On May 2, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will present new and compelling data during an oral presentation about its off-the-shelf SPEAR T-cell program at the annual American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) meeting (Press release, Adaptimmune, MAY 2, 2019, View Source;p=RssLanding&cat=news&id=2396799 [SID1234535607]). Data indicate that T-cells can be generated from Human Induced Pluripotent Stem Cells (hiPSC) in vitro and that these T-cells respond to cancer targets via engineered SPEAR TCRs. This process will be used to investigate the ability of this off-the-shelf SPEAR T-cell product to fight cancer.

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"Our three autologous SPEAR T-cell therapies are already in the clinic and have the potential to treat cancer in multiple solid tumor indications," said Rafael Amado, Adaptimmune’s President of R&D. "Beyond the promise of our current autologous therapies, this allogeneic approach – or more simply ‘off-the-shelf’ product – could offer treatment to more patients more quickly, and provide a homogeneous and unlimited source of therapeutic cells. We are thrilled with the progress we have made, both in the gene editing space with our partners at Universal Cells and with our internal T-cell differentiation program."

During an oral presentation scheduled for 11:30 AM ET today at the ASGCT (Free ASGCT Whitepaper) Annual Meeting, Dr. Jo Brewer, Adaptimmune’s Vice President of Allogeneic Research, will present progress to-date with Adaptimmune’s off‑the-shelf SPEAR T-cell program:

Adaptimmune has demonstrated hiPSC differentiation in a serum-free process without the addition of mouse stromal cells, which is designed to enable scale-up and GMP manufacture of a gene-edited off-the-shelf SPEAR T-cell product
Lentiviral transduction of T-cells derived from hiPSCs with a SPEAR TCR produces differentiated T-cells that can respond to cancer targets in vitro
The process starts with an hiPSC line, before the cells are rendered invisible to the host immune system with a series of Recombinant Adeno-Associated Virus (rAAV)-based gene-editing steps (the editing will be performed in association with Universal Cells, an Astellas Company)
The process has been shown to promote differentiation of cells from a pluripotent state (SSEA4+Oct4+TRA-160+) through various intermediate stages: CD34+CD45+ hematopoietic progenitor cells (HPC), pro-/pre-T CD7+CD5+cells, and CD4+CD8+ double positive cells towards CD3+CD8+TCR+ single positive T-cells

On May 2, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release first quarter 2019 financial results after the market closes on Thursday, May 9th, 2019 (Press release, Intrexon, MAY 2, 2019, View Source [SID1234535658]). The Company will not host a conference call associated with the earnings release.

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On May 2, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational highlights and financial results for the first quarter ended March 31, 2019 (Press release, Intellia Therapeutics, MAY 2, 2019, View Source [SID1234535544]). Additionally, the Company highlighted important corporate milestones for 2019.

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"2019 is off to a productive start in support of our mission to advance genome editing to treat a range of severe and life-threatening diseases. We are excited by our achievements in gene knockout and insertion across both our in vivo and engineered cell therapy efforts. In particular, we presented data at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) showing unprecedented CRISPR-mediated, targeted gene insertion in the liver of non-human primates, achieving normal circulating human levels of protein production," said Intellia President and Chief Executive Officer John Leonard, M.D. "These achievements highlight Intellia’s leadership in CRISPR/Cas9 genome editing as we advance our pipeline towards the clinic. Looking ahead, we remain on track to file an IND application next year for NTLA-2001, our lead in vivo candidate for the treatment of transthyretin amyloidosis, and expect to nominate a development candidate in our first engineered cell therapy program for acute myeloid leukemia by year-end."

First Quarter 2019 and More Recent Operational Highlights

ATTR Program: Intellia’s lead candidate for the treatment of transthyretin amyloidosis (ATTR), which demonstrated an average of >95% reduction in circulating transthyretin (TTR) protein in non-human primates (NHPs), has been nominated as the Company’s first in vivo development candidate to advance into Investigational New Drug (IND)-enabling toxicology studies. Preliminary results from substantially completed dose-range finding (DRF) studies showed a favorable tolerability profile; and data from multiple studies in NHPs demonstrated durable liver editing with sustained reduction of circulating TTR through 10 months of observation following a single dose.

Today, Intellia announced plans to begin IND-enabling toxicology studies of NTLA-2001 in mid-2019 and that it remains on track to submit an IND application in 2020. NTLA-2001 is being co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron), with Intellia as the lead development and commercialization party.
AML Program: Intellia and its research collaborators at IRCCS Ospedale San Raffaele presented new in vitro data at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), showing that CRISPR/Cas9 editing resulted in >98% knockout of endogenous T cell receptors (TCRs) followed by insertion of Wilms’ Tumor 1 (WT1)-specific TCRs into >95% of isolated T cells. In addition, the engineered T cells were functional and capable of specifically killing high levels of a panel of leukemic blasts from patients that expressed the WT1 epitope. Based on these results, Intellia has identified multiple lead TCRs restricted to the HLA-A*02:01 allele to move into functional testing in patient-derived xenograft models for an autologous TCR-based therapy targeting WT1 for the treatment of acute myeloid leukemia (AML). These studies are expected to begin in mid-2019 and will inform the nomination of the Company’s first engineered cell therapy development candidate by the end of 2019.

In Vivo Insertion in NHPs: At the 2019 ASGCT (Free ASGCT Whitepaper) Meeting, Intellia presented data demonstrating the first CRISPR-mediated, targeted transgene insertion in the liver of NHPs, using Factor 9 (F9) as a model gene. F9 is a gene that encodes for Factor IX (FIX) protein, a blood-clotting protein that is missing or defective in hemophilia B patients. In a collaboration between Intellia and Regeneron, researchers combined Intellia’s lipid nanoparticle (LNP) delivery system of CRISPR/Cas9 with an adeno-associated virus (AAV) containing a proprietary bi-directional insertion template. NHP data showed that a single administration achieved ~3-4 μg/mL of circulating human FIX protein at day 14 and was sustained through 28 days (~3-5 μg/mL) of completed observation in an ongoing study. The levels of circulating human FIX protein demonstrated in NHPs correspond with the normal 3-5 μg/mL range of human FIX protein levels (source: Amiral et al, Clin. Chem., 1984). The NHP data shared also incorporates the improved CRISPR/Cas9 LNP identified from the ATTR program and demonstrates the modularity of Intellia’s platform to apply learnings to other programs. This data expands on the clinically relevant human FIX protein levels achieved in mice, first reported in October, which have remained stable through 10 months of observation.

Modular In Vivo Knockout Update: Today, at the 2019 ASGCT (Free ASGCT Whitepaper) Meeting, Intellia will present new data demonstrating that independent CRISPR-mediated knockout of each of two targets of interest, either lactate dehydrogenase A (Ldha) or hydroxyacid oxidase 1 (Hao1), via the Company’s proprietary LNP delivery technology, results in a durable, therapeutically relevant reduction of oxalate excretion in a disease mouse model of primary hyperoxaluria type 1 (PH1).

LDHA and HAO1 are enzymes involved in oxalate production. In people with PH1, mutations in a specific liver enzyme cause the production of a surplus of oxalate, which can combine with calcium to form insoluble deposits in the kidney and throughout the body, leading to damage of the kidneys, heart, eyes and skeletal system. An approximate 30% reduction in urinary oxalate in patients with PH1 is considered to be therapeutically relevant (source: Nephrology Dialysis Transplantation 1999; 14:2556-2558). In collaboration with the University of Alabama at Birmingham, Intellia researchers found that a CRISPR-mediated knockout of the Ldha gene in a PH1 mouse model disrupts LDHA protein production and reduces urinary oxalate levels by 63%. Researchers also observed that a CRISPR-mediated knockout of the Hao1 gene disrupts glycolate-to-glyoxylate conversion, resulting in a urinary oxalate level reduction of 57% in a PH1 mouse model. In each individual knockout approach, these reduced levels of urinary oxalate were sustained for at least 15 weeks.

Today’s presentation, titled "CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria," is accessible through the Events and Presentations page of the Investor Relations section of Intellia’s website.
Upcoming Milestones

The Company has set forth the following for 2019 pipeline progression:

ATTR:
Initiate IND-enabling toxicology studies in mid-2019
Commence manufacturing of NTLA-2001 Phase 1 materials
AML:
Initiate functional testing in patient-derived xenograft models of multiple lead TCRs in mid-2019
Nominate first engineered cell therapy development candidate by the end of 2019
First Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $296.6 million as of March 31, 2019, compared to $314.1 million as of December 31, 2018. The decrease was driven by cash used to fund operations of approximately $29 million, which was offset in part by $6.0 million of funding received under the Novartis collaboration, $3.6 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $1.5 million of ATTR cost reimbursements made by Regeneron, and $0.4 million in proceeds from employee-based stock plans.
Collaboration Revenue: Collaboration revenue increased by approximately $3.0 million to $10.4 million during the first quarter of 2019, compared to $7.5 million during the first quarter of 2018. The increase in collaboration revenue in 2019 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron is obligated to fund approximately 50% of the development costs for the ATTR program.
R&D Expenses: Research and development expenses increased by $1.2 million to $23.7 million during the first quarter of 2019, compared to $22.5 million during the first quarter of 2018. This increase was driven primarily by the advancement of Intellia’s research programs, research personnel growth to support these programs, as well as the expansion of the development organization.
G&A Expenses: General and administrative expenses increased by $3.1 million to $10.5 million during the first quarter of 2019, compared to $7.4 million during the first quarter of 2018. This increase was driven primarily by employee and intellectual property (IP)-related expenses to support Intellia’s growing research and development efforts.
Net Loss: The Company’s net loss was $21.9 million for the first quarter of 2019, compared to $21.4 million during the first quarter of 2018.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of March 31, 2019, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the first half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss First Quarter 2019 Earnings

The Company will discuss these results on a conference call today, May 2, 2019, at 8 a.m. ET. The investor presentation may be downloaded starting at 7:30 a.m. ET from the Events and Presentations page of the Investor Relations section of Intellia’s website at intelliatx.com.

To join the call:

U.S. callers should dial 800-458-4148 and use conference ID# 7725705, approximately five minutes before the call.
International callers should click here to access dial-in information and use conference ID# 7725705, approximately five minutes before the call.
A replay of the call will be available on Intellia’s website, beginning on May 2, 2019 at 12 p.m. ET.

On May 2, 2019 Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported results for the first quarter ended March 31, 2019 (Press release, Cambrex, MAY 2, 2019, View Source [SID1234535561]).

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First Quarter 2019 Highlights

Completed the acquisition of Avista Pharma Solutions ("Avista"), an early clinical phase contract development, manufacturing and testing organization, for approximately $252 million in total cash consideration. This transaction closed on January 2, 2019.

Net revenue was $159.5 million, an increase of 13% compared to the same quarter last year. Excluding the impact of currency, net revenue increased 17%.

Income from continuing operations was $10.5 million and Diluted EPS was $0.31 per share compared to $24.2 million and $0.72 per share, respectively, for the same quarter last year. Adjusted Income from continuing operations and Diluted EPS were $20.2 million and $0.60 per share compared to $25.8 million and $0.77 per share, respectively, for the same quarter last year (see table at the end of this press release).

Adjusted EBITDA was $41.1 million compared to $37.9 million in the same quarter last year (see table at the end of this press release).

Net debt excluding lease obligations was $430.0 million at the end of the quarter compared to $204.1 million at December 31, 2018. The change during the quarter was primarily the result of acquiring Avista and related expenses, positively offset by $28.7 million of Free cash flow. The Company entered into an $800 million amended credit facility in January of 2019 in connection with the Avista acquisition.

The Company continues to expect full year 2019 Net revenue, which excludes the impact of foreign currency, to be between 21% and 25% higher than 2018 Net revenue. Adjusted EBITDA is still expected to be between $150 and $160 million (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).

"The first quarter was a very productive quarter for Cambrex. Our financial performance was in line with our full year expectations, and we saw many examples of the synergies we anticipated when we acquired Halo and Avista. While there is still much work to be done, we took significant steps towards realizing our vision of building the leading fully integrated global small molecule CDMO. As our commercial team gains experience selling all of our services, and awareness of the full scope of our offering grows with existing and prospective customers, we expect the synergies to become more and more significant moving forward," commented Steven M. Klosk, President and Chief Executive Officer.

"We continue to invest in our facilities to ensure we have world class capabilities that position us to take advantage of ongoing positive CDMO market trends. During the quarter, we announced several new investments in our business including expanded cGMP liquid filling capacity at our Mirabel, Quebec facility, and expanded laboratories to facilitate increased generic API development capabilities at our site outside of Milan, Italy. In April, we completed construction of a new production area to manufacture highly potent drug substances at our Charles City, Iowa facility, and expect to begin production during the second quarter of 2019."

Basis of Reporting

The Company has provided a reconciliation of GAAP to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjustments provide useful information to investors due to the magnitude and nature of certain amounts recorded under GAAP.

As a result of the recent Halo and Avista acquisitions and consistent with how the business is managed, the Company has three reportable segments, Drug Substance ("DS"), which includes the legacy Cambrex API business excluding the High Point, North Carolina facility, Drug Product ("DP"), which includes the former Halo business, and Early Stage Development and Testing ("ESDT"), which includes the former Avista business in addition to the High Point facility.

First Quarter 2019 Operating Results – Consolidated, Continuing Operations

Net revenue was $159.5 million, an increase of $18.4 million, or 13%, from $141.1 million in the same quarter last year. Results include a 4% unfavorable impact of foreign exchange compared to the first quarter of 2018. Net revenue during the first quarter of 2019 includes the acquisitions of Halo and Avista. Compared to the same quarter last year, the Drug Substance segment revenues declined due to lower volumes.

Gross margin was 34% for the first quarter of 2019 compared to 36% in the same quarter last year.

Operating profit was $20.3 million for the first quarter of 2019 compared to $30.4 million in the same quarter last year. Operating profit for 2019 includes a $4.2 million increase in amortization expense for purchased intangibles and $6.1 million in acquisition and integration expenses. Adjusted EBITDA was $41.1 million compared to $37.9 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $3.5 million resulting in an effective tax rate of 25% compared to $5.8 million and an effective tax rate of 19% in the same quarter last year. Income tax expense for the first quarter of 2018 would have been approximately 20% excluding the immediate recognition of certain effects of share-based compensation. The increase in the tax rate for 2019 as compared to 2018 is primarily due to higher state taxes as a result of state tax reform and the Company’s expanded state tax presence due to recent acquisitions, as well as the geographic mix of income.

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Income from continuing operations was $10.5 million, or $0.31 per diluted share, compared to $24.2 million, or $0.72 per diluted share, in the same quarter last year.

Adjusted Income from continuing operations was $20.2 million, or $0.60 per share, compared to $25.8 million, or $0.77 per share, in the same quarter last year.

Capital expenditures were $19.2 million and depreciation and amortization was $14.7 million compared to $23.8 million and $7.5 million, respectively, in the same quarter last year.

Net debt was $430.0 million at the end of the quarter compared to $204.1 million at December 31, 2018. The change during the quarter was primarily the result of acquiring Avista and related transaction and integration expenses, positively offset by $28.7 million of Free cash flow.

First Quarter 2019 Operating Results – Drug Substance ("DS") segment

Net revenue was $112.1 million compared to $136.6 in the same quarter last year, an 18% decrease. This includes a 4% unfavorable impact of foreign exchange compared to the first quarter of 2018. The decrease was due to lower volumes of certain branded APIs, primarily from Cambrex’s largest product, partially offset by higher sales of clinical phase products and generic APIs.

Gross profit in the first quarter of 2019 was $43.4 million compared to $50.0 million in the same quarter last year. Gross margin increased to 39% from 37% in the same quarter last year. The increase in margin was primarily driven by a favorable impact from foreign currency, favorable product mix related to generic APIs and lower inventory charges due to batch failures in 2018 partially offset by lower production volumes.

Selling, general and administrative ("SG&A") expenses were $9.4 million in the first quarter of 2019 compared to $11.5 million in the same quarter last year. The decrease was mainly due to lower consulting costs associated with a 2018 operational excellence initiative and the impact of foreign currency.

Operating profit was $31.2 million compared to $35.4 million in the first quarter of 2018. The decrease was due to lower gross profit partially offset by lower operating expenses as described above.

First Quarter 2019 Operating Results – Drug Product ("DP") segment

Net revenue in the first quarter of 2019 was $24.5 million. The former Halo business that comprises what is now the DP segment was acquired in September of 2018.

Gross profit was $6.0 million and gross margin was 25% in the first quarter of 2019.

SG&A expenses were $6.2 million in the first quarter of 2019, which includes amortization of purchased intangibles of $3.0 million.

Operating loss was $0.3 million in the first quarter of 2019 which includes amortization of purchased intangibles of $3.0 million.

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First Quarter 2019 Operating Results – Early Stage Development and Testing ("ESDT") segment

The Company’s Cambrex High Point ("CHP") facility is included in the ESDT segment for both periods presented. The former Avista businesses that comprise the majority of what is now the ESDT segment were acquired in January of 2019. The 2018 results for this segment include only the High Point facility, formerly part of Cambrex’s legacy API business.

Net revenue in the first quarter of 2019 was $22.9 million compared to $4.5 million in the same quarter last year. The increase is due to the acquisition of Avista and a 31% increase in CHP’s first quarter 2019 revenue.

Gross profit was $5.5 million in the first quarter of 2019 compared to $0.9 million in the same quarter last year. Gross margin was 24% in the first quarter of 2019 compared to 20% in the same period last year.

SG&A expenses were $6.5 million in the first quarter of 2019, which includes amortization of purchased intangibles of $1.4 million.

Operating loss was $2.5 million in the first quarter of 2019, which includes $1.2 million in integration expenses and $1.4 million of amortization of purchased intangible assets. Operating loss for the first quarter of 2018 was $0.4 million.

First Quarter 2019 Operating Results – Corporate Headquarters

SG&A expenses were $2.9 million in the first quarter of 2019 compared to $4.0 million in the same quarter last year. The decrease is primarily the result of lower due diligence costs related to mergers and acquisition activities.

Consolidated acquisition and integration expenses were $6.1 million for the first quarter of 2019, of which $4.9 million is reflected in the Corporate Headquarters cost center and $1.2 million is reflected in the ESDT segment. There were no acquisition and integration expenses during the first quarter of 2018.

Operating loss at Corporate in the first quarter of 2019 was $8.1 million compared to $4.6 million in the same quarter last year.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2019 financial performance versus its expectations from the previous quarter. The expectations in the table below reflect expected results from the business including the recent acquisitions of Halo and Avista. All expectations for 2019, including growth relative to 2018, are based on actual and expected ASC 606 results for both years.

Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential future acquisitions and related transaction and integration expenses, including expenses related to the recent acquisitions of Halo Pharma and Avista Pharma Solutions, divestitures, restructuring activities, certain tax items discussed below, and the impact of foreign currency on Net revenue.

EBITDA, Adjusted EBITDA and Adjusted Income from continuing operations per share for 2019 will be computed on a basis consistent with the reconciliation of the current quarter financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt (excluding lease obligations, M&A and integration expenses), net of cash during the year. Adjusted effective tax rate excludes the immediate recognition of certain benefits of share-based compensation and certain other items adjusted for in the non-GAAP reconciliation tables at the end of this release.

The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax laws or rates within the countries in which the Company operates and the effects of certain share-based payments.

Cambrex expects M&A and related integration expenses for 2019 to be between $9 and $11 million. These amounts are excluded from the guidance for consolidated Adjusted EBITDA, Adjusted income from continuing operations per share and Free cash flow included above. These expenses include approximately $3.8 million of transaction and $2.3 million of integration expenses incurred in conjunction with the acquisition of Avista in early January and expected on-going integration expenses across most functional areas for the remainder of 2019. This estimate also includes certain anticipated expenses related to IT systems, but does not include costs to upgrade the two newly acquired businesses to Cambrex’s ERP software, which are planned to occur over the course of 2019 and 2020.

Expectations above include preliminary estimates for Depreciation and Amortization expense associated with purchase accounting for the Avista acquisition. Cambrex expects to finalize the purchase accounting for Avista during the second quarter of 2019. As a result, expected Depreciation and Amortization expense and its impact on expected Adjusted income from continuing operations per share in the table above could change when purchase accounting is finalized.

Refer to the tables at the end of this press release which include items typically adjusted to arrive at the Company’s non-GAAP results.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s Form 10-Q for first quarter 2019 is filed with the Securities and Exchange Commission ("SEC").

Conference Call and Webcast

A conference call to discuss the Company’s first quarter 2019 results will begin at 8:30 a.m. Eastern Time on May 2, 2019 and can be accessed by calling 1-800-682-0995 for domestic and +1-334-323-0522 for international. Please use the passcode 2251796 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through May 9, 2019 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 2251796 to access the replay.

On May 2, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported first quarter 2019 financial results on Thursday, May 9, 2019, after the close of U.S. markets (Press release, CytomX Therapeutics, MAY 2, 2019, View Source [SID1234535577]). Following the announcement, the company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website at View Source Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:
U.S. Dial-in Number: (877) 809-6037
International Dial-in Number: (615) 247-0221
Conference ID: 9496795
An archived webcast replay will be available on the Company’s website from May 9, 2019, until May 15, 2019.