On July 25, 2018 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1 study evaluating investigational agent TP-0184, an activin A receptor type 1 (ACVR1) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, JUL 25, 2018, View Source [SID1234527870]). The Phase 1, open-label, dose-escalation study will evaluate the safety, pharmacokinetics, and pharmacodynamics of TP-0184 administered orally daily for the first 21 days of a 28-day cycle across a range of doses.

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"The initiation of this study of TP-0184 represents an important milestone for Tolero Pharmaceuticals, as it marks the second investigational agent from our development program to enter the clinical research stage this year,"said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "We look forward to understanding more about the profile of TP-0184 and its role in inhibiting ACVR1, which is mutated in approximately 1-4 percent of solid tumors and 32 percent of diffuse intrinsic pontine gliomas (DIPGs), an aggressive form of pediatric brain cancer."

The primary objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of TP-0184 orally administered daily for 21 days, over a range of doses in patients with advanced solid tumors. Secondary objectives in the study are to evaluate the pharmacokinetics and pharmacodynamics of TP-0184, observe patients for any evidence of antitumor activity of TP-0184 by objective radiographic assessment, and establish the recommended Phase 2 dose for future studies with TP-0184. The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03429218).

About TP-0184
TP-0184 is small molecule inhibitor of ACVR1, an activin A receptor type 1 (ACVR1) inhibitor, which is involved in the transforming growth factor beta (TGFβ) signaling pathway. ACVR1, also known as activin receptor-like kinase 2 (ALK2), is mutated in multiple types of cancers, including diffuse intrinsic pontine glioma (DIPG), a malignancy with high morbidity and mortality affecting the pediatric population.1,2,3 ACVR1 mutations are present in approximately 1-4 percent of solid tumors and, more commonly, in 32 percent of diffuse intrinsic pontine gliomas (DIPGs), a brain cancer with high morbidity and mortality afflicting the pediatric population.4,5 There is currently no approved therapy for the treatment of DIPG. ACVR1 is also involved in regulation of iron hemostasis, through stabilization of hepcidin and reduction of bioavailable iron, which is associated with anemia of chronic inflammation.4 TP-0184 is currently being evaluated in a Phase 1 clinical trial in advanced solid tumors (NCT03429218).

On July 25, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported that the Company will release its 2018 second quarter financial results on Tuesday, August 7, 2018, before the market opens (Press release, Eagle Pharmaceuticals, JUL 25, 2018, View Source [SID1234527851]).

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date Tuesday, August 7, 2018
Time 8:30 a.m. EDT
Toll free (U.S.) 877-876-9177
International 785-424-1669
Webcast (live and replay)
www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-727-5306 (US) or 402-220-2670 (International) and entering conference call ID EGRXQ218. The webcast will be archived for 30 days at the aforementioned URL.

On July 25, 2018 Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that it will report second quarter 2018 financial results after the close of U.S. financial markets on Wednesday, August 1, 2018 (Press release, Immune Design, JUL 25, 2018, View Source [SID1234527871]). Immune Design management will host a webcast conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on August 1, 2018 to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source and will be archived there for at least 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 3376676.

On July 25, 2018 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2018 (Press release, Integra LifeSciences, JUL 25, 2018, View Source [SID1234527855]).

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Second Quarter 2018 Consolidated Results

Reported revenue was $366.2 million, an increase of 29.8% compared to the second quarter of 2017; the acquisition of Codman contributed $79.2 million of revenue to the second quarter, and organic revenues increased 3.4%. Relative to the foreign currency rates used in April 2018 guidance, the second quarter revenues would have been $368.4 million, if the foreign currency rates were stable throughout the quarter;

GAAP earnings per share was $0.14, flat compared to the second quarter of 2017;

Adjusted earnings per share was $0.60, reflecting an increase of 33.3% compared to the second quarter of 2017;

The company has successfully exited the first wave of Codman transition services agreements and assumed full operational control of all commercial services and functions covering approximately 60% of the revenue associated with the acquired business;

The company is raising the low end of its full-year 2018 total revenue and earnings per share guidance as follows:

Total revenue of $1.475 billion to $1.490 billion (previously $1.470 billion to $1.490 billion);

Guidance range reflects lower foreign currency benefit based on current rates (expected foreign currency benefit was reduced from $15 million to $8 million)

GAAP EPS of $0.71 to $0.77 (previously $0.69 to $0.77);

Adjusted EPS of $2.36 to $2.42 (previously $2.34 to $2.42); and

The company is reiterating full-year 2018 organic sales growth guidance of approximately 5%.

Total revenues for the second quarter of 2018 were $366.2 million, reflecting an increase of 29.8% over the second quarter of 2017. Sales in the Codman Specialty Surgical segment increased 49.8% compared to the second quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair and Advanced Energy businesses. Sales in the Orthopedics and Tissue Technologies segment increased 3.6%, reflecting broad-based strength in our regenerative technologies business, following the completion of the commercial expansion strategy.

Total organic revenues increased 3.4% over the second quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates.
"We look forward to an acceleration in organic growth in the second half of 2018, as we realize the benefits of a larger sales organization, improved sales productivity and an expanded product portfolio," said Peter Arduini, Integra’s president and chief executive officer. "The successful integration of Codman and the completion of the hiring associated with our OTT channel expansion strategy increase our confidence for the second half of the year."
The company reported GAAP net income of $11.4 million, or $0.14 per diluted share, for the second quarter of 2018, compared to GAAP net income of $10.8 million, or $0.14 per diluted share, in the second quarter of 2017. The slight increase in GAAP net income is a result of higher revenues and better operating expense leverage.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.

Adjusted EBITDA for the second quarter of 2018 was $85.9 million, or 23.5% of revenue, compared to $62.7 million, or 22.2% of revenue, in the second quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs.
Adjusted net income for the second quarter of 2018 was $50.5 million, an increase of 42.7% from the prior year’s quarter. Adjusted earnings per share for the second quarter of 2018 was $0.60, an increase of 33.3% over the prior year’s quarter.
2018 Full-Year Outlook

The company is raising the low end of its full-year 2018 total revenue guidance by $5 million to a new range of $1.475 billion to $1.490 billion. The company is also raising the low end of its full-year 2018 GAAP earnings per share guidance range to $0.71 to $0.77, and adjusted earnings per share guidance range to $2.36 to $2.42, an increase of two cents.
The company expects full-year 2018 organic revenue growth to be approximately 5.0%, consistent with prior guidance.
"We were pleased with the strong operational performance from both segments in the second quarter, which enabled us to achieve 40% growth in adjusted net income and 130 basis points of adjusted EBITDA margin expansion, compared to the prior year’s quarter," said Glenn Coleman, Integra’s chief financial officer. "Given the strong momentum we expect in the second half of 2018, we are raising the low-end of our revenue and EPS guidance ranges."

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, July 25, 2018, to discuss financial results for the second quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (334) 323-0522 and using the passcode 7616000. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through July 30, 2018 by dialing (719) 457-0820 and using the passcode 7616000. The webcast will also be archived on the website.

On July 25, 2018 On July 25, 2018 OncBioMune Pharmaceuticals, Inc. reported that it has entered into a securities purchase agreement (the "Purchase Agreement") with an institutional investor for the sale of a convertible note in the aggregate principal amount of $150,000 (the "Note") (Filing, 8-K, Oncbiomune, JUL 25, 2018, View Source [SID1234528398]). The Note bears interest at 8% per year and will mature on the one year anniversary of the date of issue. The Note is convertible into common stock at a 25% discount to the average of the closing prices of the common stock for the prior five trading days including the date upon which a notice of conversion is received by the Company or its transfer agent. The holder will not have the right to convert any portion of its Note if the holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to its conversion.

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The Note may be prepaid at the Company’s option at a 105% premium between 30 days and 180 days after issuance, and at a 110% premium between 180 days after issuance and the maturity date. Upon certain events, the holder may redeem the note for 125% of the principal plus accrued but unpaid interest. The Note also includes certain penalties upon the occurrence of an event of default, including an increase in the principal and reduction in the conversion rate, as further described in the Note. The Company agreed to use its best efforts to file a proxy statement and take all necessary corporate actions in order to obtain shareholder approval to increase its authorized shares of common stock or effect a reverse split to allow for reserving sufficient shares of common stock to allow full conversion of the Note.

The foregoing description of the Purchase Agreement and Note is not complete and is qualified in its entirety by reference to the full text of the Purchase Agreement and Note, copies of which are filed as Exhibits 10.1 and 10.2, respectively, to this report and are incorporated herein by reference.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant

Information concerning the Company’s issuance of the Note as set forth in Item 1.01 above is incorporated herein to this Item 2.03 by this reference.

Item 3.02 Unregistered Sales of Equity Securities

Information concerning the Company’s issuance of the Note as set forth in Item 1.01 above is incorporated herein to this Item 3.02 by this reference.

The Note and shares of common stock underlying the Note are not registered under the Securities Act of the 1933, as amended (the "Securities Act"), or any state securities laws. The Company has relied on the exemption from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder. In connection with the holder’s execution of the Purchase Agreement, the holder represented to the Company that it is an "accredited investor" as defined in Regulation D of the Securities Act and that the securities being purchased by it are being acquired solely for their its own account and for investment purposes and not with a view to the future sale or distribution.