On November 6, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has selected Medpace, Inc. as the Contract Research Organization (CRO) to conduct PharmaCyte’s clinical trial in locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, NOV 6, 2018, View Source [SID1234530787]).

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PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented on PharmaCyte’s selection saying, "Our Clinical Trial Leadership Team (CTLT) worked diligently to identify and select the right CRO to conduct our clinical trial in LAPC. Medpace is an established and highly regarded full-service CRO with expertise in numerous therapeutic areas focused on supporting the biotech sector. It is a scientifically-driven organization with a dedicated in-house study team supported by outstanding medical experts to lead the way. Medpace has an extensive portfolio of successfully completed clinical trials, including those involving pancreatic cancer.

"Although we considered several outstanding CRO candidates, we felt that Medpace was the ideal choice to be our CRO as the team at Medpace provides experience and a range of services to conduct virtually every aspect of our Phase 2b clinical trial in LAPC. In 2018, Medpace was ranked among the top 10 CROs in the world. During the selection process, it was easy to see why Medpace is so highly ranked."

Selection of the CRO for PharmaCyte’s clinical trial in LAPC was performed by PharmaCyte’s CTLT led by Dr. Linda Sher, PharmaCyte’s Chief Medical Officer, and Dr. Manuel Hidalgo who will serve as Principal Investigator for the trial. The selection process was both laborious and time-consuming. Initially, 10 CRO candidates were identified. After an initial screening, this number was reduced to 8. Thereafter, careful examination and scrutiny of the qualifications and references of the 8 candidates led to the selection of the top 4 candidates.

Each of the 4 remaining candidates was then sent a Request for Proposal (RFP) to conduct the trial. After receiving the RFP proposals, interviews of the 4 remaining CROs were conducted by telephone. Finally, an in-depth analysis by PharmaCyte’s CTLT was conducted, which reduced the number of CRO candidates to the top 2. The top 2 CRO candidates were interviewed in person by members from the CTLT. Both candidates were outstanding and impressive.

The decision to select Medpace was unanimous among the members of the CTLT evaluation team. Although Medpace is a multidisciplinary full-service CRO, its largest therapeutic area of focus is in oncology, and it is very experienced in conducting pancreatic cancer clinical trials.

"Medpace is pleased to have been chosen by PharmaCyte Biotech to conduct its Phase 2b study in LAPC," said Lyon Gleich, MD, FACS, Vice President, Medical Department, Oncology at Medpace. "Our team has the appropriate therapeutic experience in conducting clinical trials in pancreatic cancer. We look forward to partnering with PharmaCyte Biotech and utilizing our knowledge and experience in oncology clinical trials to conduct this important study."

On November 6, 2018 Principia Biopharma Inc. (Nasdaq: PRNB), a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported financial results for the third quarter ended September 30, 2018 (Press release, Principia Biopharma, NOV 6, 2018, View Source [SID1234530827]).

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"The completion of our IPO with gross proceeds of approximately $122.2 million was the highlight of the third quarter for Principia. In addition, we continued with preparations for our upcoming PRN1008 Phase 3 trial in patients with pemphigus, and we achieved an important milestone in our collaboration with Sanofi for our BTK inhibitor PRN2246," said Martin Babler, Chief Executive Officer of Principia.

Third Quarter Financial Results

For the three months ended September 30, 2018, Principia reported net income of $6.7 million compared to a net loss of $7.1 million for the same period in 2017.

Collaboration revenue was $18.6 million for the three months ended September 30, 2018, compared to $1.5 million for the same period in 2017. The increase was due to the revenue recognition of an upfront payment of $40.0 million received in December 2017, as well as the revenue recognition of milestone payments totaling $15.0 million received in 2018, related to the Company’s collaboration with Sanofi.

Total research and development expenses were $9.2 million for the three months ended September 30, 2018, including stock-based compensation expense of $0.3 million, compared to $6.1 million for the same period in 2017, including stock-based compensation expense of $0.2 million. The increase in total research and development expenses was mainly due to an increase in PRN1008 program costs related to the initiation of an ITP clinical trial in December 2017, certain manufacturing campaigns as well as an increase in employee related expenses.

General and administrative expenses were $2.9 million for the three months ended September 30, 2018, including stock-based compensation expense of $0.4 million, compared to $1.3 million for the same period in 2017, including stock-based compensation expense of $0.1 million. The increase in total general and administrative expenses was primarily attributable to employee related expenses and facility costs.

Cash, cash equivalents, and short-term investments were $188.3 million as of September 30, 2018, compared to $41.1 million as of December 31, 2017. The increase in cash reflects net proceeds of $49.8 million from Principia’s Series C convertible preferred stock financing, and $113.6 million from Principia’s initial public offering (IPO).

On November 6, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results for the third quarter ended September 30, 2018, and provided a business update (Press release, Adaptimmune, NOV 6, 2018, View Source [SID1234530851]).

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"We have now completed the three dose escalation cohorts of the studies with MAGE-A4 and MAGE-A10, our leading wholly owned programs. The Safety Review Committee has agreed that the higher pre-conditioning regimen and cell doses are tolerable and there were no dose limiting toxicities. These studies will now move into the expansion phase, which allows us to treat patients with up to ten billion cells, without a pre-determined stagger across a broad range of tumor types. We have also continued dosing patients in the AFP study with 100 million cells and anticipate escalating to Cohort 2 in early 2019. We expect to report our next clinical data by no later than our first quarter financial results in May 2019," said James Noble, Chief Executive Officer.

Clinical momentum in wholly owned programs

Ongoing MAGE-A10 and MAGE-A4 studies

· There are three ongoing studies with MAGE-A10 and MAGE-A4 SPEAR T-cells

· Two MAGE-A10 studies: one in non-small cell lung cancer (NSCLC) and a triple tumor study in bladder, melanoma, and head & neck cancers

· A MAGE-A4 basket study in NSCLC, bladder, melanoma, synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), head & neck, ovarian, gastric, and esophageal cancers

· All three studies are first-in-human trials utilizing a modified 3+3 design with escalating target doses of 100 million (Cohort 1), 1 billion (Cohort 2), and 5 billion (Cohort 3) transduced SPEAR T-cells to evaluate safety, including dose limiting toxicities (DLTs)

· The preconditioning regimen in the first two cohorts was cyclophosphamide (600mg/m2/day) and fludarabine (30 mg/m2/day) on days -7, -6 and -5, and an extra day of fludarabine was added to the third cohorts and expansion phases, as clinical and translational data indicate that this extra day may be important for optimal T-cell expansion post-infusion

· Following the initial three cohorts, the Safety Review Committee (SRC) meets to decide whether to progress to the expansion phase, which has a target dose of 5 billion cells (range 1.2 to 10B) without pre-determined intervals between patient dosing

· The SRC recommended moving into the expansion phase for the MAGE-A10 triple tumor and MAGE-A4 basket studies

· As in the first two cohorts of these studies, there was no evidence of toxicity related to off-target binding or alloreactivity in the third cohorts at target doses of 5 billion cells

· Most adverse events were consistent with those experienced by cancer patients undergoing chemotherapy or other immunotherapies

ESMO data

· Initial safety data from the first two cohorts of the MAGE-A10 and MAGE-A4 studies were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress (https://bit.ly/2PdB3CR)

· In brief, these data showed:

· Disease progressed for all eight patients treated in the first dose cohorts of the two MAGE-A10 studies (five patients with lung cancer, two with head & neck cancer, and one with melanoma)

· For the three patients treated in Cohort 2 of the MAGE-A10 study (all lung cancer patients), one patient died of pneumonia (unrelated to therapy) and two had stable disease (SD), albeit transient

· Of the six patients treated in Cohorts 1 and 2 of the MAGE-A4 basket study, best response was SD in four patients and progressive disease (PD) in two patients

·One patient in the MAGE-A4 basket study with SD had an overall 27% reduction of target lesions observed at Week 6, and was assessed as PD at the time of the second scan, which took place after the ESMO (Free ESMO Whitepaper) poster cut-off date

· No evidence of toxicity related to off-target binding or alloreactivity at target doses of 100 million or 1 billion cells

· Most adverse events consistent with those experienced by cancer patients undergoing chemotherapy or other immunotherapies

· Transduced cells detectable in peripheral blood at levels consistent with dose

Data from ongoing AFP study

· Dosing in Cohort 1 of AFP study is ongoing

· Anticipate dose escalation to Cohort 2 in early 2019.

NY-ESO data updates to be presented at SITC (Free SITC Whitepaper)

·The NY-ESO program transitioned to GSK in July 2018

·An abstract summarizing NY-ESO SPEAR T-cells in MRCLS was accepted for presentation at SITC (Free SITC Whitepaper), and is available online today

· Data in the abstract state that out of ten MRCLS patients, there were four with partial responses (PRs) and four with SD, as per investigator assessment

· These data will be updated in a poster at SITC (Free SITC Whitepaper)

· Overall, there was evidence of reduction in target lesions in seven patients out of eight evaluable patients

· The data submitted in the abstract included investigator assessments. These assessments showed a best response of four confirmed PR, one unconfirmed PR, and three patients with SD out of eight evaluable patients

· Two of the responses were confirmed before the minimum 28 days required by RECIST v1.1 (22 and 25 days), and the patients subsequently progressed

· Therefore, the response rate by RECIST, which will be presented in the poster, is two confirmed PRs and six patients with SD out of the eight evaluable patients

· Patients in the MRCLS study received the same preconditioning regimen as was used in Cohort 4 of the synovial sarcoma study, and these patients had less durable responses compared to Cohort 1 patients in the synovial sarcoma study, who received a more intense preconditioning regimen

· The most frequent AEs were consistent with those experienced by patients with cancer who are undergoing cytotoxic chemotherapy or other immunotherapies

· A second poster with NY-ESO data will also be presented at SITC (Free SITC Whitepaper) summarizing translational research conducted in the context of the NY-ESO synovial sarcoma study examining serum factors that lead to T-cell expansion with different preconditioning regimens (including the impact of fludarabine), tumor micro-environment analyses pre- and post-infusion, and SPEAR T-cell functionality post-infusion. This abstract is also available online.

Manufacturing

Adaptimmune on its way to becoming a fully integrated cell therapy company

· 2018 has been a successful year for manufacturing with the Navy Yard facility regularly producing target cell doses > 1 billion cells with more than 50% producing > 5 billion cells

· Producing cell doses across multiple solid tumor indications

· Cells have been manufactured for a number of patients who could enter the MAGE-A4 and/or MAGE-A10 expansion phases, once eligible

Other corporate news

Adaptimmune is focused on its next stage of development and in a strong position to deliver success with SPEAR T-cell therapies

· Announced the closing of a registered direct offering of Adaptimmune’s American Depositary Shares ("ADSs") (https://bit.ly/2MZFEIH) with net proceeds of approximately $100 million

· Adaptimmune intends to use the net proceeds from this offering to advance the Company’s wholly owned pipeline of SPEAR T-cell candidates through clinical trials as well as for other general corporate purposes

· Completed transition of NY-ESO IND to GSK and received approximately $26 million in milestone payments

· Funded through to late 2020 with cash and cash equivalents of $153.1 million and total liquidity(1) of $237.7 million

· Held annual Scientific Advisory Board meeting in October with Adaptimmune R&D leaders and external experts in immunology and oncology (bios available here: https://bit.ly/2PvHH4w); focused on optimal employment of NY-ESO learnings in ongoing and future studies as well as strategies for novel target identification

Financial Results for the three and nine month period ended September 30, 2018

· Cash / liquidity position: As of September 30, 2018, Adaptimmune had cash and cash equivalents of $153.1 million and Total Liquidity(1) of $237.7 million.

· Revenue: Revenue for the three and nine months ended September 30, 2018 was $40.8 million and $58.0 million, respectively, compared to $27.2 million and $33.6 million for the same periods of 2017. The revenue in the three and nine months ended September 30, 2018 includes $39.1 million of revenue for the license to NY-ESO, which commenced in September 2018.

· Research and development ("R&D") expenses: R&D expenses for the three and nine months ended September 30, 2018 were $23.5 million and $75.5 million, respectively, compared to $24.0 million and $62.2 million for the same periods of 2017. The R&D expenses in the nine months ended September 30, 2018 has increased compared to the same period in 2017 due to increased clinical trial and related manufacturing activities. R&D expenses in the three months ended September 30, 2018 compared to the same period in 2017 decreased due to the transfer of the NY-ESO program to GSK.

· General and administrative ("G&A") expenses: G&A expenses for the three and nine months ended September 30, 2018 were $10.3 million and $32.8 million, respectively, compared to $8.1 million and $22.3 million for the same periods of 2017. The increase was primarily due to increased personnel costs consistent with the Company’s planned infrastructure growth.

· Other (expense) income, net: Other expense for the three and nine months ended September 30, 2018 was $2.2 million and $10.5 million, respectively, compared to an income of $3.6 million and $7.2 million for the same periods of 2017. Other income primarily comprises unrealized foreign exchange gains, which fluctuate depending on exchange rate movements and the amount of foreign currency assets and liabilities.

· Net income (loss): Net income (loss) attributable to holders of the Company’s ordinary shares for the three and nine months ended September 30, 2018 was an income of $5.2 million and a loss of $59.3 million, respectively, ($0.01 and $(0.10) per ordinary share) compared to a loss of $0.9 million and $42.9 million, respectively, ($(0.00) and $(0.08) per ordinary share) in the same periods of 2017.

(1) Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

Financial guidance

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations through to late 2020.

Conference call information

The Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) today. 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, please dial (833) 652-5917 (U.S.) 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 (2458438).

On November 6, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal first-quarter 2019, provided an update on recent business highlights, revised its fiscal year 2019 financial guidance and provided fiscal second-quarter 2019 financial guidance (Press release, Myriad Genetics, NOV 6, 2018, View Source [SID1234530868]).

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"Earnings during the quarter exceeded expectations based upon strong hereditary cancer and new product volume growth," said Mark C. Capone, president and CEO, Myriad Genetics. "Late in the quarter we identified two issues that impacted revenue for GeneSight and prenatal testing and as a result we have revised revenue guidance for fiscal 2019. We view these issues as transitory and given the progress on profitability, earnings guidance for the fiscal year remains unchanged. As we realize synergies from the Counsyl acquisition, continue to grow new product volumes, and secure additional new product coverage decisions, we expect revenue growth and profitability to further accelerate."

Business Highlights

Hereditary Cancer

Achieved seventh consecutive quarter of year-over-year hereditary cancer testing volume growth.

A landmark study published in the Journal of the American Medical Association demonstrated the importance of Myriad’s unique variant reclassification program. The study, which evaluated over 1.45 million patient test reports over a 10-year period, found that approximately 25 percent of all variants of unknown significance were reclassified. Nine percent of these amended reports led to an upgrade of a previously unclassified variant to a deleterious mutation.

A recent study published in Obstetrics and Gynecology, which evaluated almost 4,000 women presenting at 15 OBGYN practices, found that when patients were screened using the National Comprehensive Cancer Network guidelines, 24 percent of women who provided family history information met criteria for hereditary cancer testing.

Added the 29th gene, HOXB13, to the myRisk Hereditary Cancer panel. Men with a deleterious mutation in the HOXB13 gene have up to a 52 percent lifetime risk of developing prostate cancer and should receive incremental screening.

GeneSight

GeneSight test volume increased 28 percent year over year.

A record 15,500 physicians, including almost 2,500 new ordering doctors, ordered a GeneSight test in the fiscal first quarter.

Anticipate acceptance of the landmark GUIDED study in the fiscal second quarter of 2019.

Published the results of the IMPACT study in the Journal of Psychiatric Research. In the study, patients treated by primary care physicians had 27 percent greater symptom improvement, 35 percent increased response and 63 percent greater remission than those treated by psychiatrists.

Published the results of the Optum health economic study in Personalized Medicine. The study found that patients in the GeneSight cohort had cost savings of $5,505 in the first year. This result was highly statistically significant even after adjusting for pre-test differences between the two arms. When evaluating the subset of patients with major depressive disorder, patients who received GeneSight had total cost savings of $6,050 in the first year which also was highly statistically significant.

Prenatal testing volume increased 16 percent year over year in the fiscal first quarter.

Announced publication of a large clinical utility study for ForeSight in Genetics in Medicine. The study found that the ForeSight test led to significant changes in pregnancy management with 77 percent of at risk couples taking steps to avoid having an affected offspring such as prenatal diagnostic testing and in-vitro fertilization.

Vectra

Published results of a study demonstrating the minimally important difference in Vectra scores in Clinical Rheumatology. This data will form the basis of the future Vectra medical management tool on the test report.

Received favorable guidelines supporting Vectra from Bendcare, a national organization representing greater than 160 rheumatologists in the United States.

Prolaris

Fiscal first-quarter revenue increased 59 percent year over year to $6.2 million with double-digit volume growth.

Announced positive coverage decision from Blue Shield of California for Prolaris. This decision increases total covered commercial lives for Prolaris by 5 million and the number of total commercial lives covered to over 25 million lives in the United States.

EndoPredict

Fiscal first-quarter revenue increased 33 percent year-over-year to $2.4 million.

myPath Melanoma

Received a positive draft local coverage determination from Noridian Healthcare Solutions for myPath Melanoma.

Received a positive guideline recommendation from the American Academy of Dermatology for use of myPath Melanoma in equivocal lesions.

Companion Diagnostics

Received our second FDA approval for patients with HER2- metastatic breast cancer for BRACAnalysis CDx in conjunction with Pfizer’s PARP inhibitor talazoparib.

Announced new research agreement with Pfizer in neo-adjuvant triple negative breast cancer using BRACAnalysis CDx.

Filed supplementary PMA for BRACAnalysis CDx for use in conjunction with AstraZeneca’s PARP inhibitor Lynparza for maintenance in first-line ovarian cancer.

Fiscal Year 2019 and Fiscal Second-Quarter 2019 Financial Guidance

Below is a table summarizing Myriad’s revised fiscal year 2019 and fiscal second-quarter 2019 financial guidance:

Myriad’s fiscal year 2019 and fiscal second-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, November 6, 2018, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-672-8962. International callers may dial 1-303-223-4363. All callers will be asked to reference reservation number 21897521. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On Novembber 6, 2018 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 third quarter 2018 financial results (Press release, CytomX Therapeutics, NOV 6, 2018, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2018-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2018-financial" rel="nofollow">View Source [SID1234530888]).

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As of September 30, 2018, CytomX had cash, cash equivalents and short-term investments of $464.6 million.

"During the third quarter, CytomX made broad progress across our highly innovative pipeline of Probody therapeutics," said Sean McCarthy D.Phil., president and chief executive officer. "CX-072, our lead PD-L1 Probody drug candidate, continues to advance in the clinic, as evidenced by our presentations at ESMO (Free ESMO Whitepaper) that reinforce the encouraging safety and clinical activity profiles of CX-072 as both a monotherapy and in combination with ipilimumab. These clinical data also provide further proof-of-concept for our unique platform. During the quarter, we also initiated a clinical trial for CX-2029, a CD71-directed Probody drug conjugate partnered with AbbVie, continued to advance CX-2009, our PDC targeting CD166, and recently filed an IND for CX-188, our Probody therapeutic targeting PD-1. The ongoing translation of our novel science into the clinic is exciting to see."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a potentially best in class Probody therapeutic targeting PD-L1, a clinically- and commercially-validated anti-cancer target.
CytomX presented updated interim clinical data from two arms of the Phase 1/2 PROCLAIM-CX-072 program with a data cutoff of August 3, 2018 at the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting.
CX-072 monotherapy was studied in PD-L1/PD-1 inhibitor naïve patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Parts A and A2).
The Maximum Tolerated Dose (MTD) was not reached.
Of the 46 patients treated, Grade 3/4 treatment-related adverse events (TRAE) were reported in five patients (11%) and Grade 3/4 immune-related adverse events (irAEs) were observed in 3 patients (7%).
Of the 18 patients treated at doses of 3 mg/kg or above, 3 (17%) achieved an objective response with 1 confirmed and ongoing partial response (PR) and 2 unconfirmed PRs observed. Stable disease was observed in 8 patients (44%) for an overall Disease Control Rate (DCR) of 61%.
CX-072 in combination with Yervoy (ipilimumab) was studied in patients with advanced unresectable solid tumors or lymphomas for which no PD-L1 or PD-1 inhibitor was approved or available for their disease (Part B).
Of the 20 patients treated, Grade 3/4 TRAEs were reported in four patients (20%) and Grade 3/4 immune-related adverse events (irAEs) were reported in 2 patients (10%).
Of the 14 patients treated with 3 mg/kg of ipilimumab and 0.3 – 10 mg/kg of CX-072, 3 (21%) achieved an objective response with 1 confirmed complete response (CR), and 2 confirmed PRs observed. Stable disease was observed in 21% of patients for an overall DCR of 43%.
CytomX continues to enroll and dose patients in monotherapy expansion cohorts in 8 undisclosed tumor types at the dose of 10mg/kg (Part D). Initial clinical data from Part D is expected in 2019.
CytomX continues to enroll and dose patients in a combination trial of CX-072 plus Zelboraf (vemurafenib) in patients with V600E BRAF-positive melanoma (Part C).
CytomX will be presenting clinical translational data from Part A2 of the CX-072 monotherapy trial later this week as a poster and in a rapid-fire oral presentation at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
The Company will be hosting an Analyst and Investor event on Saturday, November 10th at SITC (Free SITC Whitepaper) that will be webcast. Webcast details can be found under the Investor and News section of the Company’s website at www.CytomX.com.

PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a first in class Probody drug conjugate (PDC) that targets CD166, a broadly and highly expressed tumor antigen.
In the second quarter of 2017, CytomX initiated the PROCLAIM-CX-2009 Phase 1/2 clinical program to evaluate the safety and preliminary anti-tumor efficacy of CX-2009.
Part A (monotherapy dose escalation) was initiated at a dose of 0.25 mg/kg with an anticipated top dose of 6 mg/kg. As of November 2, 2018, the enrolling dose level was 10 mg/kg.
Part A2, was initiated in the second quarter of 2018. In Part A2, patients with CD166+++ expressing tumors are enrolled to receive CX-2009 at doses of 4 mg/kg and above already cleared in Part A (6 patients per dosing cohort). Biopsies are mandatory in A2. As of November 2, 2018, patients were being enrolled in a 9 mg/kg dosing cohort.
CytomX anticipates providing a comprehensive update on the CX-2009 program in the first half of 2019 following the substantial completion of Parts A and A2.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC.
CytomX initiated Part A of the PROCLAIM-CX-2029 Phase 1/2 clinical program in July 2018.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program

CytomX filed an Investigational New Drug (IND) application for CX-188 in October and expects to commence dose escalation studies following IND clearance from the U.S. Food and Drug Administration.
Financial Highlights

In July, CytomX completed an underwritten public offering of 5,867,347 common shares which resulted in net proceeds of $134.6 million to CytomX.
Third Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments totaled $464.6 million as of September 30, 2018, compared to $374.1 million as of December 31, 2017.

Revenue was $12.5 million for the three months ended September 30, 2018, compared to $24.1 million for the three months ended September 30, 2017. The decrease was primarily attributable to the recognition during the third quarter of 2017, in full in accordance with ASC 605, of $14.0 million in revenue (net of the associated sublicense fee of $1.0 million) related to the milestone payment from AbbVie after meeting certain milestones required to begin GLP toxicology studies under the collaboration agreement with AbbVie ("AbbVie CD71 Agreement"). This increase was partially offset by an increase in the third quarter of 2018 of $1.5 million in revenue resulting from the change in method of revenue recognition related to the AbbVie CD71 Agreement from straight-line under ASC 605 to percentage-of-completion under ASC 606 and an increase of $1.5 million in revenue related to the Amgen Collaboration and Licensing Agreement ("Amgen Agreement") executed in September 2017.

Research and development expenses decreased by $1.4 million during the three months ended September 30, 2018 compared to the corresponding period in 2017. The decrease was primarily attributed to the recognition, during the third quarter of 2017, of $10.7 million of non-cash in-process research and development expense and $1.2 million of sublicense fee payable to the University of California, Santa Barbara, both as a result of the Amgen Agreement. These amounts were partially offset by increases in the third quarter of 2018 of $3.2 million in personnel-related expenses and other allocated overhead expenses resulting from an increase in headcount, $2.7 million in lab contracts and services expenses primarily related to CX-2009 Phase 1/2 clinical development and $4.0 million in clinical trial expenses primarily related to CX-072, CX-2009 and CX-2029.

General and administrative expenses increased by $1.9 million during the three months ended September 30, 2018 compared to the corresponding period in 2017. This increase was largely attributed to an increase of $2.1 million in personnel related expenses due to increases in headcount.

Conference Call and Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the Investor and News page of CytomX’s website at View Source or by dialing (877) 809-6037 or (615) 247-0221 and using the passcode 9616738. A replay of the webcast will be available on the CytomX website from November 6, 2018 to November 13, 2018.