On March 11, 2021 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported fourth quarter and year-end 2020 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAR 11, 2021, View Source [SID1234576509]).

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Recent Events & Highlights

Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States

Presented data on smoker and e-cigarette user attitudes and perceptions on quitting at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting on February 24, 2021

Closed financing of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses, in December 2020

Facilitated Smoking Cessation Key Opinion Leader Virtual Roundtable in November 2020

"We concluded 2020 in the best financial position since the Company’s inception and with the Phase 3 ORCA-2 trial underway at 15 well-established smoking cessation research centers in the United States. As we look to the year ahead, our focus will continue to be on execution of this pivotal trial, completion of additional NDA-enabling activities, and exploration of new opportunities for expansion into additional populations, such as vaping and e-cigarette users, who may benefit from a new cessation therapeutic option like cytisinicline," commented John Bencich, Chief Executive Officer of Achieve.

Phase 3 ORCA-2 Trial

Achieve’s first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. The trial is expected to complete enrollment by the middle of the 2021.

Data Highlighting Smoker Dissatisfaction with Available Treatments Presented at SRNT

Achieve data presented at the SRNT Annual Meeting in February 2021 provided insights into current and former smokers’ perceptions on currently available cessation treatment options. In a survey of 1,122 individuals, overall satisfaction and perceived efficacy with available therapies was low, with the best performing treatment leading to satisfaction in less than one-third of the respondents. The study found a majority of prescription cessation medication users do not complete their full 3-month

course of therapy, with 53% reporting less than 1 month of use. Smokers reported side effects and lack of efficacy as the most common reason for discontinuation or lack of initiation with varenicline or bupropion.

Data Elucidating Vaping/e-Cigarette Users Behavior and Quitting Intentions Presented at SRNT

Two Achieve posters were presented at the SRNT Annual Meeting in February 2021 reporting findings from a survey of 508 users of nicotine vape products. The results showed that the primary reason to initiate e-cigarettes/vaping was to quit combustible cigarettes. While proven successful in the cohort of subjects who only utilize vape, dual users, those who vape but also continue to smoke, reported 2-times heavier nicotine use than their counterparts. Additionally, the data indicated that 73% of e-cigarette/vape users intend to quit vaping in the next 3-12 months. Of those who intend to do so in the next 3 months, more than half reported they would be "very/extremely likely to try a new prescription product" to help them quit.

Completed $17.3 Million Financing in December 2020

In December 2020, Achieve announced the closing of an underwritten public offering of 2,472,500 shares of its common stock at a public offering price of $7.00, for total gross proceeds of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This included the full exercise of the underwriter’s over-allotment option to purchase an additional 322,500 shares of common stock.

Virtual Smoking Cessation KOL Roundtable on November 17, 2020

Achieve hosted a virtual roundtable on cytisinicline and smoking cessation in November 2020. Five esteemed experts in the field of smoking cessation discussed the ongoing Phase 3 ORCA-2 trial, reviewed recent cytisinicline data, and presented evidence supporting the importance of smoking cessation in the midst of the COVID-19 pandemic.

Financial Results

As of December 31, 2020, the company’s cash, cash equivalents, and restricted cash was $35.9 million. Total operating expenses for the fourth quarter and year ended December 31, 2020 were $4.7 million and $14.8 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2020 was $4.7 million and $14.7 million, respectively.

As of March 11, 2021, Achieve had 6,149,917 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30pm Eastern time today, Thursday, March 11, 2021. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9395238. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On March 11, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that preclinical feasibility data supporting an Actinium-225-based CD45-targeted Next-Generation conditioning agent has been accepted for poster presentation at the American Association of Cancer Research (AACR 2021) annual meeting being held virtually April 10th – 15th, 2021 (Press release, Actinium Pharmaceuticals, MAR 11, 2021, View Source [SID1234576525]). The data to be presented includes initial dose escalation, safety, tolerability, and conditioning experiments of an Ac-225-based CD45 ARC or antibody radiation conjugate. Dosimetry results with this Ac-225-based alpha emitting ARC showed selective accumulation in immune cell target organs such as bone marrow, spleen, and liver with the potential for lower exposure to non-target tissues from longer path length beta emitter radioisotopes like Iodine-131 and Lutetium-177. The data to be presented demonstrate that conditioning with this Ac-225-based CD45-targeting agent result in depletion of peripheral immune cells and hematopoietic progenitor cells, thereby enabling engraftment of donor cells. A dose dependent response was observed with low doses depleting white blood without effecting hematopoietic progenitor cells, representing a lymphodepletive dose that is relevant for adoptive cell therapies such as CAR-T, while higher doses eliminated peripheral immune cells and hematopoietic progenitor cells, which is applicable to ex vivo gene therapies and BMT or bone marrow transplant.

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This program further augments Actinium’s targeted conditioning portfolio that is led by Iomab-B, an ARC consisting or the radioisotope Iodine-131 and the CD45 targeting antibody apamistamab. In total, apamistamab has been studied in several hundred patients. Iomab-B is currently being studied in the pivotal Phase 3 SIERRA trial for BMT conditioning in patients with active relapsed or refractory acute myeloid leukemia age 55 and above that is expected to complete enrollment in 2021.

Details of the poster presentation at AACR (Free AACR Whitepaper) are as follows:

Dr. Dale Ludwig, Actinium’s Chief Scientific and Technology Officer said, "We are excited to present this data supporting an Ac-225 antibody radiation-conjugate at AACR (Free AACR Whitepaper) and to have the opportunity to develop potentially safer and better targeted chemotherapy-free conditioning agents. Recent cases of secondary malignancies potentially tied to toxic chemotherapy regimens highlight the urgent need for improved conditioning to enable the very promising cell and gene therapy strategies to treat diseases such as Sickle Cell Disease and Beta-Thalassemia. As advances in cell and gene therapies address more disease indications and thus a larger overall patient population, our commitment to developing targeted conditioning agents to improve patient access to the these potentially curative therapies and patient outcomes grows stronger. We look forward to further optimizing this construct to enable advancement into the clinic."

Actinium is developing the only multi-target, multi-indication, clinical-stage pipeline for targeted conditioning and the only ARC based targeted conditioning regimens in development. This Ac-225-CD45 construct to be highlighted at AACR (Free AACR Whitepaper) resulted from Actinium’s AWE or Antibody Warhead Enabling technology platform. AWE encompasses Actinium’s intellectual property of over 140 patents, know-how, and clinical experience including nearly 150 patients treated with alpha emitters like Ac-225 for which Actinium is an industry leader. Specific to Ac-225, Actinium has gold-standard linker technology with a strong stability and safety profile and patents covering composition of matter, formulations, methods of use and methods of manufacturing the radioisotope Actinium-225 in a cyclotron. In addition to fueling Actinium’s R&D efforts, AWE is being utilized in collaborative research partnership with Astellas Pharma, Inc. who is focused on the development of theranostics for solid tumors.

Sandesh Seth, Actinium’s CEO, said "This new program and initial data is yet another example of the potential of Actinium’s AWE platform technology and our team’s ability to create disruptive agents for oncology therapeutics and cell and gene-based therapies. It also exemplifies Actinium’s strong commitment to advancing and increasing access to life-changing and potentially curative therapies. With 2021 expected to be a transformational year for Actinium marked with key clinical milestones including completion of the SIERRA trial it is also exciting to see our R&D efforts delivering tangible results that will position us for continued future success."

On March 11, 2021 Nouscom, a clinical stage immuno-oncology biotech developing next generation viral-vector based immunotherapies, reported it has received approval from the Spanish National Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) to start a Phase 1b trial of its personalized cancer immunotherapy, NOUS-PEV (Press release, NousCom, MAR 11, 2021, View Source [SID1234576548]). NOUS-PEV will be investigated in the study as a potential treatment for patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC).

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NOUS-PEV is a personalized vaccine designed for each patient based on selection and prioritization of mutations unique to that patient’s tumor. The strategy is based on Nouscom’s heterologous prime boost platform underpinning its lead off-the-shelf clinical program NOUS-209, composed of a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Virus (MVA). Each of the two viral vector systems encodes multiple personalized neoantigens selected with a proprietary algorithm (VENUS[1]), which prioritizes up to 60 mutations that represent the most immunogenic neoantigens.

Results from preclinical proof-of-concept studies (published in Nature Communications[2]) demonstrated that a single administration of the GAd vaccine incorporating many neoantigens can eradicate large tumors when combined with checkpoint inhibition such as anti-PD1 or anti-PD-L1 treatment and triples the efficacy of such checkpoint inhibitors. The preclinical results also demonstrated strong and broad CD8+ and CD4+ neoantigen-specific T cell responses following vaccination, which are known to be indicative of a clinical anti-tumor effect.

The new Phase 1b trial will evaluate the safety, feasibility, and preliminary efficacy per RESIST 1.1 criteria of NOUS-PEV in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in 28 patients with either locally advanced 1L melanoma or 1L NSCLC expressing more than 50% PD-L1. This multicenter trial will be conducted in Spain and other European countries.

Patricia Delaite, M.D., Chief Medical Officer of Nouscom, said: "We have generated exciting pre-clinical data, which demonstrated the ability of NOUS-PEV to present multiple cancer neoantigens to the immune system and promote potent and broad immune responses. The enhanced anti-tumor effects seen by combining NOUS-PEV with checkpoint inhibitors suggests these two approaches are highly synergistic and could potentially overcome tumor resistance to anti-PD1 immunotherapies to address a high unmet medical need. We look forward to starting this trial in the coming weeks and to generating results that we hope will confirm these exciting results in patients."

Dr. Marina Udier, Chief Executive Officer of Nouscom, said: "The regulatory approval of this highly sophisticated study to assess our personalized vaccine NOUS-PEV is another critical milestone for the company. Similar to our lead program, NOUS-209, NOUS-PEV leverages the strength and capacity of our platform based on viral vectors, encoding a large number of neoantigens, with proven robust performance in animal models, which we believe has the potential to translate into real clinical benefits for patients."

[1]Vaccine Encoded NeoAg Unrestricted Selection (VENUS)

[2]A.M. D’Alise et al. Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade, Nature Communications 2019

On March 11, 2021 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2020 and provided a corporate update (Press release, Addex Therapeutics, MAR 11, 2021, View Source [SID1234576471]).

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"We ended 2020 in a strong financial position, which was supplemented by our successful $11.5 million fundraising at the beginning of 2021," said Tim Dyer, CEO of Addex. "Throughout 2020, we advanced preparations for the start of clinical studies targeting large underserved market opportunities. Clinical studies starting in the first half of 2021 include two internal programs, dipraglurant in Parkinson’s disease LID and blepharospasm. Additionally, our partner, Janssen is expected to start clinical studies with ADX71149 for epilepsy in the second quarter. Our collaboration with Indivior continues to move forward at a rapid pace and expect to deliver compounds for IND enabling studies by the end of this year."

Select Upcoming Milestones:

Q2 21 – Phase 2a study starting: ADX71149 for epilepsy. Partnered with Janssen
H1 21 – Phase 2b/3 study starting: dipraglurant for Parkinson’s disease LID (Uncontrolled, involuntary muscle movement)
H1 21 – Phase 2a study starting: dipraglurant for blepharospasm (Uncontrolled squeezing or twitching of the eyelids)
Q4 21 – Phase 2a data: dipraglurant for blepharospasm
H1 22 – Phase 2a data: ADX71149 for epilepsy
Q4 22 – Phase 2b/3 data: dipraglurant for Parkinson’s disease LID (PD-LID)
2020 Operating Highlights:

Ended 2020 with a strong cash position of $20.2 million (CHF 18.7 million), coupled with an additional $11.5 million fundraising on January 11, 2021, provides runway till mid 2022
Ensured dipraglurant is ready to start pivotal registration study in levodopa induced dyskinesia associated with Parkinson’s disease (PD-LID) following delay due to the global Covid-19 crisis; study initiation expected H1 2021
Prepared dipraglurant exploratory placebo-controlled clinical trial in blepharospasm patients, which is scheduled to start in H1 2021
Partner, Janssen prepared the start of a Phase 2a proof of concept clinical study of ADX71149 for epilepsy, which is scheduled to start in Q2 2021
GABAB PAM research program entered clinical candidate selection phase
Extended research agreement with Indivior until June 30, 2021, with a commitment for an additional funding of $2.8 million
Awarded CHF600K Innosuisse grant in collaboration with SIB (Swiss Institute of Bioinformatics) to identify new therapeutic indications for ADX10061 (D1 antagonist) program
Appointed Darryle D. Schoepp, PhD, one of the world’s leading and most successful neuroscience drug developers as Chairman newly formed scientific advisory board
Advanced Eurostars / Innosuisse funded mGlu7 negative allosteric modulator research program for post-traumatic stress disorder
Continue to advance remaining preclinical programs to their next value inflection points
Listed American Depositary Shares (ADS) representing our ordinary shares on the Nasdaq Stock Market on January 29, 2020
Financial Summary:
Income increased by CHF 1.0 million to CHF 3.9 million in 2020 compared to CHF 2.8 million in 2019, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.

R&D expenses decreased by CHF 2.1 million to CHF 10.4 million in 2020 compared to CHF 12.4 million in 2019, primarily due to delays in starting certain clinical development activities due to the global coronavirus pandemic. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third-party R&D.

G&A expenses increased by CHF 0.7 million to CHF 5.7 million in 2020 compared to CHF 5.0 million in 2019 mainly due to the increase of CHF 1.3 million relating to increased directors and officer’s liability insurance premiums partially offset by a decrease of CHF 0.5 million in audit and legal fees.

The net loss for 2020 was CHF 12.9 million compared to CHF 14.8 million for 2019 primarily due to the decrease in R&D costs. Basic and diluted loss per share decreased to CHF 0.48 for 2020, compared to CHF 0.56 for 2019.

Cash and cash equivalents amounted to CHF 18.7 million at December 31, 2020 compared to CHF 31.5 million at December 31, 2019. This decrease of CHF 12.8 million is mainly due to the net loss.

2020 Condensed Consolidated Interim Financial Statements:
The full-year 2020 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held today, March 11, 2021, at 16:00 CET (15:00 GMT / 10:00 EST / 07:00 PST) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

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]).

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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.