On August 8, 2019 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin therapies*, reported the appointment of Nicolas Leupin, M.D., MBA, to the role of Chief Medical Officer and Member of Management Board as of September 1, 2019 (Press release, Molecular Partners, AUG 8, 2019, View Source [SID1234538424]). Dr. Leupin will succeed Chief Medical Officer Andreas Harstrick, M.D., who will remain with the company and continue to support its medical strategy.

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!

Dr. Leupin is a medical oncologist with a proven track record in drug development, most recently as Chief Medical Officer of argenx, a clinical-stage biotechnology company developing antibody-based therapies for treatment of severe autoimmune diseases and cancer. In that role he led the company’s global clinical strategy and execution, successfully supporting the company’s transformation into a late-stage clinical company, and was responsible for translating preclinical hypotheses into innovative proof-of concept clinical trials.

Prior to argenx, Dr. Leupin held roles of increasing responsibility at Celgene, where he supported the clinical development of several drug candidates in lymphoma and multiple myeloma, resulting in regulatory filings in Europe and the U.S.

"Nicolas’ deep experience in developing and translating innovative therapeutic concepts into patient value will be a key asset to Molecular Partners, as we broaden our pipeline of novel DARPin drug candidates in our quest to change the treatment paradigms in oncology," said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. "We’re very grateful to Andreas for his important contributions to shepherd our first oncology DARPin candidates into multiple clinical trials, and to prove the capabilities of systemic administration for this drug class, with long half-life and very low immunogenic risks. Further, his expertise and leadership were instrumental to generate first patient value with MP0250 in multiple myeloma."

"It’s a very exciting time in the history of cancer therapy, and Molecular Partners’ approach has all the ingredients to play a key role in moving the needle of medicine," said Dr. Leupin. "Thanks to their unique architecture, DARPin molecules allow for clever therapeutic designs, and could therefore offer new solutions for difficult-to-treat cancers. As Chief Medical Officer, my focus will be to fully exploit the huge potential of this new class of drugs in order to offer innovative options for patients who are most in need."

Financial Calendar
August 27, 2019 Publication of Half-year Results 2019 (unaudited)
October 31, 2019 Interim Management Statement Q3 2019
December 12, 2019 R&D Day in New York
View Source

*DARPin is a registered trademark owned by Molecular Partners AG

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates can engage more than five targets, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid and hematological tumors. MP0274, the second-most advanced DARPin candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads to induction of apoptosis. MP0274 is currently in phase 1. The company’s lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. MP0310 is expected to enter into the clinic in H2 2019. Molecular Partners is also advancing a growing preclinical and research pipeline in immuno-oncology that features its "I/O toolbox" and additional development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On August 8, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2019 (Press release, Puma Biotechnology, AUG 8, 2019, View Source [SID1234538440]). Unless otherwise stated, all comparisons are for the second quarter 2019 compared to the second quarter of 2018.

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!

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the second quarter of 2019 was $53.8 million, compared to net NERLYNX revenue of $50.8 million in the second quarter of 2018. Net NERLYNX revenue in the first six months of 2019 was $99.4 million, compared to net NERLYNX revenue of $86.8 million in the first six months of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $37.4 million, or $0.97 per share, for the second quarter of 2019, compared to a net loss of $44.3 million, or $1.17 per share, for the second quarter of 2018. Net loss for the first six months of 2019 was $47.5 million, or $1.23 per share, compared to a net loss of $68.7 million, or $1.82 per share, for the first six months of 2018.

Non-GAAP adjusted net loss was $22.0 million, or $0.57 per share for the second quarter of 2019, compared to non-GAAP adjusted net loss of $22.2 million, or $0.59 per share for the second quarter of 2018. Non-GAAP adjusted net loss for the first six months of 2019 was $13.9 million, or $0.36 per share, compared to non-GAAP adjusted net loss of $21.2 million, or $0.56 per share, for the first six months of 2018. Non-GAAP adjusted net loss excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second quarter of 2019 was $44.2 million, compared to net cash used in operating activities of $17.6 million in the second quarter of 2018. Net cash provided by operating activities for the first six months of 2019 was $28.1 million, compared to net cash used in operating activities of $23.9 million in the first six months of 2018. At June 30, 2019, Puma had cash, cash equivalents, and marketable securities of $117.7 million, compared to cash, cash equivalents and marketable securities of $165.4 million at December 31, 2018. The reduction in cash, cash equivalents and marketable securities in the second quarter was the result of the previously disclosed repayment of the $155 million outstanding loan using cash on hand and $100 million in new borrowings from an amended and restated loan agreement in June 2019.

"The second quarter of 2019 included the achievement of several key milestones for Puma," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "This included sequential NERLYNX sales growth and the expansion of our global presence with NERLYNX with our European licensing agreement with Pierre Fabre. We saw the achievement of additional key milestones in July with the filing of the new drug application for neratinib in the metastatic breast cancer indication and obtaining approval for NERLYNX in the extended adjuvant indication from Health Canada."

Mr. Auerbach added, "We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the second quarter ended June 30, 2019, total revenue was $53.9 million, of which $53.8 million was net NERLYNX revenue and $0.1 million was royalty revenue received from Puma’s sub-licensees. This compares to total revenue of $50.8 million in the second quarter of 2018, all of which was net product revenue. For the first six months of 2019, total revenue was $153.0 million, of which $99.4 million was net product revenue, $53.5 million was license revenue received from Puma’s sub-licensees, and $0.1 million was royalty revenue. This compares to total revenue for the first six months of 2018 of $117.3 million, of which $86.8 million was net product revenue and $30.5 million was license revenue.

Operating Costs and Expenses

Total operating costs and expenses were $79.7 million in the second quarter of 2019, compared to $92.2 million in the second quarter of 2018. Operating costs and expenses in the first six months of 2019 were $168.9 million, compared to $182.1 million in the first six months of 2018.

Cost of Sales:

Cost of sales was $9.3 million for the second quarter of 2019 and $17.3 million for the first six months of 2019, compared to $8.8 million for the second quarter of 2018 and $15.2 for the first six months of 2018.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses (SG&A) were $33.5 million for the second quarter of 2019, compared to $40.1 million for the second quarter of 2018. SG&A expenses for the first six months of 2019 were $79.0 million, compared to $76.7 million for the first six months of 2018. The approximately $2.3 million year-to-date increase resulted primarily from increases of approximately $2.9 million for professional fees, such as legal fees and marketing and commercial support, $0.6 million in office and banking expenses, and $0.4 million in payroll and payroll-related expenses. These were partially offset by decreases of approximately $1.4 million in travel and meeting-related expenses and $0.2 million related to stock-based compensation expense.

Research and Development Expenses:

Research and development (R&D) expenses were $36.9 million for the second quarter of 2019, compared to $43.3 million for the second quarter of 2018. R&D expenses for the first six months of 2019 were $72.6 million, compared to $90.2 million for the first six months of 2018. The $17.6 million year-to-date decrease resulted primarily from decreases of approximately $13.8 million for stock-based compensation, $3.5 million for internal R&D primarily related to payroll and payroll-related expenses, and $0.5 million in consulting fees related to clinical trials.

Total Other Income (Expenses)

Total other expenses were $11.6 million for the second quarter and $31.6 million for the first six months of 2019, compared to total other expenses of $2.9 million for the second quarter and $3.9 million for the first six months of 2018. The increase in other expenses recorded in the first six months of 2019 primarily included $16.4 million related to a March 2019 jury verdict against Puma and $8.1 million related to the debt refinancing.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 8, 2019. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

On August 8, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the second quarter ended June 30, 2019 (Press release, Vaxart, AUG 8, 2019, View Source [SID1234538458]).

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!

"We have made significant progress this quarter, achieving a number of important milestones. We completed enrollment in our Phase 1b bivalent norovirus vaccine study and we expect to have topline results by October of this year," said Wouter Latour, M.D., chief executive officer of Vaxart. "Norovirus causes $60 billion in global healthcare related costs annually, and our oral tablet vaccine would be ideal to help protect vulnerable populations such as older adults and the very young. We remain committed to developing the norovirus vaccine, and we are now preparing to start a Phase 2 study with our bivalent norovirus vaccine in 2020, assuming we achieve positive results in the current Phase 1b trial."

"With regard to universal flu, the collaboration with Janssen is an important endorsement of our oral vaccine platform and could position us as a key player in the future of influenza vaccine development. In parallel, we continue our efforts to advance our own oral seasonal flu vaccine, which demonstrated the potential to provide better protection than currently marketed injectable vaccines, such as FluzoneTM, in a human challenge study. Given our focus on the bivalent norovirus and universal flu vaccine programs, we have deprioritized the monovalent norovirus vaccine challenge study and now plan to file our human papilloma virus (HPV) Investigational New Drug application (IND) in 2020," continued Dr. Latour.

Recent Corporate Highlights:

● Completed enrollment in the Phase 1b bivalent norovirus vaccine clinical trial. The vaccine consists of an oral norovirus GI.1 vaccine tablet and an oral norovirus GII.4 vaccine tablet administered concurrently. The trial is designed to evaluate safety and immunogenicity and Vaxart expects to report topline data in early Q4 2019.

● Entered into a research collaboration agreement with Janssen Vaccines & Prevention B.V. (Janssen) to evaluate Vaxart’s proprietary oral vaccine platform for the Janssen universal influenza vaccine program.

● Priced an underwritten public offering which closed in April. As of June 30, 2019, the aggregate gross proceeds were $10.0 million.

● Entered into an agreement with Lonza Houston to supply vaccine for the planned Phase 2 bivalent norovirus study in 2020.

● Presented preclinical data at the 29th European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam which showed that Vaxart’s oral quadrivalent seasonal influenza vaccine conferred 100% protection against a lethal H5N1 pre-pandemic influenza challenge in ferrets, while in the Fluzone group only 62% of the animals survived.

● Published the comprehensive results from a preclinical trial of Vaxart’s chikungunya vaccine in the peer reviewed journal, Vaccine. The preclinical results demonstrated that Vaxart’s vaccine candidate induced significant neutralizing antibodies against chikungunya virus as well as protective efficacy against virus-induced pathologic changes.

● Presented preclinical results of Vaxart’s oral Respiratory Syncytial Virus (RSV) vaccine in a poster presentation at the American Society of Microbiology 2019, demonstrating the Vaxart vaccine induces respiratory mucosal memory and protection against RSV infection in cotton rats.

Following a review of the development strategy for norovirus, Vaxart has deprioritized the monovalent GI.1 challenge study. Consequently, the Company is preparing to initiate a Phase 2 safety and immunogenicity study with Vaxart’s bivalent norovirus vaccine in 2020, to be followed by a Phase 3 efficacy study, assuming FDA concurrence.

Financial Results for the Three Months Ended June 30, 2019

● Vaxart reported a net loss of $5.6 million for the second quarter of 2019 compared to $8.9 million for the second quarter of 2018. The principal reasons for the decrease were the absence of a $1.6 million one-off non-cash impairment charge recorded in the second quarter of 2018 and a reduction in research and development expenditure.

● Vaxart ended the quarter with cash and cash equivalents of $16.3 million compared to $8.4 million at March 31, 2019. The increase was primarily due to the $8.7 million net raised as a result of the underwritten offering in April 2019, partially offset by cash used in operations.

● Revenue for the quarter was $85,000 compared to $608,000 in the second quarter of 2018. The decrease was almost entirely due to the absence of revenue of $520,000 from the BARDA contract which ended in 2018.

● Research and development expenses were $3.7 million for the quarter compared to $5.0 million for the second quarter of 2018. The decrease was mainly due to the absence of clinical trials costs for teslexivir and costs incurred for the now-completed BARDA contract, partially offset by higher clinical trial and manufacturing costs incurred in the Company’s norovirus program.

● General and administrative expenses were $1.4 million for the quarter compared to $1.8 million for the second quarter of 2018. The decrease was mainly due to lower legal costs and a reduction in personnel costs.

On August 8, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported financial results for the second quarter ended June 30, 2019 (Press release, ViewRay, AUG 8, 2019, View Source [SID1234538474]).

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!

Second Quarter 2019 Summary:

The Company is updating 2019 guidance and now anticipates total revenue in the range of $80 million to $95 million, and total cash usage to be in the range of $80 million to $90 million.
Total revenue was $30.2 million in the quarter, primarily from 5 revenue units, compared to $16.4 million, primarily from 3 revenue units, for the same period last year.
Received 3 new orders in the quarter for MRIdian systems totaling $18.1 million, compared to orders totaling $34.6 million for the same period last year.
Total backlog was $219.3 million as of June 30, 2019, compared to $199.7 million as of June 30, 2018.
Cash and cash equivalents were $122.1 million as of June 30, 2019.
Chief Financial Officer Ajay Bansal will be leaving the company effective September 30, 2019.
"We are disappointed to take down guidance for the year, but we believe it is prudent given the timing of installations around year-end," said Scott Drake, President and CEO. "We remain focused on the long-term opportunity versus short term variability and are confident that we will demonstrate the momentum of our growing pipeline and end-user demand moving forward. Today we are also announcing the departure of our Chief Financial Officer, Ajay Bansal. We thank him for his service over the last three years and wish him well. We are in the midst of a retained search to find his replacement."

Second Quarter 2019 Financial Results:

Total revenue for the three months ended June 30, 2019, was $30.2 million, compared to $16.4 million for the same period last year.

Total cost of revenue was $26.9 million, compared to $16.4 million for the same period last year.

Total gross profit was $3.2 million, compared to $0.1 million for the same period last year.

Total operating expenses were $29.5 million, compared to $18.3 million for the same period last year.

Net loss was $30.8 million, or $0.32 per share, compared to $22.0 million, or $0.30 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $122.1 million at June 30, 2019.

Financial Guidance:

The Company is updating 2019 guidance and now anticipates total revenue in the range of $80 million to $95 million, and total cash usage to be in the range of $80 million to $90 million.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, August 8, 2019 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 1695303. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until August 15, 2019. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 1695303.

On August 8, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a price of $15.25 per share, with expected gross proceeds to Stemline of $76,250,000 (Press release, Stemline Therapeutics, AUG 8, 2019, View Source [SID1234538521]). Stemline has also granted the underwriters a 30-day option to purchase up to 750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about August 13, 2019, subject to customary closing conditions.

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!

J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC are acting as co-lead managers for the offering and ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, and Aegis Capital Corp. are acting as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL-401), (ii) clinical trials for additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and potentially other diseases such as certain lymphomas; (iii) clinical development of additional pipeline candidates (felezonexor (SL-801), SL-1001, SL-901 and SL-701); (iv) research and development and regulatory activities; (v) potential acquisitions and in-licensing; and (vi) other general corporate purposes.

Stemline has filed a preliminary prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-230341) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The preliminary prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including CMML, MF, and AML.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including BPDCN, certain myeloproliferative neoplasms (MPNs) including CMML and MF, AML (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.