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 August 1, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration, reported that it will report its second quarter 2018 financial and operating results after the close of U.S. financial markets on Wednesday, August 8, 2018 (Press release, Tracon Pharmaceuticals, AUG 1, 2018, View Source [SID1234528296]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

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Conference call and webcast:
Date: August 8, 2018
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 3189378
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section

A replay of the webcast will be available for 60 days on the website.