On August 1, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter ended June 30, 2018 (Press release, Mirati, AUG 1, 2018, View Source [SID1234528278]).

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"In June we successfully completed a financing, with net proceeds of $130.7 million, enabling us to expand our sitravatinib and KRAS programs," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We plan to present sitravatinib data at the 2018 European Society of Medical Oncologists Congress (ESMO) (Free ESMO Whitepaper) in October and to file our Investigational New Drug application (IND) for MRTX849, a potent and selective inhibitor of KRAS G12C, in the fourth quarter of 2018."

Financial Results for the Second Quarter 2018

Cash, cash equivalents, and short-term investments were $260.2 million at June 30, 2018, compared to $150.8 million at December 31, 2017. In June 2018, we completed a public offering of our common stock and pre-funded common stock warrants with net proceeds of $130.7 million.

License and collaboration revenues for the six months ended June 30, 2018 were $9.5 million, compared to none in the same period of 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd., which became effective January 7, 2018.

Research and development expenses for the second quarter of 2018 were $23.8 million, compared to $15.0 million for the same period in 2017. Research and development expenses for the six months ended June 30, 2018 were $43.5 million compared to $29.4 million for the same period in 2017. The increase in research and development expenses for both the three and six months ended June 30, 2018 is primarily due to an increase in third party research and development expense for sitravatinib due to the continuation and expansion of ongoing clinical trials. The increase is also related to continued development of our KRAS inhibitor program for costs associated with preparing to file a planned IND application for our selected lead clinical compound, MRTX849. These increases are partially offset by a decrease in glesatinib expenses.

General and administrative expenses for the second quarter of 2018 were $4.8 million, compared to $3.7 million for the same period in 2017. General and administrative expenses for the six months ended June 30, 2018 were $10.0 million compared to $7.3 million for the same period of 2017. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three and six months ended June 30, 2018 compared to the same periods in 2017.

Net loss for the second quarter of 2018 was $27.9 million, or $0.94 per share basic and diluted, compared to net loss of $18.3 million, or $0.74 per share basic and diluted for the same period in 2017. Net loss for the six months ended June 30, 2018 was $42.6 million, or $1.45 per share, compared to $36.2 million, or $1.47 per share, for the same period of 2017.

On August 1, 2018 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the quarter and six months ended June 30, 2018, and provided updates on its clinical development programs (Press release, Conatus Pharmaceuticals, AUG 1, 2018, View Source [SID1234528294]).

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Program Updates
The company is conducting three Phase 2b clinical trials in collaboration with Novartis – the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH):

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in the fourth quarter of 2018 followed by an integrated treatment extension period for clinical outcomes;

ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and

ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
During the second quarter, the company announced completion of enrollment in the ENCORE-PH clinical trial. In addition, the company announced an oral presentation at The International Liver Congress 2018, the Annual Meeting of the European Association for the Study of the Liver (EASL), reporting reductions in bacteria-driven inflammation and related liver injury with the company’s pan-caspase inhibitor IDN-7314 in a mouse model of primary sclerosing cholangitis (PSC).

Financial Results
The net loss for the second quarter of 2018 was $4.5 million compared with $5.4 million for the second quarter of 2017. The net loss for the first six months of 2018 was $9.5 million compared with $9.0 million for the first six months of 2017.

All revenues were related to the company’s collaboration with Novartis. Total revenues were $8.8 million for the second quarter of 2018 compared with $10.0 million for the second quarter of 2017. The decrease was primarily due to lower research and development expenses resulting in corresponding lower revenues from Novartis, partially offset by the effects of adopting the ASC 606 revenue recognition standard. Total revenues were $18.5 million for the first six months of 2018 compared with $17.0 million for the first six months of 2017. The increase was primarily due to higher research and development expenses resulting in corresponding higher revenues from Novartis, and the effects of adopting the ASC 606 revenue recognition standard.

Research and development expenses were $10.7 million for the second quarter of 2018 compared with $13.2 million for the second quarter of 2017. The decrease was primarily due to lower spending related to the ENCORE-NF and ENCORE-PH clinical trials and manufacturing activities, partially offset by higher spending related to the ENCORE-LF clinical trial and new product candidate development. Research and development expenses were $22.8 million for the first six months of 2018 compared with $21.1 million for the first six months of 2017. The increase was primarily due to higher spending related to the ENCORE-LF and ENCORE-PH clinical trials and new product candidate development, partially offset by lower spending related to the ENCORE-NF clinical trial.

General and administrative expenses were $2.6 million for the second quarter of 2018 compared with $2.2 million for the second quarter of 2017. General and administrative expenses were $5.3 million for the first six months of 2018 compared with $5.0 million for the first six months of 2017. The increases in general and administrative expenses for both periods were primarily due to higher personnel costs.

Cash, cash equivalents and marketable securities were $57.7 million at June 30, 2018, compared with $74.9 million at December 31, 2017, and a projected year-end 2018 balance of between $35 million and $40 million. The company believes that current financial resources, together with the anticipated reimbursements for 50% of the costs for the ongoing clinical trials, without including any potential milestone payments under the Novartis collaboration, are sufficient to maintain operations through top-line results from the three ENCORE Phase 2b clinical trials by the end of 2019, as well as to fund initial pipeline expansion activities.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 9853049. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On August 1, 2018 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported it will host a second quarter 2018 investor update conference call and webcast at 4:30 p.m. on Wednesday, August 8, 2018 (Press release, Akebia, AUG 1, 2018, View Source [SID1234528295]).

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Individuals interested in participating in the call should dial (877) 458-0977 (U.S. and Canada) or (484) 653-6724 (international) using conference ID number 1398303. To access the webcast, visit the Investors section of Akebia’s website at www.akebia.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

Beginning the morning of August 9, 2018, the call will be available for replay via telephone and the archived webcast will be available on Akebia’s website. To listen to the telephone replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 1398303. The telephone replay will be available for six days following the call.

On August 1, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, and Orano Med (formerly AREVA Med) a subsidiary of Orano, a nuclear biotech company developing innovative therapies in oncology, reported that the two companies have entered into an agreement to combine certain proprietary technologies from each company to create a novel oncologic therapy (Press release, Cellectar Biosciences, AUG 1, 2018, View Source [SID1234528397]). The collaboration will focus on the development of novel phospholipid drug conjugates (PDC) utilizing Orano Med’s unique alpha emitter, lead-212 (212Pb), conjugated to Cellectar’s phospholipid ether (PLE). The companies intend to evaluate the new PDC in up to three oncology indications.

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"We believe that the combination of Cellectar’s targeted delivery with Orano Med’s powerful alpha emitter offers the potential to create a novel and highly potent cancer therapy," said James Caruso, chief executive officer of Cellectar Biosciences. "This collaboration is an ideal strategic fit and provides an excellent opportunity to expand our radiotherapeutic portfolio beyond CLR 131, a highly potent beta emitter, and establish one of the most complete oncology-focused radiotherapeutic portfolios."

Cellectar’s proprietary PLE and PLE analogs provide targeted delivery of various molecules, including radioisotopes, to malignant tumor cells with up to 30-fold more payload delivered to the tumor versus normal tissues. Orano Med’s 212Pb is a unique alpha emitter that provides high energy delivery over a shorter distance than other radioisotopes. The higher energy associated with alpha particles causes non-repairable double stranded DNA breaks. As a result, enhanced tumor targeting of the construct may allow the 212Pb to provide greater efficacy at lower doses with less side effects.

Orano Med has partnered 212Pb with other companies to create a broad pipeline of tumor targeting 212Pb therapies. These other collaborations are using diverse biological targeting vectors or pursuing indications separate from those planned in this collaboration. Many of these approaches utilize antibodies or peptides; the most advanced of these approaches has recently entered a Phase 1 clinical trial.

Cellectar and Orano Med believe that the PLE conjugated to 212Pb could be an ideal drug candidate and provide improved anti-cancer effects beyond those seen with some of the other delivery technologies.

"This collaboration with Cellectar is an exciting opportunity for Orano Med. Our 212Pb is a powerful radioactive isotope that at low doses kills cancer cells and has limited impact on nearby healthy cells. We believe that 212Pb conjugated to Cellectar’s PLE has great potential to improve patient outcomes by having a better efficacy and safety profile than other technologies," said Julien Dodet, CEO of Orano Med.

Under the terms of the agreement, early preclinical costs will be shared equally between the organizations with both parties having an option to advance and commercialize the PDC alone or in collaboration with each other. The option is exercisable after establishment of early proof of concept data.

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About 212Pb

212Pb is a promising agent for use in the field of alpha particle radiotherapy that has been tested in clinical trials. Alpha particle emitting radiotherapies, like 212Pb, cause double stranded DNA breaks by releasing high energy particles over a short distance. 212Pb represents one of the more powerful alpha emitters and has a half-life of 10.6 hours.

On July 31, 2018 Hologic, Inc. (Nasdaq: HOLX) reported the Company’s financial results for the fiscal third quarter ended June 30, 2018 (Press release, Hologic, JUL 31, 2018, View Source [SID1234528280]).

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"We posted good financial results in the third quarter, with both revenue and EPS exceeding our guidance," said Steve MacMillan, Hologic’s Chairman, President and Chief Executive Officer. "Our Breast Health and international businesses continued their strong recent performance. And Surgical and Cynosure both showed sequential improvement, in line with our expectations."

Recent Highlights

Global revenue growth was driven by the Breast Health and international businesses.
Breast health revenue of $307.9 million increased 8.5%, or 7.4% in constant currency, compared to the prior year period.
International revenue, excluding the acquired Cynosure business, increased 20.2%, or 14.5% in constant currency, to $163.8 million.
Completed today the acquisition of Faxitron Bioptics, a privately-held leader in digital specimen radiography, for approximately $85 million.
Announced that Chief Financial Officer Bob McMahon will depart to join Agilent; Chief Accounting Officer Karleen Oberton promoted to CFO.
Continued to advance research and development pipeline, launching several new products; ThinPrep Integrated Imager in the United States; Panther Fusion MRSA assay in Europe; Panther Fusion respiratory assays in Canada; and TempSure Vitalia in North America.
Repurchased 2.2 million shares of common stock for $80.8 million. The Company’s Board of Directors also approved a new $500 million share repurchase plan to replace the previous authorization.

Throughout this press release, all dollar figures are in millions, except EPS. Some totals may not foot due to rounding. Unless otherwise noted, all results are compared to the corresponding prior year period. Non-GAAP results exclude certain cash and non-cash items as discussed under "Use of Non-GAAP Financial Measures." Constant currency percentage changes show current period revenue results as if the foreign exchange rates were the same as those in the prior year period.

Other Financial Highlights

U.S. revenue of $616.8 million decreased (0.3%). Total international revenue of $207.2 million increased 10.5%, or 5.5% in constant currency.
Gross margin was 52.9% on a GAAP basis, and 62.6% on a non-GAAP basis. GAAP gross margin increased 210 basis points, while non-GAAP declined 50 basis points, primarily due to geographic and product sales mix.
GAAP net income of $112.9 million increased 89.7%. Adjusted non-GAAP earnings before interest, taxes, depreciation and amortization (EBITDA) was $261.7 million, an increase of 0.4%.
Total debt outstanding at the end of the quarter was $3.2 billion. The Company ended the quarter with cash and equivalents of $575.4 million, and a net leverage ratio (net debt over adjusted EBITDA) of 2.6 times.
On a trailing 12 months basis, adjusted Return on Invested Capital (ROIC) of 12.4% declined 20 basis points.
Financial Guidance for Fiscal 2018

Based on the Company’s strong performance in the fiscal third quarter, Hologic is increasing its full-year 2018 revenue guidance and raising its EPS guidance slightly at the midpoint.

Hologic’s financial guidance for the fourth quarter and full fiscal year 2018 is shown in the tables immediately below. The guidance is based on a full year non-GAAP tax rate of approximately 23%, and diluted shares outstanding of approximately 278 to 279 million for the full year. As a reminder, percentage changes versus the prior year are affected by the blood screening divestiture and the Cynosure acquisition, both of which closed in the second quarter of fiscal 2017. Constant currency guidance assumes that foreign exchange rates are the same in fiscal 2018 as in fiscal 2017. Current guidance assumes that recent foreign exchange rates persist for all of fiscal 2018.

Use of Non-GAAP Financial Measures

The Company has presented the following non-GAAP financial measures in this press release: constant currency revenues; non-GAAP gross profit; non-GAAP gross margin; non-GAAP operating expenses; non-GAAP income from operations; non-GAAP operating margin; non-GAAP interest expense; non-GAAP pre-tax income; non-GAAP tax rate; non-GAAP net margin; non-GAAP net income; non-GAAP diluted EPS; adjusted EBITDA; and adjusted ROIC. Constant currency presentations show reported period revenue results as if the foreign exchange rates were the same as those in effect in the comparable prior year period. The Company defines its non-GAAP net income, EPS, and other non-GAAP financial measures to exclude, as applicable: (i) the amortization of intangible assets; (ii) impairment of goodwill and intangible assets; (iiI) additional depreciation expense from acquired fixed assets and accelerated depreciation related to business consolidation and closure of facilities; (iv) additional expense resulting from the purchase accounting adjustment to record inventory at fair value; (v) non-cash interest expense related to amortization of the debt discount from the equity conversion option of convertible notes; (vi) restructuring and divestiture charges, facility closure and consolidation charges and costs incurred to integrate acquisitions (including retention, transaction bonuses, legal and professional consulting services) and separate divested businesses from existing operations; (vii) transaction related expenses for divestitures and acquisitions; (viii) gain on disposal of business; (ix) debt extinguishment losses and related transaction costs; (x) the unrealized (gains) losses on the mark-to-market of forward foreign currency contracts for which the Company has not elected hedge accounting; (xi) litigation settlement charges (benefits) and non-income tax related charges (benefits); (xii) other-than-temporary impairment losses on investments and realized (gains) losses resulting from the sale of investments; (xiii) the one-time discrete impact of tax reform primarily related to remeasuring net deferred tax liabilities and providing taxes for the deemed repatriation of foreign earnings (xiv) other one-time, non-recurring, unusual or infrequent charges, expenses or gains that may not be indicative of the Company’s core business results as detailed in our reconciliations of such adjustments; and (xv) income taxes related to such adjustments. The Company defines adjusted EBITDA as its non-GAAP net income plus net interest expense, income taxes, and depreciation and amortization expense included in its non-GAAP net income.

These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. The Company’s definition of these non-GAAP measures may differ from similarly titled measures used by others.

The non-GAAP financial measures used in this press release adjust for specified items that can be highly variable or difficult to predict. The Company generally uses these non-GAAP financial measures to facilitate management’s financial and operational decision-making, including evaluation of Hologic’s historical operating results, comparison to competitors’ operating results and determination of management incentive compensation. These non-GAAP financial measures reflect an additional way of viewing aspects of the company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting Hologic’s business.

Because non-GAAP financial measures exclude the effect of items that increase or decrease the company’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.

Future Non-GAAP Adjustments

Future GAAP EPS may be affected by changes in ongoing assumptions and judgments, and may also be affected by non-recurring, unusual or unanticipated charges, expenses or gains, which are excluded in the calculation of the Company’s non-GAAP EPS guidance as described in this press release.

Conference Call and Webcast

Hologic’s management will host a conference call at 4:30 p.m. ET today to discuss its financial results for the third quarter of fiscal 2018. Approximately 10 minutes before the call, dial 888-224-1005 (in the U.S.) or +1 323-794-2551 (international) and enter access code 9960251. A replay will be available approximately two hours after the call ends through Friday, August 24, 2018. The replay numbers are 888-203-1112 (U.S.) or +1 719-457-0820 (international), access code 9960251. The Company will also provide a live webcast of the call at View Source