On November 5, 2019 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, reported third quarter 2019 financial results (Press release, Evelo Biosciences, NOV 5, 2019, View Source [SID1234550294]). Additionally, in a separate press release, the Company announced positive interim clinical data in a Phase 1b trial in individuals with mild to moderate psoriasis being treated with a high dose of EDP1815, its clinical candidate for the treatment of a range of inflammatory diseases.

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"We now have further clinical data that support our potential ability to treat systemic inflammatory disease through oral delivery of pharmaceuticals to the small intestinal axis," said Simba Gill, Ph.D., chief executive officer of Evelo. "The clinical activity demonstrated by EDP1815 in psoriasis further validates our platform and highlights Evelo’s potential to bring new medicines with the potential to be effective, safe, convenient and affordable to millions of people living with chronic diseases."

Inflammation

Interim Clinical Data Highlights

About the EDP1815 Phase 1b clinical trial in mild to moderate psoriasis, high dose cohort

Eighteen individuals with mild to moderate psoriasis were randomized 2:1 to receive a daily oral administration of 2.76g (5x or high dose) of EDP1815 or placebo for 28 days. The primary endpoint is safety and tolerability. Secondary and exploratory endpoints include lesion severity score (LSS) and Psoriasis Area and Severity Index (PASI), both measures of clinical activity, as well as cellular histological biomarkers and blood immune cell biomarkers taken from biopsies and blood samples at the start and end of the dosing period, respectively. Safety and tolerability and secondary clinical endpoints are also measured at day 42, 2 weeks after completion of dosing.

EDP1815 – positive interim Phase 1b clinical data at high dose

In a separate press release, Evelo reported positive interim clinical data from the high dose cohort in its Phase 1b trial of EDP1815 in mild to moderate psoriasis.
EDP1815 continued to be well tolerated in this cohort, with no overall difference reported from placebo.
At the end of the 28-day dosing period, the high dose cohort showed a mean reduction in LSS consistent with previously reported data for a low dose cohort.
Two weeks following the completion of the dosing period, at day 42, the high dose cohort showed continued reductions from baseline in both mean LSS and PASI, which may be indicative of a sustained clinical effect and dose response.
A range of histological and molecular biomarkers were measured in the high dose cohort, with trends in line with the clinical effects of EDP1815 at the cohort level.
Evelo plans to advance EDP1815 into Phase 2 in early 2020. This placebo-controlled dose and formulation selection trial will investigate daily dosing of EDP1815 in mild to moderate psoriasis patients over 16 weeks. Evelo expects to report initial data from the trial in late 2020.
Anticipated Milestones

EDP1815 – Phase 1b new formulation in psoriasis and atopic dermatitis

Given the newly released positive EDP1815 data and the planned Phase 2 trial, Evelo will not enroll any further cohorts of individuals with psoriasis in the ongoing Phase 1b clinical trial.
The Company expects to report initial clinical data from a cohort of individuals with mild to moderate atopic dermatitis to be dosed with a new formulation in the second quarter of 2020.
EDP1066 – Phase 1b new formulation in atopic dermatitis

Evelo expects to report initial clinical data from a cohort of individuals with mild to moderate atopic dermatitis, dosed with a new formulation, in the first quarter of 2020.
Oncology

Clinical Studies and Anticipated Milestones

EDP1503 – Phase 1/2

Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.
The cohort of patients with microsatellite stable colorectal cancer who had previously failed all therapies for metastatic disease is fully recruited. No clinical responses have been evident; however, several patients in this cohort have experienced extended stable disease. Cellular infiltration biomarker changes were also observed in tumor biopsies taken from those patients during the EDP1503 monotherapy period, which are consistent with preclinical observations for EDP1503. Evelo continues to monitor patients in this cohort.
Given newly approved treatments for triple-negative breast cancer, Evelo anticipates that the majority of triple negative breast cancer patients to be recruited will have relapsed following prior PD-1/L1 therapy, similarly to those in the PD-1 relapsed cohort.
Evelo expects to report further clinical data from this trial in the first half of 2020.
Business Highlights

In September 2019, Evelo appointed David Epstein as chairman of its Board of Directors. Mr. Epstein, who has been a director of Evelo since March 2017, brings extensive experience and relationships in the biotech and pharmaceutical industries to his role as chairman. He currently serves as chairman of the Board of Directors of Rubius Therapeutics and Axcella Health and as a director at International Flavors and Fragrances. From January 2010 – July 2016, Mr. Epstein served as chief executive officer of Novartis Pharmaceuticals, a division of Novartis AG. In conjunction with Mr. Epstein’s appointment, Noubar Afeyan, Ph.D., co-founder of Evelo and chief executive officer of Flagship Pioneering, stepped down from his role on Evelo’s Board.
Third Quarter 2019 Financial Results

Cash Position: As of September 30, 2019, cash and cash equivalents were $97.1 million, as compared to cash, cash equivalents and investments of $147.9 million as of December 31, 2018 and $113.5 million as of June 30, 2019. This decrease was due to cash used to fund operating activities and capital expenditures for the third quarter of 2019. Evelo expects that its cash and cash equivalents, together with funds available under tranche 2 of its debt facility, will enable it to fund its planned operating expenses and capital expenditure requirements to the end of 2020.
Research and Development Expenses: R&D expenses were $15.6 million for the three months ended September 30, 2019, compared to $11.2 million for the three months ended September 30, 2018. The increase of $4.4 million was due primarily to increases in costs related to Evelo’s inflammation clinical programs and research platform expenses, as well as increased personnel costs.
General and Administrative Expenses: G&A expenses were $5.9 million for the three months ended September 30, 2019, compared to $5.2 million for the three months ended September 30, 2018. The increase of $0.7 million was due primarily to increased personnel costs to support Evelo’s growth.
Net Loss: Net loss attributable to common stockholders was $21.6 million for the three months ended September 30, 2019, or $0.67 per basic and diluted share, as compared to a net loss of $15.9 million for the three months ended September 30, 2018, or $0.50 per basic and diluted share.
Conference Call

Evelo will host a conference call and webcast at 8:30 a.m. EST today to review the new clinical data for EDP1815. To access the call please dial 866-795-3242 (domestic) or 409-937-8909 (international) and refer to conference ID 7788384. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo’s website at View Source The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

On November 5, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Jim Hippel, Chief Financial Officer, will present at the Stephens Nashville Investment Conference on Wednesday, November 13, 2019 at 9:45 a.m. CST (Press release, Bio-Techne, NOV 5, 2019, View Sourcenews/detail/164/bio-techne-to-present-at-the-stephens-nashville-investment-conference [SID1234550293]). The conference will be held at the Omni Nashville Hotel in Nashville, TN. A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source

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On November 5, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Tuesday, November 12, 2019 following release of its third quarter 2019 financial results (Press release, Oncolytics Biotech, NOV 5, 2019, https://ir.oncolyticsbiotech.com/news/detail/481/oncolytics-biotechr-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights [SID1234550292]).

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The live call may be accessed by dialing 844-407-9500 or callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877)-481-4010, using the replay code 56787 and will be available for one week.

A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.

On November 5, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2019 (Press release, Curis, NOV 5, 2019, View Source [SID1234550291]).

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"This past quarter, we made significant progress in advancing our clinical programs for fimepinostat and CA-4948, with continued enrollment across both Phase 1 trials and data readouts on-track for both programs in the fourth quarter of this year. We are particularly encouraged by the early indications of anti-cancer activity with CA-4948." said James Dentzer, President and Chief Executive Officer of Curis. "We are pleased by the safety and tolerability profile of CA-170 in our Phase 1 study and continue to believe VISTA is an important and scientifically-validated target. However, initial data suggest that CA-170 may not be an effective monotherapy agent for addressing VISTA in mesothelioma patients. We plan to further evaluate the translational science and clinical pharmacodynamics of CA-170, as well as the patient data from our Phase 1 study, to determine the optimal future clinical strategy for CA-170."

Third Quarter 2019 and Recent Operational Highlights

Precision oncology, fimepinostat (HDAC/PI3K inhibitor):

Curis is evaluating fimepinostat (a MYC suppressor) with venetoclax (a BCL-2 inhibitor) combination regimen in an ongoing Phase 1 study in diffuse large B-cell lymphoma (DLBCL), including patients with double-hit/double-expressor (DH/DE) lymphoma. DLBCL is often driven by specific alterations in both MYC and BCL2. In the clinic, fimepinostat and venetoclax have each demonstrated single-agent activity. In preclinical models, fimepinostat administered in combination with venetoclax resulted in an enhanced benefit relative to each agent alone.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Curis is evaluating CA-4948 in an ongoing Phase 1 dose escalation study in patients with non-Hodgkin lymphoma (NHL), including those with oncogenic MYD88 mutations and toll-like receptor (TLR) pathway activation. Curis plans to continue dose escalation in the study to determine the optimal dose for clinical development.
Curis plans to initiate a separate Phase 1 trial of CA-4948 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), a focus on those with spliceosome mutations that encode oncogenic IRAK4-L.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):

Curis released initial efficacy data from its Phase 1 study of CA-170 in malignant plural mesothelioma (MPM) patients (high VISTA expressors) in conjunction with the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. The Phase 1 study was designed to evaluate the safety, recommended Phase 2 dose, and maximum tolerated dose of CA-170. Secondary endpoints included pharmacokinetic (PK) and anti-cancer activity, and exploratory endpoints included biomarkers and pharmacodynamic (PD) effects. The study enrolled 12 patients with MPM across 6 study sites within the U.S. and U.K., randomizing patients into two cohorts. The high-dose cohort received 1,200 mg twice-daily (BID) of CA-170, while the low-dose cohort received 200 mg BID of CA-170. Patients who did not respond or experienced disease progression at the 200 mg BID dose were crossed over to the high-dose cohort.
Of 12 patients enrolled, 11 patients have discontinued study treatment, with no partial or complete responses observed, per Response Evaluation Criteria In Solid Tumors (RECIST), Immune-related Response Criteria (irRC) or modified RECIST 1.1 for mesothelioma.
Of 11 patients on treatment for at least one post-baseline disease assessment, 7 had a best response of stable disease:
2 of 3 (66%) patients at the 200 mg BID dose (mean duration of 64 days)
5 of 8 (63%) patients assigned or escalated to the 1,200 mg BID dose (mean duration of 115 days)
CA-170 was generally safe and well-tolerated, with low rates of drug-related, immune-related or serious adverse events, and showed dose-proportional clinical PK.
Based on these data, Curis does not intend to enroll additional patients in this study. The Company plans to further evaluate the translational science and clinical pharmacodynamics of CA-170, in addition to patient data from the Phase 1 study, to assess the potential of future clinical studies of CA-170.
The Company is presenting the results from the Phase 1 study at the SITC (Free SITC Whitepaper) 2019 Annual Meeting in National Harbor, Maryland:

Date/Time:

Saturday, November 9, 2019, 4:45 p.m. EST

Location:

Prince George’s Exhibition Hall C

Poster Number:

O28

Title:

First-in-Class Small Molecule CA-170 Targeting VISTA: A Report on Efficacy Outcomes from a Cohort of 12 Malignant Pleural Mesothelioma (MPM) Patients in Study CA-170-101

Corporate:

In August 2019, Curis announced the appointments of Reinhard von Roemeling, M.D., as Senior Vice President, Clinical Development, and Christine Guertin as Vice President, Regulatory Affairs & Quality Assurance.
In September 2019, Curis announced the promotion of Bill Steinkrauss to Chief Financial Officer.
Upcoming 2019 Milestones

The company will be presenting at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held December 7-10, 2019 in Orlando, FL, and will provide an update on:
Initial safety data from the Phase 1 study of the combination of fimepinostat and venetoclax in patients with R/R DLBCL, including patients with DH/DE lymphoma; and
Updated safety and efficacy data from the Phase 1 dose escalation study of CA-4948 in patients with NHL.
Third Quarter 2019 Financial Results

Curis reported a net loss of $6.4 million, or $0.19 per share on both a basic and diluted basis for the third quarter of 2019, as compared to a net loss of $7.2 million, or $0.22 per share on both a basic and diluted basis for the same period in 2018.

Revenues for the third quarter of 2019 were $2.9 million, as compared to $2.8 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $8.2 million for the third quarter of 2019, as compared to $9.3 million for the same period in 2018, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the third quarter of 2019, as compared to $0.2 million for the same period in 2018.

Research and Development Expenses (R&D). R&D expenses were $5.1 million for the third quarter of 2019, as compared to $5.0 million for the same period in 2018. The increase was primarily driven by increased costs related to clinical activities for CA-4948.

General and Administrative Expenses (G&A). G&A expenses were $2.9 million for the third quarter of 2019 as compared to $4.1 million for the same period in 2018. The decrease was primarily driven by lower personnel, legal and consulting services during the period.

Other Expenses. Net other expense for the third quarter 2019 was $1.1 million, as compared to $0.8 million for the same period in 2018. Net other expense for the third quarter 2019 primarily consisted of imputed interest expense related to future royalty payments, whereas in 2018 the expense related to interest accrued on Curis Royalty’s debt obligations.

As of September 30, 2019, Curis’s cash, cash equivalents, marketable securities and investments totaled $28.0 million and there were approximately 33.2 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into the second half of 2020.

Conference Call Information

Curis management will host a conference call today, November 5, 2019, at 8:30 a.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On November 5, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, NOV 5, 2019, View Source;5 [SID1234550290]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on November 6, 2019, to 5:00 p.m., New York City time, on November 8, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on November 4, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source