July 2, 2021, we received net proceeds of $37,118,100 from a public offering, after deducting underwriting discounts and commissions of $2,494,900 and other offering expenses of $387,000 incurred. The Company issued and sold 8,000,000 shares of common stock in the public offering at a price of $5.00 per share. In connection with the public offering, 400,000 representative warrants were issued with a price of $6.25 per share
Key Hires in Bioinformatics, Manufacturing, Clinical Translational Medicine and Operations: The Company added 24 new hires to positions across Bioinformatics, Manufacturing, Clinical Translational Medicine, and Operations. This represents a total of 37 employees, which is an increase from 13 as of December 31, 2020.

Q3 2021 Financial Highlights

Cash Position: Cash and cash equivalents were $36,161,800 as of September 30, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $11,165,300, and $713,500 for operating activities, and investing activities, respectively. There were cash inflows of $36,881,100 from financing activities.

R&D Expenses: Our research and development expenses increased by $2,261,000, or 184.47%, to $3,486,700 for the three months ended September 30, 2021, from $1,225,700 for the three months ended September 30, 2020. Our research and development expenses increased by $4,504,300, or 127.74%, to $8,030,400 for the nine months ended September 30, 2021, from $3,526,100 for the nine months ended September 30, 2020. The increase was attributable to increased headcount, manufacturing, and experimentation costs for our ALEXIS-ISO-1 clinical trial development.

G&A Expenses: Our general and administrative expenses increased by $1,465,600, or 123.16%, to $2,655,600 for the three months ended September 30, 2021, from $1,190,000 for the three months ended September 30, 2020. Our general and administrative expenses decreased by $5,068,500, or 41.86%, to $7,040,700 for the nine months ended September 30, 2021 from $12,109,200 for the nine months ended September 30, 2020. This decrease was primarily due to reduced stock compensation expenses.

Net Loss: Our net loss decreased to $14,953,600 during the nine months ended September 30, 2021 compared to $15,635,300 during the nine months ended September 30, 2020.

On March 11, 2022 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that management will participate in the Oppenheimer & Co. Annual Healthcare Conference, taking place March 15-17, 2022 as well as the Barclays Global Healthcare Conference, taking place March 15-17 (Press release, Cellectis, MAR 11, 2022, View Source [SID1234609973]). Details for both presentations are below:

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Oppenheimer & Co. Annual Healthcare Conference:

Date: March 16

Time: 4:00pm EST

Webcast: View Source;page=clls&url=View Source

Barclays Global Healthcare Conference:

Date: March 17

Time: 9:30am EST

Webcast: View Source;tp_key=0d6c4a2a9d&tp_special=8

Live webcasts of these events and a replay of these webcasts will be available under the "Events and Webcasts" section on the Investor page of the of the Company’s at website: View Source

On March 11, 2022 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the first quarter of 2022 on Friday, April 29, 2022. Company executives will review financial results and address inquiries from investors and analysts during a conference call at 8:00 a.m. ET on the same date (Press release, Bristol-Myers Squibb, MAR 11, 2022, View Source [SID1234609970]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source To be directly connected to the conference call, enter your information here; the link will be active 15 minutes prior to the scheduled start time of the call, and does not require a dial-in number or operator assistance to be connected. Investors and the public can also access the live webcast by dialing in the U.S. toll free 866-409-1555 or international +1 786-789-4797, confirmation code: 5513095. Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available on View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on April 29 through 11:30 a.m. ET on May 13, 2022, by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 5513095.

On March 11, 2022 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 its financial results for the year ended December 31, 2021 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 11, 2022, View Source [SID1234609969]).

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"We continued to make steady progress throughout 2021 in pursuit of our mission to bring innovative therapies to the fight against cancer. We continue to build on the body of clinical evidence in support of our technology, were delighted to present data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December and look forward to presenting encouraging preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We look forward to achieving a number of value-creating milestones throughout the balance of the year as we seek to leverage the full potential of our DNAbilize platform."

Recent Corporate Highlights

Presented Data from Ongoing Phase 2 Study of Prexigebersen at 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In December, Bio-Path presented a poster highlighting the safety and preliminary efficacy data from its Phase 2 study of prexigebersen (BP1001) at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The poster, titled, "Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen (BP1001) in Patients with High-Risk and Relapsed/Refractory Acute Myeloid Leukemia (AML)," was presented by Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center. The poster described the safety and preliminary efficacy of Bio-Path’s lead drug candidate, prexigebersen (liposomal Grb2 antisense), from a Phase 2 study in combination with decitabine or decitabine plus venetoclax as a potential treatment for patients diagnosed with AML.

Announced Presentation at 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In March, Bio-Path announced an upcoming poster presentation at the 2022 AACR (Free AACR Whitepaper) Annual Meeting, taking place in Atlanta, GA. Dr. Maria Gagliardi, a Research Scientist at Bio-Path Holdings, will discuss preclinical studies of BP1003 (liposomal STAT3 antisense) in combination with paclitaxel or fluorouracil as a potential treatment against breast and ovarian cancer cells.
Financial Results for the Year Ended December 31, 2021

The Company reported a net loss of $10.4 million, or $1.55 per share, for the year ended December 31, 2021, compared to a net loss of $10.9 million, or $2.83 per share, for the year ended December 31, 2020.

Research and development expense for the year ended December 31, 2021, decreased to $5.9 million, compared to $6.6 million for the year ended December 31, 2020, primarily due to timing of activities related to our clinical trial for prexigebersen in AML partially offset by an increase in manufacturing expenses related to drug product batch releases in the fourth quarter of 2021.

General and administrative expense for the year ended December 31, 2021, increased to $4.5 million, compared to $4.3 million for the year ended December 31, 2020, primarily due to increased stock-based compensation expense.

As of December 31, 2021, the Company had cash of $23.8 million, compared to $13.8 million at December 31, 2020. Net cash used in operating activities for the year ended December 31, 2021, was $9.9 million compared to $11.0 million for the comparable period in 2020. Net cash provided by financing activities for the year ended December 31, 2021, was $20.0 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full-year 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 5089985. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On March 11, 2022 AstraZeneca and MSD’s Lynparza (olaparib) reported that it has been approved in the US for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery (Press release, AstraZeneca, MAR 11, 2022, View Source [SID1234609968]).

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The approval by the US Food and Drug Administration (FDA) was based on results from the OlympiA Phase III trial presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The New England Journal of Medicine.1

In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death, by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 95% confidence interval [CI] 0.46-0.74; p<0.0001).

New updated results from the OlympiA trial also showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS), reducing the risk of death by 32% versus placebo (based on a HR of 0.68; 95% CI 0.50-0.91; p=0.0091). The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials. The OS data will be presented at an upcoming European Society for Medical Oncology virtual plenary on 16 March 2022.

Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020.2 Almost 91% of all breast cancer patients in the US are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5-10% of patients.3,4

Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said: "Today’s approval of olaparib is great news for patients with a specific inherited form of breast cancer. Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high and new treatment options are needed. OlympiA has shown that identifying a BRCA1/2 mutation in women with high risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "This important approval gives early-stage breast cancer patients in the US with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today. Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients’ lives versus placebo. These data underline the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "For patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer, who often present with more aggressive disease, today’s approval is an important step forward. Compared to placebo, Lynparza as adjuvant treatment offers these patients the potential to live longer without their cancer recurring. We thank the patients, caregivers and healthcare providers for their participation in the OlympiA trial."

Lynparza is now indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for Lynparza.

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. In the EU, this indication also includes patients with locally advanced breast cancer.

Notes

Financial considerations

Following this approval for Lynparza in the US, AstraZeneca will receive a regulatory milestone payment from MSD of $175m, anticipated to be booked as Collaboration Revenue by the Company during the first quarter of 2022.

Early breast cancer

Early breast cancer is defined as cancer confined to the breast with or without regional lymph node involvement, and the absence of distant metastatic disease.5 In the US, the 5-year survival rate is 99% for localised breast cancer (only found in the breast area) and 86% for regional breast cancer (cancer that has spread outside the breast to nearby structures or lymph nodes).3

Despite advances in the treatment of early breast cancer, up to 30% of patients with high-risk clinical and/or pathologic features recur within the first few years6, and patients with gBRCA mutations are more likely to be diagnosed at a younger age than those without these mutations.7

Breast cancer is one of the most biologically diverse tumour types with various factors fuelling its development and progression.8 The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.9

OlympiA

OlympiA is a Phase III, double-blind, parallel group, placebo-controlled, multicentre trial testing the efficacy and safety of Lynparza tablets versus placebo as adjuvant treatment in patients with gBRCAm high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.10

The primary endpoint of the trial is iDFS defined as time from randomisation to date of first locoregional or distant recurrence or new cancer or death from any cause.11

The OlympiA Phase III trial is led by the Breast International Group in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, the US National Cancer Institute, AstraZeneca and MSD. The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.12

BRCA

BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells.11

When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.11-14

Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as new hormonal agents – NHAs).

Inhibition of PARP proteins with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.

Lynparza is currently approved in a number of countries across PARP-dependent tumour types with defects and dependencies in the DDR pathway including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD)-positive advanced ovarian cancer, respectively; for germline BRCAm, HER2-negative metastatic breast cancer (in the EU this includes locally advanced breast cancer); for germline BRCAm metastatic pancreatic cancer; and HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm only in the EU and Japan).

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.

Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. The companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines independently.

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex and Zoladex and the next-generation oral selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

The PARP inhibitor, Lynparza, is an approved targeted treatment option for early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD continue to research Lynparza in breast cancer patients with an inherited BRCA mutation.

Building on the first approval of Enhertu, a HER2-directed antibody drug conjugate (ADC), in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.