MaxCyte Reports First Quarter Financial Results

On May 9, 2022 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, reported financial results for the first quarter ended March 31, 2022 and increased full year 2022 revenue guidance (Press release, MaxCyte, MAY 9, 2022, View Source [SID1234613928]).

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First Quarter Highlights

Total revenue of $11.6 million in the first quarter of 2022, an increase of 78% over the first quarter of 2021 driven by strong growth in the core business; core business revenues grew 48% consisting of revenue from cell therapy customers increasing by 57% and drug discovery customers by 23%.
Generated a total of $2.0 million in Strategic Platform License (SPL) Program-related revenue in the first quarter of 2022, compared to immaterial SPL Program-related revenue in the first quarter of 2021.
2022 revenue guidance includes expectations for core business revenue growth to be at least 25% and expected SPL Program-related revenue of approximately $4 million.
With the addition of Intima Bioscience in February 2022, the total number of SPLs now stands at 16.
"We are pleased with this positive start to 2022 at MaxCyte, with very strong first quarter results, including 48% year-over-year core business revenue growth driven by ongoing significant growth in sales to cell therapy customers. We are encouraged by the continued expansion of our portfolio of SPLs with the addition of Intima Bioscience, our sixteenth SPL, as well as the exciting clinical progress of our existing SPL partners. The milestone revenue recorded over the period reflects the progress being made by our partners in early and mid-stage clinical development programs," said Doug Doerfler, President and CEO of MaxCyte.

"I am proud of our continued support for the clinical progress of our partners and the success of our growing global commercial team.

"In addition to the progress made by SPL programs that have entered the clinic, our SPL partners are using MaxCyte’s technology to work on a broad range of new cell types, approaches and indications including solid tumors and autoimmune disease, which also demonstrates the depth and breadth of our ExPERT platform. Ongoing investments in our field and lab science teams and the progress of our in-house manufacturing initiative leaves us well-positioned to support growing adoption of the ExPERT platform technology for cellular-based research and next-generation therapeutic development."

The following table provides details regarding the sources of our revenue for the periods presented.

Total revenue for the first quarter of 2022 was $11.6 million, compared to $6.5 million in the first quarter of 2021, representing growth of 78%.

Core business revenue was $9.6 million, including revenue growth from cell therapy customers of 57% and from drug discovery customers of 23%, compared to core business revenue of $6.5 million in the same period last year.

Our SPL Program-related revenue was $2.0 million, compared to immaterial SPL Program-related revenue in the first quarter of 2021.

Gross profit for the first quarter of 2022 was $10.5 million (91% gross margin), compared to $5.8 million (89% gross margin) in the same period of the prior year. The increase in gross margin was driven by the higher SPL Program-related revenues; excluding SPL Program-related revenues, gross margin was relatively unchanged.

Operating expenses for the first quarter of 2022 were $14.7 million, compared to operating expenses of $12.2 million in the first quarter of 2021. The prior year operating expenses included $3.9 million of CARMA-related expenses that did not recur in 2022, as we have ceased developing the CARMA platform. The overall increase in operating expenses was primarily driven by increased headcount to support growth in field sales and science, manufacturing and lab teams. Growth in public company-related and stock-based compensation expense also contributed to the higher level of expenses compared with the same period a year ago.

First quarter 2022 net loss was $4.1 million compared to net loss of $7.1 million for the same period in 2021; EBITDA, a non-GAAP measure, was a loss of $3.7 million for the first quarter of 2022, compared to a loss of $6.4 million for the first quarter of the prior year; stock-based compensation expense was $2.5 million versus $1.3 million for the same period in the prior year.

Total cash, cash equivalents and short-term investments were $246.3 million as of March 31, 2022.

2022 Revenue Guidance

Management is increasing 2022 revenue guidance based on our expectations for the core business.

We expect core business revenue (instruments and disposables to cell therapy and drug discovery customers and excluding program-related revenue) to grow at least 25% compared to 2021 core business revenue. We also continue to expect SPL Program-related revenue to be approximately $4 million in 2022.

Webcast and Conference Call Details

MaxCyte will host a conference call today, May 9, 2022, at 4:30 p.m. Eastern Time. Interested parties may access the live teleconference by dialing (844) 679-0933 for domestic callers, (918) 922-6914 for international callers, for 0203 1070 289 U.K domestic callers, or for 0800 0288 438 U.K. international callers followed by Conference ID: 1953037. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

Non-GAAP Financial Measures

This press release contains EBITDA, which is a non-GAAP measure defined as earnings, before interest, tax, depreciation and amortization. MaxCyte believes that EBITDA provides useful information to management and investors relating to its results of operations. The company’s management uses this non-GAAP measure to compare the company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The company believes that the use of EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.

Management does not consider EBITDA in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of EBITDA is that it excludes significant expenses that are required by GAAP to be recorded in the company’s financial statements. In order to compensate for these limitations, management presents EBITDA together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of net loss, the most comparable GAAP financial measure, to EBITDA is included at the end of this release. MaxCyte urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.

Syros to Report First Quarter 2022 Financial Results on Monday, May 16, 2022

On May 9, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 16, 2022 to report its first quarter 2022 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, MAY 9, 2022, View Source [SID1234613944]).

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To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 4664097. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT7104, a Bispecific Antibody Targeting PD-L1 and CD47 for the Treatment of Advanced Solid Tumors

On May 9, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT7104, a bispecific antibody that specifically blocks the interaction of human PD-L1 and CD47 with their corresponding receptors (Press release, BioThera Solutions, MAY 9, 2022, View Source [SID1234613960]).

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BAT7104 was designed to inhibit the PD-1/PD-L1 and CD47/SIRP-α pathways. By an "imbalanced" design with finely tuned binding affinity to CD47 and high affinity to PD-L1, BAT7104 is expected to avoid RBC depletion and block CD47 on CD47+/PD-L1+ tumors in a more selective and tumor-enriched manner. BAT7104 was shown to effectively inhibit both pathways in vitro and demonstrated synergistic activity in inducing complete tumor regression in vivo. In non-human primates (NHP) study, BAT7104 was well tolerated with no adverse effects, suggesting a favorable therapeutic index in future clinical development. "BAT7104 has demonstrated higher anti-tumor activity with better safety profile in preclinical studies". Commented Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "As the first bispecific antibody of Bio-Thera, we are pleased to see BAT7104 enter clinical development in Australia, and we will continue bringing more innovative anti-tumor drugs to cancer patients." Dr. Shengfeng Li continued.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT7104 is designed to assess the safety and tolerability of BAT7104. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. Another early stage Phase 1 clinical study evaluating BAT7104 is being conducted in China in patients with solid tumors and lymphoma. In addition, Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early stage clinical studies.

10-Q – Quarterly report [Sections 13 or 15(d)]

Verastem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Adaptimmune Reports First Quarter Financial Results and Business Update

On May 9, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Adaptimmune, MAY 9, 2022, View Source [SID1234613880]).

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"We have four clear areas of focus this year: to file the BLA for afami-cel, continue to build our MAGE-A4 franchise, scale up our manufacturing capabilities, and continue to advance our allogeneic products. We have made good progress with each in 2022," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We remain funded into early 2024 and will continue to execute across these objectives."

Roadmap to BLA submission for afami-cel1 in 2022 (first-generation product targeting MAGE-A4)

Adaptimmune is preparing the BLA and targeting submission to the US Food and Drug Administration (FDA) in Q4 2022 for the treatment of synovial sarcoma.
Updated data based on pooled analyses of characteristics associated with clinical responses from Cohort 1 of the SPEARHEAD-1 trial and the Phase 1 trial of afami-cel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma to be presented in a poster at ASCO (Free ASCO Whitepaper).
Preclinical data at the American Society for Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) annual conference

Preclinical data from the next-generation SPEAR T-cell targeting MAGE-A4 incorporating IL-7 and CCL19 (ADP-A2M4N7X19), developed in collaboration with Noile-Immune, to be presented in a poster; the Company plans to file an IND for this next-generation SPEAR T-cell later this year.
Preclinical data from tumor-infiltrating lymphocytes (TILs) incorporating IL-7 (TIL-IL7), being developed in collaboration with the Center for Cancer Immune Therapy in Denmark, to be presented in a poster; a single-center clinical trial is planned for initiation in 2022.
Corporate
The Company appointed Dr. Joanna (Jo) Brewer as its Chief Scientific Officer effective May 4; Dr. Brewer previously served as the Company’s SVP Allogeneic Research.

Financial Results for the three months ended March 31, 2022

Cash / liquidity position: As of March 31, 2022, Adaptimmune had cash and cash equivalents of $89.5 million and Total Liquidity2 of $304.2 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
Revenue: Revenue for the three months ended March 31, 2022 was $3.6 million, compared to $0.4 million for the same period in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements.
Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2022 were $36.8 million, compared to $24.5 million for the same period in 2021. R&D expenses increased due to an increase in the number of employees engaged in research and development, increases in subcontracted expenditures, increases in in-process research and development costs and a decrease in reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2022 were $16.8 million, compared to $13.8 million for the same period in 2021 due to increases in employee-related costs and other corporate costs.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended March 31, 2022 was $50.3 million ($(0.05) per ordinary share), compared to $37.8 million ($(0.04) per ordinary share) for the same period in 2021.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022, to be filed with the Securities and Exchange Commission following this earnings release.

Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 9, 2022. The live webcast of the conference call will be available via the Events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6779362).