OncBioMune Announces Agreement with CATO BioVentures as a Strategic Investor in Support of CD71-Targeted Therapy for Refractory Cancers

On May 1, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapy, is reported that it has received a letter of interest from CATO BioVentures, the venture capital affiliate of Cato Holding, a privately held family fund (Press release, Oncbiomune, MAY 1, 2019, View Source [SID1234535498]).

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This agreement is in support of the development plan of OncBioMune’s patented CD71-targeted chemotherapy combining paclitaxel, gallium, and transferrin, otherwise known as "PGT."

PGT is designed to deliver the chemotherapeutic agent paclitaxel to cancer cells over-expressing the transferrin receptor (aka CD71). Paclitaxel is currently FDA-approved in two forms: as solvent-based paclitaxel (sb-paclitaxel, Taxol) and protein-based paclitaxel (nab-paclitaxel, ABRAXANE).

PGT binds paclitaxel to the human protein transferrin as opposed to albumin, which is employed in nab-paclitaxel. This creates the potential to target the paclitaxel to CD71, which has been shown to be over-expressed on many different cancer types. Additionally, PGT takes advantage of the fact that the transferrin protein has binding sites for iron that can bind a different metal ion, gallium, which has anti-cancer activity. In theory, this creates a novel protein drug complex which has the capacity to deliver two, non-cross resistant cancer therapeutics in a targeted fashion.

"We are excited that CATO BioVentures has a belief in our science that would motivate them to become a strategic investor in OncBioMune. We are hopeful that this show of support from such a high quality provider will act as a catalyst to assist us in additional favorable fundraising activities," commented Dr. Brian Barnett, Chief Executive Officer at OncBioMune. "It has already been a pleasure working with the team of the CATO Research CRO arm as we start the process of putting together a clinical development plan for our proprietary therapy, PGT, and strive toward the goal of getting PGT accessible to patients with refractory cancers that represents a large area of unmet medical need."

Penumbra, Inc. to Present at the Bank of America Merrill Lynch 2019 Health Care Conference

On May 1, 2019 Penumbra, Inc. (NYSE: PEN) reported that its management team is scheduled to present at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas, NV on Wednesday, May 15, 2019 (Press release, Penumbra, MAY 1, 2019, View Source [SID1234535514]).

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Event:

Bank of America Merrill Lynch 2019 Health Care Conference

Date:

Wednesday, May 15, 2019

Time:

4:00pm ET / 1:00pm PT

A webcast of the presentation will be available by visiting the investors section of the company’s website at www.penumbrainc.com. The webcast will be available on the company’s website for at least two weeks following the event.

Triumvira Submits Investigational New Drug (IND) Application to the FDA and Clinical Trial Application (CTA) to Health Canada to Evaluate TAC01-CD19, a T Cell Antigen Coupler Therapy, in Ph 1/2 TACTIC-19 Trial

On May 1, 2019 Triumvira Immunologics Inc. (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, has reported simultaneously submitted an IND to the U.S. Food and Drug Administration and a CTA to Health Canada to initiate a Phase 1/2, first-in-human trial of TAC01-CD19, a TAC-T cell therapy product engineered to target CD-19 in patients with Relapsed/Refractory Large B-Cell Lymphoma (TACTIC-19) (Press release, Triumvira Immunologics, MAY 1, 2019, View Source [SID1234535499]).

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"TAC01-CD19 has the potential to be a next generation solution for cell therapy for patients with different types of cancer," commented Paul Lammers, MD, MSc., President and CEO of Triumvira. "This filing is the result of an intensive preclinical development effort by the Triumvira team including the completion of the necessary IND-enabling studies as well as simultaneously preparing IND and CTA filings. We look forward to opening our first of five prominent clinical trial sites in the early summer of 2019."

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T and has the potential to be a next generation solution to these challenges. TAC technology is a novel way to genetically modify T cells and redirect these T cells to target cancer antigens by co-opting the natural T cell receptor (TCR) to eradicate the tumor cells. TAC01-CD19 is the lead program in Triumvira’s pipeline of several TAC programs for both solid tumors and hematological malignancies.

About TAC01-CD19

TAC-01CD19 is a novel genetically engineered T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises autologous T cells that have been genetically engineered via lentiviral transduction to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects.

About CD19 and DLBCL

CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL is expected to impact approximately 26,000 patients in the U.S. in 2018. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes (1).

NuVasive Announces First Quarter 2019 Financial Results

On May 1, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter ended March 31, 2019 (Press release, NuVasive, MAY 1, 2019, View Source [SID1234535515]).

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First Quarter 2019 Highlights

Revenue increased 5.5% to $274.8 million, or 6.4% on a constant currency basis;
GAAP operating profit margin of 7.3%; Non-GAAP operating profit margin of 14.9%; and
GAAP diluted earnings per share of $0.18; Non-GAAP diluted earnings per share of $0.53.
"In the first quarter 2019, NuVasive delivered a solid start to the year with focused execution across our U.S. Spinal Hardware, U.S. Surgical Support and International businesses," said Chris Barry, chief executive officer of NuVasive. "Coupled with these financial results, we continued to operate the business with rigor and discipline to drive profitability while strategically investing in key growth areas. This includes the recently launched X360 System for lateral single-position surgery integrated with Surgical Intelligence, further differentiation of our Advanced Materials Science portfolio and upcoming launch of the Pulse platform—all which enable our surgeon partners to provide better, more reproducible clinical outcomes for their patients through minimally invasive surgery."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

First Quarter 2019 Results
NuVasive reported first quarter 2019 total revenue of $274.8 million, a 5.5% increase compared to $260.5 million for the first quarter 2018. On a constant currency basis, first quarter 2019 total revenue increased 6.4% compared to the same period last year.

For the first quarter 2019, both GAAP and non-GAAP gross profit was $200.3 million and GAAP and non-GAAP gross margin was 72.9%. These results compared to GAAP and non-GAAP gross profit of $186.7 million and $187.1 million, respectively, and GAAP and non-GAAP gross margin of 71.7% and 71.8%, respectively, for the first quarter 2018.

The Company reported GAAP net income of $9.4 million, or diluted earnings per share of $0.18, for the first quarter 2019 compared to a GAAP net loss of $(27.1) million, or diluted loss per share of $(0.53), for the first quarter 2018. On a non-GAAP basis, the Company reported net income of $27.6 million, or diluted earnings per share of $0.53 per share, for the first quarter 2019 compared to net income of $20.6 million, or diluted earnings per share of $0.40 per share, for the first quarter 2018.

Annual Financial Guidance for 2019
The Company reiterated its full-year 2019 guidance:

Prior guidance reflects the range provided February 20, 2019. Current guidance reflects the range provided May 1, 2019.

Constant currency is a measure that adjusts US GAAP revenue for the impact of currency over the same period in the prior year.

The Company estimates revenue for full year 2019 to be in the range of $1.14 billion to $1.16 billion, reflecting reported growth in the range of 3.5% to 5.5%;
Non-GAAP earnings per share in a range of $2.20 to $2.30;
Non-GAAP operating profit margin of 15.0% to 15.5%;
EBITDA margin of 25.2% to 25.7%; and
Non-GAAP effective tax expense rate of approximately 23%.
Supplementary Financial Information
For additional financial detail, please visit the Investor Relations section of the Company’s website at www.nuvasive.com to access Supplementary Financial Information.

Reconciliation of Full Year EPS Guidance

Items may not foot due to rounding.

Prior guidance reflects the range provided February 20, 2019. Current guidance reflects the range provided May 1, 2019.

Effective tax expense rate of ~24% applied to GAAP earnings and ~23% applied to Non-GAAP earnings.

Effective tax expense rate of ~22% applied to GAAP earnings and ~23% applied to Non-GAAP earnings.

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Represents the loss recorded in connection with the settlement of the Madsen Medical, Inc. litigation matter, as well as expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

Purchase of an in-process research and development asset which had no future alternative use.

Represents costs specific to updating our quality system, product labeling, asset write-offs and product remanufacturing to comply with European medical device regulation.

The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual rate of ~43% benefit on a GAAP basis and ~18% on a non-GAAP basis in 2018.

Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes and warrants for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

Reconciliation of Non-GAAP Operating Margin %

Items may not foot due to rounding.

Prior guidance reflects the range provided February 20, 2019. Current guidance reflects the range provided May 1, 2019.

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

Expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

Represents the loss recorded in connection with the settlement of the Madsen Medical, Inc. litigation matter.

Purchase of an in-process research and development asset which had no future alternative use.

Represents costs specific to updating our quality system, product labeling, asset write-offs and product remanufacturing to comply with European medical device regulation.

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

Reconciliation of EBITDA Margin %

Items may not foot due to rounding.

Effective tax expense rate of ~43% benefit applied to GAAP earnings and ~18% applied to Non-GAAP earnings.

Effective tax expense rate of ~24% applied to GAAP earnings and ~23% applied to Non-GAAP earnings.

Effective tax expense rate of ~22% applied to GAAP earnings and ~23% applied to Non-GAAP earnings.

Prior guidance reflects the range provided February 20, 2019. Current guidance reflects the range provided May 1, 2019.

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Represents the loss recorded in connection with the settlement of the Madsen Medical, Inc. litigation matter, as well as expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

Purchase of an in-process research and development asset which had no future alternative use.

Represents costs specific to updating our quality system, product labeling, asset write-offs and product remanufacturing to comply with European medical device regulation.

Reconciliation of Non-GAAP Information
Management uses certain non-GAAP financial measures such as non-GAAP earnings per share, non-GAAP net income, non-GAAP operating expenses and non-GAAP operating profit margin, which exclude amortization of intangible assets, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses from strategic investments, and non-cash interest expense (excluding debt issuance cost). Management also uses certain non-GAAP measures which are intended to exclude the impact of foreign exchange currency fluctuations. The measure constant currency utilizes an exchange rate that eliminates fluctuations when calculating financial performance numbers. The Company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital. Additionally, the Company uses an adjusted EBITDA measure which represents earnings before interest, taxes, depreciation and amortization and excludes the impact of stock-based compensation, business transition costs, purchased in-process research and development, one-time restructuring and related items in connection with acquisitions, investments and divestitures, non-recurring consulting fees, certain litigation expenses and settlements, certain European medical device regulation costs, gains and losses on strategic investments, and other significant one-time items.

Management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to further and more consistently analyze the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional information to enable them to assess, in the same way management assesses, the Company’s current and future continuing operations. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

During the quarter ended June 30, 2018, the Company began excluding from its non-GAAP financial results certain litigation related expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property. For consistency and comparability, the Company has re-casted non-GAAP financial results for each of the quarters ended Dec. 31, 2017 and March 31, 2018 to exclude these litigation expenses in such periods, which were $0.4 million and $0.6 million, respectively.

For the Three Months Ended March 31, 2019

Reconciliation of GAAP to Non-GAAP Financial Measures

Represents expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

Represents costs specific to updating our quality system, product labeling, asset write-offs and product remanufacturing to comply with European medical device regulation.

Represents the impact from tax affecting the adjustments above at their statutory tax rate. As of May 1, 2019, the Company estimated an annual tax rate of ~22% on a GAAP basis and ~23% on a non-GAAP basis.

Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes and warrants for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

For the Three Months Ended March 31, 2018

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited – in thousands, except per share data)

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

Represents the loss recorded in connection with the settlement of the Madsen Medical, Inc. litigation matter, as well as expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

Represents the impact from tax affecting the adjustments above at their statutory tax rate. As of May 1, 2018, the Company estimated an annual tax rate of ~31% on a GAAP basis and ~23% on a non-GAAP basis.

Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes and warrants for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

Investor Conference Call
NuVasive will hold a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the first quarter 2019. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. After the live webcast, the call will remain available on NuVasive’s website through May 31, 2019. In addition, a telephone replay of the call will be available until May 8, 2019. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13689332.

Jounce Therapeutics to Announce First Quarter 2019 Financial Results and Host Conference Call on Wednesday, May 8, 2019

On May 1, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report first quarter 2019 financial results and provide a corporate update before market open on Wednesday, May 8, 2019 (Press release, Jounce Therapeutics, MAY 1, 2019, View Source [SID1234535649]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 5789371. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.