Argos Therapeutics Announces Financing of Up to $60 Million

On March 07, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported that it has entered into a securities purchase agreement for the sale of up to $60 million of Argos common stock and warrants in a private placement financing (Press release, Argos Therapeutics, MAR 7, 2016, View Source [SID:1234509400]). Argos expects that this financing will fund operations into the second quarter of 2017, when the Company expects to have final data from its pivotal phase 3 ADAPT trial of AGS-003 (the "ADAPT Study").

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The financing will take place in up to three tranches. Under the securities purchase agreement, at the initial closing, which is expected to occur on or about March 9, 2016, Argos will sell and the investors will purchase, for a total purchase price of $19,882,915, a total of 3,652,430 shares of common stock and warrants to purchase a total of 2,739,323 shares of common stock (0.75 shares of common stock for each share of common stock purchased), based on a purchase price per share of common stock and accompanying warrant equal to $5.44375. At the second closing, Argos has agreed to sell and the investors have agreed to purchase, for an additional purchase price of $29,824,520, a total of 5,478,672 shares of common stock and warrants to purchase a total of 4,109,005 shares of common stock at the same price and on the same terms as the first tranche. The second closing is conditioned on the Independent Data Monitoring Committee (the "IDMC") for the ADAPT Study at or following the IDMC’s next regular meeting following the initial closing (currently scheduled for June 2016) (the "First IDMC Meeting") recommending that Argos continue the ADAPT Study or discontinue the ADAPT Study based on favorable efficacy data. The warrants to be issued in each closing will have an exercise price of $5.35 per share and expire five years from the date of issuance. Participants in the financing include Pharmstandard International S.A., Forargos B.V., Tianyi Lummy International Holdings Group Ltd., China BioPharma Capital I, L.P., TVM V Life Science Ventures GmbH & Co. KG and Wasatch Funds Trust.

Under the securities purchase agreement, Pharmstandard has also agreed that, at Argos’s option following the satisfaction of certain conditions, including the IDMC having made a recommendation at or following its next regular meeting after the First IDMC Meeting (currently anticipated to be held in November or December 2016), that the Company continue the ADAPT Study or discontinue the ADAPT Study based on favorable efficacy data, and the Company’s cash position at such time, it shall purchase at the third closing up to $10,292,563 of shares of common stock (without warrants) at a price per share to be determined pursuant to an agreed upon formulation. The dollar amount committed to be purchased by Pharmstandard at the third closing is subject to reduction on a dollar-for-dollar basis for certain cash amounts raised by Argos after the initial closing through equity or debt financings or collaborations. All three closings will be subject to the satisfaction of certain customary closing conditions.

Argos expects that the proceeds from the initial closing will enable it to fund the company’s ongoing expenses into the third quarter of 2016, and that the proceeds from all three closings, if such closings occur, will enable it to fund the company’s ongoing expenses into the second quarter of 2017 when it expects final data from its pivotal phase 3 ADAPT trial of AGS-003.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Argos has agreed to file registration statements with the Securities and Exchange Commission ("SEC") registering the resale of the shares of common stock issued in this private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement.

This release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

8-K – Current report

On March 7, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the fourth quarter and year ended December 31, 2015 and provided recent company developments along with a business outlook for 2016 (Filing, 8-K, Manhattan Pharmaceuticals, MAR 7, 2016, View Source [SID:1234509393]).

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "2015 was a transformational year for our Company as we launched our first registration study, the GENUINE Phase 3 study, and also obtained an SPA for our proprietary combination of TG-1101 and TGR-1202, the ‘1303’ regimen, enabling our UNITY-CLL trial for patients with front-line and previously treated CLL. During 2016 we will be focused on executing our ongoing Phase 3 clinical programs as well as expanding our ‘1303’ regimen into registration-directed trials for both diffuse large b-cell lymphoma and indolent lymphomas." Mr. Weiss continued, "We are also very excited to begin exploring the potential of our products in autoimmune disorders. Our IND has been cleared by the FDA Division of Neurology and we plan to launch our first Phase 2 trial in multiple sclerosis (MS) for TG-1101 in the next 30-60 days. We believe this Phase 2 study could support the commencement of a Phase 3 program next year. From a financial perspective, with more than $100 million in cash and investments we remain well positioned to execute on our business plan."

2015 Highlights

· Expanded our product portfolio through a global collaboration with Checkpoint Therapeutics to develop and commercialize anti-PDL1 and anti-GITR antibody research programs from Dana Farber Cancer Institute in hematologic malignancies
· Commenced enrollment into the GENUINE Phase 3 clinical trial, which is now open in over 150 sites throughout the US
· Presented the first data from the triple combination study of TG-1101 + TGR-1202 + ibrutinib showing not only that the combination was well tolerated, but produced a 100% ORR in patients with high-risk CLL/SLL and a 75% ORR in indolent NHL, which includes Follicular Lymphoma and Marginal Zone Lymphoma
· Obtained an SPA for the UNITY-CLL Phase 3 clinical trial of the Company’s proprietary combination of TG-1101 + TGR-1202 (aka "TG-1303")
· Launched a new Phase 1/2 triple therapy study of TG-1101 + TGR-1202 + the PD-1 checkpoint inhibitor pembrolizumab, the first clinical trial to evaluate the safety and efficacy of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor
· Announced key data updates at the major medical conferences throughout 2015

Key Objectives for 2016

· Aggressively recruit into the GENUINE Phase 3 clinical trial
· Aggressively enroll into the UNITY-CLL Phase 3 clinical trial
· Commence the UNITY- DLBCL Phase 2b clinical trial
· Initiate a Phase 2 clinical trial in Multiple Sclerosis (MS)
· Commence a registration trial for iNHL
· Present updated data on the Phase 1 and 2 clinical trials at major hematology/oncology conferences during 2016

Financial Results for the Fourth Quarter and Full Year 2015

At December 31, 2015, the Company had cash, cash equivalents, investment securities, and interest receivable of $102.4 million, as compared to $78.9 million at December 31, 2014.

Our consolidated net loss for the year ended December 31, 2015, excluding non-cash items, was approximately $47.3 million, including other research and development expenses of $43.4 million, of which approximately $23.4 million related to manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The consolidated net loss for the year ended December 31, 2015, inclusive of non-cash items, was $63.0 million, or $1.38 per diluted share, compared to a consolidated net loss of $55.8 million for the year ended December 31, 2014. The increase in consolidated net loss during the year ended December 31, 2015 was primarily driven by increases in other research and development expenses for both TG-1101 and TGR-1202 as a result of manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs as well as launch preparation activities. The increase in other research and development expenses was partially offset by expenses recorded during 2014 in conjunction with the Company’s licensing agreements for TGR-1202 and the IRAK4 inhibitors program, and a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the fourth quarter ended December 31, 2015, excluding non-cash items, was approximately $14.8 million, including other research and development expenses of $13.7 million, of which approximately $7.4 million related to manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The consolidated net loss for the fourth quarter ended December 31, 2015, inclusive of non-cash items, was $17.6 million, or $0.37 per diluted share, compared to a consolidated net loss of $18.8 million during the comparable quarter in 2014. The decrease in consolidated net loss during the fourth quarter ended December 31, 2015 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2014, partially offset by a modest increase in other research and development expenses for TGR-1202 as a result of clinical trial expenses related to ongoing and planned future Phase 3 registration programs.

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TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2015 Financial Results and Business Update

On March 07, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the fourth quarter and year ended December 31, 2015 and provided recent company developments along with a business outlook for 2016 (Press release, TG Therapeutics, MAR 7, 2016, View Source [SID:1234509395]).

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Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "2015 was a transformational year for our Company as we launched our first registration study, the GENUINE Phase 3 study, and also obtained an SPA for our proprietary combination of TG-1101 and TGR-1202, the ‘1303′ regimen, enabling our UNITY-CLL trial for patients with front-line and previously treated CLL. During 2016 we will be focused on executing our ongoing Phase 3 clinical programs as well as expanding our ‘1303′ regimen into registration-directed trials for both diffuse large b-cell lymphoma and indolent lymphomas." Mr. Weiss continued, "We are also very excited to begin exploring the potential of our products in autoimmune disorders. Our IND has been cleared by the FDA Division of Neurology and we plan to launch our first Phase 2 trial in multiple sclerosis (MS) for TG-1101 in the next 30-60 days. We believe this Phase 2 study could support the commencement of a Phase 3 program next year. From a financial perspective, with more than $100 million in cash and investments we remain well positioned to execute on our business plan."

2015 Highlights

Expanded our product portfolio through a global collaboration with Checkpoint Therapeutics to develop and commercialize anti-PDL1 and anti-GITR antibody research programs from Dana Farber Cancer Institute in hematologic malignancies
Commenced enrollment into the GENUINE Phase 3 clinical trial, which is now open in over 150 sites throughout the US
Presented the first data from the triple combination study of TG-1101 + TGR-1202 + ibrutinib showing not only that the combination was well tolerated, but produced a 100% ORR in patients with high-risk CLL/SLL and a 75% ORR in indolent NHL, which includes Follicular Lymphoma and Marginal Zone Lymphoma
Obtained an SPA for the UNITY-CLL Phase 3 clinical trial of the Company’s proprietary combination of TG-1101 + TGR-1202 (aka "TG-1303")
Launched a new Phase 1/2 triple therapy study of TG-1101 + TGR-1202 + the PD-1 checkpoint inhibitor pembrolizumab, the first clinical trial to evaluate the safety and efficacy of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor
Announced key data updates at the major medical conferences throughout 2015

Key Objectives for 2016

Aggressively recruit into the GENUINE Phase 3 clinical trial
Aggressively enroll into the UNITY-CLL Phase 3 clinical trial
Commence the UNITY- DLBCL Phase 2b clinical trial
Initiate a Phase 2 clinical trial in Multiple Sclerosis (MS)
Commence a registration trial for iNHL
Present updated data on the Phase 1 and 2 clinical trials at major hematology/oncology conferences during 2016

Financial Results for the Fourth Quarter and Full Year 2015

At December 31, 2015, the Company had cash, cash equivalents, investment securities, and interest receivable of $102.4 million, as compared to $78.9 million at December 31, 2014.

Our consolidated net loss for the year ended December 31, 2015, excluding non-cash items, was approximately $47.3 million, including other research and development expenses of $43.4 million, of which approximately $23.4 million related to manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The consolidated net loss for the year ended December 31, 2015, inclusive of non-cash items, was $63.0 million, or $1.38 per diluted share, compared to a consolidated net loss of $55.8 million for the year ended December 31, 2014. The increase in consolidated net loss during the year ended December 31, 2015 was primarily driven by increases in other research and development expenses for both TG-1101 and TGR-1202 as a result of manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs as well as launch preparation activities. The increase in other research and development expenses was partially offset by expenses recorded during 2014 in conjunction with the Company’s licensing agreements for TGR-1202 and the IRAK4 inhibitors program, and a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the fourth quarter ended December 31, 2015, excluding non-cash items, was approximately $14.8 million, including other research and development expenses of $13.7 million, of which approximately $7.4 million related to manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The consolidated net loss for the fourth quarter ended December 31, 2015, inclusive of non-cash items, was $17.6 million, or $0.37 per diluted share, compared to a consolidated net loss of $18.8 million during the comparable quarter in 2014. The decrease in consolidated net loss during the fourth quarter ended December 31, 2015 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2014, partially offset by a modest increase in other research and development expenses for TGR-1202 as a result of clinical trial expenses related to ongoing and planned future Phase 3 registration programs.

Karolinska Development portfolio company Akinion Halts Further Development of AKN-028 due to Safety Concerns

On March 4, 2016 Karolinska Development AB (Nasdaq Stockholm: KDEV) reported that Akinion, a KDev Investments portfolio company, has halted further development of its lead product candidate AKN-028, which was being evaluated in a Phase I/II clinical study for acute myeloid leukemia (AML), due to a small number of patients experiencing severe liver toxicity (Press release, Akinion Pharmaceuticals, MAR 4, 2016, http://www.karolinskadevelopment.com/?cID=551&pid=875351&did=699813&y=2016&m=03 [SID:1234512168]). As a consequence, Karolinska Development’s portfolio Net Fair Value will decrease by SEK 78 million.

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Jim Van heusden, CEO of Karolinska Development, said: "Today´s announcement is obviously very disappointing news for patients with acute myeloid leukemia given the great need for improved treatment options for this difficult-to-treat cancer. It’s unfortunate, but also illustrates the risks inherent in investing in the development of novel drug candidates."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

vTv Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, vTv Therapeutics, 2017, MAR 4, 2016, View Source [SID1234521320]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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