On March 12, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the third quarter of fiscal year (FY) 2018 ended January 31, 2018, and provided an update on its contract manufacturing operations, and other corporate highlights (Press release, Avid Bioservices, MAR 12, 2018, View Source [SID1234524669]).

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Highlights Since October 31, 2017

"During and subsequent to our third quarter of fiscal year 2018, Avid completed two primary objectives. We successfully divested the company’s lead immuno-oncology assets to an organization with the financial resources and expertise to advance them, and we established a new operational structure that will allow our business to take full advantage of the substantial and growing demand for biologics manufacturing," said Roger Lias, Ph.D., president and chief executive officer of Avid Bioservices. "With the divestiture of our lead R&D assets, our transition to a dedicated CDMO business is complete, and our team is entirely focused on expanding and diversifying our customer base, as well as strengthening our process development capabilities. At present, we are in late-stage negotiations with several potential new customers and expect to announce the executed agreements before the end of the fiscal year. In recent weeks, we also completed a financing raising $23.2 million in gross proceeds. These funds are essential as they will support our operations, including upgrading our process development capabilities to ensure that we are fully capable of servicing our customers with the highest quality standards and equipment. We made rapid progress during the third quarter that we believe will allow us to build backlog and achieve sustainable growth in the future."

Recent CDMO Developments

Advanced eight current clients, some with multiple projects, through various stages of development.

Selected by Acumen Pharmaceuticals, Inc. to provide process development and clinical manufacturing services in support of ACU193, which is being developed for the treatment of Alzheimer’s disease.
° Avid and Acumen will immediately commence process development work with the goal of creating a robust, cost-effective and scalable process to support cGMP manufacture of ACU193.
Recent Corporate Developments and Financial Highlights

Changed company name from Peregrine Pharmaceuticals, Inc. to Avid Bioservices, Inc.
° As the Avid name is recognized in the industry for CDMO excellence and biologics manufacturing expertise, the brand is an important asset in the company’s transition to a dedicated CDMO business. The company also adopted the new NASDAQ ticker symbol, "CDMO" (NASDAQ:CDMO).

Reconstituted board of directors including six independent directors, all with significant CDMO experience.

Entered into an Asset Assignment and Purchase Agreement with Oncologie, Inc. for Avid’s phosphatidylserine (PS)-targeting program including bavituximab.
° Avid expects to receive an aggregate of $8.0 million in upfront payments over a period of six months and will be eligible to receive up to $95.0 million in development, regulatory and commercialization milestones.
° Oncologie, Inc. will be responsible for all future research, development and commercialization of bavituximab, and related intellectual property costs.
° Avid will receive royalties on net sales that are upward tiering into the mid-teens.
° Oncologie will enter into an agreement with Avid for future contract development and manufacturing activities in support of bavituximab.

Completed a public offering of 10,294,445 shares of common stock raising gross proceeds of approximately $23.2 million.
° Avid intends to use the net proceeds from the offering to support the growth of its contract manufacturing business and general corporate purposes.

The company maintains its manufacturing revenue guidance for the full FY 2018 of $50.0 million – $55.0 million.

The current manufacturing revenue backlog has increased to $39 million.

Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services was $6.8 million for the third quarter of FY 2018 compared to $10.7 million for the third quarter of FY 2017. The decline was primarily due to lower demand from one of our largest customers.

Cost of contract manufacturing increased to $11.0 million in the third quarter of FY 2018 compared to $8.0 million for the third quarter of FY 2017. The current period increase in cost of manufacturing is primarily attributed to idle capacity costs of $5.3 million due to lower facility and personnel utilization compared to no idle capacity costs reported in the same prior year quarter.

Selling, general and administrative expenses for the third quarter of FY 2018 were $4.8 million, compared to $4.4 million for the third quarter of FY 2017. The current period increase in costs was primarily due to legal and other related fees associated with the settlement agreement with certain investors regarding the composition of the company’s board of directors and legal and advisory fees associated with the Asset Assignment and Purchase Agreement with Oncologie, Inc.

As of January 31, 2018, the company’s research and development segment met all the conditions to be classified as a discontinued operation. Accordingly, the operating results of our research and development segment are reported as a loss from discontinued operations for all periods presented.

Avid’s consolidated net loss attributable to common stockholders was $12.4 million or $0.28 per share, for the third quarter of FY 2018, compared to a net loss attributable to common stockholders of $9.2 million, or $0.25 per share, for the same prior year quarter.

Avid reported $17.9 million in cash and cash equivalents as of January 31, 2018, compared to $46.8 million at fiscal year ended April 30, 2017. Following the completion of a public offering during February 2018, the company had cash and cash equivalents of $41.7 million as of February 28, 2018.
More detailed financial information and analysis may be found in Avid’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call

Avid will host a conference call and webcast this afternoon, March 12, 2018, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With nearly 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid’s services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information, please visit www.avidbio.com.

Forward-Looking Statements
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk the company may experience delays in engaging new clients, the risk that the company may experience technical difficulties in processing customer orders which could delay delivery of products to customers, revenue recognition and receipt of payment or the loss of the customer, the risk that one or more existing customers terminates its contract prior to completion or reduces or delays its demand for development or manufacturing services, the risk that the company may need to use the majority of its cash to fund operations, thereby delaying the contemplated upgrade to its process development capabilities and expansion plans, and the risk that the company may not receive the full $8 million up front payment from Oncologie. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.

On March 12, 2018 Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that it will hold a conference call on Wednesday, March 14, 2018 at 1:30 PM Pacific Time (4:30 PM Eastern Time) to discuss fourth quarter 2017 year-end financial results and provide a corporate update (Press release, Arbutus Biopharma, MAR 12, 2018, View Source [SID1234524668]).

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To access the conference call, a live webcast of the call can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. Or, alternatively, to access the conference call, please dial 1-914-495-8556 or 1-866-393-1607.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 8777644.

On March 12, 2018 -Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that financial results for the three months ended January 31, 2018 and provides a business update (Press release, Advaxis, MAR 12, 2018, View Source [SID1234524666]).

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Recent Key Accomplishments Include:

Conditional Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) for the company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (PRmCC);
Acceptance of data for publication from a Phase 2 clinical study of axalimogene filolisbac as a treatment for PRmCC in the peer-reviewed International Journal of Gynecological Cancer;
Three abstracts highlighting the company’s Listeria-based immunotherapy in combination with antibody-based immunotherapies have been accepted for poster presentation at the upcoming 2018 Keystone Symposia on Cancer Immunotherapies: Combinations (C5);
Publication of data from an investigator-initiated study of axalimogene filolisbac in combination with chemoradiation as a treatment for high-risk, locally advanced anal cancer in the International Journal of Radiation Oncology; and
$20.0 million in gross proceeds raised in a public offering of common stock.
Clinical Hold

In the evening of March 9, 2018, the company received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its Phase 1/2 combination study of axalimogene filolisbac with IMFINZI (durvalumab) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer was placed on clinical hold. The clinical hold pertains to a recent submission of a safety report to the FDA regarding a Grade 5 Serious Adverse Event (patient death) on February 27, 2018 involving respiratory failure which occurred following the sixth combination cycle in the trial. Enrollment and further dosing are on hold in this trial while the company, its partner and the FDA work closely with the site investigator to review this event in detail and to resolve this clinical hold.

Enrollment and dosing in all other Advaxis clinical programs are unaffected at this time.

"We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers. We believe in the potential of our Lm Technology to provide new advancements in the area of cancer care," stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. "We are confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers."

Management Commentary

"We are pleased with the progress we made during the quarter across a number of important areas. In particular, we were delighted to file the MAA with the EMA for conditional approval of axalimogene filolisbac for the treatment of metastatic cervical cancer, a condition that causes approximately 24,000 deaths annually in Europe," stated Mr. Lombardo. "This is a significant milestone for Advaxis as it is our first marketing application for an Lm Technology product."

"Throughout the first quarter, we continued to advance our clinical programs and were pleased to announce the publication and presentation of data in support of the potential of our Lm-based antigen delivery platform to treat a variety of cancers in peer-reviewed journals and at premier medical and scientific meetings.

"Our goals for 2018 remain steadfast as we execute our plans to advance our robust clinical development programs across our four franchises: HPV-associated cancers, neoantigen therapy, hotspot/ cancer antigens and prostate cancer. Over the coming months, we expect to make meaningful progress with these programs and to achieve a number of important value-creating milestones," Mr. Lombardo concluded.

Balance Sheet Highlights

As of January 31, 2018, Advaxis had cash, cash equivalents and investments of $59.4 million, which included $4.5 million related to its previously announced participation in the New Jersey NOL program and the receipt of $2.7 million in connection with its controlled equity offering sales agreement. The company used approximately $12.7 million in cash to fund operations during the first quarter of fiscal year 2018, mainly attributed to funding strategic development programs and related personnel and infrastructure to support the company’s progress and growth.

Following the close of the first quarter, Advaxis completed an underwritten public offering of 10,000,000 shares of common stock at $2.00 per share for gross proceeds of $20.0 million before deducting the underwriting discounts and commissions and other estimated offering expenses.

Throughout fiscal year 2018, Advaxis plans to continue to invest in its core clinical programs and expects its current cash position will be sufficient to fund its business plan into the second calendar quarter of 2019.

Financial Highlights for First Quarter Fiscal Year 2018

The net loss for the first quarter ended January 31, 2018 was $20.5 million or $0.49 per share based on 41.4 million shares outstanding. This compares with a net loss for the first quarter of fiscal year 2017 of $17.1 million or $0.43 per share based on 40.1 million shares outstanding.

Research and development expenses for the first quarter of fiscal year 2018 were $17.1 million, compared with $13.6 million for the first quarter of fiscal year 2016. The increase was primarily due to continued investment in support of the company’s preclinical and clinical development programs, including support of the AIM2CERV Phase 3 clinical trial and costs associated with the MAA filing, which are now expected to wind down, post-submission. The increase also reflects higher headcount versus the first quarter of fiscal 2017, to support research and development initiatives primarily for the neoantigen franchises.

General and administrative expenses for the first quarter of fiscal year 2018 were $5.5 million, compared with $7.3 million for the fiscal year 2017 first quarter. The decrease was largely attributable to non-cash stock-based compensation expense in the prior-year quarter.

Conference Call and Webcast Information

Advaxis’ senior management will host a conference call to review financial results, provide a business update and answer questions. The conference call and live audio webcast will begin today at 4:30 p.m. Eastern time.

To access the conference call please dial (844) 348-6133 (domestic) or (631) 485-4564 (international) and refer to conference ID 2588455. A live and archived audio webcast of the call will be available on the company’s website at ir.advaxis.com/events-presentations.

For those unable to participate in the live conference call or webcast, a recording will be available beginning two hours after the call ends. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide conference ID 2588455.

On March 12, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology, and immunology, reported financial results for the fourth quarter and year ended December 31, 2017 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, MAR 12, 2018, View Source [SID1234524665]).

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"2017 was a defining year in Aclaris’ history, with the FDA approval of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), the first and only FDA-approved topical, non-invasive treatment of raised seborrheic keratosis (SK). We have generated a high level of excitement around ESKATA in the dermatology community, and look forward to our official launch in the second quarter of 2018," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "In January 2018, we announced positive topline results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris). We also advanced our topical Janus kinase (JAK) inhibitor programs in alopecia, with results from multiple Phase 2 trials expected later this year. As our early-stage pipeline compounds advance towards the clinic, we continue to progress towards our goal of becoming a vertically integrated, commercial-stage biopharmaceutical company with a robust clinical-stage pipeline and drug discovery engine."

Clinical Pipeline Update

A-101 45% Topical Solution

In January 2018, reported positive results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45%, an investigational new drug for the treatment of common warts. A-101 45% met all primary, secondary, and exploratory endpoints of each trial analyzed to date, achieving clinically and statistically significant clearance of common warts.

Scheduled an End of Phase 2 meeting with the FDA for mid-2018, and plan to initiate two pivotal Phase 3 trials in the second half of 2018.

JAK Inhibitor

AA-202 Topical – an ongoing Phase 2 clinical trial of ATI-502 (formerly ATI-50002) for the topical treatment of alopecia areata (AA). This trial will evaluate the pharmacokinetics,

pharmacodynamics and safety of ATI-502 compared with placebo in 12 patients with AA. This randomized, double-blind clinical trial is being conducted at two investigational centers within the United States, and topline data are expected in the first half of 2018. After completing the 28-day portion of the trial, patients will then enter a 6-month open label extension during which all patients will receive drug.

AUATB-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of ATI-502 on the regrowth of eyebrows in up to 24 patients with AA. This trial is being conducted at two investigational centers in Sydney and Melbourne, Australia, and topline qualitative data are expected mid-2018.

AA-201 Topical – an ongoing Phase 2 dose ranging trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of two concentrations of ATI-502 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in up to 120 patients with AA. This trial is being conducted at 25 investigational centers within the United States and data are expected by year end 2018.

VITI-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the effect of ATI-502 on the repigmentation of facial skin in up to 24 patients with vitiligo and data are expected in the first half of 2019.

AGA-201 Topical – a planned Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetalopecia (AGA), also known as male/female pattern hair loss, which is anticipated to begin in the first half of this year. This trial will evaluate the effect of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in first half of 2019.

AUAT-201 Oral – a planned Phase 2 dose ranging trial of ATI-501 (formerly ATI-50001), an oral JAK inhibitor, for the treatment of AA which is anticipated to begin in the first half of 2018. Data are expected in mid-2019.

ATI-450

Recently presented data from pre-clinical studies of ATI-450 (formerly known as CDD-450), a selective inhibitor of the MK2 pathway, at a symposium at the American College of Rheumatology annual meeting on November 7, 2017. The abstract summarizing the data is titled "NOMID-Associated Complications in Mice Are Prevented By CDD-450, a Small Molecule Inhibitor of the Mitogen-Activated Protein Kinase-Activated Protein Kinase 2 (MK2) Pathway."

Investigational New Drug application on track for submission to the FDA in mid-2019.

Commercial Update

Expanded commercial organization to 70 people in support of a successful ESKATA launch.

Established Aclaris Market Research, Sales, Trade, Training, and Sales Operations teams.

Successfully onboarded and trained Aclaris sales force consisting of 50 Field Sales Specialists, 2 Inside Sales Representatives, 6 Regional Sales Managers, and 1 Sales Director
.
Conducted market research with over 2,500 patients and 1,400 HCPs to date.

Developed comprehensive HCP and consumer campaigns to support a successful ESKATA launch.

Finalized ESKATA pricing and positioning.

Established ESKATA speaker bureau consisting of dermatologist and NP/PA speakers.

Aclaris present at 30 key dermatology meetings in 2017.

Generated a high level of corporate awareness with the goal to position Aclaris as a leading innovative biopharmaceutical company in dermatology.
Raised awareness regarding SK disease state awareness and patient willingness to pay for SK removal.

Strong presence at 2018 Winter AAD in San Diego; Generated a high level of ESKATA awareness.
Sales force currently implementing key market readiness activities, including:

Establishing ESKATA Centers of Excellence.

Implementation of ESKATA Early Experience Initiative.

National Sales Meeting scheduled for the second quarter of 2018, followed by official ESKATA launch.

Recent Corporate Highlights

Promoted Brett Fair to Chief Commercial Officer

Continued to build our research and development and commercial infrastructure.

The United States Patent and Trademark Office recently issued U.S. Patent No. 9,895,301, which is directed to methods related to the use and administration of a certain JAK inhibitor for treating hair loss disorders.U.S. Patent No. 9,895,301 covers the use of tofacitinib for inducing hair growth and for treating hair loss disorders such as alopecia areata and AGA. Additional issued claims pertain to methods of using tofacitinib to treat particular phenotypes of alopecia areata, as well as to treat other hair loss disorders. The ‘301 Patent contains 67 claims and expires in November 2031.

This newly allowed patent is owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris and is the latest U.S. patent to issue in connection with Aclaris’ JAK drug development program for hair loss disorders.

Recently added to the NASDAQ Biotechnology Index (NASDAQ: NBI).

Financial Highlights

Liquidity and Capital Resources

As of December 31, 2017, Aclaris had aggregate cash, cash equivalents and marketable securities of $208.9 million compared to $174.1 million as of December 31, 2016. The $34.8 million increase during the year ended December 31, 2017 included:

Aggregate net proceeds of $100.2 million from the sale of common stock under an at-the-market facility with Cowen and Company LLC in April 2017 and a follow-on public offering of common stock in August 2017.

$9.6 million of cash used to acquire Confluence in August 2017, net of cash acquired.

$1.2 million of purchases of property and equipment.

Net loss of $68.5 million, offset by $0.9 million of net cash provided by working capital and $14.8 million of non-cash stock-based compensation expense, depreciation and amortization.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2017 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.

Fourth Quarter 2017 Financial Results

Net loss was $22.9 million for the fourth quarter of 2017, compared to $11.5 million for the fourth quarter of 2016. Upon new tax legislation passed in December 2017, Aclaris recognized an income tax benefit of $1.8 million related to the reversal of the deferred tax liability associated with the In-Process Research and Development recognized in the Confluence acquisition earlier this year.

Revenue of $1 million and cost of revenue of $0.8 million for the fourth quarter of 2017 related to our contract research business acquired in August 2017.

Total operating expenses for the fourth quarter of 2017 were $25.7 million, compared to $11.6 million for the fourth quarter of 2016.

Research and development expenses were $13.2 million for the fourth quarter of 2017, compared to $6.9 million for the fourth quarter of 2016. The increase of $6.3 million was primarily attributable to a $2.3 million increase in expenses related to the WART-202 and WART-203 trials, a $1.5 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount, a $2 million increase in preclinical and clinical trial development expenses related to the JAK inhibitor portfolio and a $1.5 million increase in Medical Affairs expenses and other costs, including early stage drug discovery. This increase was partially offset by a $1.3 million decrease due to the completion of our ESKATA Phase 3 clinical trials and the submission preparation of the NDA for ESKATA in November 2016.

General and administrative expenses were $12.5 million for the fourth quarter of 2017, compared to $4.7 million for the fourth quarter of 2016. The increase of $7.8 million was primarily attributable to $2.9 million in higher personnel-related expenses, including stock-based compensation, due to increased headcount, and a $1 million increase related to relocating our corporate headquarters and administrative costs related to our St. Louis, Missouri operations acquired in August 2017. Additionally, Aclaris incurred a $3.3 million increase in market research and sales operations expenses related to pre-commercial activities for ESKATA.

Full Year 2017 Financial Results

Net loss was $68.5 million for the year ended December 31, 2017, compared to $48.1 million for the year ended December 31, 2016.

Revenue of $1.7 million and cost of revenue of $1.2 million for the year ended December 31, 2017 related to the contract research business acquired in August 2017.

Total operating expenses were $72.9 million for the year ended December 31, 2017, compared to $48.6 million for the year ended December 31, 2016. Net cash used in operating activities was $54.7 million, compared to $34.6 million for the year ended December 31, 2016.

Research and development expenses were $39.8 million for the year ended December 31, 2017, compared to $33.5 million for the year ended December 31, 2016. The increase of $6.3 million was due to higher payroll-related expenses of $5.6 million due to increased headcount, including stock-based compensation expense, an increase of $4.5 million in preclinical and clinical trial development expenses related to our JAK inhibitor portfolio, an increase of $3.4 million in expenses related to the WART-202 and WART-203 trials, and a $3.6 million increase in medical affairs and early stage drug discovery activities. The increases noted above were partially offset by a $7.7 million decrease related to our ESKATA Phase 3 clinical trials costs, which were completed in November 2016, and $3.4 million in costs incurred with the acquisition of Vixen Pharmaceuticals, Inc. in the year ended December 31, 2016.

General and administrative expenses were $33.1 million for the year ended December 31, 2017, compared to $15.1 million for the year ended December 31, 2016. The increase of $18million was primarily attributable to an increase of $9.3 million in payroll-related expenses due to increased headcount, including stock-based compensation expense, an increase of $6.1 million in pre-commercial launch activities for ESKATA, a $1.3 million increase in facilities-related costs, and a $1.3 million increase in other professional fees. As of December 31, 2017, Aclaris had approximately 30.8 million shares of common stock outstanding.

2018 Financial Outlook

Aclaris expects 2018 GAAP research and development (R&D) expenses to be in the range of $67 to $75 million, which, when excluding estimated stock-based compensation of $9 million, results in 2018 non-GAAP R&D expense of $59 to $67 million. The anticipated increase in R&D expenses in 2018 is mainly due to the planned execution of Phase 2 clinical trials in AA, AGA, and vitiligo, two planned pivotal Phase 3 trials in common warts, and development of our early stage pipeline compounds.

Aclaris expects 2018 GAAP selling, general and administrative (SG&A) expenses to be in the range of $80 to $86 million, which, when excluding estimated stock-based compensation of $14 million, results in 2018 non-GAAP SG&A expense of $66 to $72 million. The anticipated increase in SG&A expenses in 2018 is primarily the result of the deployment of our new salesforce in January 2018 and the additional selling, marketing and consumer initiatives to support the commercial launch of ESKATA.

Company to Host Conference Call

Management will conduct a conference call at 8:00 a.m. ET today to discuss Aclaris’ financial results and provide a general business update. The conference will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1495576 prior to the start of the call.

On March 12, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology, and immunology, reported financial results for the fourth quarter and year ended December 31, 2017 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, MAR 12, 2018, View Source [SID1234524664]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2017 was a defining year in Aclaris’ history, with the FDA approval of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), the first and only FDA-approved topical, non-invasive treatment of raised seborrheic keratosis (SK). We have generated a high level of excitement around ESKATA in the dermatology community, and look forward to our official launch in the second quarter of 2018," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "In January 2018, we announced positive topline results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris). We also advanced our topical Janus kinase (JAK) inhibitor programs in alopecia, with results from multiple Phase 2 trials expected later this year. As our early-stage pipeline compounds advance towards the clinic, we continue to progress towards our goal of becoming a vertically integrated, commercial-stage biopharmaceutical company with a robust clinical-stage pipeline and drug discovery engine."

Clinical Pipeline Update

A-101 45% Topical Solution

oIn January 2018, reported positive results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45%, an investigational new drug for the treatment of common warts. A-101 45% met all primary, secondary, and exploratory endpoints of each trial analyzed to date, achieving clinically and statistically significant clearance of common warts.

Scheduled an End of Phase 2 meeting with the FDA for mid-2018, and plan to initiate two pivotal Phase 3 trials in the second half of 2018.

·JAK Inhibitor

oAA-202 Topical – an ongoing Phase 2 clinical trial of ATI-502 (formerly ATI-50002) for the topical treatment of alopecia areata (AA). This trial will evaluate the pharmacokinetics,

pharmacodynamics and safety of ATI-502 compared with placebo in 12 patients with AA. This randomized, double-blind clinical trial is being conducted at two investigational centers within the United States, and topline data are expected in the first half of 2018. After completing the 28-day portion of the trial, patients will then enter a 6-month open label extension during which all patients will receive drug.

AUATB-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of ATI-502 on the regrowth of eyebrows in up to 24 patients with AA. This trial is being conducted at two investigational centers in Sydney and Melbourne, Australia, and topline qualitative data are expected mid-2018.

AA-201 Topical – an ongoing Phase 2 dose ranging trial of ATI-502 for the topical treatment of AA. This trial will evaluate the effect of two concentrations of ATI-502 on the regrowth of hair in a randomized, double-blinded, parallel-group, vehicle-controlled trial in up to 120 patients with AA. This trial is being conducted at 25 investigational centers within the United States and data are expected by year end 2018.

VITI-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the effect of ATI-502 on the repigmentation of facial skin in up to 24 patients with vitiligo and data are expected in the first half of 2019.

oAGA-201 Topical – a planned Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss, which is anticipated to begin in the first half of this year. This trial will evaluate the effect of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in first half of 2019.

AUAT-201 Oral – a planned Phase 2 dose ranging trial of ATI-501 (formerly ATI-50001), an oral JAK inhibitor, for the treatment of AA which is anticipated to begin in the first half of 2018. Data are expected in mid-2019.

ATI-450

Recently presented data from pre-clinical studies of ATI-450 (formerly known as CDD-450), a selective inhibitor of the MK2 pathway, at a symposium at the American College of Rheumatology annual meeting on November 7, 2017. The abstract summarizing the data is titled "NOMID-Associated Complications in Mice Are Prevented By CDD-450, a Small Molecule Inhibitor of the Mitogen-Activated Protein Kinase-Activated Protein Kinase 2 (MK2) Pathway."

Investigational New Drug application on track for submission to the FDA in mid-2019.

Commercial Update

Expanded commercial organization to 70 people in support of a successful ESKATA launch.

Established Aclaris Market Research, Sales, Trade, Training, and Sales Operations teams.

oSuccessfully onboarded and trained Aclaris sales force consisting of 50 Field Sales Specialists, 2 Inside Sales Representatives, 6 Regional Sales Managers, and 1 Sales Director.

Conducted market research with over 2,500 patients and 1,400 HCPs to date.

Developed comprehensive HCP and consumer campaigns to support a successful ESKATA launch.

Finalized ESKATA pricing and positioning

Established ESKATA speaker bureau consisting of dermatologist and NP/PA speakers.

Aclaris present at 30 key dermatology meetings in 2017.

Generated a high level of corporate awareness with the goal to position Aclaris as a leading innovative biopharmaceutical company in dermatology.

Raised awareness regarding SK disease state awareness and patient willingness to pay for SK removal.

Strong presence at 2018 Winter AAD in San Diego; Generated a high level of ESKATA awareness.

Sales force currently implementing key market readiness activities, including:

Establishing ESKATA Centers of Excellence.

Implementation of ESKATA Early Experience Initiative.

National Sales Meeting scheduled for the second quarter of 2018, followed by official ESKATA launch.

Recent Corporate Highlights

Promoted Brett Fair to Chief Commercial Officer

Continued to build our research and development and commercial infrastructure.

The United States Patent and Trademark Office recently issued U.S. Patent No. 9,895,301, which is directed to methods related to the use and administration of a certain JAK inhibitor for treating hair loss disorders.

U.S. Patent No. 9,895,301 covers the use of tofacitinib for inducing hair growth and for treating hair loss disorders such as alopecia areata and AGA. Additional issued claims pertain to methods of using tofacitinib to treat particular phenotypes of alopecia areata, as well as to treat other hair loss disorders. The ‘301 Patent contains 67 claims and expires in November 2031.

This newly allowed patent is owned by The Trustees of Columbia University in the City of New York and exclusively licensed to Aclaris and is the latest U.S. patent to issue in connection with Aclaris’ JAK drug development program for hair loss disorders.

Recently added to the NASDAQ Biotechnology Index (NASDAQ: NBI).

Financial Highlights

Liquidity and Capital Resources

As of December 31, 2017, Aclaris had aggregate cash, cash equivalents and marketable securities of $208.9 million compared to $174.1 million as of December 31, 2016. The $34.8 million increase during the year ended December 31, 2017 included:

Aggregate net proceeds of $100.2 million from the sale of common stock under an at-the-market facility with Cowen and Company LLC in April 2017 and a follow-on public offering of common stock in August 2017.

$9.6 million of cash used to acquire Confluence in August 2017, net of cash acquired.

$1.2 million of purchases of property and equipment.

Net loss of $68.5 million, offset by $0.9 million of net cash provided by working capital and $14.8 million of non-cash stock-based compensation expense, depreciation and amortization.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2017 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.

Fourth Quarter 2017 Financial Results

Net loss was $22.9 million for the fourth quarter of 2017, compared to $11.5 million for the fourth quarter of 2016. Upon new tax legislation passed in December 2017, Aclaris recognized an income tax benefit of $1.8 million related to the reversal of the deferred tax liability associated with the In-Process Research and Development recognized in the Confluence acquisition earlier this year.

Revenue of $1 million and cost of revenue of $0.8 million for the fourth quarter of 2017 related to our contract research business acquired in August 2017.

Total operating expenses for the fourth quarter of 2017 were $25.7 million, compared to $11.6 million for the fourth quarter of 2016.

Research and development expenses were $13.2 million for the fourth quarter of 2017, compared to $6.9 million for the fourth quarter of 2016. The increase of $6.3 million was primarily attributable to a $2.3 million increase in expenses related to the WART-202 andWART-203 trials, a $1.5 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount, a $2 million increase in preclinical and clinical trial development expenses related to the JAK inhibitor portfolio and a $1.5 million increase in Medical Affairs expenses and other costs, including early stage drug discovery. This increase was partially offset by a $1.3 million decrease due to the completion of our ESKATA Phase 3 clinical trials and the submission preparation of the NDA for ESKATA in November 2016.

General and administrative expenses were $12.5 million for the fourth quarter of 2017, compared to $4.7 million for the fourth quarter of 2016. The increase of $7.8 million was primarily attributable to $2.9 million in higher personnel-related expenses, including stock-based compensation, due to increased headcount, and a $1 million increase related to relocating our corporate headquarters and administrative costs related to our St. Louis, Missouri operations acquired in August 2017. Additionally, Aclaris incurred a $3.3 million increase in market research and sales operations expenses related to pre-commercial activities for ESKATA.

Full Year 2017 Financial Results

Net loss was $68.5 million for the year ended December 31, 2017, compared to $48.1 million for the year ended December 31, 2016.

Revenue of $1.7 million and cost of revenue of $1.2 million for the year ended December 31, 2017 related to the contract research business acquired in August 2017.

Total operating expenses were $72.9 million for the year ended December 31, 2017, compared to $48.6 million for the year ended December 31, 2016. Net cash used in operating activities was $54.7 million, compared to $34.6 million for the year ended December 31, 2016.

Research and development expenses were $39.8 million for the year ended December 31, 2017, compared to $33.5 million for the year ended December 31, 2016. The increase of $6.3 million was due to higher payroll-related expenses of $5.6 million due to increased headcount, including stock-based compensation expense, an increase of $4.5 million in preclinical and clinical trial development expenses related to our JAK inhibitor portfolio, an increase of $3.4 million in expenses related to the WART-202 and WART-203 trials, and a $3.6 million increase in medical affairs and early stage drug discovery activities. The increases noted above were partially offset by a $7.7 million decrease related to our ESKATA Phase 3 clinical trials costs, which were completed in November 2016, and $3.4 million in costs incurred with the acquisition of Vixen Pharmaceuticals, Inc. in the year ended December 31, 2016.

General and administrative expenses were $33.1 million for the year ended December 31, 2017, compared to $15.1 million for the year ended December 31, 2016. The increase of $18million was primarily attributable to an increase of $9.3 million in payroll-related expenses due to increased headcount, including stock-based compensation expense, an increase of $6.1 million in pre-commercial launch activities for ESKATA, a $1.3 million increase in facilities-related costs, and a $1.3 million increase in other professional fees.

As of December 31, 2017, Aclaris had approximately 30.8 million shares of common stock outstanding.

2018 Financial Outlook

Aclaris expects 2018 GAAP research and development (R&D) expenses to be in the range of $67 to $75 million, which, when excluding estimated stock-based compensation of $9 million, results in 2018 non-GAAP R&D expense of $59 to $67 million. The anticipated increase in R&D expenses in 2018 is mainly due to the planned execution of Phase 2 clinical trials in AA, AGA, and vitiligo, two planned pivotal Phase 3 trials in common warts, and development of our early stage pipeline compounds.

Aclaris expects 2018 GAAP selling, general and administrative (SG&A) expenses to be in the range of $80 to $86 million, which, when excluding estimated stock-based compensation of $14 million, results in 2018 non-GAAP SG&A expense of $66 to $72 million. The anticipated increase in SG&A expenses in 2018 is primarily the result of the deployment of our new salesforce in January 2018 and the additional selling, marketing and consumer initiatives to support the commercial launch of ESKATA.

·Company to Host Conference Call

Management will conduct a conference call at 8:00 a.m. ET today to discuss Aclaris’ financial results and provide a general business update. The conference will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1495576 prior to the start of the call.