On May 11, 2018 Paul Changelian, Ph.D., Vice President, Biology, Aclaris Therapeutics, Inc. (NASDAQ:ACRS), reported that it will speak at the 2018 American Hair Research Summit on "Preclinical to Clinical Translation of JAK Kinase Inhibitors" on May 15 (Press release, Aclaris Therapeutics, MAY 11, 2018, View Source [SID1234526536]). The meeting is organized by the American Hair Research Society (AHRS) and will take place May 14-16 in Orlando, Florida.

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Dr. Changelian will review the history of drug discovery targeting Janus kinase (JAK) enzymes. JAK inhibitors initially were conceived as drugs to reduce organ transplant rejection but gradually were found to have utility in autoimmune diseases and oncology. Harnessing the benefits of JAK inhibition for dermatological conditions will require minimizing the potential for over suppression of the immune system and subsequent infections, through strategies such as identifying molecules highly selective for JAK1 and JAK3 inhibition or developing topical formulations with high skin permeability while minimizing systemic absorption. Current efforts to expand the range of diseases that could be targeted with JAK inhibitors will be discussed with emphasis on hair disorders, including alopecia areata and androgenetic alopecia.

Dr. Changelian is known for his key role in the discovery and development of tofacitinib, a pan-JAK inhibitor, while working as a scientist at Pfizer. In 1993, he first heard about the National Institutes of Health’s discovery of an enzyme in the Janus family of kinases involving the immune function. Seven years after initiating the discovery program, Dr. Changelian and the Pfizer immunology team selected tofacitinib for clinical development. Tofacitinib became the first JAK inhibitor approved by the FDA for an autoimmune disease. Dr. Changelian joined Aclaris in 2017 when Aclaris acquired Confluence Life Sciences, Inc., a company founded by former Pfizer scientists.

On May 11, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results and a business update for the first quarter ended March 31, 2018 (Press release, Adamis Pharmaceuticals, MAY 11, 2018, View Source [SID1234526537]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, said, "We have made a substantial amount of progress on several fronts since the beginning of the year. The development of our product pipeline continues to move forward and we have several target milestones that we hope to reach later this year. We believe the completion of these milestones will increase shareholder value. As for our progress on Symjepi , we continue to be pleased with developments regarding our discussions with potential commercialization partners. We believe that we are closer to concluding the process of naming our licensing partner and we remain focused on bringing this product to market."

Company Highlights and Product Updates

Some of the company’s product updates and accomplishments since the beginning of 2018 include the following:

Symjepi (epinephrine) Injection 0.15mg – The FDA determined that the company’s NDA for Symjepi (epinephrine) Injection 0.15mg was sufficiently complete to permit a substantive review and indicated that no potential review issues were identified as of the date of the agency’s communication in February. Approval is expected in the second half of this year.

Symjepi human factors data – Adamis presented human factors data for Symjepi at the American Academy of Allergy Asthma and Immunology joint congress with the World Allergy Organization, and another human factors study was published in the Annals of Allergy, Asthma and Immunology.

APC-1000 (Beclomethasone HFA) – Our product candidate received approval from the FDA to proceed with Phase 3 clinical studies. We continue to make progress in this area.

APC-6000 (Naloxone PFS) – We are working toward filing a New Drug Application (NDA) later this year and have completed pharmacokinetic (PK) studies.

Sales of several products sold by our U.S. Compounding, Inc. subsidiary have been increasing including Adamis’ unique compound to manage ulcers in horses. One horse that was receiving U.S. Compounding’s product recently came in first in the 2018 Kentucky Derby.

Second Quarter Financial Results

Revenues were approximately $3.2 million and $3.0 million for the three months ended March 31, 2018 and 2017, respectively. The increase in revenues (4.6%) for the three months ended March 31, 2018 compared to the comparable period of 2017 reflected an increase in the volume of sales of USC’s compounded pharmaceutical formulations resulting in part from increased sales and marketing personnel and efforts. The company’s revenues for the first quarter of 2018 increased approximately 11.9% compared to the revenues for the fourth quarter of 2017.

At March 31, 2018, the Company had cash and cash equivalents of $10.1 million. Net cash used in operating activities for the three months ended March 31, 2018 and 2017, was approximately $7.9 million and $3.5 million, respectively. Net cash used in operating activities increased primarily due to the increase in operating losses; increase in accounts receivable, inventories and prepaid expenses; and a decrease in accounts payable and accrued expenses as compared to 2017.

Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2018 and 2017 were approximately $6.5 million and $5.6 million, respectively. The increase in SG&A expenses was primarily due to new hires, compensation and stock option expenses, increases in accounting, audit and other professional fees, patent expenses, selling expenses and market research expenses related to Symjepi (epinephrine) and our APC-6000 product candidate.

Research and development expenses were approximately $2.2 million and $1.5 million for the three months ended March 31, 2018 and 2017, respectively. The increase in research and development expenses for the three months ended March 31, 2018, compared to the comparable period of the prior year was due in part to an increase in development costs of our product candidates and compensation and stock option expenses, in part due to new hires.

Net loss for the first quarter of 2018 was approximately $7.6 million, compared to net loss of approximately $5.8 million for the same period in 2017.

Future Milestones

Some of the company’s goals for the 2018 year include the following:

Finalizing and announcing the commercialization strategy for Symjepi (epinephrine) Injection 0.3mg;

FDA approval for Symjepi TM (epinephrine) Injection 0.15mg;

Initiate pivotal Phase 3 studies of APC-1000 in asthmatics;

Complete a "proof of concept" study with dry powder inhaler platform using fluticasone;

Filing an NDA for Naloxone injection;

Increase sales of compounded medications from our U.S. Compounding, Inc. subsidiary by at least 30%.

On May 10, 2018 Athersys, Inc. (NASDAQ:ATHX) reported its financial results for the three months ended March 31, 2018 (Press release, Athersys, MAY 10, 2018, View Source [SID1234526466]).

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Highlights of the first quarter of 2018 and recent events include:

Completed a $21.1 million equity investment and announced plans to expand the HEALIOS K.K. ("Healios") collaboration by June 1, 2018. This proposed expansion includes a $10 million license fee funded in an escrow account and a potential additional $25 million of committed payments over time, as well as additional possible payments including milestones and royalties, if the collaboration is fully expanded in accordance with the letter of intent disclosed in March 2018;
Advanced our preparations for the MASTERS-2 Phase 3 registration study for ischemic stroke to enable initiation of this important study and supported the continued enrollment of Healios’ TREASURE study;
Progressed Phase 1/2 study evaluating MultiStem therapy in acute respiratory distress syndrome (ARDS) patients;
Announced plans with The University of Texas Health Science Center at Houston to conduct a Phase 2 clinical trial evaluating MultiStem cell therapy for early treatment and prevention of complications after severe traumatic injury;
Established a new equity facility with Aspire Capital Fund LLC, as a follow-on to a prior facility, providing the Company with access to additional capital as needed to support its ongoing operations;
Recognized revenues of $1.1 million for the quarter ended March 31, 2018 and a net loss of $10.2 million, or $(0.08) per share; and
Ended the 2018 first quarter with $49.7 million of cash and cash equivalents, excluding the $10 million in escrow from Healios related to the proposed collaboration expansion.
"We finished the first quarter in a strong financial position, with approximately $50 million on the balance sheet and look forward to building on that as we work to complete the expansion of our partnership with Healios," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "As we and Healios recently disclosed, we have extended the timeline to complete the agreements to expand our collaboration until the end of May, and we are working together to achieve that goal.

"We are also focused on preparing for the upcoming initiation of our MASTERS-2 trial, while we continue to support the ongoing TREASURE trial in Japan," added Dr. Van Bokkelen. "In addition, we have been advancing our other clinical programs and broadening our portfolio of new opportunities, as evidenced by the recent announcement related to a clinical study in trauma. This represents another significant area of unmet clinical need that we are now well-positioned to pursue with funding support from the Medical Technology Enterprise Consortium and our collaborator, UTHealth," concluded Dr. Van Bokkelen.

First Quarter Results

Revenues decreased to $1.1 million for the three months ended March 31, 2018 compared to $1.5 million for the three months ended March 31, 2017 . Our revenues are comprised of revenue from manufacturing-related activities for Healios, royalty and related contract revenue from our collaboration with RTI Surgical, Inc. and grant revenue. Our revenue from Healios increased during the first quarter of 2018 compared to the prior year first quarter by approximately $0.3 million as we continue to supply clinical product to Healios and provide other manufacturing-related services, and we expect these revenues will be higher for the 2018 annual period as compared to the 2017 year. Regarding our royalty revenue, excluding a $1.0 million milestone payment from RTI in the 2017 first quarter, royalty revenues increased by approximately $0.2 million in the first quarter of 2018 as a result of an increase in the royalty rate that became effective late 2017 associated with our technology license to RTI. Grant revenue varies from period-to-period with new and completed grants, and the timing of grant-funded activities. Absent new grant awards, we expect our annual grant revenue to decline in 2018 from 2017 with the expiration of certain grant-funded programs.

Research and development expenses increased to $8.9 million for the three months ended March 31, 2018 from $5.6 million in the comparable period in 2017. The $3.3 million increase is primarily comprised of an increase in preclinical and clinical development costs of $2.7 million, an increase in personnel costs of $0.3 million, and an increase in internal research supplies and other research costs of $0.3 million. The increase in our clinical and preclinical costs is primarily a result of increased process development activities to support large-scale manufacturing and clinical product manufacturing costs during the period.

General and administrative expenses increased to $2.7 million for the three months ended March 31, 2018 from $2.1 million in the comparable period in 2017. The $0.6 million increase was due primarily to an increase of $0.3 million in professional fees and increases in personnel costs, stock-based compensation costs and other administrative costs compared to the same period last year.

Net loss was $10.2 million in 2018 compared to $5.6 million in 2017. The difference of $4.6 million reflects the above variances, as well as $0.4 million in insurance proceeds that we received this quarter, which were offset by a $0.7 million non-cash gain related to the fair value of our warrant liabilities recorded in the first quarter of 2017 for warrants that expired in 2017. The warrant issued in March 2018 to Healios in connection with its equity investment was treated as equity with its value recorded as additional paid-in capital with an offset in other current assets.

Net cash used in operating activities was $5.7 million for the three months ended March 31, 2018 and $5.4 million for the three months ended March 31, 2017, reflecting the increased net loss in the first quarter of 2018 (i.e., cash used to fund preclinical and clinical development activities) compared to the prior year period, as offset in part by proceeds received from Healios for our cost-share arrangement for clinical product supply and an increase in accounts payable due to service providers, such as contract manufacturers, under longer-term contracts. As of March 31, 2018, we had $49.7 million in cash and cash equivalents, compared to $29.3 million at December 31, 2017, which includes, among other things, the investment made by Healios in March 2018 and excludes the $10 million that Healios has funded into an escrow account to be released to us upon execution of the expansion agreements.

Conference Call

Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (BJ) Lehmann, President and Chief Operating Officer, will host a conference call today to review the results as follows:

Date Thursday, May 10, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 1189915
Live webcast www.athersys.com, under the Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on May 24, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 1189915.

About MultiStem

MultiStem cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in clinical studies, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

On May 10, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the first quarter ended March 31, 2018 (Press release, IntelGenx, MAY 10, 2018, View Source [SID1234526484]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 First Quarter Financial Highlights:

Total revenue was $239,000, which reflected decreases in deferred and upfront revenues of $922,000 and 408,000, respectively.
Adjusted EBITDA was ($1.8 million), compared to adjusted EBITDA of ($117,000) in the same period last year.
Cash and short-term investments totalled $2.4 million as at March 31, 2018, which did not include gross proceeds of $3.2 million raised by the Company in its May 2018 unit offering.
Recent Developments:

Presented overviews of the Company’s business at the 10th Annual Biotech Showcase in January 2018 and at the Bloom Burton & Co. Healthcare Investor Conference in May 2018.
Initiated Phase 2a proof of concept Montelukast VersaFilm clinical trial in Alzheimer’s patients, following clearance of the Clinical Trial Application by Health Canada. IntelGenx retained the services of Cogstate and JSS Medical Research as the Contract Research Organizations to support the Montelukast VersaFilm study. Patient screening is expected to begin in Q2 2018.
"With the completion of the private placement offering earlier this week, we now have sufficient financial resources to support our Montelukast Phase 2a clinical trial and to continue advancing the rest of our product pipeline toward commercialization," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx.

Financial Results:

Total revenues for the three-month period ended March 31, 2018 amounted to $239,000, compared to $1.4 million for the three-month period ended March 31, 2017. The decrease for the three-month period ended March 31, 2018 compared to the last year’s corresponding period is mainly attributable to a decrease in deferred revenues on monetization of $922,000 and a decrease in upfront revenues of $408,000, partially offset by an increase in Research and Development revenues of $218,000.

Operating costs and expenses were $2.3 million for the first quarter ended March 31, 2018, versus $1.8 million for the corresponding quarter in 2017. The increase for the three-month period ended March 31, 2018 is mainly attributable to a $153,000 increase in Research and Development expenses and a $376,000 increase in mostly non-recurring Selling, General and Administrative expenses.

For the first quarter ended March 31, 2018, the Company had an operating loss of $2.0 million, compared to an operating loss of $457,000 for the comparable period of 2017.

Net comprehensive loss was $2.3 million, or $0.03 on a basic and diluted per share basis, for the three-month period ended March 31, 2018, compared to a net comprehensive loss of $468,000, or $0.01 on a basic and diluted per share basis, for the comparable period of 2017.

As of March 31, 2018, the Company’s cash and short-term investments totalled $2.4 million, which did not include gross proceeds of $3.2 million raised in its May 2018 unit offering.

Conference Call Details:

IntelGenx will host a conference call to discuss its first quarter 2018 financial results today, May 10, 2018, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269. The call will be webcast live and archived for twelve months at www.intelgenx.com

On May 10, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming UBS Global Healthcare Conference taking place May 21-23, 2018 in New York, NY, USA (Press release, Zymeworks, MAY 10, 2018, View Source [SID1234526500]).

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The Company will present on Monday, May 21, 2018 at 2:00 p.m. ET. Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.