Market Newsdesk

XDEMVY™ (lotilaner ophthalmic solution) 0.25% received FDA approval for the treatment for Demodex blepharitis

On track to have XDEMVY and sales force in market by the end of August 2023

Completed enrollment of Galatea, a Phase 2a trial evaluating TP-04 for Rosacea, with topline data expected in 1H 2024

Strengthened balance sheet with $100 million public equity offering in August 2023

IRVINE, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results for the second quarter ended June 30, 2023, and recent business achievements.

“The FDA approval of XDEMVY for the treatment of Demodex blepharitis is a seminal milestone for Tarsus, the eye care community and most importantly for patients, many of whom have struggled for years without an approved, effective treatment option,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “We are well-positioned and well-funded, expect to launch XDEMVY later this month to capture the potentially very significant patient demand, and anticipate rapid adoption among eye care providers and meaningful prescription volume in the early days following XDEMVY’s entrance into the market.”

Recent Business Highlights and Corporate Update

• On July 24, 2023, the FDA approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis (DB)
  • First and only approved therapeutic for DB, a highly prevalent eyelid disease that impacts approximately 25 million eye care patients in the U.S.
  • XDEMVY targets the root cause of DB and in pivotal trials demonstrated significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than 2 collarettes per upper lid), mite eradication (mite density of 0 mites per lash) and erythema cure (Grade 0)
• Actively engaging in contracting discussions with all the top commercial and Medicare accounts and expect to secure commercial coverage sequentially throughout 2024 and Medicare coverage in 2025
• Completed recruitment of our 85-person sales force targeting ~15K optometrists and ophthalmologists, which represents >80% of the projected market; expect sales force to be deployed by the end of August when we anticipate product to be available
• Established unique distribution model leveraging high touch retail and digital pharmacies to offer broad patient access with a potential 2x fill rate compared to traditional approaches
• Active disease education continuing to drive awareness and encouraging eye care providers (ECPs) to proactively diagnose DB
  • Consistently > 90% of ~250 optometrists and ophthalmologists surveyed indicated they would prescribe an FDA-approved therapeutic for DB
  • “Look at the Lids” disease education campaign has generated nearly 300K unique website visits, up from 200K last quarter and nearly 3M digital/media impressions, an increase of 700K impressions since last quarter
• Saturn-2 pivotal trial results were published in the American Academy of Ophthalmology journal
  • XDEMVY met the primary, all secondary endpoints and was generally well tolerated

Achieved and Anticipated 2023 Milestones

Program	Milestone	Anticipated Indication	H1 2023	H2 2023
TP-04	Initiated Phase 2a (Galatea)	Rosacea	X
XDEMVY	FDA Approval	Demodex blepharitis		X
TP-03	Topline Phase 2a (Ersa)	Meibomian Gland Disease		●
TP-05	Topline Phase 2a (Carpo)	Lyme disease prevention		●

Second Quarter 2023 Financial Results

• Second quarter net loss for 2023 was $31.4 million, compared to a net loss of $5.7 million for the same period in 2022, which was primarily due to: (i) a decrease of $15.3 million of license fee and collaboration revenue, (ii) an increase of $9.9 million of general and administrative expenses, and (iii) an increase of $2.9 million of research and development expenses
• Second quarter 2023 there were no amounts reported within license fee and collaboration revenue related to the strategic partnership with LianBio, compared to $15.3 million for the same period in 2022
• Second quarter research and development expenses for 2023 were $12.5 million (inclusive of stock-based compensation of $1.5 million), compared to $9.6 million for the same period in 2022
• Second quarter general and administrative expenses for 2023 were $20.3 million (inclusive of stock-based compensation of $3.7 million), compared to $10.4 million for the same period in 2022, which was primarily due to a $5.3 million increase of payroll and personnel-related costs; and a $3.5 million increase of commercial and market research costs related to our commercial expansion as we prepare to launch our recently approved product, XDEMVY
• As of June 30, 2023, cash, cash equivalents and marketable securities were $178.2 million, not including the recent equity public offering of $100 million in gross proceeds, completed in August 2023

About

Demodex

Blepharitis

Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis.

About XDEMVY™

XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.

XDEMVY Indication and Important Safety Information

INDICATIONS AND USAGE

XDEMVY is indicated for the treatment of Demodex blepharitis.

Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis.

For additional information, please see full prescribing information available at: www.xdemvy.com.

About Tarsus Pharmaceuticals, Inc.

Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the timing and availability of XDEMVY for prescription, the market size, acceptance, demand, prescription fill rate and adoption rate for XDEMVY; our ability to achieve distribution and patient access for XDEMVY and timing and breadth of payer coverage; our sales force size and hiring plans; our ability to continue to educate the market about Demodex blepharitis, the market size for TP-03, TP-04, and TP-05, the timing, objectives, and results of the clinical trials, anticipated regulatory and development milestones, our ability to continue investing in our business, future events and Tarsus’ plans for and the anticipated benefits of its product candidates including TP-03, TP-04 and TP-05, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward- looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus’ ability to maintain regulatory approval for and successfully commercialize XDEMVY for the treatment of Demodex blepharitis, Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product, XDEMVY for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus’ ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus’ business and operations; even if TP-03, TP-04, TP-05, or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis, MGD, rosacea, Lyme disease prevention, and/or other diseases or conditions targeted by Tarsus’ products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus’ product candidates, particularly XDEMVY for the treatment of Demodex blepharitis, TP-03 for the treatment of MGD, TP-04 for the treatment of Rosacea, as well as TP-05 for the prevention of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2022 filed on March 17, 2023 and the most recent Form 10-Q quarterly filing filed with the SEC, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:
Adrienne Kemp
Sr. Director, Corporate Communications
(949) 922-0801
[email protected]
Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223
[email protected]

TARSUS PHARMACEUTICALS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(unaudited)

	Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Revenues:
License fees and collaboration revenue	$	—			$	15,277			$	2,500			$	15,816
Operating expenses:
Cost of license fees and collaboration revenue		—				522				—				555
Research and development		12,546				9,603				24,902				21,684
General and administrative		20,275				10,376				35,371				18,322
Total operating expenses		32,821				20,501				60,273				40,561
Loss from operations before other income (expense) and income taxes		(32,821	)			(5,224	)			(57,773	)			(24,745	)
Other income (expense):
Interest income		2,226				297				4,519				311
Interest expense		(815	)			(544	)			(1,499	)			(874	)
Other (expense) income, net		(47	)			106				(41	)			143
Unrealized gain (loss) on equity investments		15				(121	)			(50	)			(313	)
Change in fair value of equity warrants issued by licensee		18				(257	)			1				(502	)
Total other income (expense), net		1,397				(519	)			2,930				(1,235	)
Provision for income taxes		—				—				—				(1	)
Net loss	$	(31,424	)		$	(5,743	)		$	(54,843	)		$	(25,981	)
Other comprehensive loss:
Unrealized gain on marketable securities and cash equivalents		47				—				51				—
Comprehensive loss	$	(31,377	)		$	(5,743	)		$	(54,792	)		$	(25,981	)
Net loss per share, basic	$	(1.17	)		$	(0.24	)		$	(2.05	)		$	(1.15	)
Net loss per share, diluted	$	(1.17	)		$	(0.24	)		$	(2.05	)		$	(1.15	)
Weighted-average shares outstanding, basic		26,815,733				24,332,531				26,779,203				22,531,384
Weighted-average shares outstanding, diluted		26,815,733				24,332,531				26,779,203				22,531,384

TARSUS PHARMACEUTICALS, INC.

BALANCE SHEETS

(In thousands, except share and par value amounts)

	June 30, 2023				December 31, 2022
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	106,773			$	71,660
Marketable securities		71,455				145,366
Other receivables		246				3,582
Prepaid expenses		5,002				4,767
Total current assets		183,476				225,375
Property and equipment, net		1,541				957
Operating lease right-of-use assets		2,137				575
Long-term investments		322				371
Other assets		1,451				585
Total assets	$	188,927			$	227,863
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and other accrued liabilities	$	9,459			$	9,910
Accrued payroll and benefits		5,306				5,519
Total current liabilities		14,765				15,429
Term loan, net		24,607				19,434
Other long-term liabilities		1,826				100
Total liabilities		41,198				34,963
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 authorized; no shares issued and outstanding		—				—
Common stock, $0.0001 par value; 200,000,000 shares authorized; 26,899,572 shares issued and outstanding at June 30, 2023 (unaudited); 26,727,458 shares issued and outstanding at December 31, 2022		5				5
Additional paid-in capital		311,353				301,732
Accumulated other comprehensive loss		(23	)			(74	)
Accumulated deficit		(163,606	)			(108,763	)
Total stockholders’ equity		147,729				192,900
Total liabilities and stockholders’ equity	$	188,927			$	227,863

CENTREVILLE, Va., Aug. 10, 2023 (GLOBE NEWSWIRE) — Parsons Corporation (NYSE: PSN) announced today that the company has been selected by United States Cyber Command (CYBERCOM) to continue support previously provided under the command, control, communications, computers, and capabilities development (C4CD) and C4CD Bridge contracts. The $109 million classified contract includes a one-year base period plus four one-year option periods.

“Our unmatched technical talent and disruptive, warfighter-focused capabilities enhance mission effectiveness for CYBERCOM as they continue defending and advancing national security interests,” said Mike Kushin, president of Parsons’ Defense and Intelligence sector. “We are proud to continue our ongoing CYBERCOM support, with a focus on the J9 Acquisition and Technology Directorate mission set.”

Parsons operates in every aspect of the all-domain battlespace and addresses emerging threats by fusing technologies across the now-connected warfighting domains (land, air, sea, space, cyberspace) and incorporates information operations, intelligence, data analytics, electronic warfare, multi-echelon command and control, and kinetic operations into a unified approach.

To unlock Parsons’ national security capabilities, visit https://www.parsons.com/national-security/

About Parsons:

Parsons (NYSE: PSN) is a leading disruptive technology provider in the national security and global infrastructure markets, with capabilities across cyber and intelligence, space and missile defense, transportation, environmental remediation, urban development, and critical infrastructure protection. Please visit
 
parsons.com
and follow us on
LinkedIn
and
Facebook
to learn how we’re making an impact.

Forward-Looking Statements

This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are based on our current expectations, beliefs and assumptions, and are not guarantees of future performance. Forward-looking statements are inherently subject to uncertainties, risks, changes in circumstances, trends and factors that are difficult to predict, many of which are outside of our control. Accordingly, actual performance, results and events may vary materially from those indicated in the forward-looking statements, and you should not rely on the forward-looking statements as predictions of future performance, results or events. Numerous factors could cause actual future performance, results and events to differ materially from those indicated in the forward-looking statements, including, among others: any issue that compromises our relationships with the U.S. federal government or its agencies or other state, local or foreign governments or agencies; any issues that damage our professional reputation; changes in governmental priorities that shift expenditures away from agencies or programs that we support; our dependence on long-term government contracts, which are subject to the government’s budgetary approval process; the size of our addressable markets and the amount of government spending on private contractors; failure by us or our employees to obtain and maintain necessary security clearances or certifications; failure to comply with numerous laws and regulations; changes in government procurement, contract or other practices or the adoption by governments of new laws, rules, regulations and programs in a manner adverse to us; the termination or nonrenewal of our government contracts, particularly our contracts with the U.S. federal government; our ability to compete effectively in the competitive bidding process and delays, contract terminations or cancellations caused by competitors’ protests of major contract awards received by us; our ability to generate revenue under certain of our contracts; any inability to attract, train or retain employees with the requisite skills, experience and security clearances; the loss of members of senior management or failure to develop new leaders; misconduct or other improper activities from our employees or subcontractors; our ability to realize the full value of our backlog and the timing of our receipt of revenue under contracts included in backlog; changes in the mix of our contracts and our ability to accurately estimate or otherwise recover expenses, time and resources for our contracts; changes in estimates used in recognizing revenue; internal system or service failures and security breaches; and inherent uncertainties and potential adverse developments in legal proceedings, including litigation, audits, reviews and investigations, which may result in materially adverse judgments, settlements or other unfavorable outcomes. These factors are not exhaustive and additional factors could adversely affect our business and financial performance. For a discussion of additional factors that could materially adversely affect our business and financial performance, see the factors included under the caption “Risk Factors” in our Registration Statement on Form S-1 and our other filings with the Securities and Exchange Commission. All forward-looking statements are based on currently available information and speak only as of the date on which they are made. We assume no obligation to update any forward-looking statement made in this presentation that becomes untrue because of subsequent events, new information or otherwise, except to the extent we are required to do so in connection with our ongoing requirements under federal securities laws.

Media Contact:
Angie Benfield
+1 803.334.5277
[email protected]

Investor Relations Contact:
Dave Spille
+1 703.775.6191
[email protected]

REDWOOD CITY, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) — Talis Biomedical Corporation (Nasdaq: TLIS), a diagnostic company dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care, today reported financial results for the second quarter ended June 30, 2023, and provided a business update.

Recent Business Highlights

• Initiated clinical study to support COVID-19 510(k) submission for clearance of the Talis One^® system
• Presented positive data at the Infectious Disease Society for Obstetrics and Gynecology (IDSOG) annual meeting differentiating the planned Talis One test menu
  • Development-stage chlamydia, gonorrhea and trichomonas (CT/NG/TV) assay demonstrated clinical performance comparable to widely used on-market molecular tests in less than 30 minutes
  • Established ability to effectively lyse multiple Candida species in under four minutes on the Talis One system, positioning the Company to develop a point-of-care vaginal infection panel
• Appointed diagnostic industry veterans, Dr. Heiner Dreismann to the Talis Biomedical Board of Directors and Dr. Andrew Lukowiak as president and chief scientific officer
• Delivered 53% improvement in year-to-date net cash used in operating activities year-over-year to support cash runway into 2025

“During the second quarter, we made important progress across our strategic priorities to develop and deliver a targeted menu of infectious disease tests that women’s and sexual health providers are seeking at the point of care,” said Rob Kelley, chief executive officer of Talis Biomedical. “With the data we are generating, our focused execution and healthy cash position, it is our plan to secure regulatory clearance for three test panels by the end of 2025. We are excited for the opportunity to capture this large and growing market and to make a meaningful impact on the delivery of timely and accurate patient care.”

Second Quarter 2023 Financial Results

Revenue was $0.6 million for the second quarter of 2023, which includes $0.5 million of NIH grant revenue. Revenue was $0.6 million for the same period in 2022.

Operating expenses were $17.0 million in the second quarter of 2023, compared to $27.8 million for the same period in 2022. The decrease was primarily driven by lower investments in raw card inventory and manufacturing as well as the realization of benefits from the spending reduction measures implemented during 2022.

Net loss was $15.0 million for the second quarter of 2023, compared to $27.0 million for the same period in 2022.

Cash and Liquidity

Unrestricted cash and cash equivalents as of June 30, 2023, were $98.2 million.

Net cash used in operating activities for the six months ended June 30, 2023 was $30.7 million, as compared to $65.8 million in the same period of 2022. This decrease was primarily driven by lower headcount costs from the Company’s spending reduction program as well as declines in payments for raw card inventory and manufacturing investments.

To support long-term financial objectives, the Company recently reduced its Redwood City, California office and lab space by two-thirds. The Company expects approximately $9 million of cash savings over the life of the lease.

About the Talis One System

The Talis One system is a compact, sample-to-answer molecular testing platform designed to enable rapid, highly accurate point-of care infectious disease testing in non-laboratory settings. The Talis One test cartridge is a fully self-contained, closed device that includes all the necessary reagents to perform a Talis One test. When loaded into the Talis One instrument, each cartridge fully automates sample lysis, nucleic acid extraction and purification, isothermal amplification, and target detection. The Talis One test system is not authorized, cleared, or approved by the FDA and is not available for sale.

About Talis Biomedical

Talis Biomedical is dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care. The Company plans to develop and commercialize innovative products on its sample-to-answer Talis One^® system to enable accurate, low cost, and rapid molecular testing. For more information, visit talisbio.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “would,” “should,” “believe,” “expect,” “anticipate,” “could,” “estimate,” “continue,” “predict,” “potential,” “forecast,” “project,” “plan,” “intend” or similar expressions, or other words that convey uncertainty of future events or outcomes can be used to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our plans to advance our pipeline, including the plans to develop Talis One assays in the women’s and sexual health markets; the size and potential of our opportunity in the women’s and sexual health markets; our ability to capitalize on any c
ompetitive advantages; our ability to position the Company to provide durable value to our shareholders; the benefits of our regulatory strategy; our futurerevenue growth and profit margins; and our ability to lower our cash burn, extend operations and extend our cash runway. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties associated with development and regulatory approval, the impact to our business from global and regional economic conditions, including as a result of government policies, war, terrorism, natural disasters, public health issues and inflationary pressures and any related impact on our ability to develop our pipeline products, our ability to achieve or sustain profitability, our ability to launch and gain market acceptance for our pipeline products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing, capacity constraints or delays in production of our products, product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These statements are based upon information available to us as of the date of this press release, 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 investors are cautioned not to unduly rely upon these statements. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Talis assumes no obligation to updates forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Contact

Media & Investors
Emily Faucette
[email protected] 
415-595-9407

Talis Biomedical Corporation 
Condensed Balance Sheets 
(in thousands) 

		June 30,				December 31,
			2023				2022
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	98,200			$	130,191
Restricted cash			1,010				—
Accounts receivable, net			532				308
Prepaid expenses and other current assets			2,223				2,783
Total current assets			101,965				133,282
Property and equipment, net			3,539				3,312
Operating lease right-of-use-assets			16,030				30,920
Other long-term assets			1,542				1,776
Total assets		$	123,076			$	169,290
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	2,491			$	3,768
Accrued compensation			3,097				4,212
Accrued liabilities			938				989
Operating lease liabilities, current portion			2,736				3,703
Total current liabilities			9,262				12,672
Operating lease liabilities, long-term portion			17,648				29,879
Total liabilities		$	26,910			$	42,551
Stockholders’ equity:
Series 1 convertible preferred stock			3				3
Common Stock			—				—
Additional paid-in capital			606,982				604,690
Accumulated deficit			(510,819	)			(477,954	)
Total stockholders’ equity			96,166				126,739
Total liabilities and stockholders’ equity		$	123,076			$	169,290

Talis Biomedical Corporation 
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands) 

		Three Months Ended June 30,								Six Months Ended June 30,
			2023				2022				2023				2022
Revenue
Grant revenue		$	533			$	70			$	1,614			$	944
Product revenue, net			48				502				185				2,815
Total revenue, net			581				572				1,799				3,759
Operating expenses:
Cost of products sold			7				1,302				27				4,823
Research and development			10,555				17,365				24,351				38,068
Selling, general and administrative			6,410				9,178				12,809				21,108
Total operating expenses			16,972				27,845				37,187				63,999
Loss from operations			(16,391	)			(27,273	)			(35,388	)			(60,240	)
Other income, net			1,357				262				2,523				178
Net loss and comprehensive loss		$	(15,034	)		$	(27,011	)		$	(32,865	)		$	(60,062	)
Net loss per share, basic and diluted		$	(8.27	)		$	(15.01	)		$	(18.11	)		$	(33.47	)
Weighted average shares used in the calculation of net loss per share, basic and diluted			1,817,288				1,799,559				1,814,994				1,794,463

 

FREMONT, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) — Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced the company will be participating in the upcoming 2023 UBS MedTech, Tools and Genomics Summit in Dana Point, CA.

Cytek management is scheduled to participate in the Emerging Life Science Technologies Across Genomics and Proteomics panel on Wednesday, August 16^th at 7:00 a.m. Pacific Time / 10:00 a.m. Eastern Time. Cytek management will be participating in one-on-one meetings with investors on Wednesday, August 16^th and Thursday, August 17^th.

About Cytek Biosciences, Inc.

Cytek Biosciences (Nasdaq: CTKB) is a leading cell analysis solutions company advancing the next generation of cell analysis tools by delivering high-resolution, high-content and high-sensitivity cell analysis utilizing its patented Full Spectrum Profiling™ (FSP™) technology. Cytek’s novel approach harnesses the power of information within the entire spectrum of a fluorescent signal to achieve a higher level of multiplexing with precision and sensitivity. Cytek’s FSP platform includes its core instruments, the Aurora and Northern Lights™ systems; its cell sorter, the Aurora CS; the flow cytometer and imaging products under the Amnis^® and Guava^® brands; and reagents, software and services to provide a comprehensive and integrated suite of solutions for its customers. Cytek is headquartered in Fremont, California with offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com.

Other than Cytek’s Northern Lights CLC system and certain reagents for use therewith, which are available for clinical use in countries where the regulatory approval has been obtained from the local regulatory authorities, including China and the European Union, Cytek’s products are for research use only and not for use in diagnostic procedures.

Cytek, Full Spectrum Profiling, FSP, Northern Lights, Amnis and Guava are trademarks of Cytek Biosciences, Inc.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Cytek uses its website (www.cytekbio.com), LinkedIn page and corporate “X” account (formerly Twitter) as channels of distribution of information about its company, products, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Cytek may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Cytek’s website, LinkedIn page, and X account in addition to following its SEC filings, news releases, public conference calls and webcasts.

Media Contact:

Stephanie Olsen
Lages & Associates
(949) 453-8080
[email protected]

Investor Relations Contact:

Paul D. Goodson
Head of Investor Relations
[email protected]

 

ESCONDIDO, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) — One Stop Systems, Inc. (Nasdaq: OSS), a leader in AI Transportable solutions on the edge, reported results for the second quarter ended June 30, 2023. All quarterly comparisons are to the same year-ago period unless otherwise noted. The company will hold a conference call at 5:00 p.m. Eastern time today to discuss the results (see dial-in information below).  

Q2 2023 Financial Highlights

• Revenue totaled $17.2 million, up 2.3% sequentially.
• OSS Europe revenue increased 17.7% to $8.9 million compared to the same year-ago quarter, with OSS Classic revenue declining 22.8% to $8.3 million primarily due to the anticipated winding down of the company’s legacy media and entertainment business as it transitions to higher margin AI Transportables, loss of revenue due to exit of an autonomous trucking customer and delay in the receipt of military orders.
• Gross margin was 27.9%, compared to 28.4% in the same year-ago quarter.
• Net loss on a GAAP basis totaled $2.4 million or $(0.12) per share, as compared to net income of $323,000, or $0.02 per share, in the same year-ago quarter. The loss included a goodwill impairment charge of $2.7 million and $1.3 million received from the federal employee retention credit program.
• Non-GAAP net loss was $84,000 or $(0.00) per share, versus non-GAAP net income of $871,000 or $0.04 per share in the same year-ago quarter.
• Adjusted EBITDA, a non-GAAP term, totaled $487,000, compared to $1.2 million in the same year-ago quarter (see definition of this and other non-GAAP measures and their reconciliation to GAAP, below).
• Cash, cash equivalents and short-term investments totaled $15.4 million on June 30, 2023, as compared to $12.7 million on March 31, 2023.

First Half 2023 Financial Highlights

• Revenue totaled $34.0 million, with OSS Europe revenue up 21.5% to $17.1 million, partially offsetting a decrease in OSS Classic revenue of 20.6% to $16.9 million.
• Gross margin was 29.0% compared to 29.2% in the first half of 2022.
• Net loss on a GAAP basis totaled $2.8 million or $(0.14) per diluted share, compared to net income of $0.9 million or $0.04 per diluted share in the first half of 2022.
• Non-GAAP net income totaled $6,000 or $0.00 per diluted share, as compared to $1.8 million or $0.09 per diluted share in the first half of 2022.
• Adjusted non-GAAP EBITDA totaled $1.0 million, as compared to $2.6 million in the first half of 2022.

Q2 2023 Operational Highlights

• Received NVIDIA certification for Rigel Edge Supercomputer™, the only edge-certified AI system using four of NVIDIA GPUs based on the NVIDIA HGX™ A100 platform. Rigel met the NVIDIA-Certified standard for performance, functionality, scalability and security.

• Demonstrated a technologically disruptive two-phase liquid immersion-cooled version of the Rigel Edge Supercomputer at the Sea-Air-Space 2023 (SAS) conference.
• Six new major program wins, which included three in AI Transportables, are expected to yield approximately $3.3 million in revenues in 2023.
• Received an initial order from a new military prime contractor for OSS 3U short-depth servers (SDS) for use by a U.S. Air Force anti-electronic warfare system, with shipments now underway. The initial order is valued at approximately $3.5 million over three years.
• Appointed Michael Knowles as president and CEO, bringing to OSS more than 30 years of leadership experience in the global aerospace and defense markets, including previously as president and general manager of a $700 million global business unit with 2,000 employees.

Subsequent Events

OSS has appointed retired three-star Vice Admiral Michael J. Dumont, and the company’s president and CEO, Michael Knowles, to its board of directors, effective as of the end of the third quarter. They will succeed two existing board members, Jack Harrison and Sita Lowman, who will be stepping down at the end of the third quarter.

Dumont, who has served on the company’s advisory board since last year, previously served as the deputy commander of U.S. Northern Command and vice commander of North American Aerospace Defense Command (NORAD). He currently serves as interim president of the California State University Maritime Academy. He also serves on the board of directors of the Marines’ Memorial Association; the board of advisors of Dataminr, an AI-powered risk management platform; and the national security advisory council of the U.S. Global Leadership Coalition.

He served five years on active duty as an Army aviator and paratrooper. Upon leaving the Army, he affiliated with the U.S. Navy Reserve as a naval aviator. Dumont has held five commands, including an air squadron, several operational units, and a joint command.

He holds a Juris Doctor from Suffolk University Law School, a Master of Science in Strategic Studies from the U.S. Army War College, and a Master of Science in National Security Strategy from the National War College.

Management Commentary  

“In Q2, revenue climbed 2.3% sequentially to $17.2 million, but was lower than expected and declined from the year-ago quarter due to a convergence of a number of factors,” stated Knowles. “We estimate about $3.3 million of the decline was due to the final wind down of our legacy media business that has yet to be replaced with AI Transportable revenues.

“We have also seen changes in the autonomous trucking industry, where there have been consolidation and departures of players from the market and an overall delay in deployment of autonomous truck solutions. Further, we experienced unexpected delays in orders from our defense and other commercial customers that totaled around $5-6 million that we now expect to be pushed into 2024.

“Despite these headwinds, our customer win rate remained at historical levels due to our competitive advantages in AI Transportables, with this boding well for future revenue growth. Our pipeline of pending major programs at the end of Q2 also remained robust and increasingly global in scope, with 19 out the 33 of these involving AI transportable applications in the U.S., Asia Pacific, and Europe.

“Our opportunities with AI and sensor fusion for military defense applications increasingly require workforce security clearances and a specially secured facility. We expect to receive such security clearance by the end of the year and see this not only opening up valuable new opportunities but also providing a competitive edge.  

“As we continue to transition the business toward these higher value opportunities, we have implemented a number of organizational changes designed to revitalize our efforts and better address the substantial market opportunities in defense and AI Transportables. This includes my appointment as the company’s new president and CEO in June and the recent appointment of Robert Kalebaugh to the new position of VP of sales.

“Robert has brought to OSS more than 30 years of business development, domain experience, and an impressive record of sales success in the defense and commercial markets. Having previously worked alongside Robert for several years, I am confident we will be able to leverage the collective strengths of our team to enhance our sales and marketing efforts and accelerate our growth strategy. Robert has already been fast at work, updating our methods and processes for greater efficiency and effectiveness, and building our sales pipeline.

“Today we also announced key board changes to better align with our strategy. We are deeply appreciative of the contributions of our departing board members who have helped guide the company through the challenging times of the global pandemic and their support of our greater focus on defense opportunities. This was reflected in our appointment of Vice Admiral Dumont as a new independent director, effective as of the end of the third quarter, who brings many key strengths to our board.

“Over the last several weeks, I have had the opportunity to engage with our customers and prospective customers in the defense and commercial markets. I believe I have been able to strengthen their confidence in OSS and reaffirm our strategy and opportunity in the AI Transportable space.

“We are also fortunate to possess an exceptionally talented and motivated operational team with strong technical and product expertise. They have created an innovation-driven environment that continues to deliver market-leading products that meet the demanding requirements for rugged datacenter-class processing at the edge—or as we say, deliver performance without compromise.

“Overall, we believe we have the right team, strategy and products that will continue to build a robust pipeline and enable us to succeed in the growing global marketplace for AI Transportables.”

Outlook

The company anticipates factors related to delays in defense and commercial program orders will continue to impact its financial performance through the second half of the year. As such, revenue is expected to total approximately $13.5 million in the third quarter of 2023.

Q2 2023 Financial Summary

Consolidated revenue in Q2 totaled $17.2 million, up 2.3% sequentially, and declined 6.0% from the same year-ago period. The decline was due to the anticipated decreased shipments to the company’s legacy media and entertainment customer. The decrease was also due to delays in defense orders and a reduction in product shipments into the autonomous truck industry where there have been consolidation and departures of players from the market and an overall delay in deployment of the technology.

Approximately $3.3 million of the quarterly decline in revenue was from the low margin legacy media business, which was partly offset in the quarter by AI Transportable revenue. OSS has substantially fulfilled the remaining orders associated with its media customer and does not expect further measurable business.

The delay in certain orders for the commercial and defense markets represent $5 million to $6 million of revenue that OSS believes will be pushed from 2023 to 2024 and represents only a deferral of revenue opportunity. While OSS experienced some delays in orders during the second quarter, the company’s win rate has remained at or above previous levels.

The company’s business is comprised of two segments: OSS Classic and OSS Europe. OSS Classic is involved in the design and manufacture of high-performance ruggedized computers, flash arrays and connectivity. OSS Europe primarily operates as a value-added reseller with minimal product customization and a renewed focus on selling OSS Classic products into the European community.

In the second quarter, OSS Classic revenue declined 22.8% to $8.3 million due to the factors mentioned above, while OSS Europe revenue increased 17.7% to $8.9 million.

The OSS Europe increase was due to additional project-based business, including approximately $1.2 million of OSS core products, and an increase in the number of smaller accounts, as well as having more available inventory to ship as compared to the same year-ago quarter.

Overall gross profit in the second quarter was $4.8 million. The overall gross margin percentage was 27.9%, as compared to 28.4% in the same period in 2022.

The gross margin for OSS Classic business decreased 3.8 percentage points to 29.2%, which was also attributable to the predominance of lower margin sales to the company’s media customer and higher mix of third-party components.

OSS Europe’s gross margin percentage improved 4.8 percentage points to 26.7%, as compared to 21.9%, due to product mix, the sale of higher margin OSS Classic products, and having sought-after products readily sold at a premium.

Overall, quarterly operating expenses increased 71.1% to $8.2 million, with operating expenses as a percentage of revenue increasing to 47.7% compared to 26.2%. The most significant component of this increase was a $2.7 million write-down attributable to an impairment of goodwill resulting from the overall financial performance of OSS Classic as compared to plan, the company’s increased focus on the defense industry, and the deferment of orders.

Another significant component was an increase of $1.3 million in general and administrative expenses, with $1.1 million attributable to increased costs associated with the company’s organizational restructuring and strategic transitioning of senior management and outside professional services.

The increase in operating expenses was partially offset by decreases of $241,000 in marketing and selling expenses and $297,000 in R&D expense.

Loss from operations totaled $3.4 million, compared to income from operations of $402,000 in the same period in 2022. This reduction was predominantly attributable to lower revenue, the write-down attributable to an impairment of goodwill, and transition costs.

Net loss on a GAAP basis was $2.4 million or $(0.12) per share, as compared to net income of $323,000 or $0.02 per share. Net loss in the second quarter also includes a one-time benefit of $1.3 million attributable to receipt of COVID –19 funds under the government’s employee retention credit program.

Non-GAAP net loss was $84,000 or $(0.00) per share, versus non-GAAP net income of $871,000, or $0.04 per share.

Adjusted EBITDA, a non-GAAP metric, was $487,000 or 2.8% of revenue, a decrease from $1.2 million or 6.5% of revenue.

Each of these non-GAAP metrics excludes $2.7 million for the impairment of goodwill and $1.3 million for the employee retention credit.

On June 30, 2023, cash and cash equivalents totaled $6.1 million, with short-term investments of $9.3 million, for a combined total of $15.4 million. This combined total represents an increase of $2.7 million as compared to the prior quarter. The increase is primarily due to the employee retention credit and a decrease in working capital requirements.

First Half 2023 Financial Summary

For the first half of 2023, consolidated revenue decreased 3.9% to $34.0 million. The decrease in revenue in the first half of 2023 is due to the reasons discussed in reference to Q2.

OSS Classic revenue decreased 20.6% to $16.9 million, with OSS Europe revenue increasing 21.5% to $17.1 million which was inclusive of $2.4 million of OSS core product.

Overall gross profit was $9.9 million. The overall gross margin percentage was 29.0%, as compared to 29.2%.

OSS Classic’s gross margin percentage was 32.8%, a decrease of 1.5 percentage points as compared to 34.3%. This was due to the predominance of lower margin sales to the company’s media customer and higher mix of products with third-party components.

OSS Europe contributed gross margin at a rate of 25.3%, as compared to 21.5%, an increase of 3.8 percentage points, due to product mix, increasing sales of OSS Classic products, and of having sought-after products sold at a premium.

Total operating expenses increased 45.1% to $13.5 million. The increase was primarily due to an increase of the $2.7 million write-down attributable to an impairment of goodwill and $1.8 million in general and administrative expenses, of which $1.4 million of the increase was due to increased non-recurring costs associated with the company’s organizational restructuring and outside professional services.

This increase in operating expenses was partially offset by a decrease of $346,000 in R&D expense resulting from more engineers being deployed on chargeable work for which the expense is classified as a cost of revenue.

Loss from operations totaled $3.6 million compared to income from operations of $1.1 million.

Net loss on a GAAP basis was $2.8 million or $(0.14) per diluted share, inclusive of the $1.3 million employee retention credit, compared to net income on a GAAP basis of $902,000, or $0.04 per diluted share.

Non-GAAP net income totaled $6,000 or $0.00 per diluted share, as compared to $1.8 million or $0.09 per diluted share in the same year-ago period.

Adjusted EBITDA totaled $1.0 million or 3.0% of revenue, compared to $2.6 million or 7.3% of revenue.

Both non-GAAP net income and adjusted EBITDA exclude the $2.7 million impairment of goodwill and the $1.3 million employee retention credit.

Conference Call

OSS management will hold a conference call later today to discuss its results for the second quarter ended June 30, 2023, followed by a question-and-answer period.

Date: Thursday, August 10, 2023
Time: 5:00 p.m. Eastern time (2:00 p.m. Pacific time)
Toll-free dial-in number: 1-888-886-7786
International dial-in number: 1-416-764-8658
Conference ID: 07082306
Webcast: here (live and replay)

Approximately two hours after the Q&A session, an archived version of the webcast will be available in the Investors section of the company’s website at onestopsystems.com. OSS regularly uses its website to disclose material and non-material information to investors, customers, employees and others interested in the company.

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. If you require any assistance connecting with the call, please contact CMA at 1-949-432-7566.

A replay of the call will be available after 8:00 p.m. Eastern time on the same day and through August 24, 2023.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 07082306

About One Stop Systems

One Stop Systems, Inc. (Nasdaq: OSS) is a leader in AI Transportable solutions for the demanding ‘edge.’ OSS designs and manufactures the highest performance compute and storage products that enable rugged AI, sensor fusion and autonomous capabilities without compromise. These hardware and software platforms bring the latest data center performance to the harsh and challenging applications, whether they are on land, sea or in the air.

OSS products include ruggedized servers, compute accelerators, flash storage arrays, and storage acceleration software. These specialized compact products are used across multiple industries and applications, including autonomous trucking and farming, as well as aircraft, drones, ships and vehicles within the defense industry.

OSS solutions address the entire AI workflow, from high-speed data acquisition to deep learning, training and large-scale inference, and have delivered many industry firsts for industrial OEM and government customers.

As the fastest growing segment of the multi-billion-dollar edge computing market, AI Transportables require—and OSS delivers—the highest level of performance in the most challenging environments without compromise.

OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com. You can also follow OSS on Twitter, YouTube, and LinkedIn.

Non-GAAP Financial Measures

The company believes that the use of adjusted earnings before interest, taxes, depreciation and amortization, or adjusted EBITDA, is helpful for an investor to assess the performance of the Company. The Company defines adjusted EBITDA as income (loss) before interest, taxes, depreciation, amortization, acquisition expenses, impairment of long-lived assets, financing costs, fair value adjustments from purchase accounting, stock-based compensation expense and expenses related to discontinued operations.

Adjusted EBITDA is not a measurement of financial performance under generally accepted accounting principles in the United States, or GAAP. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash operating expenses, the company believes that providing a non-GAAP financial measure that excludes non-cash and non-recurring expenses allows for meaningful comparisons between the company’s core business operating results and those of other companies, as well as providing the company with an important tool for financial and operational decision making and for evaluating our own core business operating results over different periods of time.

The company’s adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in its industry, as other companies in the company’s industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. The company’s adjusted EBITDA is not a measurement of financial performance under GAAP and should not be considered as an alternative to operating income or as an indication of operating performance or any other measure of performance derived in accordance with GAAP. The company does not consider adjusted EBITDA to be a substitute for, or superior to, the information provided by GAAP financial results.

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2023				2022				2023				2022
Net (loss) income		$	(2,399,496	)		$	322,822			$	(2,800,008	)		$	902,056
Depreciation and amortization			270,255				254,429				542,528				524,220
Stock-based compensation expense			898,008				532,636				1,372,217				915,464
Interest expense			23,939				44,949				56,644				103,665
Interest income			(104,785	)			(55,507	)			(215,051	)			(106,512	)
Impairment of goodwill			2,700,000				–				2,700,000				–
Employee retention credit (ERC)			(1,298,241	)			–				(1,298,241	)			–
Provision for income taxes			396,863				85,490				658,365				250,798
Adjusted EBITDA		$	486,543			$	1,184,819			$	1,016,454			$	2,589,691

Adjusted EPS excludes the impact of certain items, and therefore, has not been calculated in accordance with GAAP. The company believes that exclusion of certain selected items assists in providing a more complete understanding of our underlying results and trends and allows for comparability with the company’s peer company index and industry. The company uses this measure along with the corresponding GAAP financial measures to manage its business and to evaluate its performance compared to prior periods and the marketplace. The Company defines non-GAAP income (loss) as income or (loss) before amortization, stock-based compensation, expenses related to discontinued operations, impairment of long-lived assets and non-recurring acquisition costs. Adjusted EPS expresses adjusted income (loss) on a per share basis using weighted average diluted shares outstanding.

Adjusted EPS is a non-GAAP financial measure and should not be considered in isolation or as a substitute for financial information provided in accordance with GAAP. These non-GAAP financial measures may not be computed in the same manner as similarly titled measures used by other companies. The company expects to continue to incur expenses similar to the adjusted income from continuing operations and adjusted EPS financial adjustments described above, and investors should not infer from its presentation of these non-GAAP financial measures that these costs are unusual, infrequent or non-recurring.

The following table reconciles non-GAAP net income and basic and diluted earnings per share:		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2023				2022				2023				2022
Net (loss) income		$	(2,399,496	)		$	322,822			$	(2,800,008	)		$	902,056
Amortization of intangibles			15,808				15,807				31,616				31,616
Impairment of goodwill			2,700,000				–				2,700,000				–
Employee retention credit (ERC)			(1,298,241	)			–				(1,298,241	)			–
Stock-based compensation expense			898,008				532,636				1,372,217				915,464
Non-GAAP net (loss) income		$	(83,921	)		$	871,265			$	5,584			$	1,849,136
Non-GAAP net (loss) income per share:
Basic		$	(0.00	)		$	0.04			$	0.00			$	0.10
Diluted		$	(0.00	)		$	0.04			$	0.00			$	0.09
Weighted average common shares outstanding:
Basic			20,397,741				19,940,902				20,325,029				19,416,832
Diluted			20,397,741				21,180,490				20,841,127				20,346,917

Forward-Looking Statements

One Stop Systems cautions you that statements in this press release that are not a description of historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by One Stop Systems or its partners that any of our plans or expectations will be achieved, including but not limited to, to our management’s expectations for major program wins, the company’s penetration of the Defense and AI Transportable sectors, revenue growth generated by new and existing products, future changes to our business objectives, changes to our board, and other future financial projections. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in our business, including risks described in our prior press releases and in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our latest Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Media Contacts:
Katie Rivera
One Stop Systems, Inc.
Tel (760) 745-9883
Email contact

Tim Randall
CMA Media Relations
Tel (949) 432-7572
Email Contact

Investor Relations:

Ronald Both or Grant Stude
CMA Investor Relations
Tel (949) 432-7557
Email contact

ONE STOP SYSTEMS, INC. (OSS)

CONSOLIDATED BALANCE SHEETS

		Unaudited				Audited
		June 30,				December 31,
		2023				2022
ASSETS
Current assets
Cash and cash equivalents		$	6,100,317			$	3,112,196
Short-term investments			9,321,456				10,123,535
Accounts receivable, net			9,225,346				11,327,244
Inventories, net			21,463,925				20,775,366
Prepaid expenses and other current assets			1,231,609				502,156
Total current assets			47,342,653				45,840,497
Property and equipment, net			2,432,900				2,570,124
Operating lease right-of use assets			569,296				731,043
Deposits and other			48,093				60,243
Goodwill			4,420,510				7,120,510
Intangible assets, net			10,538				42,154
Total Assets		$	54,823,990			$	56,364,571
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable		$	2,811,093			$	4,592,713
Accrued expenses and other liabilities			4,987,695				3,013,869
Current portion of operating lease obligation			583,675				536,588
Current portion of notes payable			3,012,945				2,952,447
Total current liabilities			11,395,408				11,095,617
Long-term debt, net of current portion			–				409,294
Deferred tax liability, net			136,746				138,662
Operating lease obligation, net of current portion			148,830				397,249
Total liabilities			11,680,984				12,040,822
Commitments and contingencies
Stockholders’ equity
Common stock, $0.0001 par value; 50,000,000 shares authorized; 20,543,024 and 20,084,528 shares issued and outstanding, respectively			2,053				2,008
Additional paid-in capital			46,404,428				45,513,807
Accumulated other comprehensive income			1,239,084				510,485
Accumulated deficit			(4,502,559	)			(1,702,551	)
Total stockholders’ equity			43,143,006				44,323,749
Total Liabilities and Stockholders’ Equity		$	54,823,990			$	56,364,571

ONE STOP SYSTEMS, INC. (OSS)

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2023				2022				2023				2022
Revenue		$	17,211,532			$	18,303,343			$	33,993,426			$	35,356,020
Cost of revenue			12,413,594				13,103,025				24,124,726				25,015,047
Gross profit			4,797,938				5,200,318				9,868,700				10,340,973
Operating expenses:
General and administrative			3,072,880				1,821,445				5,357,981				3,596,133
Impairment of goodwill			2,700,000				–				2,700,000				–
Marketing and selling			1,483,965				1,724,913				3,270,646				3,196,633
Research and development			954,650				1,252,037				2,149,978				2,496,152
Total operating expenses			8,211,495				4,798,395				13,478,605				9,288,918
(Loss) income from operations			(3,413,557	)			401,923				(3,609,905	)			1,052,055
Other income (expense), net:
Interest income			104,785				55,507				215,051				106,512
Interest expense			(23,939	)			(44,949	)			(56,644	)			(103,665	)
Employee retention credit (ERC)			1,298,241				–				1,298,241				–
Other income (expense), net			31,837				(4,169	)			11,614				97,952
Total other income, net			1,410,924				6,389				1,468,262				100,799
Income before income taxes			(2,002,633	)			408,312				(2,141,643	)			1,152,854
Provision for income taxes			396,863				85,490				658,365				250,798
Net (loss) income		$	(2,399,496	)		$	322,822			$	(2,800,008	)		$	902,056
Net (loss) income per share:
Basic		$	(0.12	)		$	0.02			$	(0.14	)		$	0.05
Diluted		$	(0.12	)		$	0.02			$	(0.14	)		$	0.04
Weighted average common shares outstanding:
Basic			20,397,741				19,940,902				20,325,029				19,416,832
Diluted			20,397,741				21,180,490				20,325,029				20,346,917

Presentation highlights the antitumor response of VP-315 for the non-surgical treatment of Basal Cell Carcinoma (BCC) as determined by clinical and histological lesion clearance

There are approximately 3-4 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for non-surgical treatment options

WEST CHESTER, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the presentation of lesion clearance data from Part 1 of an ongoing Phase 2 study of VP-315 for the treatment of basal cell carcinoma (BCC). The presentation is titled “VP-315, an Investigational Non-surgical Immunotherapy in Subjects with Biopsy Proven Basal Cell Carcinoma” and highlights the antitumor response of VP-315 as determined by clinical and histological clearance of treated BCC lesions. Dr. Neal Bhatia MD, Director of Clinical Dermatology Therapeutics Clinical Research in San Diego and Principal Investigator for the study, presented the data at the 2023 American Academy of Dermatology Innovation Academy, which is being held from August 10-13^th, in Tampa, FL.

Part 1 Study Results

• Subjects received once daily dosing of VP-315, administered intratumorally, in up to 2 biopsy-proven BCC lesions for up to 6 treatments over a 2-week period.
• Six lesions were treated at the 8 mg dose and post-treatment clinical assessment and excisions were performed at Day 49 (Range 35-70), followed by histological evaluation.
• Consistent clinical and histological clearance of treated BCC lesions was observed by Day 49 post-treatment with the 8 mg dose of VP-315, with 4 of 6 subjects (67%) showing complete tumor clearance. The other 2 subjects showed a partial response in tumor burden reduction (95% tumor clearance and 30% tumor clearance).
• Optimization of the 8 mg dosing regimen is under investigation in Part 2 of the study.
• These early encouraging results from Part 1 support VP-315 as a potential non-surgical therapeutic approach for BCC.

“We are pleased to report these encouraging results for our novel oncolytic peptide therapy, VP-315, in basal cell carcinoma at this year’s American Academy of Dermatology Innovation Academy,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals. “Based on the stronger than expected activity we observed in patients receiving the 8 mg dose of VP-315, we recently made the decision to expand Part 2 of the ongoing Phase 2 trial which we believe will accelerate the clinical development of VP-315.”

“While surgery remains the most commonly used treatment for basal cell carcinoma, many patients are poor surgical candidates due to their general health or experience surgical fatigue and would welcome a non-surgical treatment approach,” said Dr. Gary Goldenberg, Chief Medical Officer of Verrica Pharmaceuticals. “The VP-315 program is designed to address these issues through targeted delivery of an oncolytic peptide specifically engineered to stimulate the patient’s own immune system and destroy cancer cells, while minimizing the impact on the surrounding healthy skin cells. The positive data presented at the 2023 AAD Innovation Academy meeting shows that VP-315 has been observed to induce biologic activity against tumor cells in basal cell carcinoma, demonstrating positive clinical and histologic clearance even at this early stage of development. We are excited to continue our investigation of this highly innovative and promising new treatment for basal cell carcinoma, and with the expansion of Part 2, we have increased the number of participating clinical sites and expect to conclude the study in the first half of 2024.”

About AAD

Headquartered in Rosemont, Illinois, the American Academy of Dermatology was founded in 1938. With a membership of more than 20,500 physicians worldwide, the AAD is committed to: advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair, and nails.

About the Phase 2 Trial of VP-315

The Phase 2 trial is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 80 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729.

About VP- 315

VP-315 is a potential first-in-class oncolytic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death, which may offer a non-surgical option for patients suffering from skin cancer. The technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. VP-315 is a chemotherapeutic administered intratumorally and works by inducing lysis of intracellular organelles of tumor cells such as mitochondria, thereby unleashing a broad spectrum of tumor antigens for T cell responses. Verrica has an exclusive worldwide license to develop and commercialize VP-315 for dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials.

About Basal Cell Carcinoma

Basal cell carcinoma is the most common form of cancer in the U.S., and incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring.

About Verrica Pharmaceuticals Inc.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica’s lead product, YCANTH™ (cantharidin), became the first treatment approved by the FDA to treat pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for dermatologic oncology conditions. For more information, visit www.verrica.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development and potential benefits of VP-315, including the enrollment of the Phase 2 clinical trial, the expansion of the VP-315 program into squamous cell carcinoma, the potential of VP-315 to be first-in-class and the initiation of any future trials or clinical programs. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2022, Verrica’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

Terry Kohler 

Chief Financial Officer
[email protected]

Kevin Gardner

LifeSci Advisors
[email protected]

Chris Calabrese

LifeSci Advisors
[email protected]

MOUNTAIN VIEW, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) — Iridex Corporation (Nasdaq: IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, today reported financial results for the second quarter ended July 1, 2023.

Second Quarter 2023 Highlights

• Generated total revenue of $12.9 million, a decrease of 7% year-over-year
• Cyclo G6® product family revenue of $3.7 million increased 5% year-over-year
  • 41 Cyclo G6 Glaucoma Laser Systems sold, compared to 48 in the prior year period
  • 15,500 Cyclo G6 probes sold representing a 9% revenue increase and 4% unit increase year-over-year
• Retina product revenue was $6.9 million, a decrease of 9% year-over-year
• 16 posters presented at the World Glaucoma Congress demonstrate rising clinical interest in MicroPulse® Transcleral Laser Therapy and the Cyclo G6 product family
• Cash and cash equivalents totaled approximately $9.8 million as of July 1, 2023

“Our second quarter results reflect continued modest glaucoma business growth offset by declines in surgical and medical retina systems and lower royalty revenue. Softer capital equipment shipments reflected elongated purchasing cycles that led to the decline in the retina business in the quarter, but we expect capital demand to stabilize during the second half of the year,” said David Bruce, Iridex President and CEO. “While our initiatives to accelerate G6 probe utilization are taking longer to gain traction, we remain confident we are building the foundation for long-term adoption in the large population of moderate stage glaucoma patients. We are making progress with Sweep Management software system upgrades, increasing awareness of the effective dosing guidance that enables consistent clinical outcomes, and advancing toward a planned large multicenter prospective trial to further validate the safety and effectiveness of MPTLT. We believe these initiatives coupled with increasing positive proof of efficacy and safety, such as those presented at this year’s World Glaucoma Congress, will increase our future growth rate.”

Second Quarter 2023 Financial Results

Revenue for the three months ended July 1, 2023 was $12.9 million compared to $13.8 million during the same period of the prior year. Total product revenue from the Cyclo G6 glaucoma product group was $3.7 million, an increase of 5% compared to the second quarter of 2022. Retina product revenue decreased 9% compared to the prior year period to $6.9 million, primarily driven by softness in capital equipment demand. Other revenue, decreased $0.4 million compared to the prior year period to $2.3 million in the second quarter of 2023, primarily driven by the lower royalties due to expiration of licensed patents.

Gross profit for the second quarter of 2023 was $5.4 million or a 41.7% gross margin, a decrease compared to $6.3 million, or a 45.6% gross margin, in the same period of the prior year, primarily driven by lower revenues, with margins reduced by production overhead absorbed by less revenue.

Operating expenses for the second quarter of 2023 decreased to $8.3 million for the second quarter of 2023 compared to $8.4 million in the same period of the prior year. The Company implemented cost savings measures, including a reduction in headcount which resulted in separation costs of approximately $200 thousand during the quarter, to streamline operations and extend operating runway.

Net loss for the second quarter of 2023 was $2.8 million, or $0.17 per share, compared to a net loss of $2.2 million, or $0.14 per share, in the same period of the prior year.

Cash and cash equivalents totaled $9.8 million as of July 1, 2023. Cash use of $1.2 million in the second quarter declined compared to $2.9 million in the first quarter of 2023.

Guidance for Full Year 2023

With lower than expected probe unit sales growth and capital equipment softness in the first half of the year, the Company is updating its full year 2023 expectations as follows: Cyclo G6 probe sales of 61,000 to 63,000 units representing approximately 1% to 5% growth over 2022 and Cyclo G6 systems installed base expansion of 210 to 230 systems. Total revenue for the full year is expected to be $55 million to $57 million, representing flat to 3% growth year-over-year, after adjusting for approximately $1.5 million reduction in royalty revenue. The updated financial outlook reflects stabilization in capital equipment demand and a more gradual G6 probe utilization ramp.

Webcast and Conference Call Information

Iridex’s management team will host a conference call today beginning at 2:00 p.m. PT / 5:00 p.m. ET. Investors interested in listening to the conference call may do so by accessing the live and recorded webcast on the “Event Calendar” page of the “Investors” section of the Company’s website at www.iridex.com.

About Iridex

Iridex Corporation is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. The Company’s proprietary MicroPulse® technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions. Iridex’s current product line is used for the treatment of glaucoma and diabetic macular edema (DME) and other retinal diseases. Iridex products are sold in the United States through a direct sales force and internationally primarily through a network of independent distributors into more than 100 countries. For further information, visit the Iridex website at www.iridex.com.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical expectations and commercial momentum, market adoption and expansion, demand for and utilization of the Company’s products, financial guidance and results and expected sales volumes. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2023. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

Investor Relations Contact

Philip Taylor
Gilmartin Group
[email protected]

IRIDEX Corporation Condensed Consolidated Statements of Operations (In thousands, except per share data) (unaudited)
		Three Months Ended									Six Months Ended
		July 1,				July 2,					July 1,				July 2,
		2023				2022					2023				2022
Total revenues		$	12,855			$	13,755				$	26,561			$	27,142
Cost of revenues			7,492				7,488					15,260				14,898
Gross profit			5,363				6,267					11,301				12,244
Operating expenses:
Research and development			1,845				1,922					3,594				4,038
Sales and marketing			4,264				4,607					8,547				8,907
General and administrative			2,148				1,898					4,398				3,736
Total operating expenses			8,257				8,427					16,539				16,681
Loss from operations			(2,894	)			(2,160	)				(5,238	)			(4,437	)
Other income (expense), net			138				(64	)				404				(158	)
Loss from operations before provision for income taxes			(2,756	)			(2,224	)				(4,834	)			(4,595	)
Provision for income taxes			10				17					22				37
Net loss		$	(2,766	)		$	(2,241	)			$	(4,856	)		$	(4,632	)
Net loss per share:
Basic		$	(0.17	)		$	(0.14	)			$	(0.30	)		$	(0.29	)
Diluted		$	(0.17	)		$	(0.14	)			$	(0.30	)		$	(0.29	)
Weighted average shares used in computing net loss per share:
Basic			16,036				15,894					16,018				15,888
Diluted			16,036				15,894					16,018				15,888

IRIDEX Corporation Condensed Consolidated Balance Sheets (In thousands and unaudited)
		July 1,				December 31,
		2023				2022
Assets
Current assets:
Cash and cash equivalents		$	9,821			$	13,922
Accounts receivable, net			8,799				9,768
Inventories			11,129				10,608
Prepaid expenses and other current assets			1,216				1,468
Total current assets			30,965				35,766
Property and equipment, net			397				462
Intangible assets, net			1,810				1,977
Goodwill			965				965
Operating lease right-of-use assets, net			1,138				1,665
Other long-term assets			1,664				1,455
Total assets		$	36,939			$	42,290
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	4,278			$	3,873
Accrued compensation			2,163				2,448
Accrued expenses			1,395				1,548
Other current liabilities			825				968
Accrued warranty			215				168
Deferred revenue			2,310				2,411
Operating lease liabilities			1,049				1,037
Total current liabilities			12,235				12,453
Long-term liabilities:
Accrued warranty			138				106
Deferred revenue			10,881				11,742
Operating lease liabilities			210				732
Other long-term liabilities			25				26
Total liabilities			23,489				25,059
Stockholders’ equity:
Common stock			171				169
Additional paid-in capital			87,647				86,802
Accumulated other comprehensive loss			(40	)			(24	)
Accumulated deficit			(74,328	)			(69,716	)
Total stockholders’ equity			13,450				17,231
Total liabilities and stockholders’ equity		$	36,939			$	42,290