On May 11, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2023 (Press release, Cullinan Oncology, MAY 11, 2023, View Source [SID1234631497]).

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"We made important progress in the first quarter of this year and believe that 2023 will be a transformational year for Cullinan Oncology," said Nadim Ahmed, Chief Executive Officer of Cullinan. "Consistent with our guidance on reporting first clinical data from two of our ongoing Phase 1 studies by mid-year, preliminary safety data for CLN-049 were published in abstract form today as part of the 2023 EHA (Free EHA Whitepaper) Congress and first clinical data for CLN-619 will be presented during a poster session at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. Additionally, enrollment in the zipalertinib pivotal study will now continue at the 100mg BID dose only. We also continue to progress our diverse pipeline: both CLN-978 and CLN-617 received FDA clearance of IND applications in the first quarter, which will allow us to initiate first-in-human studies this year. Finally, we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications. Together, these achievements position us well with six programs in the clinic this year as we work toward our mission of creating new standards of care for patients with cancer."

Portfolio Highlights

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Zipalertinib: Enrollment will continue solely at the 100 mg BID dose level in the pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy.

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Further enrollment in the 150mg BID cohort was recently discontinued based upon recommendation of the safety review committee.

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CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

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Preliminary safety data from an ongoing first in human study were published in abstract form as part of the 2023 EHA (Free EHA Whitepaper) Congress.
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Cytokine production and low-grade clinical cytokine release syndrome (CRS) consistent with the postulated mechanism of action were observed at the initial dose levels in the now completed single ascending dose study using IV administration.

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Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.

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CLN-619: CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis by both cytotoxic innate and adaptive immune cells. CLN-619 has broad therapeutic potential and is being investigated as both a monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
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First clinical data will be presented during a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting on June 3, 2023.

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New preclinical data on the anti-tumor mechanism of CLN-619 were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.

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CLN-418: CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor-associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues. Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors, with initial clinical data expected in 2024.

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In February, Cullinan Oncology licensed the exclusive U.S. development and commercial rights to CLN-418 from Harbour Biomed for an upfront fee of $25 million, with the potential for up to an additional $148 million in development and regulatory milestones and up to $415 million in sales-based milestones, as well as tiered royalties on potential U.S. commercial sales.

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CLN-978: CLN-978 is a novel CD19xCD3 bispecific therapeutic with extended serum half-life and robust potency against target cells expressing low levels of CD19.

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Cullinan received FDA clearance of its IND application for CLN-978 in January and anticipates initiating a Phase 1 clinical study in 2023.

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CLN-617: CLN-617 is a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection.

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Cullinan received FDA clearance of its IND application for CLN-617 in March and anticipates initiating a Phase 1 clinical study in 2023.

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New preclinical data highlighting the therapeutic potential of CLN-617 was presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April.

First Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $503.5 million as of March 31, 2023. This balance reflects the $25 million upfront payment to Harbour Biomed upon the execution of the licensing agreement for CLN-418. Cullinan expects its cash resources to provide runway into 2026 based on its current operating plan.

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R&D Expenses: Research and development (R&D) expenses were $52.1 million for the first quarter of 2023, compared to $21.3 million for the fourth quarter of 2022. R&D expenses for the first quarter of 2023 and fourth quarter of 2022 included $3.1 million and $2.9 million of equity-based compensation expenses, respectively. Excluding the impact of equity-based compensation expenses, the increase in R&D expenses was primarily related to the upfront payment to Harbour Biomed upon the execution of the licensing agreement for CLN-418, and higher clinical and clinical supply costs driven by the advancement and expansion of our pipeline.

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G&A Expenses: General and administrative (G&A) expenses were $10.7 million for the first quarter of 2023, compared to $11.3 million for the fourth quarter of 2022. G&A expenses in the first quarter of 2023 and fourth quarter of 2022 included $4.2 million and $4.6 of equity-based compensation expenses, respectively. The decrease in G&A expenses, excluding equity-based compensation, was primarily driven by a decrease in professional fees.

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Net Loss: Net loss (before items attributable to noncontrolling interest) for the first quarter of 2023 was $58.1 million, compared with net loss of $27.1 million for the fourth quarter of 2022. Net losses included the items described above, partially offset by interest income of $4.5 million and $3.4 million in the first quarter of 2023 and fourth quarter of 2022, respectively, and an income tax benefit of $1.9 million in the fourth quarter of 2022.

On May 11, 2023 ChromaDex Corp. (NASDAQ:CDXC), a global bioscience company dedicated to healthy aging, reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Brianna Gerber, reported that it will be participating in the Lytham Partners Spring 2023 Investor Conference (Press release, ChromaDex, MAY 11, 2023, View Source [SID1234631496]).

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Mr. Fried and Mrs. Gerber will be participating in virtual one-on-one meetings throughout the event on Thursday, May 18, 2023.

To arrange a meeting with the ChromaDex management team, please contact Lytham Partners at 1×[email protected], or register online by clicking the link here: ChromaDex Investor Meetings – Lytham Partners.

For additional information on ChromaDex, visit www.chromadex.com.

On May 11, 2023 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported its financial and operating results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Chemomab, MAY 11, 2023, View Source [SID1234631495]).

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"I am pleased to report that we have continued to make good progress on multiple fronts since our last quarterly update," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "In January we reported encouraging top-line results from our CM-101 Phase 2 liver fibrosis trial in nonalcoholic steatohepatitis (NASH) patients. In this study CM-101 appeared safe and demonstrated improvement across multiple disease-related fibrotic and inflammatory biomarkers. In our view, these data have been generally well-received by opinion leaders and potential partners. Importantly, these results also are consistent with the encouraging biomarker changes that were observed in two earlier CM-101 clinical trials and reinforce our optimism about CM-101’s potential as a treatment for fibro-inflammatory diseases."

Dr. Pfost continued, "We continue to make good progress in advancing our CM-101 Phase 2 clinical program in primary sclerosing cholangitis (PSC). We have opened additional clinical sites, added an open label extension and enhanced our patient outreach activities, supporting our goal of reporting top-line data in the second half of next year."

"Turning to systemic sclerosis (SSc), earlier this year we reported that our Investigational New Drug (IND) submission for our CM-101 Phase 2 trial was cleared by the FDA. We have been working diligently to prepare for the start of this proof-of-concept trial and we are on track to open our initial U.S. sites around mid-year. We expect to report data from this trial in the latter part of 2024. We also are supporting our clinical programs with an active schedule of scientific presentations at major medical meetings in the U.S. and Europe, and we anticipate several scientific publications in respected journals going forward. These activities aim to build knowledge about, and interest in, our unique approach to fibro-inflammatory diseases among researchers and opinion leaders."

"Since our last call, we have also added two exceptional senior executives—our Chief Medical Officer, Dr. Matt Frankel, and our Vice President of Corporate Development and Strategy, Dr. Mitch Jones. Matt brings us a wealth of global clinical and medical affairs experience, along with his track record in helping to bring numerous drugs to market. Mitch is an MD/PhD with a rich combination of science and business skills that make him uniquely well qualified to lead the corporate development function at Chemomab."

"I am also pleased to announce that today we are extending our estimated cash runway by another quarter through the first half of 2024," said Dr. Pfost. "We accomplished this extension while maintaining the resources needed to advance our two clinical programs towards our expected data read-outs in the second half of 2024. In conclusion, we believe that CM-101 has the potential to make a difference in deadly diseases with few current treatment options and we are committed to staying laser-focused on assessing its potential."

Clinical Update

Reported Top-line Results from CM-101 Phase 2 Liver Fibrosis Trial in NASH Patients

Top-line results were reported in January demonstrating that CM-101 met its primary endpoint of safety and tolerability and showed positive activity across multiple liver fibrosis biomarkers and physiologic assessments. These results provide insights supporting the overall CM-101 clinical development program as well as pharmacokinetic and tolerability data needed to inform next steps in the development of the current subcutaneous formulation of CM-101.

Advanced Phase 2 Trial in PSC Patients

Late last year, the independent Drug Monitoring Committee for the PSC trial reviewed CM-101 safety data and cleared the addition of a planned higher dose arm to the trial. In recent months Chemomab has opened additional clinical trial sites and implemented a protocol amendment adding the higher dose cohort and an open label extension. Currently Chemomab believes it is on track to report top-line data from the double-blind portion of this trial in the second half of 2024.

Received FDA IND Clearance for CM-101 Phase 2 Trial in SSc Patients

Following the recent IND clearance, Chemomab is finalizing plans to open the Phase 2 SSc trial to patient enrollment by mid-year. The study will be conducted at multiple sites in the U.S., Europe and Israel. It aims to confirm the critical role of CCL24 in SSc and to establish biological and clinical proof-of-concept for CM-101 in patients with SSc. The study is designed to generate additional information about disease mechanisms and to enable more informed decisions about future patient stratification strategies and the selection of endpoints for registrational studies. An initial data read-out is planned for the second half of 2024.

First Quarter 2023 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $32.8 million as of March 31, 2023, compared to $39.9 million at December 31, 2022.
Research and Development (R&D) Expenses: R&D expenses were $6.9 million for the quarter ended March 31, 2023, compared to $2.7 million for the same quarter in 2022. The increase was primarily due to increased clinical and preclinical activities.
General and Administrative (G&A) Expenses: G&A expenses were $2.2 million for the quarter ended March 31, 2023, compared to $2.6 million for the same quarter in 2022.
Net Loss: Net loss was $8.8 million, or a net loss of approximately $0.04 per basic and diluted ordinary share for the first quarter of 2023, compared to $5.1 million, or a net loss of approximately $0.02 per basic and diluted ordinary share for the quarter ended March 31, 2022. The weighted average number of ordinary shares outstanding, basic and diluted, was 220,996,240 (equal to approximately 11 million ADSs) for the quarter ended March 31, 2023.
For further details on the company’s financial results for the quarter ended March 31, 2023, please refer to the company’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission today.

Conference Call and Webcast

Chemomab management will host a conference call for investors today, Thursday, May 11, 2023, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions.

Click this Webcast link to access the live webcast or replay. The live webcast and replay can also be accessed at the News & Events section of the Investors page on the Chemomab website at investors.chemomab.com/events.

To access the conference call via telephone, shareholders and other interested parties can dial
+1 (877) 407-9208 (in the U.S.) or +1 (201) 493-6784 (outside the U.S., including Israel) and enter passcode 3735393. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call.

Or click on Call meTM starting 15 minutes before the scheduled start time for instant telephone access without having to wait for an operator.

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.

On May 11, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the first quarter of 2023 (Press release, Charles River Laboratories, MAY 11, 2023, View Source [SID1234631494]). For the quarter, revenue was $1.03 billion, an increase of 12.6% from $913.9 million in the first quarter of 2022.

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Acquisitions contributed 1.8% to consolidated first-quarter revenue growth, and the divestiture of the Avian Vaccine business in December 2022 reduced reported revenue growth by 2.5%. The impact of foreign currency translation reduced reported revenue growth by 2.1%. Excluding the effect of these items, organic revenue growth of 15.4% was driven by the Discovery and Safety Assessment (DSA) and Research Models and Services (RMS) business segments.

On a GAAP basis, first-quarter net income attributable to common shareholders was $103.1 million, an increase of 10.9% from $93.0 million for the same period in 2022. First-quarter diluted earnings per share on a GAAP basis were $2.01, an increase of 11.0% from $1.81 for the first quarter of 2022. GAAP earnings per share included a loss from the Company’s venture capital and other strategic investments of $0.03 per share in the first quarter of 2023, compared to a loss of $0.20 per share for the same period in 2022. The Company’s venture capital and other strategic investment performance has been excluded from non-GAAP results.

On a non-GAAP basis, net income was $143.0 million for the first quarter of 2023, an increase of 1.3% from $141.1 million for the same period in 2022. First-quarter diluted earnings per share on a non-GAAP basis were $2.78, an increase of 1.1% from $2.75 per share for the first quarter of 2022.

The GAAP and non-GAAP net income and earnings per share increases were primarily driven by higher revenue and operating income, partially offset by increased interest expense and a higher tax rate, as well as the impact of the Avian Vaccine divestiture.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We had a strong start to the year with a continuation of the healthy demand and pricing environment in our DSA segment, resulting in better-than-expected first quarter results. We believe that our clients have the funding to move their promising drug candidates forward, and the strength of our backlog continues to support more than one year of DSA revenue. Based on changing macroeconomic factors and following the unprecedented level of biomedical research activity that occurred over the past several years, demand trends are normalizing towards pre-pandemic levels. However, these trends, when balanced with our strong first-quarter financial performance, continue to give us confidence in our financial guidance for 2023."

First-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $199.8 million in the first quarter of 2023, an increase of 13.2% from $176.5 million in the first quarter of 2022. The Explora BioLabs acquisition contributed 8.9% to RMS revenue growth, and the impact of foreign currency translation reduced revenue by 2.5% in the quarter. Organic revenue growth of 6.8% was primarily driven by broad-based growth for small research models, research model services, and the Cell Solutions business.

In the first quarter of 2023, the RMS segment’s GAAP operating margin decreased to 20.2% from 27.1% in the first quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 23.4% from 29.9%. The GAAP and non-GAAP operating margin decreases were driven primarily by the timing of large model shipments in China, as well as the segment’s overall revenue mix.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $662.4 million in the first quarter of 2023, an increase of 21.7% from $544.3 million in the first quarter of 2022. The impact of foreign currency translation reduced revenue by 2.1%, and the SAMDI Tech acquisition contributed 0.2% to reported DSA revenue growth in the quarter. Organic revenue growth of 23.6% was driven principally by broad-based growth in the Safety Assessment business, resulting from higher study volume and meaningful price increases.

In the first quarter of 2023, the DSA segment’s GAAP operating margin increased to 25.9% from 19.3% in the first quarter of 2022, and on a non-GAAP basis, the operating margin increased to 29.0% from 22.9%. The GAAP and non-GAAP operating margin increases were driven by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $167.3 million in the first quarter of 2023, a decrease of 13.4% from $193.1 million in the first quarter of 2022. The impact of the Avian Vaccine divestiture reduced revenue by 9.7%, and the impact of foreign currency translation reduced revenue by 1.9%. The decrease of 1.8% in organic revenue for the quarter was driven primarily by lower revenue in the CDMO business, which faced a challenging year-over-year comparison due to commercial readiness milestones in the first quarter of last year, and the Biologics Testing Solutions business, which experienced lower-than-anticipated testing volumes at the beginning of the year and a difficult comparison associated with last year’s COVID-related testing revenue. These factors were partially offset by revenue growth in the Microbial Solutions business.

In the first quarter of 2023, the Manufacturing segment’s GAAP operating margin decreased to 1.3% from 24.0% in the first quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 13.7% from 33.1% in the first quarter of 2022. The GAAP and non-GAAP operating margin declines were the result of lower operating margins in each of the segment’s business units, particularly the CDMO and Biologics Testing Solutions businesses.

Updates 2023 Guidance

The Company is updating its 2023 financial guidance, which was initially provided on February 22, 2023. The Company is narrowing its revenue growth and earnings per share outlooks to reflect the strong first-quarter financial performance and expectations for the remainder of the year that are largely consistent with its initial outlook. This outlook continues to reflect the anticipated impact of Cambodian NHP supply constraints, which is expected to affect the Company’s financial results principally in the second half of the year.

The Company’s 2023 guidance for revenue growth and earnings per share is as follows:

2023 GUIDANCE

CURRENT

PRIOR

Revenue growth, reported

2.0% – 4.5%

1.5% – 4.5%

Impact of divestitures/(acquisitions), net

~1.5%

~1.5%

Impact of 53rd week in 2022

~1.5%

~1.5%

Unfavorable/(favorable) impact of foreign exchange

0.0% – (0.5)%

0.0% – (0.5)%

Revenue growth, organic (1)

5.0% – 7.5%

4.5% – 7.5%

GAAP EPS estimate

$7.45 – $8.45

$7.40 – $8.60

Acquisition-related amortization

~$2.00

~$2.00

Acquisition and integration-related adjustments (2)

~$0.10

~$0.10

Venture capital and other strategic investment losses/(gains), net (3)

$0.03

—

Other items (4)

$0.30 – $0.35

~$0.20

Non-GAAP EPS estimate

$9.90 – $10.90

$9.70 – $10.90

Footnotes to Guidance Table:
(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.
(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives.
(3) Venture capital and other strategic investment performance only includes recognized gains or losses. The Company does not forecast the future performance of these investments.
(4) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) investigations by the U.S. government into the NHP supply chain related to our Safety Assessment business; and severance and other costs related to the Company’s efficiency initiatives.
Webcast

Charles River has scheduled a live webcast on Thursday, May 11th, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Non-GAAP Reconciliations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, such as non-GAAP earnings per diluted share, non-GAAP operating income, non-GAAP operating margin, and non-GAAP net income. Non-GAAP financial measures exclude, but are not limited to, the amortization of intangible assets, and other charges and adjustments related to our acquisitions and divestitures, including the gain on our sale of our Avian Vaccine business; expenses associated with evaluating and integrating acquisitions and divestitures, including advisory fees and certain other transaction-related costs, as well as fair value adjustments associated with contingent consideration; charges, gains, and losses attributable to businesses or properties we plan to close, consolidate, or divest; severance and other costs associated with our efficiency initiatives; the write-off of deferred financing costs and fees related to debt financing; investment gains or losses associated with our venture capital and other strategic equity investments; certain legal costs in our Microbial Solutions business related to environmental litigation and in our Safety Assessment business related to U.S. government investigations into the NHP supply chain; and adjustments related to the recognition of deferred tax assets expected to be utilized as a result of changes to the our international financing structure and the revaluation of deferred tax liabilities as a result of foreign tax legislation. This press release also refers to our revenue on both a GAAP and non-GAAP basis: "organic revenue growth," which we define as reported revenue growth adjusted for foreign currency translation, acquisitions, divestitures, and the impact of the 53rd week in 2022. We exclude these items from the non-GAAP financial measures because they are outside our normal operations. There are limitations in using non-GAAP financial measures, as they are not presented in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. In particular, we believe that the inclusion of supplementary non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of our core operating results and future prospects without the effect of these often-one-time charges, and is consistent with how management measures and forecasts the Company’s performance, especially when comparing such results to prior periods or forecasts. We believe that the financial impact of our acquisitions and divestitures (and in certain cases, the evaluation of such acquisitions and divestitures, whether or not ultimately consummated) is often large relative to our overall financial performance, which can adversely affect the comparability of our results on a period-to-period basis. In addition, certain activities and their underlying associated costs, such as business acquisitions, generally occur periodically but on an unpredictable basis. We calculate non-GAAP integration costs to include third-party integration costs incurred post-acquisition. Presenting revenue on an organic basis allows investors to measure our revenue growth exclusive of acquisitions, divestitures, the 53rd week in 2022, and foreign currency exchange fluctuations more clearly. Non-GAAP results also allow investors to compare the Company’s operations against the financial results of other companies in the industry who similarly provide non-GAAP results. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations presented in accordance with GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules and regulations. Reconciliations of the non-GAAP financial measures used in this press release to the most directly comparable GAAP financial measures are set forth in this press release, and can also be found on the Company’s website at ir.criver.com.

On May 11, 2023 Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the first quarter ended March 31, 2023 (Press release, Century Therapeutics, MAY 11, 2023, View Source [SID1234631493]).

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"We are keenly focused on advancing our next generation iNK and gamma delta iT platforms to deliver transformative allogeneic cell therapies to patients with unmet need," said Greg Russotti, Ph.D., interim Chief Executive Officer, Century Therapeutics. "For our lead candidate, CNTY-101, we remain on track to report initial data from Schedule A of the ongoing Phase 1 ELiPSE-1 trial in patients with relapsed or refractory CD19 positive B-cell lymphomas by year end. With a strong balance sheet expected to support operations into 2026 and a highly talented team, we believe we are well positioned to successfully execute on our mission."

Business Highlights & Upcoming Milestones

· At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023, the Company presented preclinical data from its iPSC-based cell therapy platform supporting the selection of CNTY-101 as its lead product candidate. Additional preclinical data characterizing epigenetic and transcriptomic donor-specific differences iNK cells were also shared. A copy of each poster is available in the "Science" section of the Company’s website at View Source

· In March 2023, the Company announced the appointment of Greg Russotti, Ph.D., as interim Chief Executive Officer. Dr. Russotti, who served as the Company’s Chief Technology Officer since January 2020, succeeds Lalo Flores, Ph.D., who stepped down as Chief Executive Officer and as a member of the Company’s Board of Directors. In addition, Michael C. Diem, M.D., was promoted to the role of Chief Financial Officer and Hy Levitsky, M.D., assumed his prior role as President of Research and Development.

· The first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas is ongoing. The Company remains on track to report preliminary data from Schedule A of the trial, including pharmacokinetics, pharmacodynamics, and safety, by year end.

· At the upcoming American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Company will present a Trials in Progress poster related to its Phase 1 ELiPSE-1 trial. A copy of the poster, titled, "The ELiPSE-1 Study: A Phase 1 Multicenter Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B Cell Malignancies", will be made available on the Posters section of Century’s website following the presentation.

First Quarter 2023 Financial Results

· Cash Position: Cash, cash equivalents, and marketable securities were $334.8 million as of March 31, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $29.2 million for the three months ended March 31, 2023, compared to net cash provided by operations of $86.8 million for the three months ended March 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $122.1 million).

· Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option and license agreement with Bristol-Myers Squibb was $1.7 million for the three months ended March 31, 2023, compared to $1.1 million for the same period in 2022.

· Research and Development (R&D) expenses: R&D expenses were $24.9 million for the three months ended March 31, 2023, compared to $21.2 million for the same period in 2022. The increase in R&D expenses was primarily due to an increase in personnel expenses related to the reduction in force in January of 2023, costs for preclinical studies and clinical expenses for advancing CNTY-101, and facility costs.

· General and Administrative (G&A) expenses: G&A expenses were $8.9 million for the three months ended March 31, 2023, compared to $7.3 million for the same period in 2022. The increase in G&A expenses was primarily due to an increase in personnel-related expenses to build our infrastructure, as well as increased information technology and facility costs.

· Net loss: Net loss was $31.3 million for the three months ended March 31, 2023, compared to $37.5 million for the three months ended March 31, 2022.

Financial Guidance

· The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million, including non-cash stock-based compensation expense of $12 million to $17 million.

· The Company estimates its cash, cash equivalents, and investments will support operations into 2026.