On March 11, 2021 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global oncology technology solutions provider engaged in transforming drug discovery and development through data-driven research strategies and innovative pharmacology, biomarker and data platforms, reported its financial results for the third fiscal quarter ended January 31, 2021 (Press release, Champions Oncology, MAR 11, 2021, View Source [SID1234576487]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Third Quarter and Recent Highlights:

•Delivered record quarterly revenue of $10.8 million, an increase of 20% year over year
•Reported non-GAAP income from operations, excluding stock-based compensation, depreciation and amortization, of $1.3 million
•Expanded Lumin Bioinformatics proprietary SaaS platform with proteomic module integration

Ronnie Morris, CEO of Champions, commented, "We are pleased with our third quarter results and we continue to execute our long term strategy of investing in the development of new products and services to increase our revenue streams."

David Miller, CFO of Champions, added, "We delivered another record quarter with revenue increasing to $10.8 million. In addition to the growth in our product and service offerings, we’re bringing the outsourced ex-vivo work in-house to our labs which we expect will impact margins positively in the future."

Third Fiscal Quarter Financial Results

For the third quarter of fiscal 2021, revenue increased 20.0% to $10.8 million compared to $9.0 million for the third quarter of fiscal 2020. The increase in revenue was due to a continued increase in sales,

Exhibit 99.1
both in number and size of studies, and the expansion of both our platform and product lines. Our contract amounts have increased as we perform more complex studies and end point analysis testing. Total costs and operating expenses for the third quarter of fiscal 2021 were $10.0 million compared to $8.6 million for the third quarter of fiscal 2020, an increase of $1.5 million or 17.1%.

For the third quarter of fiscal 2021, Champions reported income from operations of $763,000, including $232,000 in stock-based compensation and $297,000 in depreciation and amortization expenses, an increase of $330,000 compared to income from operations of $433,000, inclusive of $229,000 in stock-based compensation and $219,000 in depreciation and amortization expenses, in the third quarter of fiscal 2020. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $1.3 million for the third quarter of fiscal 2021 compared to non-GAAP income from operations of $881,000 in the third quarter of fiscal 2020, an increase of $411,000.
Cost of oncology solutions was $4.8 million for the three-months ended January 31, 2021, an increase of $0.5 million, or 12.0% compared to $4.3 million for the three-months ended January 31, 2020. For the three- months ended January 31, 2021, gross margin was 55.2% compared to 52.0% for the three-months ended January 31, 2020. The increase in cost of oncology services for the three-month period was mainly due to an increase in compensation and lab supply expenses. The increase in cost of sales is generally in line with the expected contribution based on the growth in revenue, study volume, and expansion into new services. Gross margin varies based on timing differences between expense and revenue recognition and was boosted by the revenue recognized from outsourced work where costs were partially recognized in prior quarters.
Research and development expense for the three-months ended January 31, 2021 was $1.9 million, an increase of $488,000 or 35.1%, compared to $1.4 million for the three-months ended January 31, 2020, respectively. The increase was due to increased compensation and lab supply expense as we continued to develop new service capabilities and endpoint analysis testing. Additionally, we incurred proteomic sequencing costs as our investment in characterizing our TumorBank continued, adding valuable data to our platform. Sales and marketing expense for the three-months ended January 31, 2021 was $1.5 million, an increase of $185,000, or 14.2%, compared to $1.3 million for the three-months ended January 31, 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development team. General and administrative expense for the three-months ended January 31, 2021 was $1.8 million, an increase of $280,000, or 18.0%, compared to $1.6 million for the three-months ended January 31, 2020, respectively. The increase was primarily due to compensation and IT related expenses.
Net cash used in operating activities was $107,000 for the three-months ended January 31, 2021 compared to net cash provided by operating activities of $280,000 for the same period last year. The decrease in cash flow from operations was primarily due to a significant reduction in our accounts payable balance along with timing differences in other working capital accounts in the ordinary course of business.

The Company ended the quarter in a strong cash position with a $7.4 million cash balance compared to $3.3 million at the end of the same period last year. The Company has no debt.

Year-to-Date Financial Results

For the first nine months of fiscal 2021, revenue increased 30.4% to $30.5 million, as compared to $23.4 million for the first nine months of fiscal 2020. For the first nine months of fiscal 2021, total

Exhibit 99.1
operating expenses increased 27.6% to $29.7 million, as compared to $23.3 million for the first nine months of fiscal 2020. The increase in revenue was due to increased sales, both in number and size of studies, an increase in demand for our services, the growth of the platform, and the expansion of our product line. Our customers are seeking more complex study designs and end point analysis testing, contributing to the larger contract sizes.

For the first nine months of fiscal 2021, Champions reported income from operations of $795,000, which includes $437,000 in stock-based compensation and $881,000 in depreciation and amortization expenses, an increase of $686,000 or 629%, compared to income from operations of $109,000, inclusive of $437,000 in stock-based compensation and $579,000 depreciation, for the first nine months of fiscal 2020. Excluding stock-based compensation and depreciation, Champions reported non-GAAP operating income of $2.1 million for the first nine months of fiscal 2021 compared to non-GAAP operating income of $1.1 million in the same period last year.

Cost of oncology solutions was $15.8 million for the first nine months of fiscal 2021 compared to $12.0 million for the first nine months of fiscal 2020, an increase of $3.9 million or 32.3%. Gross margin was 48.1% for the first nine months of fiscal 2021 compared to 48.8% for the first nine months of fiscal 2020. The increase in cost of oncology services for the nine month period was mainly due to an increase in compensation, lab supply, and outsourced lab service expenses. Gross margin varies based on timing differences between expense and revenue recognition and was driven lower by the increase in costs on growing study volume in advance of revenue recognition. The cost of outsourced lab services amplified this impact.

Research and development expense was $5.1 million for the first nine months of fiscal 2021 an increase of $1.1 million, or 27.0% compared to $4.0 million for the first nine months of fiscal 2020. The increase was due to increased compensation and lab supply expense as we continued to develop new service capabilities and endpoint testing analysis, and incurred sequencing costs as we continued to characterize our TumorBank. Sales and marketing expense for the first nine months of fiscal 2021 was $4.0 million, an increase of $893,000, or 28.3% compared to $3.2 million for the first nine months of fiscal 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our sales force. General and administrative expense was $4.7 million for the first nine months of fiscal 2021, an increase of $568,000, or 13.8% compared to $4.1 million for the first nine months of fiscal 2020. General and administrative expenses are primarily comprised of compensation, insurance, accounting fees, and depreciation expenses and have increased to support the overall infrastructure growth of the company.

Net cash provided by operations was $299,000 for the first nine months of fiscal 2021 compared to net cash provided by operations of $360,000 in fiscal 2020, a decrease of $61,000 or 16.9%. The decrease in cash from operations was primarily due to timing differences in working capital accounts in the ordinary course of business.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its third quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."
Full details of the Company’s financial results will be available by Wednesday, March 17, 2021 in the Company’s Form 10-Q at www.championsoncology.com.

On March 11, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today provided a business update and reported fourth quarter and full year 2020 financial results (Press release, Oncternal Therapeutics, MAR 11, 2021, View Source [SID1234576486]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In 2021, we are advancing a deep pipeline of differentiated oncology assets. We have now initiated early-stage work in ROR1-targeting immunotherapies, including CAR-T and CAR-NK cell therapies, while moving forward the later-stage clinical development of cirmtuzumab, an antibody targeting ROR1, in MCL, which has generated encouraging data in this difficult to treat cancer. At the same time, we continue to evaluate TK216, an ETS inhibitor which has generated promising results in Ewing sarcoma," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We have also strengthened our balance sheet by raising $125 million in 2020, which provides us with the runway to advance our promising programs into 2023. We have several key data read-outs pending in the second quarter this year."

Recent Highlights

In January 2021, we announced an agreement with Lentigen Technology, Inc., a wholly-owned subsidiary of Miltenyi Biotec B.V. & Co. KG, to manufacture lentiviral vectors to support Oncternal’s investigational ROR1-targeting CAR-T cell therapy program.
In January 2021, we announced a research and development collaboration with Karolinska Institutet in Stockholm, Sweden, to advance novel ROR1-targeting CAR-T and CAR-NK cell therapies from the laboratory into the clinic.
In December 2020, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial of cirmtuzumab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib in patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Virtual Annual Meeting. Best objective response rate of 87%, including complete response (CR) rate of 47%, was reported for 15 evaluable patients with relapsed/refractory (r/r) MCL. Median progression-free survival (PFS) was not reached for patients with MCL, with the 95% confidence interval above 17.5 months, after a median follow-up of 12.1 months. The median PFS was not reached for patients with treatment-naïve CLL (n=19) after a median follow-up of 16.6 months, and median PFS was 29.5 months for patients with r/r CLL (n=30) after a median follow-up of 17.1 months. The combination of cirmtuzumab and ibrutinib was well tolerated in this trial.
In November 2020, we announced an interim clinical data update from the ongoing Phase 1/2 clinical trial evaluating TK216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with r/r Ewing sarcoma at the Connective Tissue Oncology Society 2020 Virtual Annual Meeting. The reported disease control rate (CR, partial response or stable disease) was 43%, including two patients with durable complete responses that were ongoing at over 1.5 years and 8 months on treatment.
In October 2020, we announced that the U.S. Food and Drug Administration granted Rare Pediatric Disease designation for TK216 for the treatment of Ewing sarcoma.
In November and December 2020, we raised an aggregate of approximately $109 million in gross proceeds from two underwritten offerings.
Expected Upcoming Milestones

Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study in Q2 2021
Clinical data update for patients with HER2-negative breast cancer in the ongoing Phase 1b study in Q2 2021
Preclinical data in additional ROR1 expressing tumors in Q2 2021
ROR1 CAR-T program
First-in-human dosing in China in the second half of 2021
TK216 (ETS inhibitor) program
Clinical data for patients with Ewing sarcoma treated in the ongoing Phase 1/2 expansion cohort in Q2 2021
Preclinical data in additional ETS-driven tumors in Q2 2021
Fourth Quarter and Full Year 2020 Financial Results
Our grant revenue was $1.6 million for the fourth quarter ended December 31, 2020. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL. For the full year 2020, grant revenue was $3.4 million.

Our total operating expenses for the fourth quarter ended December 31, 2020 were $4.4 million. Research and development expenses for the quarter totaled $3.0 million, and general and administrative expenses for the quarter totaled $1.5 million. Net loss for the fourth quarter was $2.6 million, or a loss of $0.09 per share, basic and diluted. For the full year 2020, total operating expenses were $20.9 million. Net loss for the full year 2020 was $17.2 million, or a loss of $0.85 per share, basic and diluted.

As of December 31, 2020, we had $116.7 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into 2023. As of December 31, 2020, we had approximately 48.8 million shares of common stock outstanding.

Management Webcast
As previously announced, Oncternal will host a webcast today, March 11, 2020, at 5:00 p.m. ET. The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On March 11, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the virtual Oppenheimer 31st Annual Healthcare Conference at 2:30 p.m. ET on Tuesday, March 16, 2021 (Press release, Amgen, MAR 11, 2021, View Source [SID1234576485]). David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On March 11, 2021 PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, and BioVectra Inc., an innovative global contract development and manufacturing organization (CDMO), reported a commercial scale supply agreement for the production of bentracimab, PhaseBio’s lead product candidate currently in a global Phase 3 clinical trial (Press release, PhaseBio Pharmaceuticals, MAR 11, 2021, View Source [SID1234576484]). Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta (ticagrelor).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, BioVectra will provide its integrated CDMO services for the manufacturing of the active pharmaceutical ingredient (API) of bentracimab for use in PhaseBio’s ongoing global clinical trials and for global commercial use upon regulatory approval. Utilizing a cost-efficient, E.coli-based manufacturing process at its manufacturing site in Windsor, Nova Scotia, BioVectra recently completed the first GMP run of bentracimab at commercial scale. Going forward, PhaseBio plans to integrate API manufactured at commercial scale at BioVectra into the ongoing Phase 2b and Phase 3 REVERSE-IT clinical trials to support global regulatory filings.

"As we prepare for the next phase of growth for bentracimab, we’re pleased to sign this agreement with BioVectra for the commercial supply and development of our novel reversal agent," said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. "Having recently expanded our global Phase 3 REVERSE-IT trial into Canada and the European Union, and with other countries on the horizon, the signing of this agreement and the completion of our first commercial-scale manufacturing run are important steps as we continue preparing our regulatory filings and commercialization efforts for bentracimab. We believe BioVectra will be an excellent partner as we move down the path of developing and potentially commercializing the first specific antiplatelet reversal agent for ticagrelor."

Pending approval of the drug by regulators, the partnership will enable PhaseBio to supply bentracimab at launch in the U.S. to key trauma and critical care centers. Based on data from IQVIA, PhaseBio believes that providing adequate bentracimab supply for initial stocking and demand-based reorders for these key centers will make bentracimab accessible to approximately 80% of the population in the U.S. who are prescribed P2Y12 inhibitors like ticagrelor.

"We’re excited to be partnering with PhaseBio under this new commercial agreement for the high-volume scale-up and global supply of bentracimab," said Oliver Technow, Chief Executive Officer of BioVectra. "BioVectra is an expert CDMO with proven, specialized capability in scaling the most complex biologic drug substances produced from fermentation. Leveraging our fully integrated approach and 50 years of experience, our highly-skilled team looks forward to continuing to make a difference in patients’ lives by delivering on and supporting PhaseBio’s global commercialization of bentracimab from our new, large-scale Microbial Biomanufacturing facility."

About Bentracimab (PB2452)

Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, bentracimab demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor’s antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of antiplatelet drugs. The Phase 1 clinical trial of bentracimab in healthy volunteers was published in the New England Journal of Medicine in March 2019. In April 2019, bentracimab received Breakthrough Therapy Designation from the FDA. Breakthrough Therapy Designation may be granted by the FDA when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapy. In September 2019, PhaseBio completed a Phase 2a trial in which bentracimab was investigated in older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In both arms of the trial, bentracimab achieved immediate and sustained reversal of the antiplatelet effects of ticagrelor and was generally well-tolerated, with only minor adverse events reported. These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. PhaseBio initiated the REVERSE-IT trial, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a Biologics License Application for bentracimab in both major bleeding and urgent surgery indications. There are currently no approved reversal agents for ticagrelor or any other antiplatelet drugs.

On March 11, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported that James Caruso, president and CEO, will present a company overview and be available for 1×1 meetings at the following upcoming conferences (Press release, Cellectar Biosciences, MAR 11, 2021, View Source [SID1234576482]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Oppenheimer 31st Annual Healthcare Conference

Date: March 16, 2021
Presentation Time: 8:00 am ET
Available for 1×1 meetings
Webcast: To register, click on the link HERE
Maxim Group 2021 Emerging Growth Virtual Conference

Date: March 17-19, 2021
Webcast: To register, click on the link HERE
The company’s presentation is available for on-demand viewing in the link HERE.