Adamis Pharmaceuticals Announces Pricing of Public Offering of Common Stock and Warrants

On August 1, 2019 Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including respiratory disease, allergy and opioid overdose, reported the pricing of its previously announced underwritten public offering of 12,000,000 shares of its common stock and warrants to purchase up to 12,000,000 shares of its common stock (Press release, Adamis Pharmaceuticals, AUG 1, 2019, View Source [SID1234538038]). Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined public offering price of $1.00, resulting in gross proceeds of approximately $12,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the company and excluding the proceeds from the exercise of any warrants. All shares of common stock and warrants to purchase common stock to be sold in the public offering are being sold by Adamis. The warrants will be exercisable commencing on the date of issuance, will expire five years from the date of issuance, and have an exercise price of $1.15 per share, subject to certain adjustments. The shares of common stock and warrants will be purchased together but will be issued separately and will be immediately separable upon issuance.

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The offering is expected to close on August 5, 2019, subject to the satisfaction of customary closing conditions. The company has also granted the underwriters a 30-day option to purchase up to 1,800,000 additional shares of its common stock and/or warrants to purchase up to 1,800,000 additional shares of its common stock.

Raymond James & Associates, Inc. is acting as the sole book-running manager for the offering. Maxim Group LLC is acting as lead manager for the offering.

The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, manufacturing, capital expenditures, hiring additional personnel, acquisitions of new technologies or products, the repayment, refinancing, redemption or repurchase of existing or future indebtedness or capital stock and working capital.

The securities described above are being offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 18, 2018. A preliminary prospectus supplement and the related prospectus have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and an accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida, or by telephone at (800) 248-8863, or e-mail at [email protected].

Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the company and the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

SenesTech, Inc. to Report Second Quarter 2019 Financial Results on Tuesday, August 13, 2019

On August 1, 2019 SenesTech, Inc. (NASDAQ: SNES), a developer of proprietary technologies for managing animal pest populations through fertility control, reported that will report financial results for its second quarter of 2019, ended June 30, 2019, after the market close on Tuesday, August 13, 2019 (Press release, SenesTech, AUG 1, 2019, View Source [SID1234538054]). The Company has scheduled a conference call that same day, Tuesday, August 13, 2019, at 5:00 pm ET, to review the results.

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Second Quarter 2019 Conference Call Details

Date and Time: Tuesday, August 13, 2019 at 5:00 pm ET

Call-in Information: Interested parties can access the conference call by dialing (844) 308-3351 or (412) 317-5407.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

To Ask a Question: There will be three options to ask a question during the call:

Questions can be asked live during the call-in portion of the conference call.
The live webcast will feature an option to submit questions in writing during the event.
If you are unable to attend the event, you can submit a question in advance to [email protected].
Replay: A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation #10134038. A webcast replay will be available in the Investor Relations section of the Company’s website at View Source for 90 days.

About SenesTech
SenesTech is changing the paradigm of pest management by targeting the root cause of the problem: reproduction.

ContraPest is an innovative technology with an approach

Rakuten Medical Secures Additional Investment from Rakuten to Further Develop its Photoimmunotherapy Platform Capabilities Investment to also support pipeline growth, and global business and commercial expansion

On August 1, 2019 Rakuten Medical, Inc., a clinical-stage, global biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy (PIT) platform, reported that it has raised approximately US $100 million on July 31, 2019, in a Series C-1 Preferred Stock financing from Rakuten, Inc., a global leader in internet services headquartered in Japan (Press release, Rakuten Medical, AUG 1, 2019, View Source [SID1234538083]). This investment is increasing Rakuten’s equity share of Rakuten Medical to 22.6 percent.

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Rakuten Medical intends to use the additional injection of capital to expand the development of the company’s oncology-focused PIT platform, strengthen its business and commercial functions, and provide resources to further identify and evaluate new investigational compounds and indications for the potential treatment of other types of cancers using PIT.

"The additional investment from Rakuten solidifies our commitment to accelerating Rakuten Medical’s business and commercial development," said Mickey Mikitani, chairman and CEO of Rakuten Medical. "I believe we can cultivate a sustainable health care ecosystem to provide patients with safe and easy access to, and better care in, the treatment of cancer, regardless of their nationality or income. Culturally, the technology industry has revolutionized society by being bold, action-driven and innovative; and we hope to do the same at Rakuten Medical by exploring opportunities that will combine Rakuten’s technology expertise with Rakuten Medical’s first-in-class Photoimmunotherapy platform."

Based on the additional investment, Rakuten Medical will become an equity-method affiliate of Rakuten in the third quarter of this fiscal year.

About Photoimmunotherapy
Photoimmunotherapy (PIT) is an investigational, anti-cancer treatment platform that is comprised of a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye 700DX). Transient excitation of IRDye 700Dx with non-thermal red light (690 nm) is believed to result in anti-cancer activity, which is mediated by biophysical processes that may compromise the membrane integrity of cells. The requirement of targeted binding of antibody-IR700 conjugate to a specific antigen on the cell surface and subsequent illumination is believed to result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also lead to the systemic induction of innate and adaptive immunity.

Agios Reports Business Highlights and Second Quarter 2019 Financial Results

On August 1, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the second quarter ended June 30, 2019 (Press release, Agios Pharmaceuticals, AUG 1, 2019, View Source [SID1234537982]).

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"In the second quarter we demonstrated our ability to execute across all areas of our business. Our commercial team continues to deliver on the AML launch for TIBSOVO and prepare for our first potential solid tumor launch on the heels of the positive ClarIDHy study in cholangiocarcinoma," said Jackie Fouse, Ph.D., chief executive officer at Agios. "On the clinical side, we continued to broaden our IDH program into earlier lines of AML therapy and expand our PKR programs into new disease areas while enrolling the PK deficiency pivotal studies. In addition, we completed dose escalation in our AG-270 Phase 1 trial and are on track to initiate the next phase of development. The great progress we made during the quarter keeps us on track to deliver on our remaining 2019 milestones and drive further value across our portfolio."

SECOND QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS

Received approval from the U.S. Food and Drug Administration (FDA) on May 2, 2019 for single agent TIBSOVO for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Announced the Phase 3 ClarIDHy trial of TIBSOVO in advanced previously treated cholangiocarcinoma patients with an IDH1 mutation met its primary endpoint, demonstrating improvement in progression-free survival by independent radiology review compared with patients who received placebo.
Presented updated data from the Phase 1 studies of TIBSOVO in frontline AML, both as a monotherapy and in combination with azacitidine, and the first data from the perioperative study of TIBSOVO and vorasidenib in glioma at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data presentations can be found here.
Began dosing patients in the Phase 1 dose-escalation trial of AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH), in advanced lymphoma.
Completed the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in methylthioadenosine phosphorylase (MTAP)-deleted tumors.
Appointed Orlando Oliveira to the role of senior vice president and general manager, international. Mr. Oliveira will be responsible for building and leading the company’s operations outside of the U.S. in support of the expected launch of TIBSOVO in Europe and potentially other select markets.
KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in the remainder of 2019:

Oncology:

Submit a supplemental new drug application to the FDA for TIBSOVO for advanced previously treated IDH1 mutant cholangiocarcinoma by year-end.
Initiate a registration-enabling Phase 3 study of vorasidenib in low-grade glioma with an IDH mutation by year-end.
Initiate expansion phase for the Phase 1 study of AG-270 in MTAP-deleted tumors, including two combination arms with AG-270 and taxanes in non-small cell lung cancer and pancreatic ductal adenocarcinoma, in the third quarter.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency by year-end 2019:
ACTIVATE-T: A single-arm trial of up to 40 regularly transfused patients
ACTIVATE: A 1:1 randomized, placebo-controlled trial of 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
ANTICIPATED 2019 DATA PRESENTATIONS

Full data from the Phase 3 ClarIDHy study of TIBSOVO in IDH1 mutant advanced previously treated cholangiocarcinoma have been submitted for presentation at the European Society for Medical Oncology Congress taking place in Barcelona, Spain from September 27-October 1, 2019.
Data from the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with MTAP-deleted tumors have been submitted to the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place in Boston from October 26-30, 2019.
Data from IDH and PKR programs have been submitted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in Orlando, Fla. from December 7-10, 2019, including new data from the extension phase of the Phase 2 DRIVE PK study of mitapivat in adults with PK deficiency and important translational data from the Phase 1 combination study of TIBSOVO and azacitidine in frontline AML.
SECOND QUARTER 2019 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2019 was $26.2 million, which includes $13.7 million of net product revenue from U.S. sales of TIBSOVO, $9.0 million in collaboration revenue and $2.7 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to revenue of $40.4 million for the second quarter of 2018, which included recognition of a $15 million milestone from Celgene related to Celgene’s filing of an MAA to the EMA for IDHIFA and $12.4 million from the signing of the CStone collaboration.

Cost of Sales: We began U.S. sales of TIBSOVO in the third quarter of 2018. Cost of sales were $0.3 million for the second quarter of 2019.

Research and Development (R&D) Expenses: R&D expenses were $107.4 million for the second quarter of 2019 compared to $86.7 million for the second quarter of 2018. The increase in R&D expense was primarily attributable to vorasidenib Phase 3 low grade glioma trial start-up costs, the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia, and clinical trial activity related to the ongoing Phase 1 trials for AG-270 and AG-636.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $32.4 million for the second quarter of 2019 compared to $26.6 million for the second quarter of 2018. The increase in SG&A expense was primarily attributable to costs to support commercialization of TIBSOVO and personnel costs related to increased headcount.

Net Loss: Net loss was $109.9 million for the second quarter of 2019 compared to $68.7 million for the second quarter of 2018.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of June 30, 2019 were $624.0 million compared to $805.4 million as of December 31, 2018. The net decrease of $181.4 million in cash position was primarily driven by net expenditures to fund operations, including a onetime cash expense of $19.2 million for bonus payouts during the first quarter. The company expects that its cash, cash equivalents and marketable securities as of June 30, 2019, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss second quarter 2019 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 9319039. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

Coherus BioSciences Reports Corporate Highlights and Second Quarter 2019 Financial Results

On August 1, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), corporate highlights and reported financial results for the quarter ended June 30, 2019 (Press release, Coherus Biosciences, AUG 1, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" rel="nofollow">View Source [SID1234538007]).

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Second Quarter 2019 Company Highlights

Net product revenue for the second quarter of 2019 was $83.4 million and net income was $23.6 million, or $0.32 per share on a fully diluted basis. Net income was $3.6 million or $0.05 per share on a fully diluted basis for the first half of 2019. Cash flow from operations for the quarter was also positive at $12.7 million.
Uptake of UDENYCA (pegfilgrastim-cbqv) is progressing strongly across all segments (340B hospitals, non-340B hospitals and community oncology clinics), with increased uptake in the 340B segment after receiving transitional pass-through status from Centers for Medicare & Medicaid Services on April 1, 2019.
After just two quarters on the market, UDENYCA is the U.S. market leading pegfilgrastim biosimilar with greater than approximately 13% of unit market share at the end of June 2019, and it is anticipated to reach over 20% of unit market share by the end of 2019.
Second Quarter 2019 Financial Results

Net product revenue for the second quarter of 2019 was $83.4 million. Cost of goods sold for the second quarter of 2019 was $0.6 million, resulting in a gross profit margin of 99 percent for the second quarter of 2019, up from 94 percent in the first quarter of 2019.
Research and development (R&D) expense for the second quarter of 2019 was $18.9 million, as compared to $26.5 million for the same period in 2018. R&D expense for the six months ended June 30, 2019 was $37.7 million, as compared to $52.0 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs in the first quarter of 2019 and a decrease in CHS-0214 development costs.
Selling, general and administrative (SG&A) expense for the second quarter of 2019 was $36.5 million, as compared to $18.4 million for the same period in 2018. SG&A expense for the six months ended June 30, 2019 was $69.1 million, as compared to $35.0 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives, as well as legal costs in support of litigations.
Cash, cash equivalents and investments in marketable securities for the second quarter totaled $111.9 million at June 30, 2019, as compared to $96.4 million at March 31, 2019 and $72.4 million at December 31, 2018. Cash flow from operations was $12.7 million for the second quarter of 2019.
Net income attributable to the Company for the second quarter of 2019 was a 23.6 million, or $0.32 per share on a fully diluted basis, compared to a net loss of ($43.6) million, or ($0.68) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Six Months from June 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
• Continue as market leading pegfilgrastim biosimilar of choice.
• Achieve 2019 exit unit market share of 20% or greater.
• Increase penetration into all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
• Complete certain development objectives to support BLA filing in 2020.
CHS-0214, biosimilar candidate to Enbrel (etanercept)
• Prepare for BLA supporting activities, pending legal developments.
CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)
• Advance the development of the ophthalmology pipeline.
CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")
• Initiate clinical phase program in NASH.
Conference Call Information

When: Thursday, August 1, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9268814
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.