On March 6, 2020 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Ardelyx, MAR 6, 2020, View Source [SID1234555285]).

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"2019 was a year of significant progress at Ardelyx. We successfully hit all of our key milestones bringing us closer to submitting a New Drug Application to the FDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis in mid-2020 and potentially providing this first in class agent to patients in need," said Mike Raab, president and chief executive officer of Ardelyx. "We enter 2020 well-positioned with data from three successful Phase 3 trials for tenapanor in hyperphosphatemia, key ex-U.S. partnerships and two years of cash on hand to prepare for U.S. commercialization of our novel therapy."

Key Accomplishments in 2019

Published positive Phase 3 results of tenapanor for the treatment of hyperphosphatemia in the Journal of the American Society of Nephrology.
Appointed renowned nephrologist, Geoffery A. Block, M.D., to the company’s board of directors.
Began the process of building a highly talented and experienced cardiorenal commercial team.
Announced positive, statistically significant results from the Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have uncontrolled hyperphosphatemia despite phosphate binder treatment.
Received FDA approval for IBSRELA (tenapanor). The company continues to seek a strategic partner to market IBSRELA in the United States.
Expanded collaborative partnership with Kyowa Kirin Co., Ltd (KKC) with a new research agreement and a $20.0 million equity investment in Ardelyx under a Stock Purchase Agreement.
Announced positive topline results from the PHREEDOM study evaluating tenapanor as a monotherapy for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo.
Raised approximately $135 million, net of underwriting discounts and commissions, following a successful underwritten public offering of 23,000,000 shares of common stock to support commercial launch preparation for tenapanor for the control of serum phosphorus in patients with CKD on dialysis. The capital raised in the fourth quarter of 2019 extends the company’s cash runway into early 2022, based on its current operating plan.
Initiated the Phase 4 NORMALIZE study and announced initial results demonstrating that a significant number of patients achieved normal serum phosphorus levels with tenapanor alone or with tenapanor and only one to three sevelamer tablets a day.
On-Track to Submit NDA for Tenapanor for the Control of Serum Phosphorus in mid-2020: Ardelyx is on-track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenapanor for the control of serum phosphorus in mid-2020.

Full Year 2019 Financial Results

Cash Position: As of December 31, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $247.5 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.
Revenue and Cost of Revenue: Total revenues were $5.3 million for the year ended December 31, 2019 related to the company’s ex-U.S. collaboration partnerships, and cost of revenues was $0.6 million related to payments due to AstraZeneca in accordance with the company’s termination agreement entered into with AstraZeneca in June 2015 compared to total revenues of $2.6 million and cost of revenues of $0.5 million for the year ended December 31, 2018.
R&D Expenses: Research and development expenses were $71.7 million for the year ended December 31, 2019, an increase of $2.3 million, or 3%, compared to $69.4 million for the year ended December 31, 2018. The increase consisted of a $3.7 million increase in our internal program costs and a $1.4 million decrease in our external program costs. The increase in our internal costs of $3.7 million was primarily due to an increase in headcount and related personnel costs and an increase in stock-based compensation expenses. The decrease in our external program costs of $1.4 million included a $4.6 million decrease in expenses primarily related to manufacturing of tenapanor and regulatory expenses related to our IBS-C NDA in 2018, partially offset by $2.5 million increase in clinical development expenses related to our RDX013 program and a $0.7 million increase primarily related to our tenapanor clinical trial expenses that includes an out-of-period adjustment recorded during the second quarter of 2019 that reduced clinical trial expenses by $3.6 million related to our tenapanor clinical trials.
G&A Expenses: General and administrative expenses were $24.3 million for the year ended December 31, 2019, an increase of $0.6 million, or 2%, compared to $23.7 million for the year ended December 31, 2018.
Net Loss: Net loss for the year ended December 31, 2019, was $94.9 million compared to a net loss of $91.3 million for the year ended December 31, 2018.
Financial Guidance

Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments will be sufficient to fund the company’s operations until early 2022 based on its current operating plans.

On March 6, 2020 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported the rescheduling of its fourth quarter and annual 2019 financial results and company update from Wednesday, March 11, 2020 to Wednesday, March 18, 2020 after market close (Press release, Cumberland Pharmaceuticals, MAR 6, 2020, View Source [SID1234555284]). A conference call and live Internet webcast will be held on Wednesday, March 18, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9759981. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high quality prescription brands to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and oncology market segments. These medical specialties are categorized by moderately concentrated prescriber bases that we believe can be penetrated effectively by targeted sales forces. The Company’s portfolio of FDA approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
Caldolor (ibuprofen) Injection, for the treatment of pain and fever;
Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation;
Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.
For more information on Cumberland’s approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company’s website www.cumberlandpharma.com.

The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD"), Hepatorenal Syndrome ("HRS") and Portal Hypertension ("PH").

On March 6, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported the closing of its previously announced rights offering (the "Rights Offering") (Press release, CTI BioPharma, MAR 6, 2020, View Source [SID1234555283]). At the closing, CTI BioPharma sold and issued an aggregate of 15,698,995 shares of its common stock (the "Common Stock") and an aggregate of 4,429.2423 shares of its series X convertible preferred stock (the "Series X Preferred") pursuant to the exercise of subscription rights and Oversubscription Rights in the Rights Offering by existing holders of CTI Biopharma’s Common Stock and series O convertible preferred stock. The Rights Offering was fully backstopped by certain existing stockholders of CTI BioPharma who agreed to purchase any shares of Common Stock and/or Series X Preferred offered in the Rights Offering that were not subscribed for (the "Oversubscription Rights"). CTI BioPharma raised aggregate gross proceeds of approximately $60.0 million in the Rights Offering.

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Of the total shares of Common Stock and Series X Preferred sold and issued in the Rights Offering, certain affiliates of BVF Partners L.P. purchased 3,047 shares of Series X Preferred, Stonepine Capital, LP purchased 3,267,127 shares of Common Stock and 673.2873 shares of Series X Preferred, OrbiMed Private Investments VI, LP purchased 4,520,600 shares of Common Stock and 298 shares of Series X Preferred and New Enterprise Associates, Inc. purchased 3,390,450 shares of Common Stock and 410.955 shares of Series X Preferred, in each case, pursuant to the exercise of their subscription rights and Oversubscription Rights.

The Rights Offering was made pursuant to CTI BioPharma’s effective shelf registration statement on file with the Securities and Exchange Commission (the "SEC") and a prospectus supplement and accompanying prospectus filed with the SEC on February 14, 2020.

JMP Securities served as financial advisor to CTI BioPharma in connection with the Rights Offering.

On March 6, 2020 AmerisourceBergen reported that it is continuing its strategic relationship with the American Oncology Network, LLC (AON), a high-growth medical oncology provider with a focus on supporting the long-term viability of oncology treatment in community-based settings (Press release, AmerisourceBergen, MAR 6, 2020, View Source [SID1234555282]). AmerisourceBergen will support AON in its effort to accelerate key strategic priorities to scale its integrated value-based care delivery model nationwide.

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AON currently serves an expanding network of partner practices across 11 states, providing dedicated end-to-end administrative support, access to an extensive array of centralized ancillary services, and proven practice management expertise. Delivered through its local market, physician-led model, AON empowers community-based practices with the necessary tools, support and capital to effectively navigate today’s increasingly dynamic healthcare landscape and practice value-based care within the community at scale.

"Our partnership with AmerisourceBergen is an important part of our effort to grow our network, expand our solution suite, and deliver exceptional services to our partner practices and their patients," said AON CEO Brad Prechtl, MBA.

AON Board Member & Chairman Dr. Stephen Orman added, "AmerisourceBergen is an industry leader with a proven track record of achieving exceptional results, and we look forward to collaborating further to expand our national oncology network."

AmerisourceBergen’s ION Solutions supports AON with GPO contracting. Oncology Supply handles distribution of chemotherapy and supportive care products to AON practices. Additional integrated service offerings available to AON practices through ION and Oncology Supply include:

Dedicated account teams that actively consult on inventory and create operational efficiencies
Robust inventory of specialty and full-line oral, infusible and injectable products
Technology, analytics and informatics solutions to drive higher-quality and lower-costs
Inventory management solutions
Centralized library of precision medicine testing recommendations and resources through ION Solutions’ Precision Medicine Center
Ongoing educational conference series designed to facilitate peer-to-peer learning and networking and strengthen the community of independent oncologists
The largest, longest-tenured pharmacy program that assists community oncology practices in successfully optimizing a medically integrated dispensing program
"As a company that’s pharmaceutical-centered and community focused, we strive for partners like AON," said Brian Ansay, President Specialty Physician Group Purchasing, AmerisourceBergen. "AON’s physician-led model and patient-centric services are creating new opportunities in community oncology, and we are excited about their vision for the future."

AON is physician led and physician governed. For more information about AON, please visit: www.AONcology.com.

On March 6, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) is reported that further to the Conditional Approval from the TSX Venture Exchange for a non-brokered Private Placement to accredited investors of up to 25,000,000 units at $0.12 per unit ("Unit"), to raise up to $3,000,000 that was announced on January 30, 2020, and the closing of the first tranche of that placement, of 1,485,000 units, raising $178,200, on January 30, 2020, two further closings have taken place, on March 4, 2020, of 7,459,139 units, raising $895,096, and on March 5, 2020, of 2,000,000 units, raising $240,000. Each Unit is comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue (Press release, MedX Health, MAR 6, 2020, View Source [SID1234555281]). The securities issued on January 30, 2020, March 4, 2020 and March 5, 2020, will be restricted from trading for four months from their respective dates of issue.

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The Company is also pleased to announce that on March 5, 2020, it closed the debt settlement announced in its Press Release dated March 3, 2020, pursuant to which is settled $372,071 of debt owed to an arm’s length trade creditor by issuance of 3,103,878 Units. The securities comprised in the Units issued on this debt settlement will be restricted from trading for four months from the date of issue.

In connection with the non-brokered private placement, agent’s warrants ("Agent’s Warrant(s)"), as described below, were also issued. Each Agent’s Warrant, which is non-transferable, is exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the respective dates of issue. In connection with the January 30, 2020 Closing, a cash commission of $10,080 was paid and 84,000 Agent’s Warrants were issued. In connection with the March 4, 2020 Closing, a cash commission of $60,720 was paid and 506,000 Agent’s Warrants were issued. In connection with the March 5, 2020 Closing, a cash commission of $19,200 was paid.

The Company is further pleased to announce that it is proposing a further non-brokered Private Placement to accredited investors of up to 20,833,333 units at $0.12 per unit ("Unit"), to raise up to $2,500,000. Each Unit will be comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. Closing of the Placement, which will take place in tranches, will be subject to receipt of subscriptions and a number of other conditions, including without limitation the receipt of all relevant regulatory and Stock Exchange approvals or acceptances. Qualified Agents may receive commissions in respect of subscriptions introduced by them by way of cash equal to 8% of funds so introduced, and issuance of agent’s warrants ("Agent’s Warrant(s)") equal in number to 8% of the number of units so subscribed for. Each Agent’s Warrant, which is non-transferable, will be exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the Closing.