On February 25, 2020 Allakos Inc. (the Company) (Nasdaq: ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update of its ongoing and planned development activities (Press release, Allakos, FEB 25, 2020, View Source [SID1234554717]).

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!

2019 Accomplishments

Reported positive results from ENIGMA, a randomized, double-blind, placebo-controlled Phase 2 study using antolimab (AK002) in patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE). The study met all prespecified primary and secondary endpoints.
Podium presentations of the ENIGMA study results were made at the 2019 United European Gastroenterology Week (Barcelona, Spain; October 2019) by Dr. Joseph Murray, MD and at the 2019 American College of Gastroenterology Annual Scientific Meeting (San Antonio, Texas; October 2019) by Dr. Evan Dellon, MD, MPH.
Reported positive topline results with antolimab (AK002) in three open-label studies in patients with Chronic Urticaria (CU), Severe Allergic Conjunctivitis (SAC) and Indolent Systemic Mastocytosis (ISM). In these studies, antolimab (AK002) depleted blood eosinophils and improved patient and physician reported symptoms.
Closed an underwritten public offering in August 2019, issuing 5,227,272 shares of common stock at an offering price of $77.00 per share. Aggregated net proceeds received from the offering were approximately $377.5 million, net of underwriting discounts and commissions and offering expenses.
Granted orphan drug designation in October 2019 from the United States Food and Drug Administration for the treatment of Eosinophilic Esophagitis (EoE) with antolimab (AK002).
Upcoming 2020 Milestones

Initiation of a randomized, double-blind, placebo-controlled Phase 3 study using antolimab (AK002) in patients with EG and/or EGE in the first quarter 2020.
Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study using antolimab (AK002) in patients with EoE in the first quarter 2020.
Clinical safety and efficacy results from a six-month, open-label Phase 1 study using antolimab (AK002) in patients with Mast Cell Gastrointestinal Disease (MGID) in the first quarter of 2020.
Clinical safety and efficacy results from the open-label, long-term extension component of the ENIGMA study in patients with EG and/or EGE in the first half of 2020.
Completion of a Phase 1 study in healthy volunteers evaluating the safety, tolerability and pharmacokinetics of a subcutaneous formulation of antolimab (AK002) in the second half of 2020.
Fourth Quarter and Full Year 2019 Financial Results

Research and development expenses were $16.6 million in the fourth quarter of 2019 as compared to $11.0 million in the same period in 2018, an increase of $5.6 million. Research and development expenses were $61.9 million for the full year 2019 as compared to $33.3 million in the same period in 2018, an increase of $28.6 million.

General and administrative expenses were $10.3 million in the fourth quarter of 2019 as compared to $4.5 million in the same period in 2018, an increase of $5.8 million. General and administrative expenses were $29.6 million for the full year 2019 as compared to $12.4 million in the same period in 2018, an increase of $17.2 million.

Allakos reported a net loss of $24.6 million in the fourth quarter of 2019 as compared to $14.5 million in the same period in 2018, an increase of $10.1 million. Net loss per basic and diluted share was $0.51 for the fourth quarter of 2019 compared to $0.35 in the same period in 2018. For the full year 2019, net loss was $85.4 million and net loss per basic and diluted share was $1.89 compared to $43.5 million and $2.20, respectively, for the same period in 2018.

Allakos ended fiscal year 2019 with $495.9 million in cash, cash equivalents and marketable securities.

On February 25, 2020 AIVITA Biomedical, Inc., a biotechnology company (the "Company") specializing in innovative stem cell applications, reported the first closing of its $25 million Series B-2 preferred stock investment round (Press release, AIVITA Biomedical, FEB 25, 2020, View Source [SID1234554716]). The first closing of $12.5 million was led by Matthew Katz, an entrepreneur and investor who has been appointed to AIVITA’s board of directors. The financing round also includes other healthcare-focused venture capital firms.

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!

Matthew Katz is founder and CEO of Verifi, Inc., a customized software solution that systematically identifies payment risk. He is also the head of Zoo Station, his family office focused on investing in early stage startups. He has successfully founded and partnered several businesses and consulting firms and is a welcome addition to AIVITA’s board of directors.

"We are excited to welcome Matthew to our board of directors," said Dr. Hans S. Keirstead, Chairman and CEO of AIVITA. "Matt brings deep experience in corporate development, operations and partnership strategy to AIVITA at a time when our programs are expanding and maturing."

On February 25, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year 2019 and provided research and development (R&D) and business highlights (Press release, Aclaris Therapeutics, FEB 25, 2020, View Source [SID1234554715]).

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!

"In 2019, we repositioned the company to focus on our core competency in developing small molecule kinase inhibitors. Thus far, we are very pleased with the progression of our immuno-inflammatory pipeline, as well as with the positive results from our Phase 1 clinical trial of ATI-450, an oral small molecule MK2 inhibitor," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "We look forward to initiating a Phase 2a trial of ATI-450 in subjects with rheumatoid arthritis in the first half of this year and executing on our new business plan."

R&D Highlights:

ATI-450:
ATI-450 is an investigational oral small molecule MK2 inhibitor.
ATI-450-PKPD-101: A Phase 1 single and multiple ascending dose (SAD/MAD) trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects.
Preliminary data from this trial demonstrated that ATI-450:
resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;
had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; and
had no meaningful food effect or drug-drug interaction with methotrexate.
ATI-450-RA-201: Aclaris intends to initiate a Phase 2a clinical trial for ATI-450 in subjects with rheumatoid arthritis in the first half of 2020.
Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 for an additional immuno-inflammatory indication.

ATI-1777:
ATI-1777 is an investigational topical soft-Janus Kinase (JAK) inhibitor compound that Aclaris is developing as a potential treatment for moderate-to-severe atopic dermatitis.
Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020.
If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in both healthy subjects and subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis.

ATI-2138:
ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease.
Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021.
Corporate Highlights:

Divested RHOFADE (oxymetazoline hydrochloride) cream, 1% to EPI Health, LLC and repaid in full $30 million term loan with Oxford Finance LLC, in October 2019.
Appointed Vincent Milano to the Board in January 2020.
Business Development Highlights:

Aclaris continues to pursue strategic alternatives, including seeking partners for:
A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
ESKATA: to commercialize ESKATA (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources

As of December 31, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $75.0 million compared to $168.0 million as of December 31, 2018. For the quarter and year ended December 31, 2019, net cash used in operating activities was $20.4 million and $96.4 million, respectively. As of December 31, 2019, Aclaris had no long-term debt outstanding and had approximately 41.5 million shares of common stock outstanding.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential business development transactions or financing activities.

Fourth Quarter 2019 and Year-to-Date Financial Results

The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris’ historical format. Aclaris believes this format provides comparability with its previously filed financial statements.
Total costs and expenses from continuing operations for the fourth quarter of 2019 were $18.4 million, compared to $26.9 million for the fourth quarter of 2018. For the year ended December 31, 2019, total costs and expenses were $115.3 million, compared to $90.9 million in 2018.
These amounts included non-cash stock-based compensation expenses of $3.2 million and $16.1 million for the quarter and year ended December 31, 2019, respectively, compared to $4.2 million and $16.6 million for the prior year periods, respectively.
For the year ended December 31, 2019, there was also a $18.5 million non-cash charge for the impairment of goodwill. There was no such charge in the prior year.
R&D expenses were $11.5 million and $64.9 million for the quarter and year ended December 31, 2019, respectively, compared to $19.0 million and $60.8 million for the quarter and year ended December 31, 2018, respectively.
The year-over-year fourth quarter decrease of $7.5 million was mainly the result of Aclaris’ Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution, which were at or near completion in the third quarter of 2019, as well as a reduction in personnel-related costs.
These reductions were offset by increased expenses related to Aclaris’ preclinical development programs and the Phase 1 clinical trial for ATI-450 which was initiated in 2019, and by a milestone expense related to one of Aclaris’ licensing agreements.
General and administrative expenses were $5.8 million and $27.2 million for the quarter and year ended December 31, 2019, respectively, compared to $6.6 million and $25.6 million for the quarter and year ended December 31, 2018, respectively.
Loss from continuing operations was $19.2 million for the fourth quarter of 2019, compared to $24.7 million for the fourth quarter of 2018. Loss from continuing operations was $113.5 million for the year ended December 31, 2019, compared to $82.1 million for the year ended December 31, 2018.
The gain from discontinued operations was $0.6 million for the fourth quarter of 2019, compared to a loss of $13.9 million for the fourth quarter of 2018. The loss from discontinued operations was $47.8 million for the year ended December 31, 2019, compared to $50.6 million for the year ended December 31, 2018.
Net loss was $18.6 million for the fourth quarter of 2019, compared to net loss of $38.6 million for the fourth quarter of 2018, and was $161.4 million for the year ended December 31, 2019, compared to $132.7 million for the year ended December 31, 2018.
Company to Host Conference Call

Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call 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 9958112 prior to the start of the call.

On February 25, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a second-quarter 2020 dividend of $0.16 per share (Press release, West Pharmaceutical Services, FEB 25, 2020, View Source [SID1234554708]). The dividend will be paid on May 6, 2020, to shareholders of record as of April 22, 2020.

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!

On February 25, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the fourth quarter and year ended December 31, 2019, and provided full-year 2020 financial guidance (Press release, Vericel, FEB 25, 2020, View Source [SID1234554707]).
Fourth Quarter 2019 Financial Highlights

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!

Total net product revenues increased 26% to $39.4 million, compared to $31.3 million in the fourth quarter of 2018, marking the eleventh consecutive quarter with record revenues for the reported quarter;

MACI net revenue of $33.6 million and Epicel net revenue of $5.8 million;

Gross margin of 73%, compared to gross margin of 72% in the fourth quarter of 2018;

Net income of $9.5 million, or $0.20 per share, compared to $5.2 million, or $0.11 per share, in the fourth quarter of 2018; and

Non-GAAP adjusted EBITDA of $12.8 million, compared to $7.7 million in the fourth quarter of 2018.
Full-Year 2019 Financial Highlights

Total net product revenues increased 30% to $117.9 million, compared to $90.9 million in 2018;

MACI net revenue of $91.6 million and Epicel net revenue of $26.2 million;

Gross margin of 68%, compared to gross margin of 65% in 2018;

Net loss of $9.7 million, or $0.22 per share, which includes the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid;

Non-GAAP adjusted net income, excluding the $17.5 million upfront license payment to MediWound, of $7.8 million, or $0.18 per share, compared to a net loss of $8.1 million, or $0.20 per share, in 2018;

Non-GAAP adjusted EBITDA of $21.2 million, compared to $4.7 million in 2018; and

As of December 31, 2019, the company had $79.0 million in cash and investments, compared to $82.9 million as of December 31, 2018; excluding the $17.5 million license payment to MediWound, the company’s cash balance increased by $13.6 million in 2019.
Business Highlights and Updates

Initiated the MACI sales force expansion from 49 to 76 sales territories and from six to nine sales regions, which remains on track to be implemented on April 1, 2020;

Announced initiation of the NexoBrid Expanded Access Treatment Protocol (NEXT) to treat patients with deep partial- and full-thickness burns in the United States during the preparation and review of the NexoBrid Biologics License Application;

Announced that that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has begun procuring NexoBrid for emergency stockpile as part of the U.S. Department of Health and Human Services’ mission to build national preparedness for public health medical emergencies; and

Planning a mid-2020 submission of the NexoBrid Biologics License Application to the FDA.
"Our fourth-quarter and full-year results reflect a landmark year for the company in which we not only continued to deliver significant revenue growth, but also achieved strong profit growth and added an exciting new product to our portfolio," said Nick Colangelo, President and CEO of Vericel. "With expected sustained strong double-digit growth ahead for MACI, together with continued growth for Epicel and the anticipated launch of NexoBrid, we believe that Vericel is well-positioned to deliver substantial revenue, profit, and cash flow growth in the years ahead."
2020 Financial Guidance
The company expects total net revenues for 2020 to be in the range of $141 million to $146 million, including full-year revenue of approximately $3.0 million from BARDA’s emergency stockpile purchases of NexoBrid.
Fourth Quarter 2019 Results
Total net product revenues for the quarter ended December 31, 2019 increased 26% to $39.4 million, compared to $31.3 million in the fourth quarter of 2018. Total net product revenues for

the quarter included $33.6 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $5.8 million of Epicel (cultured epidermal autografts) net revenue, compared to $25.1 million of MACI net revenue and $6.2 million of Epicel net revenue, respectively, in the fourth quarter of 2018.
Gross profit for the quarter ended December 31, 2019 was $28.8 million, or 73% of net revenues, compared to $22.7 million, or 72% of net revenues, for the fourth quarter of 2018.
Total operating expenses for the quarter ended December 31, 2019 were $19.6 million, compared to $16.7 million for the same period in 2018. The increase in operating expenses was primarily due to a $1.3 million increase in stock-based compensation expense, a $0.7 million increase in MACI sales force expenses driven by the expansion in the second quarter of 2019, and a $0.7 million increase in patient reimbursement support services.
Vericel’s net income for the quarter ended December 31, 2019 was $9.5 million, or $0.20 per share, compared to $5.2 million, or $0.11 per share, for the fourth quarter of 2018.
Non-GAAP adjusted EBITDA was $12.8 million for the quarter ended December 31, 2019, compared to $7.7 million in the fourth quarter of 2018. A table reconciling non-GAAP measures is included in this press release for reference.
Full-Year 2019 Results
Total net product revenues for the year ended December 31, 2019 increased 30% to $117.9 million, compared to $90.9 million in 2018. Total net product revenues included $91.6 million of MACI net revenue and $26.2 million of Epicel net revenue, compared to $67.7 million of MACI net revenue and $23.1 million of Epicel net revenue, respectively, in 2018.
Gross profit for the year ended December 31, 2019 was $80.3 million, or 68% of net revenues, compared to $58.7 million, or 65% of net revenues, in 2018.
Total operating expenses for the year ended December 31, 2019 were $91.5 million, including the $17.5 million upfront license payment to MediWound for North American rights to NexoBrid. Excluding the $17.5 million license payment, operating expenses were $74.0 million, compared to $62.6 million in 2018. Other increases in operating expenses include a $5.0 million increase in stock-based compensation expenses, an incremental $2.6 million in MACI sales force expenses driven by the expansion in the second quarter of 2019, a $2.4 million increase in marketing expenses, and a $1.8 million increase in patient reimbursement support services.
Vericel’s net loss for the year ended December 31, 2019 was $9.7 million, or $0.22 per share, which includes the $17.5 million upfront license payment to MediWound for North American rights to NexoBrid. Non-GAAP adjusted net income, excluding the $17.5 million upfront license payment to MediWound, was $7.8 million, or $0.18 per share, compared to a net loss of $8.1 million, or $0.20 per share, in 2018. A table reconciling non-GAAP measures is included in this press release for reference.

Non-GAAP adjusted EBITDA was $21.2 million for the year ended December 31, 2019, compared to $4.7 million in 2018. A table reconciling non-GAAP measures is included in this press release for reference.
As of December 31, 2019, the company had $79.0 million in cash and investments, compared to $82.9 million as of December 31, 2018. Excluding the $17.5 million license payment to MediWound, the company’s cash balance increased by $13.6 million in 2019.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Standard Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s second-quarter 2019 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until February 25, 2021. A replay of the call will also be available until 11:00am (EDT) on March 1, 2020 by calling (855) 859-2056, or from outside the U.S. at (404) 537-3406. The conference ID is 1269587.