On February 13, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) reported business highlights and financial results for the fourth quarter and year ended December 31, 2019 (Press release, Agios Pharmaceuticals, FEB 13, 2020, View Source [SID1234554260]. In addition, Agios highlighted key 2020 corporate milestones and data presentations for its clinical development programs.

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"On the heels of a busy and productive 2019, I’m more confident than ever in the strength of our team and our ability to make a meaningful impact on the lives of patients through great science, a deep pipeline and differentiated therapies," said Jackie Fouse, Ph.D., chief executive officer at Agios. "In 2020, our clinical development team is focused on advancing our Phase 3 PK deficiency studies in order to submit a new drug application in 2021, finalizing our pivotal development plan for the PK activation program in thalassemia and establishing proof-of-concept in sickle cell disease. In addition, we are driving enrollment in several Phase 3 studies for our IDH inhibitors in both malignant hematology and solid tumors. Our commercial team is focused on achieving an ambitious revenue target for TIBSOVO and increasing market development activities in preparation for a potential launch in PK deficiency."

ANTICIPATED 2020 KEY MILESTONES

Agios expects the following key milestones in 2020:

Hematologic Malignancies

Deliver full-year U.S. revenue for TIBSOVO of $105-115 million
Receive European Medicines Agency CHMP opinion for TIBSOVO in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by year-end
Complete enrollment of the Phase 3 AGILE trial of TIBSOVO in combination with azacitidine in adult patients with previously untreated IDH1 mutant AML by year-end
Complete enrollment of the relapsed or refractory myelodysplastic syndrome arm of the TIBSOVO Phase 1 study of IDH1 mutant advanced hematologic malignancies by year-end
Solid Tumors

File supplemental new drug application (sNDA) for TIBSOVO in previously treated IDH1 mutant cholangiocarcinoma by year-end
Rare Genetic Diseases

Announce topline data for ACTIVATE and ACTIVATE-T pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency by year-end
Submit updated data from the Phase 2 study of mitapivat in thalassemia for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June and finalize pivotal development strategy by year-end
Achieve proof-of-concept for mitapivat in sickle cell disease by mid-2020
Receive investigational new drug (IND) clearance for AG-946, a next generation PKR activator, and initiate a first-in-human study in healthy volunteers in the first half of 2020
Research

Achieve at least one new development candidate by year-end
FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS

Revenue: Total revenue for the fourth quarter of 2019 was $35.4 million, which includes $12.9 million in collaboration revenue, $19.6 million of net product revenue from sales of TIBSOVO and $3.0 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to $30.0 million for the fourth quarter of 2018, which included $18.4 million in collaboration revenue, $9.4 million of net product revenue from U.S. sales of TIBSOVO and $2.2 million in royalty revenue from net global sales of IDHIFA. Total revenue for the year ended December 31, 2019 was $117.9 million compared to $94.4 million for the year ended December 31, 2018. The increase in 2019 revenue was primarily driven by net U.S. sales of TIBSOVO and were offset by a decline in collaboration revenue due to the recognition of a milestone from Celgene and the upfront payment from CStone in 2018.

Cost of Sales: Cost of sales were $0.3 million for the fourth quarter of 2019 compared to $0.7 million for the fourth quarter of 2018, and $1.3 million for the year ended December 31, 2019 compared to $1.4 million for the comparable period in 2018.

Research and Development (R&D) Expenses: R&D expenses were $106.2 million for the fourth quarter of 2019 compared to $93.8 million for the fourth quarter of 2018 and $410.9 million for the year ended December 31, 2019 compared to $341.3 million for the comparable period in 2018. The increase in R&D expense was primarily attributable to clinical trial activity for mitapivat in PK deficiency and thalassemia; start-up costs for the vorasidenib Phase 3 INDIGO study in low-grade glioma, including required clinical pharmacology studies and companion diagnostic development; and ongoing enrollment in the TIBSOVO Phase 3 AGILE and HOVON frontline AML combination studies. R&D expense also increased as a result of ongoing research efforts across our discovery platform programs.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $34.8 million for the fourth quarter of 2019 compared to $31.9 million for the fourth quarter of 2018, and $132.0 million for the year ended December 31, 2019 compared to $114.1 million for the year ended December 31, 2018. The increase in SG&A expense was primarily attributable to increased investment in marketing activities in preparation for the potential launch of mitapivat and personnel costs related to increased headcount to support growing operations.

Net Loss: Net loss was $102.4 million for the fourth quarter of 2019 compared to $91.8 million for the fourth quarter of 2018, and $411.5 million for the year ended December 31, 2019 compared to a net loss of $346.0 million for the year ended December 31, 2018.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of December 31, 2019 were $717.8 million compared to $805.4 million as of December 31, 2018. The change in cash was primarily driven by expenditures to fund operations of $464.4 million offset by the net proceeds of $277.2 million from the November follow-on offering and cash inflows of $99.3 million from product sales, stock option exercises, royalty revenue, and collaboration reimbursements and milestones. The company expects that its cash, cash equivalents and marketable securities as of December 31, 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 collaboration-related payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2021.

CONFERENCE CALL INFORMATION

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss fourth quarter and full year 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 referring to conference ID 4195413. 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.

About Agios/Celgene Collaboration
IDHIFA (enasidenib) and AG-270 are part of our collaboration with Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company. Under the terms of our 2010 collaboration agreement focused on cancer metabolism, Celgene has worldwide development and commercialization rights for IDHIFA. Agios continues to conduct certain clinical development activities within the IDHIFA development program and is eligible to receive reimbursement for those development activities and up to $80 million in remaining milestone payments, and royalties on any net sales. Celgene and Agios are currently co-commercializing IDHIFA in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts. AG-270 is part of a 2016 global research collaboration agreement with Celgene focused on metabolic immuno-oncology. Celgene has the option to participate in a worldwide 50/50 cost and profit share with Agios, under which Agios is eligible for up to $169 million in clinical and regulatory milestone payments for the program.

On February 13, 2020 Bonnie J Addario Lung Cancer Foundation reported that Patients with lung cancer face the challenge of drug resistance, while researchers focus on extending treatment duration (Press release, Bonnie J Adodario Lung Cancer Fundation, FEB 13, 2020, View Source [SID1234554284]). In collaboration with the patient group ALK Positive, we have awarded a new research collaboration grant dedicated to overcoming ALK+ treatment resistance.

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ALK mutations occur in nearly 5% of patients with non-small cell lung cancer (NSCLC). Currently, five ALK-specific inhibitors (alectinib, brigatinib, ceritinib, crizotinib, and lorlatinib) have greatly extended the lives of patients. The downside is that drug resistance kicks in far too often. The search for innovative approaches to prevent drug resistance and extend treatment duration is imperative to ALK+ patients and to all individuals living with lung cancer.

This grant was awarded to Dr. Trever Bivona, associate professor of medicine at the University of California – San Francisco, and Dr. Christine Lovly, associate professor of medicine at Vanderbilt University Medical Center. The research will focus on understanding why ALK specific drugs stop working and will test the use of drug combinations to delay or prevent resistance. The project is entitled "Transforming ALK+ lung cancer into a chronic or curable condition by combating drug resistance."

This collaboration seeks to fill key knowledge gaps in our understanding of ALK inhibitor response and resistance, with an overarching goal of identifying new targets that improve responses to ALK inhibitor therapy and, ultimately, improve the quantity and quality of life for patients. The project was selected after a rigorous internal and external review process by a committee consisting of patients living with ALK+ NSCLC and some of the world’s foremost ALK experts.

In this era of precision medicine, patients are disrupting the research paradigm by funding and selecting projects that deliver maximum benefit to their community. All of us at GO2 Foundation are pleased to partner with ALK Positive on this research collaboration grant. We look forward to continuing to fuel life-saving research.

Please help save, extend, and improve the lives of those vulnerable, at risk, and living with lung cancer and make a contribution today.

On February 13, 2020 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported operational highlights and financial results for the year ended December 31, 2019 on Thursday, February 20, 2020, and will host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, FEB 13, 2020, View Source [SID1234554300]). The dial-in information for the call is as follows:

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U.S. (toll free): 1-888-347-5280
International: +1 412-902-4280

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

On February 13, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the pricing of its previously announced registered underwritten public offering of 3,181,818 shares of its common stock at a price to the public of $55.00 per share (Press release, Deciphera Pharmaceuticals, FEB 13, 2020, View Source [SID1234554316]). The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $175.0 million. The offering is expected to close on or about February 19, 2020, subject to customary closing conditions. In addition, Deciphera has granted the underwriters a 30-day option to purchase up to 477,272 additional shares of its common stock.

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J.P. Morgan, Piper Sandler and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds from the offering to fund general corporate purposes, which may include research and development and clinical development costs to support the advancement of its drug candidates, including the continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; general and administrative expenses; and other general corporate purposes.

An automatic shelf registration statement (including a prospectus) relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on February 12, 2020 and became effective upon filing. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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.

On February 13, 2020 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported that it has completed the first closing under a recently executed Securities Purchase Agreement with Innoviva, Inc. (NASDAQ: INVA) ("Innoviva"), a company with a portfolio of royalties that include respiratory assets partnered with Glaxo Group Limited (Press release, AmpliPhi Biosciences, FEB 13, 2020, View Source [SID1234554282]). In connection with the closing, Armata issued 993,139 common shares and warrants to purchase 993,139 common shares in exchange for net proceeds of approximately $2.8 million. The first closing occurred following the satisfaction of certain closing conditions, including the execution of voting agreements by greater than 50.1% of the existing common stockholders of Armata in support of the $25 million private placement financing transaction. In connection with the closing, Richard Bear and Michael S. Perry, D.V.M., Ph.D., resigned from Armata’s Board of Directors and two individuals designated by Innoviva, Sarah Schlesinger, M.D. and Odysseas Kostas, M.D., were appointed to fill the newly created vacancies. Armata also announced that it has withdrawn its registration statement on Form S-1 that was previously filed with the SEC.

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"We are very pleased to close the first tranche of this Securities Purchase Agreement with Innoviva, and, together with my fellow Directors, we welcome Drs. Kostas and Schlesinger to our Board," stated Todd R. Patrick, Chief Executive Officer of Armata. "These additional funds significantly strengthen our financial position and provide ample cash runway to pursue meaningful clinical and corporate milestones in 2020 and 2021. We are very fortunate to partner with Innoviva and we look forward to mutual success as we advance our emerging bacteriophage platform to treat the growing global health challenge of multi-drug resistant infections."

Pursuant to and subject to the terms and conditions of the Securities Purchase Agreement and related agreements, Innoviva will purchase a total of approximately 8.7 million newly issued shares of Armata’s common stock, at a price of $2.87 per share, and warrants to purchase up to approximately 8.7 million additional shares of Armata’s common stock, at an exercise price of $2.87 per share. The stock purchases will occur in two tranches, the first of which has now been completed. Upon the closing of the second tranche, which is expected to occur during the first quarter of 2020, subject to the satisfaction or waiver of certain closing conditions, including approval by Armata shareholders, Innoviva will purchase approximately 7.7 million additional shares of common stock and warrants to purchase approximately 7.7 million additional shares of common stock for an aggregate purchase price of $22.2 million.

Immediately following the closing of the second tranche, expected in the first quarter of 2020, Armata will have approximately 18.6 million shares of common stock and warrants exercisable for approximately 10.6 million shares of common stock outstanding. The Company expects the proceeds from the offering to provide sufficient cash resources to achieve meaningful clinical milestones in 2020 and 2021.

This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.