On May 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the quarter ended March 31, 2021 (Press release, Guardant Health, MAY 6, 2021, View Source [SID1234579364]).

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Recent Highlights
•Revenue of $78.7 million for the first quarter of 2021, an increase of 17% over the corresponding period of 2020
•Reported 18,390 tests to clinical customers and 3,522 tests to biopharmaceutical customers in the first quarter of 2021, representing an increase of 21% and a decrease of 33%, respectively, over the first quarter of 2020
•Successfully launched Guardant Reveal, the first blood-only test with a 7-day turnaround time, for residual disease and recurring monitoring in patients with early-stage colorectal cancer and received positive early feedback from oncologists
•Received Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test to be reimbursed at a rate of $5,000 effective April 1, 2021, for all Medicare patients
•Study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrated that Guardant Reveal identifies patients most likely to recur with high clinical accuracy
•Appointed Dr. Craig Eagle as Chief Medical Officer
"I am proud of our team for their continued hard work this quarter. Despite continuing impacts of COVID, we achieved record revenue and solid growth in our clinical business, and continued to progress our product pipeline," said Helmy Eltoukhy, PhD, co-founder and CEO. "I am so excited about what is ahead for Guardant and believe 2021 will be a pivotal year for us as we expand our product portfolio and invest across our business to build the foundations for complete cancer testing across the continuum of care."
First Quarter 2021 Financial Results
Revenue was $78.7 million for the three months ended March 31, 2021, a 17% increase from $67.5 million for the three months ended March 31, 2020. Precision oncology revenue grew 6% driven predominantly by an increase in clinical testing revenue which grew 31% over the prior year period. There were 18,390 clinical tests and 3,522 biopharmaceutical tests performed during the first quarter of 2021. Development services and other revenue increased 106% primarily related to the timing of project related milestones for companion diagnostic development programs.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $49.9 million for the first quarter of 2021, an increase of $2.9 million from $47.0 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63%, as compared to 70% for the corresponding prior year period.
Operating expenses were $157.8 million for the first quarter of 2021, as compared to $81.9 million for the corresponding prior year period, an increase of 93%. Non-GAAP operating expenses were $100.7 million for the first quarter of 2021, as compared to $65.9 million for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common stockholders was $109.7 million for the first quarter of 2021, as compared to $27.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.09 for the first quarter of 2021, as compared to $0.29 for the corresponding prior year period. Non-GAAP net loss was $49.4 million for the first quarter of 2021, as compared to $15.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.49 for the first quarter of 2021, as compared to $0.16 for the corresponding prior year period.
Adjusted EBITDA loss was $45.4 million for the first quarter of 2021, as compared to a $15.5 million loss for the corresponding prior year period.
Cash, cash equivalents and marketable securities were $1.9 billion as of March 31, 2021.
2021 Guidance
Guardant Health now expects full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020. Clinical volumes for 2021 are expected to be greater than 90,000 tests, growing at least 42% over 2020.
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Webcast Information
Guardant Health will host a conference call to discuss the first quarter 2021 financial results after market close on Thursday, May 6, 2021 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.
Non-GAAP Measures
Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.

We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments; changes in estimated fair value redeemable noncontrolling interest; contingent consideration; acquisition related expenses, amortization of intangible assets, and other non-recurring items.

Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income; interest expense; other income (expense), net, provision for (benefit from) income taxes; depreciation; and amortization expense; stock-based compensation expense and related employer payroll tax payments; adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.

We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

On May 6, 2021 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the period ending March 31, 2021 (Press release, NGM Biopharmaceuticals, MAY 6, 2021, View Source [SID1234579363]).

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"In the first quarter of 2021, we achieved a key milestone in our oncology portfolio with the initiation of the randomized, placebo-controlled component of our NGM120 study in patients with metastatic pancreatic cancer," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We also continued to make progress across our four other ongoing Phase 2 and Phase 2b programs. We remain on track to report topline data from our Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with NASH in the second quarter and we expect to complete enrollment in our Phase 2 CATALINA clinical study of NGM621 in patients with geographic atrophy by mid-year. Our team continues to work diligently to advance our two lead immuno-oncology product candidates into the clinic later this year."

Dr. Woodhouse continued, "We demonstrated strong pipeline and corporate execution despite the continued challenges presented by the COVID-19 pandemic and continue to focus on our mission to translate powerful biology with urgency and rigor to deliver life-changing medicines."

Key First Quarter and Recent Highlights

Liver and metabolic diseases

Anticipate reporting topline data from the Phase 2b ALPINE 2/3 study of aldafermin in patients with NASH with liver fibrosis stage 2 or 3 (F2-F3) in the second quarter. ALPINE 2/3 is a Phase 2b clinical study of aldafermin in patients with biopsy-confirmed NASH and liver fibrosis F2 or F3. The 24-week study will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 24.
Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with NASH with liver fibrosis stage 4 (F4) and compensated cirrhosis. NGM continued enrollment in the Phase 2b ALPINE 4 clinical study of aldafermin in patients with biopsy-confirmed NASH with F4 liver fibrosis and compensated cirrhosis. The 48-week study is designed to enroll approximately 160 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of ALPINE 4 is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 48.
Merck continued the Phase 2b study of MK-3655 in patients with NASH with F2-F3 liver fibrosis. In November 2020, Merck initiated a global Phase 2b multicenter study of MK-3655 for the treatment of F2-F3 NASH. The 52-week randomized, double-blind study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg doses of MK-3655 compared to placebo. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM’s completion of a proof-of-concept study. NGM retains an option, at the initiation of the first Phase 3 clinical trial for MK-3655, to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue sharing arrangement of up to 50% for MK-3655.
Retinal diseases

Expect to complete enrollment in the Phase 2 CATALINA study of NGM621 in patients with GA by mid-year. NGM continues to enroll patients in the Phase 2 CATALINA study, a multi-center, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal (IVT) injections of NGM621 every four weeks or every eight weeks in patients with geographic atrophy (GA) in one or both eyes secondary to age-related macular degeneration. NGM anticipates completing enrollment by mid-year. The primary endpoint is the rate of change in GA lesion area, as measured by fundus autofluorescence imaging, over 52 weeks of treatment.
Presented Phase 1 safety and pharmacokinetics (PK) data for NGM621 in patients with GA at the Angiogenesis, Exudation, and Degeneration 2021 – Virtual Edition. Single and multiple IVT injections of NGM621 appeared safe and well tolerated in this first-in-human study, with no patients experiencing serious adverse events, drug-related adverse events, endophthalmitis, intraocular inflammation or choroidal neovascularization. The serum PK of NGM621 was linear and dose-proportional. Based on ocular PK/pharmacodynamics (PD) modeling, NGM believes NGM621 has the potential for up to an every eight-week dosing regimen.
Cancer

Initiated a Phase 2 placebo-controlled component of an ongoing Phase 1/2 study of NGM120 in January, testing NGM120 as a first-line treatment in combination with gemcitabine and Abraxane (paclitaxel protein bound) in patients with metastatic pancreatic cancer. NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled component of NGM120 in combination with gemcitabine and Abraxane as a first line treatment in patients with metastatic pancreatic cancer as part of its ongoing Phase 1/2 trial. This Phase 2 component of the Phase 1/2 study is designed to enroll approximately 60 patients and will assess the efficacy, safety and tolerability of NGM120 or placebo in combination with gemcitabine and Abraxane against both cancer and cancer-related cachexia endpoints. The Phase 1a/1b dose-finding portion of the study is still ongoing, and NGM expects to report interim results from that portion of the study in the second half of the year.
Continued to progress two new oncology clinical candidates, NGM707 and NGM438, toward the clinic. These programs are part of NGM’s strategy to treat cancer through myeloid reprogramming that reverses immune suppression in the tumor microenvironment. NGM707 is a dual antagonist antibody that inhibits Immunoglobulin-like transcript 2 (ILT2) and Immunoglobulin-like transcript 4 (ILT4). NGM438 is an antagonist antibody that inhibits Leukocyte-associated immunoglobulin-like receptor 1 (LAIR1). NGM expects to initiate a first-in-human Phase 1 trial for NGM707 in patients with advanced solid tumors in mid-2021 and for NGM438 in patients with advanced solid tumors during the fourth quarter.
Corporate

Completed a public offering of common stock. In January, NGM completed an underwritten public offering of 5,324,074 shares of its common stock for net proceeds to NGM of $134.6 million, which included the full exercise by the underwriters of their over-allotment option to purchase additional shares, at a price to the public of $27.00 per share.
Nomination of Roger M. Perlmutter for election to Board of Directors. On April 28, 2021, NGM announced that the company has nominated Roger M. Perlmutter, M.D., Ph.D. to stand for election to the company’s board of directors at its June 8, 2021 annual meeting of stockholders. Dr. Perlmutter brings decades of expertise and renowned leadership in drug discovery and development with global healthcare companies including Merck and Amgen.
Extended deadline for Merck collaboration extension notice. Merck has a unilateral option to extend the research and early development phase of its ongoing strategic collaboration with NGM, which would, if exercised by Merck, extend the research phase of the collaboration for an additional two-year period from March 2022 to March 2024. Merck was required to notify NGM of its unilateral decision whether to exercise its option in March 2021, but in order to allow the parties to negotiate potential modifications to the terms of the collaboration agreement, on March 12, 2021, Merck and NGM agreed to extend the deadline for Merck’s decision until June 30, 2021. NGM expects that any modified collaboration would result in a level of annual research support from Merck during any extension of the current research phase after March 2022 that is meaningfully lower than the annual research support Merck provided NGM during the initial five-year term and the first extension period. NGM also expects that if Merck and NGM are unable to reach agreement on modified terms, Merck will not elect to extend the research phase of the collaboration and that NGM’s obligation to fund its own research and development efforts will substantially increase after March 2022.
First Quarter 2021 Financial Results

NGM reported a net loss of $27.5 million for the quarter ended March 31, 2021, compared to a net loss of $19.1 million for the same period in 2020.
Related party revenue from our collaboration with Merck was $21.6 million for the quarter ended March 31, 2021, compared to $24.4 million or the same period in 2020. The decrease in related party revenue of $2.8 million in 2021 was primarily attributable to a decrease in the recognition of the initial upfront payment received from Merck in 2015 that was included in the transaction price and fully recognized by March 2020.
Research and development, or R&D, expenses were $40.7 million for the quarter ended March 31, 2021, compared to $38.4 million for the same period in 2020. R&D expenses increased $2.3 million in 2021, primarily due to a $3.5 million increase in personnel-related expenses and an increase in external expenses driven by our ongoing clinical and pre-clinical studies of NGM621, NGM438 and NGM707. These increases were partially offset by a decrease of $4.6 million in our manufacturing activities and ongoing clinical trials of aldafermin and $1.2 million in external expenses related to our other development programs.
General and administrative expenses were $8.7 million for the quarter ended March 31, 2021, compared to $6.6 million for the same period in 2020. The $2.1 million increase in general and administrative expenses in 2021 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations as a public company.
Cash, cash equivalents and short-term marketable securities were $412.7 million as of March 31, 2021, compared to $295.2 million as of December 31, 2020.
Merck Collaboration

Under the current terms of NGM’s collaboration with Merck, Merck has a one-time option to license NGM pipeline programs – other than aldafermin, NGM386 and NGM395 – following human proof-of-concept trials under the terms of the companies’ ongoing strategic collaboration. Upon exercising any such option, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The current terms of the collaboration also provide NGM with the option to participate in the co-promotion of any co-funded program in the United States. In January 2019, Merck exercised its first option under the collaboration to license MK-3655, previously referred to as NGM313. As described above, the parties continue to negotiate potential modifications to the terms of the collaboration.

On May 6, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the first quarter ended March 31, 2021 (Press release, Puma Biotechnology, MAY 6, 2021, View Source [SID1234579362]). Unless otherwise stated, all comparisons are for the first quarter of 2021 compared to the first quarter of 2020.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the first quarter of 2021 was $45.8 million, compared to $48.6 million in the first quarter of 2020.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $16.5 million, or $0.41 per basic share and $0.40 per diluted share, for the first quarter of 2021, compared to a net loss of $16.9 million, or $0.43 per share, for the first quarter of 2020.

Non-GAAP adjusted net income was $22.4 million, or $0.56 per basic share and $0.55 per diluted share for the first quarter of 2021, compared to non-GAAP adjusted net loss of $8.0 million, or $0.20 per share, for the first quarter of 2020. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2021 was $15.7 million, compared to net cash used in operating activities of $11.5 million in the first quarter of 2020. At March 31, 2021, Puma had cash, cash equivalents and marketable securities of $109.1 million, compared to cash, cash equivalents and marketable securities of $93.4 million at December 31, 2020.

"During the first quarter, we continued to face the challenges brought about by the COVID-19 pandemic and the reduction in commercial access caused by it," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We are hopeful that with the progress made with vaccinations, commercial access will improve in 2021 which will greatly aid our commercial abilities. We continue to remain focused on and committed to providing support to patients battling cancer."

"In terms of clinical development, we are pleased that during the first quarter we were able to achieve the completion of enrollment in the randomized cohorts of the Phase II SUMMIT trial of neratinib for patients with hormone receptor-positive breast cancer that has a HER2 mutation. Enrollment in the other cohorts in SUMMIT continued as well, including for patients with EGFR exon 18 mutated non-small cell lung cancer and HER2 mutated cervical cancer. Additionally, our global partners continued to launch NERLYNX in several new countries during the first quarter and we look forward to launches in additional countries throughout 2021."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation (2021); (ii) reporting Phase II data from the SUMMIT trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2-2021); (iii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2-mutated

hormone receptor positive breast cancer and HER2-mutated cervical cancer (2021); (iv) reporting data from the Phase II TBCRC-022 trial of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2-2021); (v) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2021); and (vi) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries (2021)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the first quarter ended March 31, 2021, total revenue was $98.2 million, of which $45.8 million was net product revenue, $50.0 million was license revenue and $2.4 million was royalty revenue. The $50.0 million of license revenue in the first quarter of 2021 represents an upfront payment for providing our existing partner Pierre Fabre with development, manufacturing, and commercial rights to NERLYNX in Greater China. Total revenue was $51.2 million in the first quarter of 2020, of which $48.6 million was net product revenue, $2.0 million was license revenue, and $0.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $78.0 million for the first quarter of 2021, compared to $65.5 million for the first quarter of 2020.

Cost of Sales

Cost of sales was $29.6 million for the first quarter of 2021, of which $20.0 million represents a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China. Cost of sales was $9.1 million for the first quarter of 2020.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $28.2 million for the first quarter of 2021, compared to $30.9 million for the first quarter of 2020. The $2.7 million decrease resulted primarily from decreases in stock-based compensation expense of approximately $1.1 million, travel and meetings of approximately $1.4 million and other expenses of approximately $0.4 million, partially offset by an increase in professional fees of approximately $0.3 million.

Research and Development Expenses

Research and development expenses were $20.2 million for the first quarter of 2021, compared to $25.5 million for the first quarter of 2020. The $5.3 million decrease resulted primarily from decreases in clinical trial costs of approximately $2.7 million, stock-based compensation expense of approximately $2.0 million and consultant and contractor costs of approximately $0.6 million.

Total Other Expenses

Total other expenses were $3.7 million for the first quarter of 2021, compared to $2.6 million for the first quarter of 2020. The $1.1 million increase resulted primarily from decreases in interest income and other income of approximately $0.5 million, as well as an increase in interest expense of $0.5 million.

Conference Call

Puma Biotechnology will host a conference call to discuss its first quarter 2021 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 6, 2021. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 6, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported first quarter 2021 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 6, 2021, View Source [SID1234579360]).

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"Building on the sustained and focused performance by the CytomX team throughout 2020, we made excellent progress in the first quarter of 2021 with an ongoing emphasis on our two lead clinical product candidates, praluzatamab ravtansine (CX-2009) and CX-2029, both of which are in key Phase 2 studies addressing late-stage cancers with substantial unmet need," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also continued to innovate with the unveiling of our work on conditionally activated cytokines that leverages the depth of our expertise in protein engineering, protease biology, and our understanding of the tumor microenvironment. Our leadership in the field of conditional activation and the versatility of our Probody technology platform position us for success in realizing our vision of transforming lives with safer, more effective therapies," added Dr. McCarthy.

Business Highlights and Recent Developments

Hosted a virtual investor event and webcast with industry experts John Lambert Ph.D., former chief scientific officer, ImmunoGen; Sara M. Tolaney, M.D., Dana-Farber Cancer Institute, Harvard Medical School; and Melissa L. Johnson, M.D., Sarah Cannon Research Institute, as well as company executives, to discuss CytomX’s Probody technology platform and the two lead product candidates, praluzatamab ravtansine (CX-2009) and CX-2029. An archived replay of the webcast can be accessed on the Events and Presentations section of CytomX’s website.
Began enrolling patients with human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer into a Phase 2 multi-cohort study evaluating our anti-CD166 conditionally activated antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009) as monotherapy and, in patients with triple-negative breast cancer (TNBC), in combination with pacmilimab (CX-072), our conditionally activated anti-PD-L1 antibody.
Patient enrollment continued in the Phase 2 expansion study evaluating CX-2029, the anti-CD71 conditionally activated ADC in co-development with our partner AbbVie, as a single agent in four cohorts: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma.
Featured presentation at the Triple Negative Breast Cancer (TNBC) Drug Development Digital Summit 2021, by Alison L. Hannah, M.D., CytomX’s chief medical officer, titled "Clinical Development of Praluzatamab Ravtansine (CX-2009), a Conditionally Activated Probody Drug Conjugate (PDC) Targeted Against CD166 (ALCAM) in Patients with Advanced Breast Cancer." The oral presentation can be downloaded using this link.
Presented preclinical data highlighting an improved therapeutic window and potent anti-cancer activity for a conditionally activated interferon alpha-2b at the Cytokine-Based Cancer Immunotherapies Summit, demonstrating successful broadening of the Probody technology platform to cytokine modalities. The oral presentation can be downloaded using this link.
Our partner, Bristol Myers Squibb, expanded the scope of the Part 2b evaluation of BMS-986249, a Probody version of the CTLA-4-targeting antibody, ipilimumab, in combination with the anti-PD-1 antibody, nivolumab, with three new indications, advanced hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and advanced TNBC. This combination is also being evaluated by Bristol Myers Squibb in a randomized study in patients with metastatic melanoma. Bristol Myers Squibb also continued to evaluate BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab in a Phase 1 clinical trial.
In collaboration with Amgen, investigational new drug application (IND)-enabling studies continued for CX-904, our conditional T-cell engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and CD3 on T cells.
IND-enabling studies for CX-2043, our third conditionally activated ADC directed against the epithelial cell adhesion molecule (EpCAM/Trop-1), were delayed as a result of recent supply chain interruptions. We no longer expect to submit an IND for CX-2043 in 2021.
Raised approximately $108 million from a follow-on public equity offering to support clinical and preclinical pipeline advancement and operations.
Anticipated 2021 Events

Initial data from the praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth quarter of 2021.
Initial data from the CX-2029 Phase 2 expansion study in the fourth quarter of 2021.
IND submission for CX-904 in late 2021.
First Quarter 2021 Financial Results
Cash, cash equivalents and short-term investments totaled $393.8 million as of March 31, 2021, compared to $316.1 million as of December 31, 2020.

Revenue was $16.0 million for the three months ended March 31, 2021 compared to $49.6 million for the corresponding period in 2020. The decrease of $33.6 million was due to a $28.9 million decrease in revenue from AbbVie primarily related to the $40.0 million milestone payment earned in March 2020 associated with the CX-2029 project, a $10.0 million decrease in revenue from Bristol Myers Squibb for a milestone payment earned from the CTLA-4 program in February 2020, offset by an increase in revenue of $4.4 million from Astellas mainly driven by the full quarter recognition of the $80.0 million upfront payment related to the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $20.4 million during the three months ended March 31, 2021 to $22.4 million compared to $42.8 million for the corresponding period in 2020. The decrease was largely attributed to a decrease of $11.2 million in licensing expenses and a decrease of $8.5 million in laboratory contracts and services, decreased clinical trial spend and timing of manufacturing activities.

General and administrative expenses were essentially flat during the three months ended March 31, 2021 amounting to $9.2 million compared to $9.6 million for the corresponding period in 2020.

Conference Call & Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at www.cytomx.com or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) using the passcode 5397530. An archived replay of the webcast will be available on the Company’s website until May 13, 2021.

On May 6, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2021 and provided a corporate update (Press release, Athersys, MAY 6, 2021, View Source [SID1234579359]).

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"Since our recent call, we remain on track with respect to our operating plans," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "We look forward to important progress during the remaining course of the year, including expected top-line results from the TREASURE and ONE-BRIDGE studies in Japan."

"Additionally, we remain focused on important priorities for the year, which include advancing our MASTERS-2 study and other clinical programs, supporting our partner, Healios, as it prepares for important regulatory applications, and in further developing our commercial manufacturing processes and planning," added Mr. Lehmann.

Highlights of the first quarter of 2021 and recent events include:

Announcement by our Japanese partner, HEALIOS K.K. (Healios), of the completion of patient enrollment in the ONE-BRIDGE study evaluating the safety and efficacy of MultiStem (invimestrocel) cell therapy for the treatment of pneumonia-induced acute respiratory distress syndrome (ARDS) and COVID-induced ARDS;
Reached a cooperation agreement with Healios to resolve the legal matter between its CEO and Athersys Board member, Dr. Kagimoto, and the Company, and initiated negotiations to address open matters important to continued development, regulatory progress and successful commercialization in Japan following approval;
Recognized net loss of $26.5 million, or $0.13 net loss per share, for the quarter ended March 31, 2021; and
Ended the first quarter with $64.2 million of cash and cash equivalents.
"We believe that we are well positioned to advance our MultiStem programs over this year and further develop the capabilities important to longer term commercial success," concluded Mr. Lehmann.

First Quarter Results

There were no revenues for the three months ended March 31, 2021 and March 31, 2020, respectively. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Healios.

Research and development expenses increased to $17.5 million for the three months ended March 31, 2021 from $12.1 million for the comparable period in 2020. The $5.4 million net increase is primarily associated with increases in clinical trial and manufacturing process development costs of $4.3 million, personnel costs of $0.7 million and stock compensation costs of $0.4 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

General and administrative expenses increased to $8.8 million for the three months ended March 31, 2021 compared to $3.5 million in the comparable period in 2020. The $5.3 million increase was primarily related to legal expenses incurred in connection with the complaint filed by Dr. Kagimoto against the Company, its settlement, and the expenses associated with Dr. Van Bokkelen’s resignation and his separation letter agreement, including $2.3 million of non-cash stock compensation expense.

Net loss for the first quarter of 2021 was $26.5 million compared to a net loss of $15.6 million in the first quarter of 2020. The difference primarily results from the above variances.

During the three months ended March 31, 2021, net cash used in operating activities was $17.1 million compared to $12.1 million in the three months ended March 31, 2020. At March 31, 2021, we had $64.2 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.

Conference Call

William (B.J.) Lehmann, Jr., Interim Chief Executive Officer, Ivor Macleod, Chief Financial Officer, John Harrington, Executive Vice President and Chief Scientific Officer and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive the toll-free number, a direct entry passcode and a registrant ID.

On May 7th at 12:00 PM EDT, a replay of the event will be available on the webcast link at www.athersys.com under the investors’ section. Shareholders may also call in for on-demand listening on May 7th at 12:00 PM EDT until 11:59 PM Eastern Time on May 12, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 4548767.