On March 11, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Leap Therapeutics, MAR 11, 2022, View Source [SID1234609977]).

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Leap Highlights:

Presented positive new data from the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the ESMO (Free ESMO Whitepaper) Annual Congress and ASCO (Free ASCO Whitepaper) GI Cancers Symposium
Completed a $103.6 million public offering of common stock and pre-funded warrants to purchase common stock, resulting in net proceeds of $96.8 million
Entered partnership on companion diagnostic with Leica Biosystems to advance care for cancer patients
Presented clinical data from its Phase 2 clinical trial of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer
"2021 was year of substantial clinical accomplishments for Leap as we presented positive data from our DisTinGuish clinical trial, which demonstrated compelling efficacy driven by enhanced clinical responses and survival benefit associated with high tumoral DKK1 expression that is independent of PD-L1 expression in patients with first-line gastroesophageal junction (G/GEJ) cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Following our public offering, we are well funded to advance DKN-01 into the next stages of development in G/GEJ and other cancers, and we look forward to presenting updated data from the DisTinGuish Study in the second half of 2022."

Business Update

Leap Completed a $103.6 Million Public Offering of Common Stock and Pre-Funded Warrants to Purchase Common Stock. In September 2021, Leap announced the commencement and closing of an underwritten public offering of 27,568,072 shares of its common stock, including the sale of an additional 4,740,000 shares of its common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares, and of pre-funded warrants to purchase 8,771,928 shares of its common stock. Aggregate gross proceeds to Leap from the offering were $103.6 million, including $7.25 million invested by its collaborator and existing investor BeiGene, Ltd., resulting in net proceeds after underwriting discounts and commissions and offering expenses of $96.8 million.

Entered Partnership on Companion Diagnostic with Leica Biosystems to Advance Care for Cancer Patients. In January 2022, Leap and Leica Biosystems, a cancer diagnostics company, entered into an agreement to develop a companion diagnostic to detect DKK1. The assay developed by Leica will utilize RNAscope technology on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity to help identify patients most likely to benefit from DKN-01 treatment.
DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Positive New Data from the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab and Chemotherapy Presented at the ASCO (Free ASCO Whitepaper) GI Cancer Symposium. The Company presented positive updated new data from the first-line cohort of the Phase 2a study in patients with gastric or gastroesophageal junction cancer (G/GEJ) and initial findings from the still-enrolling Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced G/GEJ patients with high tumoral DKK1 expression.

First-Line Part A Key Findings:
Overall preliminary median progression-free survival (PFS) was 10.7 months
PFS was longer in DKK1-high patients at 11.9 months, compared to 10.7 months in DKK1-low patients
Preliminary median duration of response (DoR) was 10.7 months in DKK1-high patients, compared to 7.9 months in DKK1-low patients
Median overall survival has not been reached
Among patients who received a full first cycle of DKN-01 (modified intent to treat, n=22), the objective response rate (ORR) was 68%, including one complete response (CR) and 14 partial responses (PR)
90% ORR in DKK1-high patients (n=10)
56% ORR in DKK1-low patients (n=9)
Activity was independent of PD-L1 expression
79% ORR in PD-L1-low (vCPS < 5) and 67% ORR in PD-L1-high (vCPS > 5) patients
100% ORR in DKK1-high, PD-L1-low patients (n=6)
Combination was well tolerated, safety profile consistent with previous update and reflecting the underlying patient population

Second-Line Part B Key Findings:
DKN-01 and tislelizumab administered in DKK1-high, PD-1 naïve patients was well tolerated at both 300mg and 600mg DKN-01 doses
Among evaluable patients who received a full first cycle of DKN-01 (response evaluable modified intent to treat, n=20), the objective response rate (ORR) was 25%, including 5 PRs and 4 stable disease (SD). One additional patient has had an irPR by iRECIST criteria
PD-L1 expression is low overall in the study population and not correlated with DKK1 expression
The study is ongoing and enrolling in the 600mg DKN-01 cohort. Twelve patients were on study at the time of the data cut, four of whom had not yet had their first imaging assessment

Final Data for DKN-01 as a Monotherapy or in Combination with Paclitaxel in Groups Composed of Epithelial Endometrial Cancer (EEC), Epithelial Ovarian Cancer (EOC), or Carcinosarcoma (MMMT) Patients Presented at the SGO 2021 Virtual Meeting on Women’s Cancer. The key findings from the study were:

DKN-01 has enhanced activity in patients whose tumors express high levels of DKK1: In the group of 23 EEC patients treated with DKN-01 monotherapy for whom DKK1 expression data was available, patients with DKK1-high tumors (n=8) achieved 1 CR and 1 PR, along with greater ORR (25% vs. 0%), DCR (63% vs. 7%), and median PFS (4.3 months vs. 1.8 months [HR 0.26; 95 CI: 0.09, 0.75]) compared to patients with DKK1-low tumors (n=15). In the group of 24 EEC patients treated with DKN-01 plus paclitaxel, 72% of whom had received three or more prior systemic therapies, DKK1-high patients (n=11) had improved median PFS (5.4 months vs. 1.8 months [HR 0.34; 95% CI: 0.12, 0.97]) compared to DKK1-low patients (n=9).
Selected Year-End and Fourth Quarter 2021 Financial Results

Net Loss was $40.6 million for the year ended December 31, 2021, compared to $27.5 million for the year ended December 31, 2020. The increase was primarily due to increased research and development expenses and general and administrative expenses.

License revenues were $1.5 million for each of the full years 2021 and 2020, and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. License revenues were $0.4 million for each of the fourth quarters 2021 and 2020.

Research and development expenses were $32.2 million for the full year 2021, compared to $20.4 million for the same period in 2020. Research and development expenses were $8.1 million for the fourth quarter ended 2021, compared to $5.1 million for the same period in 2020. The increases were primarily due to an increase in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns, an increase in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, and an increase in payroll and other related expenses due to an increase in headcount of research and development full time employees.

General and administrative expenses were $10.8 million for the full year 2021, compared to $9.6 million for the same period in 2020. General and administrative expenses were $2.8 million for the fourth quarter ended 2021, compared to $2.4 million for the same period in 2020. The increases were primarily due to an increase in payroll and other related expenses due to an increase in headcount of general and administrative full time employees and an increase in compensation expense.

Cash and cash equivalents totaled $114.9 million at December 31, 2021. Research and development incentive receivables totaled $1.2 million at December 31, 2021.

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.