On November 7, 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 third quarter 2019 financial results (Press release, CytomX Therapeutics, NOV 7, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-third-quarter-2019-financial" rel="nofollow">View Source [SID1234550635]).

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As of September 30, 2019, CytomX had cash, cash equivalents and short-term investments of $325.7 million.

"The CytomX clinical pipeline made excellent progress in Q3 as we continued to advance multiple Probody therapeutic programs across the portfolio," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "The initiation of a Phase 2 trial of our anti-PD-L1 Probody CX-072 in combination with ipilimumab in patients with relapsed refractory melanoma marks our ongoing evolution into a product-focused company seeking to realize the full potential of our novel technology platform. Our first in class Probody Drug Conjugate programs, CX-2009 and CX-2029, also continued to move forward and our pipeline overall is positioned for significant data updates in 2020."

Business Highlights and Recent Developments

CX-072 Anti-PD-L1 Probody Therapeutic Clinical Program

In October, CytomX announced the initiation of the PROCLAIM (Probody Clinical Assessment In Man) CX-072-002 Phase 2 study evaluating the efficacy and tolerability of the anti-PD-L1 Probody CX-072, in combination with the anti-CTLA-4 antibody, ipilimumab, in patients with relapsed or refractory melanoma. The study utilizes a Simon Two-Stage design with approximately 40 patients being enrolled into Stage 1. CytomX anticipates initial data from Stage 1 in 2020. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03993379.
The Company also announced in October updated clinical data from the Phase 1 PROCLAIM-CX-072-001 dose-finding study of CX-072 in combination with ipilimumab. With enrollment complete, 27 evaluable patients had received ipilimumab (3, 6 or 10 mg/kg) combined with CX-072 (0.3, 1, 3 or 10 mg/kg), with the study achieving a disease control rate (stable disease or better) of 37%. 5 patients achieved confirmed objective responses by RECIST v1.1, including one complete response, for an overall response rate (ORR) of 19% in this heavily pretreated patient population. The median duration of response was 14.6 months (1.9 – 21.2 months) with 4 of the 5 responders still on treatment as of the latest data snapshot. Of the 27 patients treated across all doses, Grade 3/4 treatment related adverse events (TRAEs) were reported in 9 (33%) patients. Grade 3/4 immune-related adverse events (irAEs) were reported in 3 (15%) patients.
Enrollment within the monotherapy cohorts of the PROCLAIM-CX-072-001 study is complete with evaluation of the activity and tolerability of CX-072 monotherapy continuing with ongoing treatment in select cohorts. Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03013491.
CX-2009 Anti-CD166 Probody Drug Conjugate Clinical Program

CytomX anticipates announcing next steps for the PROCLAIM-CX-2009 clinical program by the end of 2019.
BMS-986249 Anti-CTLA-4 Probody Therapeutic Clinical Program

Bristol-Myers Squibb (BMS) is conducting a Phase 1/2a dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in advanced solid tumors.
BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment. Additional information on this trial is available at ClinicalTrials.gov using the Identifier NCT03369223.
CX-2029 Anti-CD71 Probody Drug Conjugate Clinical Program

CytomX continued enrollment of patients in the PROCLAIM-CX-2029 Phase 1/2 study, which is partnered with AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas. Additional information on this trial is available at ClinicalTrials.gov using the Identifier NCT003543813.
Additional Corporate Highlights

In October, the Company announced the appointment of Amy C. Peterson, M.D., as executive vice president and chief development officer. In this new role, Dr. Peterson will have oversight of a multi-disciplinary team focused on advancing all aspects of CytomX’s clinical development activities.
In July, the Company announced that its partner AbbVie selected a second target under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates. The target selection triggered a $10 million payment to CytomX from AbbVie.
Third Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $325.7 million as of September 30, 2019, compared to $436.1 million as of December 31, 2018.

Revenue was $10.7 million for the three months ended September 30, 2019, compared to $12.5 million for the three months ended September 30, 2018. The decrease in revenue of $1.8 million for the three months ended September 30, 2019 compared to the corresponding period in 2018 was primarily due to a $1.7 million decrease in revenue recognition under the CD71 Agreement with AbbVie due to ongoing dose escalation.

Research and development expenses increased $0.4 million during the three months ended September 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $1.3 million in personnel-related expenses primarily due to an increase in headcount; an increase of $0.7 million in consulting expenses resulting from increased clinical trial activities and an increase of $0.8 million in the allocation of information technology and facilities related expenses driven partly from an increase in headcount; which amounts were offset by a decrease of $2.4 million in laboratory contracts and services and laboratory supplies as a result of timing of manufacturing activities as well as reduced costs relating to CX-188 which is not presently being advanced.

General and administrative expenses increased by $0.3 million during the three months ended September 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $0.4 million in consulting expenses primarily related to IT, software implementation and finance services; an increase of $0.5 million in dues and subscriptions primarily related to software and other IT services; an increase of $0.2 million in building maintenance charges; which amounts were partially offset by a decrease of $0.8 million of information technology and facilities-related expenses allocated to the general and administrative functions.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/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 & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 9449326. An archive of the webcast will be available on the CytomX website from November 7, 2019, until November 14, 2019.

On November 7, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that five abstracts relating to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, FL, which takes place December 7-10, 2019 (Press release, Onconova, NOV 7, 2019, View Source [SID1234550651]).

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Oral Presentation:

1.Phase II Study of Oral Rigosertib Combined with Azacitidine (AZA) As First Line Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Combination Therapies
Abstract: 566
Date: Monday, December 9, 2019
Presentation Time: 7:00 AM – 8:30 AM
Location: W311 EFGH (Orange County Convention Center)
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Poster Presentations:

2.Genomic Profiling in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) Following HMA Failure: Baseline Results from the INSPIRE Study (04-30)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster II
Abstract: 3015
Date: Sunday, December 8, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

3.The INSPIRE Study in Higher-Risk Myelodysplastic Syndrome (HR-MDS): A Novel Phase 3 Study Adaptive Design for Hematological Malignancies in Adults
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Abstract: 4249
Date: Monday, December 9, 2019
Presentation Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Anna Jonasova, MD, General University Hospital in Prague, 1st Internal Clinic – Clinic of Hematology, Prague, Czech Republic

4.Phase 3, Multi-Center, International, Randomized, Double-Blind, Placebo Controlled Study of Oral Rigosertib + Injectable Azacitidine (AZA) Versus Injectable Azacitidine in Treatment-Naïve Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Abstract: 4268
Date: Monday, December 9, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

5.The Sequenced Combination of Rigosertib and Azacitidine Has Modulatory Effects on CXCL8, RIG-I like Receptor (RLR) and Wnt/β-Catenin Signaling and Downstream Hematopoiesis Pathways in an in Vitro Model of the Myelodysplastic Syndrome
Session Name: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster III
Abstract: 4231
Date: Monday, December 9, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Richa Rai, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

On November 7, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary intratumoral immunotherapy products to kill tumors and increase immune system recognition of solid cancers, reported new preliminary data from the ongoing Phase 1/2 clinical study of INT230-6, the Company’s lead product candidate (Press release, Intensity Therapeutics, NOV 7, 2019, View Source [SID1234550667]). These data will be presented on Saturday, November 9, in an oral podium presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting, being held in National Harbor, MD.

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"The data being presented at SITC (Free SITC Whitepaper) advance our understanding of this new treatment, and identify a patient population that seems to derive the most benefit," said presenter and study investigator Jacob Thomas, MD, Assistant Professor of Clinical Medicine, Keck School of Medicine of the University of Southern California. "Our study included a highly refractory patient population, nonetheless several patients have had long term benefit. We observed a disease control rate of 39 percent in evaluable patients, with several patients showing disease control for over one year. In patients that had over 50 percent of total tumor burden injected, seven out of eight patients have shown disease control including all four patients enrolled with metastatic breast cancer. The treatment is well tolerated, and no patients had to discontinue therapy due to treatment-related toxicity. Additional benefits included tumor shrinkage and no further tumor growth or new tumors."

"We are excited that the data thus far reproduce the animal findings that intratumoral injection of INT230-6 stays in the tumor and the patients tolerate the procedure and drugs well. It also demonstrates cancer cell death in treated and in uninjected tumors with systemic immune activation," said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "Having the ability to safely reduce tumor cell burden and prime an immune response is an important advance in our ability to manage refractory cancers, we look forward to evaluating the combination with Keytruda and other immune agents."

The oral podium presentation includes data on 45 heavily pretreated patients with 17 different types of advanced or metastatic solid tumors who have failed a median of three prior therapies and are not candidates for approved, available therapies.

A pharmacokinetic (PK) analysis revealed limited exposure in the blood of INT230-6’s active anticancer agents, cisplatin (CIS) and vinblastine (VIN), supporting that the majority of INT230-6 is retained in the tumor, with few systemic toxicities. The findings are consistent with the low incidence of systemic adverse events despite intratumoral doses of INT230-6 escalating up to 160 mL, which is twice the amount of VIN that would typically be contained in a standard intravenous (IV) dose.

Furthermore, the immune activation data observed were consistent with nonclinical data, as local delivery of INT230-6 into tumors induced an immune response with increases of CD4+ and CD8+ T-cells in the blood and in the tumor microenvironment without any immune-related adverse events. An abscopal response was demonstrated in seven patients who overall showed tumor shrinkage in 10 non-injected tumors.

Oral Podium Presentation Information

Title: Intratumoral INT230-6 injection into solid tumors kills tumors and induces immune cell infiltration leading to abscopal responses and prolonged disease control in multiple refractory cancer types
Abstract Number: O31
Date/Time: Saturday, November 9, 2019, 3:45-4:00 p.m. ET
Session: Concurrent Session 309: Single Agent Phase 1 Clinical Trials
Location: Prince George’s Exhibition Hall C
Presenter: Jacob Thomas, MD, Assistant Professor of Clinical Medicine, University of Southern California

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity collaborative research, published in July 2019, showed that there was also strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

On November 7, 2019 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported its third quarter 2019 financial results and provided a corporate update (Press release, Protalix, NOV 7, 2019, View Source [SID1234550700]).

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"This has been a consequential quarter for Protalix during which we continued to make solid progress on our goals to move our Fabry program toward commercialization and to pursue strategic partnerships and alliances, and we commenced efforts to improve our capital structure," said Dror Bashan, Protalix’s President and Chief Executive Officer. "During the third quarter, we completed enrollment in our pivotal, head-to-head BALANCE study evaluating PRX‑102 compared to Fabrazyme. We also recently reported positive 12-month interim data from our switch-over Phase III BRIDGE study comparing PRX‑102 to another standard-of-care treatment, Replagal."

"With three, now fully enrolled Phase III clinical trials of PRX‑102, we have a robust and thorough clinical program for the treatment of Fabry disease," concluded Mr. Bashan. "Our management, scientific and clinical teams are all fully committed to bringing this important treatment to the Fabry patient community."

Third Quarter 2019 and Recent Clinical and Corporate Highlights

The Company, together with its development and collaboration partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced the completion of enrollment in the Phase III BALANCE clinical trial of PRX‑102 for the treatment of Fabry disease. The head-to-head Phase III BALANCE clinical study is designed to evaluate the safety and efficacy of PRX‑102 compared to agalsidase beta (Fabrazyme) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta. To date, more than 66 patients are being treated in the Company’s various extension studies after opting to continue treatment with PRX‑102 after completion of an original study.
The Company announced positive 12-month interim on-treatment data from the first 16 out of the 22 adult patients (9 males and 7 females) enrolled in the BRIDGE Phase III open label switch-over study of PRX‑102 for the treatment of Fabry disease. The interim data demonstrate a mean improvement in kidney function, in both male and female patients, when switched from agalsidase alfa (Replagal) to PRX‑102, and will help to support the expected U.S. Food and Drug Administration ("FDA") BLA filing under Accelerated Approval.
The Company and Chiesi plan the submission of a BLA for PRX‑102 via the FDA’s Accelerated Approval pathway based on data from the completed Phase I/II clinical trials of PRX‑102 and the ongoing Phase III BRIDGE clinical trial by April 2020.
Financial Results for the Nine Months Ended September 30, 2019

The Company recorded revenues from selling goods of $12.1 million during the nine-month period ended September 30, 2019, an increase of $4.9 million, or 67%, compared to revenues of $7.2 million for the same period of 2018. The increase is primarily due to higher sales of Elelyso in Brazil.
Research and development expenses, net, were $35.0 million for the nine months ended September 30, 2019, an increase of $11.3 million, or 47%, compared to $23.8 million for the same period of 2018. The increase resulted primarily from an increase of $8.5 million in clinical trial related costs as well as a decrease of $1.8 million in grants received from the Israeli Innovation Authority.
Selling, general and administrative expenses for the nine months ended September 30, 2019 were $6.9 million, a decrease of $1.9 million, or 21%, compared to $8.7 million for the same period in 2018. The decrease is primarily due to costs related to the Chiesi US Agreement we entered into in the third quarter of 2018, which were not incurred in the third quarter of 2019.
Net loss for the nine months ended September 30, 2019 was $18.6 million, or $0.13 per share, basic and diluted, compared to a net loss of $21.0 million, or $0.14 per share, basic and diluted, for the nine months ended September 30, 2018.
At September 30, 2019, the Company had $21.4 million in cash and cash equivalents.
The Company received a communication from NYSE American LLC stating that the Company is not in compliance with the continued listing standards as set forth in the NYSE American Company Guide as it has reported a stockholders’ equity deficiency as of June 30, 2019 and net losses in its five most recent fiscal years ended December 31, 2018. Subsequently, in accordance with the NYSE American Company Guide, the Company submitted to the NYSE American a plan to regain compliance with the continued listing standards.
The Company has engaged a first-tier financial advisory firm to assist in evaluating and pursuing strategic alternatives to maximize stakeholder value and address the foregoing.
As part of the Company’s efforts to advance its clinical development program and to realize future benefits of commercial success, the Company’s Board of Directors, along with the management team, has determined that it is in the Company’s best interest to seek to address to its capital structure.
Accordingly, the Company convened a Special Meeting of Stockholders to seek approval for the following:
– A reverse stock split at a ratio of not less than 1-for-10 and not greater than 1-for-20, with the exact ratio to be set within that range at the discretion of the Board of Directors before the day prior to the Special Meeting of Stockholders without further approval or authorization of the stockholders; and to reduce the total number of shares of the Company’s common stock that the Company is authorized to issue from 350 million to 120 million shares.
The Special Meeting of Stockholders of Protalix BioTherapeutics, Inc. to vote on the proposal will be held at 1:00 p.m., Israel time, on December 9, 2019 at the offices of the Company’s Israeli counsel, Horn & Co., Law Offices, Amot Investments Tower, 2 Weizmann Street, 24th Floor, Tel Aviv 6423902, Israel.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, November 7, 2019, at 8:30 am, Eastern Standard Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

Domestic (USA): 888-224-1005
International: 323-994-2093
Conference ID: 1931108
Webcast: http://bit.ly/2BSCaiY

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

On November 7, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that its stockholders voted to approve the company’s proposed combination with Exact Sciences Corp (NASDAQ: EXAS) at a special meeting held earlier (Press release, Genomic Health, NOV 7, 2019, View Source [SID1234550716]).

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As previously announced on July 29, 2019, Genomic Health and Exact Sciences entered into the merger agreement by which Exact Sciences will acquire Genomic Health in a cash and stock transaction. With the receipt of the required stockholder approval, Genomic Health and Exact Sciences expect to close the transaction on Friday, November 8 subject to satisfaction of the remaining customary closing conditions.

Final vote tallies from the Genomic Health special meeting of stockholders are subject to certification by the Company’s inspector of elections and will be included in a report to be filed by the Company with the Securities and Exchange Commission (the "SEC").