On May 8, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, reported its first quarter 2019 financial results (Press release, AcelRx Pharmaceuticals, MAY 8, 2019, View Source [SID1234535971]).

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"I am very pleased with the progress made in the first five weeks of the DSUVIA launch. Shifting the paradigm in healthcare facilities to a new, non-invasive treatment option for acute pain will take time; however, from my time in the field, I have seen first-hand the enthusiasm that healthcare professionals have for DSUVIA," said Vince Angotti, Chief Executive Officer of AcelRx. "In addition to our planned hospital formulary approvals, we are excited that AcelRx has already become an approved vendor for a large ambulatory surgical center network with over 300 locations across the U.S., providing further evidence that DSUVIA’s unique characteristics are meaningful to healthcare providers," continued Angotti.

First Quarter and Recent Highlights

Launched DSUVIA in the second-half of February 2019 using 15 hospital account managers, with DSUVIA available for sale for five weeks in the first quarter of 2019
Successfully completed or scheduled 46 hospital formulary reviews by mid-year, on track for 125 approvals by year-end
In addition to hospital formularies, AcelRx became an approved vendor for an ambulatory surgical center network with over 300 locations across the U.S., making DSUVIA available beyond the hospital setting
Pooled safety data from 804 patients was published in Pain Management demonstrating sufentanil sublingual tablets are well-tolerated in a wide variety of postoperative and emergency room patients
Financial Information

Cash, cash equivalents and short-term investments balance of $90.2 million as of March 31, 2019;
Combined R&D and SG&A expenses for the first quarter of 2019 totaled $11.4 million compared to $7.5 million for the first quarter of 2018. Excluding stock-based compensation expense, these amounts were $10.3 million for the first quarter of 2019 compared to $6.5 million for the first quarter of 2018. The increase in R&D and SG&A expenses is primarily due to increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
Net cash outflow for the first quarter of 2019 was $15.5 million which included $2.3 million in debt service; and
For the first quarter of 2019, net loss was $13.7 million, or $0.17 per basic and diluted share, compared to $11.6 million, or $0.23 per basic and diluted share, for the first quarter of 2018.
2019 Guidance
AcelRx remains on track to achieve 125 hospital formulary approvals by the end of 2019. The acceleration of the second phase of hiring 25 additional hospital account managers to the beginning of the third quarter from the fourth quarter also remains as planned. Quarterly combined R&D and SG&A expense for the remaining quarters of 2019 is expected to remain in the range of $15 million to $18 million, which includes approximately $2 million of non-cash stock-based compensation per quarter.

2019 financial guidance is based on the Company’s current expectations and are forward-looking statements. Actual results could differ materially depending on market conditions and the factors set forth under the safe harbor statements below.

Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Wednesday, May 8, 2019 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (888) 317-6003 for domestic callers or (412) 317-6061 for international callers, passcode 5289662. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain in adult patients severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.

On May 8, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported financial results for the first quarter ended March 31, 2019 (Press release, Arena Pharmaceuticals, MAY 8, 2019, View Source [SID1234535970]).

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"We are continuing to make significant progress on advancing our internally developed potential first- or best-in-class compounds," said Amit D. Munshi, President and CEO of Arena. "Today, we are excited to share additional detail around the ELEVATE UC program for etrasimod in ulcerative colitis that we plan to initiate mid-year. With the exciting data shown to date, demonstrating etrasimod’s sustained, long-term efficacy and safety, we hope to address the significant unmet need that still remains in inflammatory bowel disease, where 60-80% of patients are either not receiving or failing a biologic."

Pipeline Update

Etrasimod – Next generation, once-daily, oral, selective sphingosine-1-phosphate (S1P) receptor modulator in development for the treatment of multiple immune and inflammatory diseases

Ulcerative colitis (UC): The etrasimod global Phase 3 ELEVATE UC registrational program aims to include over 40 countries and will consist of two key trials to evaluate etrasimod 2 mg in subjects with moderately to severely active ulcerative colitis. Firstly, ELEVATE UC 52, a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance in approximately 370 subjects, is expected to initiate mid-year. Secondly, ELEVATE UC 12, a 12-week induction period trial in approximately 330 subjects, is expected to initiate at a later date to optimize time to market. We plan to conduct additional studies to provide evidence of differentiation for health care providers and payers.
Crohn’s disease (CD):
Phase 2b-3 planning ongoing
Atopic dermatitis (AD):
Phase 2 planning ongoing
Olorinab – Oral, peripherally active, highly selective, full agonist of cannabinoid receptor type 2 (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases

Irritable bowel syndrome (IBS) pain
Phase 2b planning ongoing
APD418 – First-in-class, calcium-independent myofilament derepressor (CMD) in preclinical development for the treatment of decompensated heart failure (DHF)

Preclinical program advancing
Etrasimod, olorinab and APD418 are investigational compounds that are not approved for any use in any country.

Financial Update

First Quarter 2019 Financial Results

Revenues totaled $801.1 million, consisting of $800.0 million of revenue from the United Therapeutics upfront payment ($785.4 million net of costs associated with the transaction) and $1.0 million of royalty revenue.
Research and development expenses totaled $45.4 million, including $3.2 million related to ralinepag development program incurred prior to the transition to United Therapeutics and $6.7 million related to non-cash share-based compensation
General and administrative expenses totaled $16.6 million, including $6.3 million related to non-cash share-based compensation
The Company recorded a tax provision of $110.3 million as a result of utilizing the deferred tax assets that were recorded in the fourth quarter of 2018
Net income attributable to stockholders of Arena was $620.1 million, the basic earnings per share was $12.53 per share and the diluted earnings per share was $12.10
At March 31, 2019, Arena’s cash, cash equivalents and investments balance was approximately $1.3 billion and approximately 49.5 million shares of Arena common stock were outstanding.

Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today, Wednesday, May 8, 2019, at 4:30 PM EDT to discuss the financial results and provide a corporate update.

When: Wednesday, May 8, 2019, at 4:30 PM EDT
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 5285824

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena’s website for 30 days shortly after the call.

On May 8, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the Bank of America Merrill Lynch 2019 Healthcare Conference on Tuesday, May 14, 2019, at 11:35 a.m. PDT at the Encore Hotel in Las Vegas, NV (Press release, Heron Therapeutics, MAY 8, 2019, View Source [SID1234535969]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On May 8, 2019 Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the development and commercialization of innovative therapeutics for dogs and cats, reported its first quarter 2019 financial results and recent business highlights (Press release, Aratana Therapeutics, MAY 8, 2019, View Source [SID1234535968]).

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"I am very pleased that we recorded revenue growth from all three of our marketed therapeutics in the first quarter, which has resulted in our strongest quarter of product sales in the history of the company," stated Craig Tooman, President and Chief Executive Officer of Aratana Therapeutics. "Moving forward, we plan to focus on driving revenues and successfully advancing our pipeline of best-in-class therapeutic candidates."

Proposed Merger with Elanco Animal Health
On April 26, 2019, Aratana signed an agreement to be acquired by Elanco Animal Health in a stock-for-stock transaction. Subject to the terms of the agreement, upon the closing of the transaction, Aratana stockholders will receive 0.1481 share of Elanco common stock and one contingent value right (CVR) for each share of Aratana common stock. The CVR of $0.25 in cash per Aratana share shall be granted to Aratana stockholders as of the closing date and paid if capromorelin achieves certain sales levels on or before the end of 2021. Including the CVR, the proposed transaction represents aggregate value of up to approximately $245 million, based on the proposed exchange ratio and the closing prices of Aratana common stock and Elanco common stock on April 24, 2019. The proposed transaction was unanimously approved by the Aratana Board of Directors and remains subject to customary closing conditions, including approval by Aratana stockholders and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Financial Results
Aratana recorded $7.4 million in total revenues for the first quarter of 2019 compared to $4.0 million in total revenues in the first quarter of 2018. Total revenues in the first quarter of 2019 included $2.5 million in NOCITA net product sales, $1.5 million in ENTYCE net product sales and $3.4 million in licensing and collaboration revenue from Elanco for GALLIPRANT. The first quarter of 2019 net loss was $6.8 million or $0.14 diluted loss per share compared to a net loss of $8.5 million or $0.19 diluted loss per share for the corresponding quarter ended March 31, 2018.

The cost of product sales totaled $1.5 million in the first quarter of 2019 compared to $0.5 million in the corresponding period in 2018. The cost of product sales in the first quarter of 2018 were lower due to sales of inventories that were previously written down. Aratana anticipates margins will improve in 2019 compared to full year 2018, as inventories have normalized based on product performance.

During the three months ended March 31, 2019, royalty expense was $1.7 million, which was an increase of $0.9 million as compared to the corresponding 2018 period. The increase was primarily a result of an increase in net sales of GALLIPRANT by Elanco and increased net product sales of NOCITA and ENTYCE.

Research and development expenses totaled $1.8 million in the first quarter ended March 31, 2019 compared to $2.2 million for the quarter ended March 31, 2018. The first quarter of 2018 included a one-time $0.5 million option fee to AskAt Inc. Aratana anticipates research and development expenses to increase slightly in the remainder of 2019 as pipeline programs continue to progress.

Selling, general and administrative expenses totaled $9.2 million for the first quarter of 2019 compared to $7.7 million for the same period in 2018. The increase was primarily due to stock-based compensation and severance expenses related to the resignation of the former Chief Executive Officer of the Company in January 2019. The Company anticipates selling, general and administrative expenses to increase for the remainder of 2019 as compared to the corresponding 2018 period due to expenses related to the proposed merger and related matters. Selling, general and administrative expenses related to current operations are expected to be relatively consistent for the remainder of 2019 as compared to the corresponding 2018 period.

As of March 31, 2019, Aratana had approximately $37.4 million in cash, cash equivalents, restricted cash and short-term investments.

Business Highlights

NOCITA (bupivacaine liposome injectable suspension): NOCITA net product sales continued to increase sequentially quarter-over-quarter as a result of the growing account base and increasing size of average monthly orders. Additionally, the Company has commenced the regulatory process for a smaller 10 mL vial size, which if approved, may allow Aratana to expand the account base from mainly specialty clinics to general practice clinics.
ENTYCE (capromorelin oral solution): In the first quarter of 2019, ENTYCE net product sales increased by more than 15 percent compared to the fourth quarter of 2018. ENTYCE was ordered by more than 9,000 accounts in the first quarter of 2019, which is an approximately 60 percent increase over the same period of 2018, and on average, accounts ordered approximately 2.3 times within the quarter.
Capromorelin for Cats: In February 2019, the Company received a technical section complete letter for safety from FDA’s Center for Veterinary Medicine (CVM) for capromorelin (AT-002) in cats. The Company’s pivotal field effectiveness study evaluating the therapeutic candidate for weight management in cats with chronic kidney disease is anticipated to complete target enrollment mid-2019.
GALLIPRANT (grapiprant tablets): Elanco continues to report strong sales of GALLIPRANT in the United States and launched GALLIPRANT in Europe in the first quarter of 2019.
AT-019: In early-2019, Aratana started transferring the manufacturing process of the active pharmaceutical ingredient and early formulation work for AT-019, a potent and innovative EP4 receptor antagonist therapeutic candidate for pain, inflammation and other indications.
Webcast & Conference Call Details
Given the pending transaction with Elanco, management will not be hosting a conference call to discuss the Company’s financial results for the first quarter of 2019. For investor inquiries, contact Aratana directly.

On May 8, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2019 (Press release, VolitionRX, MAY 8, 2019, View Source [SID1234535967]). Volition management will host a conference call tomorrow, May 9, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results, commented, "I could not be more proud of our dedicated team at Volition, and the ground-breaking work they are doing. During the first quarter, we, together with our collaborators, have made significant progress, particularly with the work on the basics of our Nu.QTM platform and its expansion into exciting new areas."

Mr. Reynolds further commented "We were very happy to report the initial data from the first of our product grade assays during this first quarter. We aim to strengthen our product pipeline beyond colorectal cancer to cover several cancers, most notably in lung cancer, and so are especially delighted to have executed an agreement with the National Taiwan University to conduct our first large-scale study in lung cancer. I am also delighted to announce that we are in the process of forming a Texas-based subsidiary to focus on the development and commercialization of our Nu.Q Vet products and help drive early revenue."

Additionally, Mr. Reynolds added "During the first quarter 2019, we further strengthened our balance sheet with existing investors exercising $6.7 million in aggregate amount of outstanding warrants to purchase shares of our common stock and end the quarter with cash and cash equivalents of $16.2 million. Subsequent to the ending of the quarter, a further $5 million in warrants were exercised for cash, making a total of $11.7 million in warrants exercised this year."

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2019 totaled $16.2 million compared to $13.4 million as of the end of 2018.
An additional $5 million in aggregate exercise price of warrants (at $3 per share of common stock) were exercised subsequent to the quarter-end, leaving approximately $4.9 million in aggregate exercise price of warrants (at $3 per share of common stock) outstanding with an expiration date of August 10, 2019.
Continue to manage cash carefully with a cash burn of $3.9 million in the first quarter of 2019.
Intellectual Property

Achieved steady growth in worldwide patent portfolio. This is a key differentiator versus many other technologies either under development or available on the market, where the patent position maybe poor and/or narrow.
– 20 patent families related to our diagnostic tests (including both human and veterinary medicine applications).
– 7 patents granted in the United States.
– 7 patents granted in the European Union.
– 25 further patents granted worldwide.
– 106 patents pending worldwide.
Proof of Concept Data

Tested our optimized product grade assays in three separate small-scale proof of concept cohorts and plan to move onto the larger clinical trial cohorts that are either in our freezer or the collection of which is underway. The preliminary results from our initial optimized product grade assays are as follows:
– In a colorectal cancer cohort (123 subjects), a single Nu.Q assay detected colorectal cancer with an Area Under the Curve (AUC) of 72% while a two-assay panel had an AUC of 84%, cancer versus healthy.
– In a lung cancer cohort (76 subjects), a single Nu.Q assay detected lung cancer, including stage I lung cancer. The AUC for this single assay was 85%, cancer versus healthy.
– In a second confirmatory lung cancer cohort (152 subjects), the same single Nu.Q assay also detected lung cancer with an AUC of 79%, cancer versus healthy.
The above proof of concept results give us confidence to move onto potentially dozens of other assays that we have under development and the large range of cohorts and trials we have collected and planned.

Presented encouraging preliminary results using our Nu.Q platform in veterinary medicine. Executed a non-binding Memorandum of Understanding with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet. Volition is in the process of establishing a Texas-based subsidiary to drive the development and commercialization of Nu.Q Vet products and help generate early revenue.
Developed Nu.Q Capture, which investigates the use of NucleosomicsTM to purify or enrich tumor associated nucleosomes. Initial studies have demonstrated that Nu.Q Capture has been able to deplete/enrich nucleosomes by 70-90% using magnetic beads in serum and plasma. This is a still a work in progress, but it is a great first step and one that excites our scientific team.
Clinical Trials

Added to our extensive clinical trial program with the execution of a contract to conduct our first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study will be conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans, including 1,000 with lung cancer.
Executed a non-binding Memorandum of Understanding with Shanghai Fosun Long March Medical Science Co., Ltd. with the shared intention to enter into a binding agreement and to conduct three small-scale clinical trials in China. One of the trials is in lung cancer, and the others are in colorectal cancer and ovarian cancer, with preliminary data expected in 2019.
Upcoming Milestones

We expect to achieve the following milestones during 2019 and beyond:

Advance our previously announced large-scale colorectal cancer trials in Europe, the U.S. and Asia.
Advance the clinical trial program for Lung Cancer, focusing initially on the significant need in Asia, most notably in China.
Through our to be formed Texas-based subsidiary, determine and announce the route to revenue for Nu.Q Vet with the aim of having a USDA-approved product in 2020.
Announce the results of multiple proof of concept cancer studies to include prostate, pancreatic and ovarian, in addition to our 27-cancer study, and to initiate larger studies.
Announce preliminary results of Nu.Q’s performance in other disease conditions, including endometriosis.
Advance the development of Nu.Q Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and sequencing.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected].

VolitionRx Limited First Quarter 2019 Earnings and Business Update Conference Call

Date: Thursday, May 9, 2019
Time: 8:30 a.m. U.S. Eastern time
U.S. & Canada Dial-in: 1-855-327-6837 (toll free)
U.K. Dial-in: 0 808-101-2791 (toll free)
Toll/International: 1-631-891-4304
Conference ID: 10006803
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the first quarter of 2019, and milestones for 2019 and beyond.