Valion Bio, Inc 8-K, filed Dec 8, 2021
Valion Bio, Inc. (VBIO)
About this 8-K
Valion Bio, Inc filed this 8-K on December 8, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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): December 8, 2021
TIVIC HEALTH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41052 | 81-4016391 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
39899 Balentine Drive, Suite 200
Newark, CA 94560
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (888) 276-6888
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 | ||
| Common Stock, par value $0.0001 per share | TIVC | The Nasdaq Stock Market LLC |
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 x
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. |
On December 8, 2021, Tivic Health Systems, Inc., a Delaware corporation (the “Company”), will participate in the Sidoti & Company LLC Virtual Micro Cap Conference. The Company’s Chief Executive Officer is scheduled to make an investor presentation at the virtual conference at 3:15 pm Eastern Time. A copy of the investor presentation is attached to this Current Report on Form 8-K (this “Report”) as Exhibit 99.1. The investor presentation has also been posted to the Company’s website in the “Investors” section.
The information in this Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
Forward-Looking Statements
This Report, including Exhibit 99.1 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Report, including Exhibit 99.1 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the “Commission”), reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit Numbers |
Description | |
| 99.1 | Investor conference presentation, dated December 8, 2021 | |
SIGNATURE
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.
Dated: December 8, 2021
| TIVIC HEALTH SYSTEMS, INC. | |||
| By: | /s/ Jennifer Ernst | ||
| Name: | Jennifer Ernst | ||
| Title: | Chief Executive Officer | ||
Exhibit 99.1
1 Bioelectronic Medicine NON - INVASIVELY TARGETING IMMUNE SYSTEM RESPONSES 2021 DECEMBER INVESTOR PRESENTATION
2 This presentation contains forward - looking statements . All statements other than statements of historical facts contained in this presentation may be forward - looking statements . Statements regarding our future results of operations and financial position, economic performance, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, acquisition strategies, investments, and future capital expenditures are all forward looking statements . Without limiting the generality of the foregoing, words such as “may,” “will,” “should,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “target,” “project,” “might,” “plan,” “predict” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward - looking statements . We caution you that any such forward - looking statements are not guarantees of future performance, and are subject to risks, assumptions and uncertainties that are difficult to predict and beyond our ability and control . Although we believe that the expectations reflected in these forward - looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward - looking statements . Any differences could be caused by a number of factors, including but not limited to : our anticipated needs for working capital ; our ability to secure additional financing ; regulatory or legal developments in the United States and other countries ; our expectation regarding timing, costs, conduct and development of our product candidates ; and our efforts to expand our products and business . Many of the important factors that will determine these results are beyond our ability to control or predict . Accordingly, you should not place undue reliance on any such forward - looking statements . Any forward - looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward - looking statement, whether as a result of new information, future developments or otherwise . New factors emerge from time to time, and it is not possible for us to predict which will arise . We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statements . In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject . These statements are based upon information available to us as of the date made, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information . These statements are inherently uncertain, and you are cautioned not to place undue reliance upon these statements . Unless otherwise indicated, information contained in this presentation concerning our industry, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third - party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable . In addition, projections, assumptions and estimates of the future performance of the industry in which we operate, and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, which could cause results to differ materially from those expressed in the estimates made by the independent parties and by us . This presentation shall not constitute an offer to sell or the solicitation of an offer to buy our securities . FORWARD LOOKING STATEMENTS
3 Management Introductions LEADERSHIP TEAM Jennifer Ernst Chief Executive Officer, Co - founder, MBA Built Tivic Health from founding to IPO in 5 years. Took prior company (Thin Film Electronics) from 8 - person R&D team to $480MM market cap in < 5 years, as CEO of US subsidiary. Blake Gurfein Chief Scientific Officer, Ph.D. Neuroscientist, Asst. Prof. of Medicine, UCSF. Pfizer, EMD Serono. Named to 40 under 40, Silicon Valley Business Journal. Four prior neuromodulation products. Briana Benz Chief Financial Officer, MBA 30 years broad based financial, investment banking and high - growth company leadership. Built over $800M in market value. Led multiple acquisition and integration activities. Previously, investment banker with Merrill Lynch Capital Markets. CPA. MBA, Columbia Business School. Ryan Sabia VP, Sales & Operations BS, Finance Global sales, marketing, and operations for omnichannel and ecommerce growth companies. Background in both health and consumer products. Dean Zikria Global Strategy, J&J, Pfizer, Allergy/Asthma Chief Commercial Officer, Intuity Medical. Commercial leadership Pfizer, J&J. Healthcare Strategy at Accenture, Deloitte. Growth leadership in Asthma & Allergy. MBA, Rutgers. BS, Biology, Rutgers. Karen Drexler Public Board Member, Compensation Chair, Nominating & Governance Chair Board of ResMed (NYSE: RSMD), OutSet Medical (NASDAQ: OM) and VIDA Diagnostics. Sale of companies to Roche, J&J. MBA, Stanford; BSE Princeton University. Sheryle Bolton Hult Faculty, Board Chair, Audit Committee Chair Experienced public company CEO. International Board Member and serial entrepreneur. Prior leadership of successful neuroscience IPO. Merrill Lynch Capital Markets. MBA, Harvard Business School. BOARD OF DIRECTORS 2021 Female Founders 100 2021 Top 25 Women in Consumer Healthtech.
4 Investment Highlights TIVIC HEALTH: FOUNDED 2016 23,000 Units Sold 2 FDA Clearances & CE Mark Over 2 3 4 18 500 + PEER - REVIEWED PUBLICATIONS REGULATORY CLEARANCES ISSUED PATENTS PATENTS PENDING 4 - AND 5 - STAR REVIEWS Commercial - phase in high - growth bioelectronics sector. FDA & CE cleared, award - winning product for sinus pain and congestion. $8B available US market , estimated based on company’s proprietary research. Selling on Tier 1 retailers , incl. Amazon, BestBuy, Walmart, Walgreens, and others. Second generation architecture in development, optimized for low - cost manufacturing. Potential applications in migraine and other indications. Experienced management , with public company growth experience. Revenue Growth (9 - month YOY) 64 %
5 THE BIG IDEA The body is an electro chemical system. Electrons can be used as medicine. 5 Bioelectronic medicine “represents a multibillion dollar opportunity, … [and has the] potential to become a pillar of medical treatment.”
6 Electrons as medicine BIOELECTRONICS’ ORIGINS 1960s Pacemakers 2010s Sleep Apnea, Rheumatoid Arthritis 1990s Deep Brain, Spinal Cord 2020s Non - Invasive Bioelectronics • Bioelectronic medicine treats disease by tuning electrical signaling carried along neural (nerve) pathways. • Tivic Health focuses on tuning these signals non - invasively. • Non - invasive = Shorter development time, lower risk, broader applicability. INVASIVE NON - INVASIVE
7 Clears congestion, stops sinus pain, non - invasively. ClearUP ® • User glides tip along facial skin around cheek, nose, brow (sinus regions) for 5 minutes, twice daily and as needed. • Low - level pulsed current flows from tip, through sinus passages. • Launched late 2019. Available through Tier 1 online retailers. • $149 list price. Margins both volume and channel dependent. FIRST COMMERCIAL PRODUCT Featured on … … and more “ Changed my life! “Unbelievable” “Godsend” “Amazing!” As of 10.21.2021
8 OUR PLATFORM FOR Non - invasive Peripheral Nerve Stimulation Programmable Parameters produce varied biological responses for different diseases and conditions Patented Form Factor enables low - level electrical current to penetrate deeply through tissue Proprietary Algorithms detect optimal treatment zones, personalize therapeutic stimulation
9 PIPELINE Other Potential Use Cases Postoperative Pain following sinus surgery 600,000 FESS (sinus) surgeries annually in US, alternative to opioids Temporomandibular Joint Disorder (TMJ) Tinnitus Trigeminal Neuralgia Otitis Media / Ear Infection Migraine Headache 39M people in US, 1B people w orldwide Extensible technology Additional potential market opportunities associated with stimulation of nerves of the face and head (trigeminal, vagus, facial). PRODUCT / PRODUCT LINE THERAPEUTIC AREA DISCOVERY /R&D CLINICAL FEASIBILITY PIVOTAL STUDY REGULATORY CLEARANCE COMMERCIAL DISTRIBUTION CONTENT PARTNERS ClearUP Ʀ Sinus Pain and Congestion npdPP Post - Operative Pain npdMI Migraine Sinus Pain and Congestion (commercial) Estimated 200M US adults, $8B estimated US market, global opportunity
10 K182025 CE 704687 DEN200006 ISSUED PATENTS (issued in 2020 & 2021) 5 PATENTS PENDING 18 STRONG INTELLECTUAL PROPERTY THREE REGULATORY CLEARANCES PEER - REVIEWED PUBLICATIONS Open - label study. Continuous reduction in pain and congestion over 4 - weeks of at - home use. Published: Bioelectronic Medicine Double - blind, sham - controlled, randomized trial. Reductions in pain and congestion vs. sham 10 minutes after treatment. Published: International Forum of Allergy & Rhinology ROBUST FOUNDATIONS
11 Oral & Intranasal Decongestants Antihistamines • Treat itchiness • Not effective for congestion and pain • Headache, sleepiness, fatigue, dry mouth, and sore throat • Insomnia, nervousness, heart palpitations, headache, sweating, nausea, trembling, weakness, rebound Saline Irrigation • Messy / impractical • Not portable • $706M US market Drugs Dominate Sinus Care … but 90% of sufferers interested in treatments that decrease use of drugs 1 (1) Market research study of 600 people with recurring sinus conditions. Company sponsored research conducted by Research America . COMPETITIVE LANDSCAPE Intranasal Steroids • Powerful drug • Burning, stinging, nose bleeds, headache, nausea, vomiting, diarrhea, sore throat, dizziness, cough
12 82% preferred ClearUP to current treatments 1 STRONG CONSUMER PREFERENCE • No pills, no sprays, nothing in the nose • No drugs, no significant side effects reported 2 • Use any time, anywhere, whenever and as often as needed (2) Most common side effect: 0.02% reported mild skin irritation in clinical studies and post - market surveillance. (1) Data from a 71 - person double - blind, randomized, controlled clinical study conducted by Stanford Medicine.
13 Maul XA, Borchard NA, Hwang PH, Nayak JV. Microcurrent technology for rapid relief of sinus pain: a randomized, placebo-controll ed, double-blinded clinical trial. Int Forum Allergy Rhinol. 2019;9:352 – 356. Fast - acting Double - blind, randomized, sham - controlled trial examined acute response. Reduction in pain and congestion, 10 - minutes after first use. #p = 0.007; *p = 0.008; two - tailed unpaired t - test comparing Sham vs. ClearUP RESULTS PUBLISHED IN CLINICAL: PEER - REVIEWED PUBLICATION Runner - Up Best Clinical Manuscript Effective for 74% of users 10 minutes after use Clinically meaningful reduction in pain and congestion
14 Goldsobel, A.B., Prabhakar, N. & Gurfein, B.T. Prospective trial examining safety and efficacy of microcurrent stimulation fo r t he treatment of sinus pain and congestion. Bioelectron Med 5, 18 (2019) doi:10.1186/s42234 - 019 - 0035 - x #p < 0.01; *p < 0.0001; two - tailed paired t - test comparing pre - treatment vs. post - treatment Continued Improvement With Regular Use CLINICAL: PEER - REVIEWED PUBLICATION 4 - week open - label study showed continued reduction in pain and congestion with daily use; also showed durable effect , relief present at 6 hours after treatment. Continued week - over - week reduction in symptoms ▼ 43.3% Reduction in Pain ▼ 44.3% Reduction in Congestion RESULTS PUBLISHED IN Effective for 88% of users after 4 weeks of use
15 Multiple pathways relieve multiple symptoms 1 . Maul, Ximena A . , et al . "Microcurrent technology for rapid relief of sinus pain : a randomized, placebo-controlled, double-blinded clinical trial . " International forum of allergy & rhinology . Vol . 9 . No . 4 . 2019 . Trigeminal nerve activation mediates pain CLINICAL: MECHANISM OF ACTION Pain Low - level current applied to sensory trigeminal nerves markedly reduces pain 1 2 . Mandel, Yossi, et al . "Vasoconstriction by electrical stimulation : new approach to control of non - compressible hemorrhage . " Scientific reports 3 . 1 ( 2013 ) : 1 - 7 . 3 . Franco, O . S . , et al . “Effects of different frequencies of transcutaneous electrical nerve stimulation on venous vascular reactivity . ” Brazilian Journal of Medical and Biological Research 47 . 5 ( 2014 ) : 411 - 418 . 4 . Malm, L . “Stimulation of sympathetic nerve fibres to the nose in cats . ” Acta otolaryngologica 75 . 2 - 6 ( 1973 ) ; 519 - 526 .. 5 . Fischer, Laurent, et al . “Adrenergic and non - adrenergic vasoconstrictor mechanisms in the human nasal mucosa . ” Rhinology 31 . 1 ( 1993 ) : 11 - 15 . Congestion Activation of sympathetic nerve fibers promotes rapid release of norepinephrine and vasoconstriction. 2 - 4 Vasoconstriction reduces swelling, increases air flow, and decreases congestion. 5 The mechanism described has been reviewed by the FDA in conjunction with FDA Clearances. The exact mechanism of action for ClearUP has not been definitively proven. Sympathetic nerve activation relieves congestion. Trigeminal nerve activation mediates pain Sympathetic nerve activation relieves congestion.
16 2019 Sinus Pain from allergies 2021 Moderate to Severe Congestion from any cause 50M monthly allergy sufferers. 1 90% experience sinus pain from allergic rhinitis. 2 27% would consider purchase @ $149. 2 = $1.8B US Market 200M US adults experience at least monthly. 1 27% would consider purchase @ $149. 2 = $8.0B US Market Large Markets, Significant Growth Opportunity MARKET SIZE CE Mark Secured for International Growth Sinus Pain, Pressure & Congestion from any cause Global problem. Future growth opportunity secured by existing regulatory clearance. ClearUP is indicated for use for temporary relief of sinus pain from allergic rhinitis (US FDA), for temporary relief of moderate to severe congestion (US FDA), and for temporary relief of sinus pain, pressure and congestion (CE Mark). (1) Data from publicly available information that has not been independently verified by the Company. (2) Market research study of 600 people with recurring sinus conditions. Company sponsored research conducted by Research America .
17 Future Channel Growth Optimize and scale highest margin channels MARKET DEVELOPMENT Early Traction Expedited Development Sept 2016 – Sept 2019 2020 - 2021 2022+ • Optimize website and D2C channels • Scale - up advertising to drive sales, capture market share • Expand social media, content marketing x Tier 1 sales relationships in place x Over 23,000 units sold x 500+ 4 - and 5 - star ratings x 3 years from founding to product sales of FDA - cleared medical device Early traction shows high - growth opportunities in D2C 2023+ 74% of target customers expect to purchase on - line, 65% from manufacturer’s website 1 o In - store o Healthcare professional (HCP) referrals o International (1) Market research study of 600 people with recurring sinus conditions. Company sponsored research conducted by Research America .
18 Tried - and - true omnichannel, multi - touchpoint approach DEMAND GENERATION BUILD CREDIBILITY / RETARGETTING 4 - & 5 - star reviews, clinical publications, value - added content (video content, blogs) DRIVE PURCHASE On - site advertising, co - operative marketing, seasonal promotions GENERATE AWARENESS Digital, cable, and CTV video advertising, social media, SEO, content marketing Currently available at … and others 89% 80% 39% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2019 2020 2021 YTD Advertising as % of Sales Buy Now
19 New design built to deliver economies of scale GEN2 ARCHITECTURE • Fewer parts • Fully automated assembly for electronics • Estimated 5x increase to line output • Flexible design allows for future products on same architecture • High on - time production through 2020 & 2021 • Favorable supply agreement for parts sourced overseas • Core manufacturing, assembly, test, warehousing and distribution on - shore GEN 1: BUILT STRONG SUPPLY CHAIN GEN2 – 2022 PLANNED RELEASE: BUILT FOR VOLUME
20 Twelve Months Ended December 31 Nine Months Ended September 30 (in thousands) FY 2020 FY 2019 Q1 - Q3 2021 Q1 - Q3 2020 Revenues $ 860 $ 420 $ 800 $ 489 Gross Profit (Loss) (225) (289) (104) (143) Operating Profit (Loss) (3,204) (3,643) (3,341) (2,399) 0 100 200 300 400 500 600 700 800 900 2019 FY 2020 FY Thousands Annual Revenue 0 100 200 300 400 500 600 700 800 900 2020 2021 Thousands 9 - Mo. Revenue $0 $200 $400 $600 $800 $1,000 $1,200 Thousands Trailing Twelve Months FINANCIALS Income Statement • Successful roll - out in “difficult” times. • Increasing revenue and gross margins. • Some quarterly fluctuations due to seasonality and retail buying patterns. Q4’19 Q3’21
21 Common Stock (outstanding at IPO) 6,265,234 Common Stock (sold in IPO with overallotment) 3,450,000 Options and warrants 649,469 Fully Diluted Shares 10,364,703 Strong Cap Table & Balance Sheet FINANCIALS • IPO completed November 2021 with oversubscription: $15M+ net proceeds • No outstanding debt or preferred stock
22 2022 Directions INVESTMENTING FOR GROWTH Expand sales and marketing • Upgrade ecommerce infrastructure, online website design and branding • Optimize and expand advertising and public relations • Increase support for social media and digital Improve gross margin • Launch ClearUP Gen 2 product with improved cost structure • Higher volume absorbing fixed & allocated costs • Increase % of sales through direct channels Secure the future • Clinical research to validate migraine and post - operative pain management opportunities • Evaluation of potential merger, acquisition & licensing opportunities Build Tivic as the trusted brand for non - invasive bioelectronic medicine
23 Summary TIVIC HEALTH FDA - cleared product in high - growth sector. Established Tier 1 channels in place. 64% revenue growth 9 - Month YOY 2020 v. 2021. $8B estimated available market. Clinical validation with leading institutions, peer - reviewed publications. Regulatory clearances for both US and international sales. Robust IP portfolio, recently issued patents. Stable supply chain . Extensible platform with multiple product opportunities. Growth strategy built for 21 st century. Experienced leadership , with public company experience, ready to scale.
24 24 Jennifer Ernst CEO, Tivic Health jennifer.ernst@tivichealth.com