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.

On November 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 that clinical translational data from PROCLAIM-CX-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented 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) (Press release, CytomX Therapeutics, NOV 6, 2018, View Source [SID1234530788]). The conference will take place from November 7-11, 2018 in Washington, DC.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Poster P87: Preliminary Evidence of Intratumoral Activation and Immunomodulatory Effect of CX-072, a Probody Therapeutic Antibody Prodrug Targeting PD-L1, in a Phase 1/2a Trial

Presenter: Luc Desnoyers, Ph.D., Senior Director of Translational Sciences, CytomX Therapeutics

Date/Time: November 9, 2018; 8:00 – 9:00 a.m. /12:45 – 2:45 p.m. /6:30 – 8:00 p.m. EST

Location: Poster Hall E, Walter E. Washington Convention Center

Preliminary Evidence of Intratumoral Activation and Immunomodulatory Effect of CX-072, a Probody Therapeutic Antibody Prodrug Targeting PD-L1, in a Phase 1/2a Trial

Presenter: Luc Desnoyers, Ph.D., Senior Director of Translational Sciences, CytomX Therapeutics

Session: Rapid Oral Abstracts

Date/ Time: November 10, 2018; 1:05 – 1:10 p.m. EST

Location: Poster Hall E, Walter E. Washington Convention Center
Analyst and Investor Event and Webcast

CytomX will host an Analyst and Investor event on Saturday, November 10, 2018 from 12:30 to 2:00 p.m. EST to review the SITC (Free SITC Whitepaper) clinical data presentation. Participants are invited to listen to a live audio webcast of the presentation at View Source or by dialing 1-877-809-6037 or 1-615-247-0221 and using code 4597498. The event will also be available for replay for 30 days on the company’s website, www.CytomX.com.

For analysts and investors interested in attending the event in person, please contact [email protected] as space is limited.

On November 6, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the third quarter ended September 30, 2018 (Press release, BioCryst Pharmaceuticals, NOV 6, 2018, View Source [SID1234530828]).

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"With enrollment in APeX-2 complete, and the successful results from ZENITH-1, we are excited with the momentum that is building towards meeting the urgent demand of HAE patients for an oral therapy option to prevent and treat their attacks," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We have many significant milestones lined up over the next several months and we are focused on delivering high quality APeX-2 data in the second quarter of 2019, filing our New Drug Application (NDA) for BCX7353 in the fourth quarter of 2019 and advancing at least one additional pipeline program into the clinic in the first half of the year," Stonehouse added.

Upcoming Key Milestones:

Complete the 250 mg and 500 mg dose cohorts of the ZENITH-1 clinical trial for acute treatment of hereditary angioedema (HAE) attacks with BCX7353 (Q1 2019)

Meet with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for input on the design of a Phase 3 clinical trial of BCX7353 for acute treatment of HAE attacks, and commence the Phase 3 trial (Summer 2019)

Report results from the APeX-2 clinical trial (Q2 2019)

Advance at least one preclinical program into the clinic and begin the Phase 1 clinical trial (1H 2019)

File NDA for BCX7353 for prevention of HAE attacks with FDA (Q4 2019)

Third Quarter 2018 Financial Results

For the three months ended September 30, 2018, total revenues were $1.5 million, compared to $8.8 million in the third quarter of 2017. The decrease was primarily associated with two infrequent 2017 events that did not recur in 2018. A $5.0 million milestone payment associated with the FDA approval of a supplemental New Drug Application (sNDA) for RAPIVAB (peramivir injection), extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older, and the recognition of $1.5 million of peramivir product sales to the company’s commercial partner, Green Cross Corporation.

Research and development (R&D) expenses for the third quarter of 2018 increased to $22.0 million from $17.5 million in the third quarter of 2017, primarily due to increased spending on the company’s HAE and preclinical programs.

General and administrative (G&A) expenses for the third quarter of 2018 increased to $7.9 million, compared to $3.3 million in the third quarter of 2017. The increase was primarily due to merger-related costs associated with the company’s terminated merger with Idera Pharmaceuticals, Inc. (Idera).

Interest expense was $2.3 million in the third quarter of 2018, compared to $2.1 million in the third quarter of 2017.

Net loss for the third quarter of 2018 was $29.6 million, or $0.28 per share, compared to a net loss of $15.1 million, or $0.18 per share, for the third quarter 2017.

Cash, cash equivalents and investments totaled $151.0 million at September 30, 2018, and reflect a decrease from $159.0 million at December 31, 2017. Cash and investments reflect the proceeds from a July 2018 enhancement to our credit facility and an August 2018 public equity offering, offset by normal operating expenses and merger related costs incurred in the nine-month period. Net operating cash use for the third quarter 2018 was $29.4 million, and for the first nine months of 2018 was $70.7 million.

Year to Date 2018 Financial Results

For the nine months ended September 30, 2018, total revenues were $17.9 million, compared to $21.3 million in the first nine months of 2017. The decrease in revenue was primarily associated with infrequent revenue events that occurred in 2017 that did not recur in 2018, as well as a decrease of revenue from galidesivir development under U.S. Government contracts. Those 2017 events were the recognition of $4.1 million of royalty revenue from Japanese government stockpiling of RAPIACTA and the recognition of $1.5 million of peramivir product sales to the company’s commercial partner, Green Cross Corporation. In the nine-month periods, there was a $5.0 million milestone and $7.0 million of deferred revenue both associated with the EMA’s approval of peramivir (ALPIVAB) recognized in the second quarter of 2018, and two infrequent events that occurred in the third quarter of 2017, as discussed in the third quarter commentary above.

R&D expenses in the first nine months of 2018 increased to $61.5 million from $50.0 million in the first nine months of 2017, primarily due to increased spending on our HAE and preclinical programs. These increases were partially offset by a decrease in the company’s peramivir and galidesivir development spending in 2018.

G&A expenses for the first nine months of 2018 increased to $25.0 million, compared to $9.2 million in the first nine months of 2017. The increase was primarily due to approximately $11 million of merger-related costs associated with the company’s terminated merger with Idera and a $4.9 million reserve for collectability of the EMA approval milestone of peramivir.

Interest expense was $6.8 million in the first nine months of 2018, compared to $6.3 million in the first nine months of 2017.

Net loss for the first nine months of 2018 was $73.8 million, or $0.73 per share, compared to a net loss of $46.2 million, or $0.58 per share, for the first nine months of 2017.

Third Quarter 2018 Corporate Developments

On September 17, 2018, BioCryst announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, had awarded BioCryst an additional $3.5 million to support clinical trials of galidesivir in patients with yellow fever.

On September 6, 2018, BioCryst announced that the Centers for Disease Control and Prevention (CDC) had awarded BioCryst a $34.7 million contract for the procurement of up to 50,000 doses of BioCryst’s approved antiviral influenza therapy, RAPIVAB (peramivir injection) over a five-year period.

On September 4, 2018, BioCryst announced initial results from the ZENITH-1 trial showing that a single 750 mg oral dose of BCX7353 was well tolerated and superior to placebo (p<0.05) against the majority of efficacy endpoints evaluated in HAE patients suffering an acute attack.

On August 6, 2018, BioCryst announced it has received Fast Track Designation by the FDA for BCX7353 for the prevention of angioedema attacks in patients with hereditary angioedema.

On August 6, 2018, BioCryst announced the full exercise of the underwriters’ option to purchase additional shares and the completion of its public offering resulting in the sale of 10,454,546 shares of its common stock at a price of $5.50 per share. The net proceeds from this offering were approximately $53.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses.

On July 25, 2018, BioCryst announced that results from the Phase 2, APeX-1 trial of BCX7353 for the prevention of attacks in patients with HAE were published in the July 26th issue of The New England Journal of Medicine.

On July 20, 2018, BioCryst entered into a $30 million secured loan facility with MidCap Financial Trust as administrative agent and lender (MidCap), pursuant to the terms and conditions of that certain Amended and Restated Credit and Security Agreement. The Credit Agreement replaces the Credit and Security Agreement dated as of September 23, 2016.

On July 10, 2018, BioCryst announced that it had terminated the previously announced merger agreement with Idera following the company’s stockholders’ failure to approve the adoption of the merger agreement. Pursuant to the merger agreement, the company reimbursed Idera $6 million in July 2018.
Financial Outlook for 2018

Based upon development plans, merger-related incurred costs from the terminated merger agreement with Idera and awarded government contracts, BioCryst continues to expect its previously issued 2018 financial outlook to be appropriate, with net operating cash use to be in the range of $85 to $105 million, and its 2018 operating expenses to be in the range of $90 to $110 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID #9090479. A live webcast of the call and slides will be available online at the investors section of the company website at www.biocryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9090479.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 was generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.