UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 10, 2022
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
(Address of principal executive offices) (Zip Code)
(760 ) 560-1501
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||||||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||||||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||||||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | ||||||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
Exagen Inc. is furnishing with this Current Report on Form 8-K a copy of its current presentation slides regarding its AVISE® RADR testing solution. The information in these slides shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EXAGEN INC. | ||||||||||||||||||||
| Date: January 10, 2022 | By: | /s/ Kamal Adawi | ||||||||||||||||||
| Kamal Adawi | ||||||||||||||||||||
| Chief Financial Officer | ||||||||||||||||||||
EXAGEN CONFIDENTIAL1 Rheumatoid Arthritis Drug Response
This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, , current and future product offerings, including AVISE RADR, reimbursement and coverage, our ability to implement an integrated testing with therapeutics strategy, the expected benefits from our partnership or promotion arrangements with third parties, research and development costs, timing and likelihood of success and plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These known risks and uncertainties are described in detail in our filings with the SEC from time to time, including under the heading "Risk Factors" in our Annual Report on Form 10-K and any subsequent filings with the SEC. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. We obtained the industry, market and competitive position data used throughout this presentation from our own internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies and publicly available information in addition to research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expressly refer to the sources from which this data is derived. In addition, while we believe our own internal research is reliable, such research has not been verified by any independent source and you are cautioned not to give undue weight to such estimates. EXAGEN CONFIDENTIAL2 Disclaimer
EXAGEN CONFIDENTIAL3 Unmet Need Currently, 70%–80% of RA patients fail to reach low disease activity2 Innovative Platform First rule-in therapy selection test for rheumatoid arthritis Exclusive Rights Exagen holds the exclusive worldwide license to the IP rights Minimally Invasive Synovial tissue is collected from a biopsy that takes place inside an existing rheumatologist’s office Payor Benefits Reduces patient cycling - Potentially large savings for payors Own the Hilltop Exagen has a well- respected and proven rheumatology infrastructure References: 1. Myasoedova et al. Arthritis & Rheumatology 2010 2. Pitzalis et al. Nature Reviews Rheumatology. 2020. Sizable TAM Rheumatoid arthritis affects 2M patients and adds 120K new patients per year1 Precision Medicine for Rheumatoid Arthritis
Significant Unmet Needs EXAGEN CONFIDENTIAL4
Low Patient Response Rates EXAGEN CONFIDENTIAL5 Do NOT achieve an ACR20 response Do NOT achieve an ACR50 response Do NOT achieve an ACR70 response References: Pitzalis et al. Nature Reviews Rheumatology. 2020. 40% 60% 80% *ACR response rates include all RA therapeutics
Large Addressable Market EXAGEN CONFIDENTIAL6 $18B in Wasted RA Therapeutic Spend Existing patients in the U.S. living with RA1 ~2 Million 70%-80% RA patients fail to reach low disease activity3 References: 1. Myasoedova et al. Arthritis & Rheumatology 2010 2. IQVIA DDD Data; IBM Truven patient claims data; Cowen Therapeutic Categories Outlook Feb 2021 3. Pitzalis et al. Nature Reviews Rheumatology. 2020. $30B Total RA Therapeutic U.S. Market each year2 120,000 Americans diagnosed with RA every year1
Precision Medicine Approach Helps Guide Treatment EXAGEN CONFIDENTIAL7
A Formula for RA Precision Medicine Clinical disease activity indices EXAGEN CONFIDENTIAL8 An ‘Individual Patient Signature’ is based on the following features: References: Ribera et al. Annals of Rheumatic Diseases. 2019. Gene expression analysis performed on synovial tissue Proteomics RA lab test
The AVISE RADR Approach to Personalized Medicine 1. Synovial Biopsy Patients undergo a minimally invasive procedure to collect 6 biopsies in one visit 2. Gene Expression Profiling Performed on synovial tissue collected from an affected joint; pathotype is determined 3. Personalized Medicine The patient’s pathotype is matched to the therapy most likely to lead to response EXAGEN CONFIDENTIAL9
Rheumatoid Arthritis Pathotypes EXAGEN CONFIDENTIAL10 References: Lewis et al. Cell Reports. 2019; Kelly et al. Ann Rheum Dis. 2015 RA pathotypes are defined by the type of immune cells present in affected joints H&E CD3 CD20 CD68 CD138 Lympho-myeloid Diffuse-myeloid Pauci-immune fibroid
Synovial Biopsy is Superior to Other Methods EXAGEN CONFIDENTIAL11 References: Lewis et al. Cell Reports. 2019; Kelly et al. Ann Rheum Dis. 2015 differently expressed transcripts in blood 8 3,000 differently expressed transcripts in synovial tissue
The Value of Precision Medicine EXAGEN CONFIDENTIAL12 Once a patient fails to respond, a doctor has 12 drugs to choose from, with no current rule-in test to guide their decision. Existing Patient Journey1 AVISE RADR Patient Journey Speed and accuracy in the treatment selection has the potential to protect a patient’s joints and be cost effective. Low disease activity Low disease activity anti-TNF B-cell depleting anti-IL6R Methotrexate References: 1. Lewis et al. Cell Reports. 2019 JAK inhibitors
AVISE RADR Position in the Patient Journey EXAGEN CONFIDENTIAL13 RA diagnosis csDMARD therapy Disease managed adequately Disease inadequately managed 1st line therapy 2nd line therapy 1 2 Patient most likely to respond to anti-TNF therapy Patient most likely to respond to B-cell depleting therapy Patient most likely to respond to anti-IL6R therapy Patient most likely to respond to JAK inhibitors
AVISE RADR expands our well-respected and proven portfolio Owning the Hilltop EXAGEN CONFIDENTIAL14
Exagen is a Leader in Rheumatology Minimally invasive Uses existing equipment Replaces the issues with rule-out empirical treatments with precision personalized medicine EXAGEN CONFIDENTIAL15 Exagen has a highly respected rheumatology salesforce in place with support and infrastructure ready to go What does this mean for Rheumatologists?
EXAGEN CONFIDENTIAL16 Unmet Need Currently, 70%–80% of RA patients fail to reach low disease activity2 Innovative Platform First rule-in therapy selection test for rheumatoid arthritis Exclusive Rights Exagen holds the exclusive worldwide license to the IP rights Minimally Invasive Synovial tissue is collected from a biopsy that takes place inside an existing rheumatologist’s office Payor Benefits Reduces patient cycling - Potentially large savings for payors Own the Hilltop Exagen has a well- respected and proven rheumatology infrastructure References: 1. Myasoedova et al. Arthritis & Rheumatology 2010 2. Pitzalis et al. Nature Reviews Rheumatology. 2020. Sizable TAM Rheumatoid arthritis affects 2M patients and adds 120K new patients per year1 Precision Medicine for Rheumatoid Arthritis
Thank You