Market Newsdesk

November 11, 2020 4:08 pm

Fathom Holdings Inc. Reports 74% Year-Over-Year Revenue Growth for 2020 Third Quarter

PR Newswire

CARY, N.C., Nov. 11, 2020 /PRNewswire/ — Fathom Holdings Inc. (Nasdaq: FTHM), a holding company that primarily operates through its wholly owned subsidiary, Fathom Realty, LLC, a national, cloud-based, technology-driven, residential real estate brokerage, today announced financial results for the 2020 third quarter and year-to-date period ended September 30, 2020.

Third Quarter 2020 Financial Results

Revenue for the 2020 third quarter grew 74% to $55.8 million, from $32.1 million for the comparable period last year. During the third quarter of 2020, Fathom completed approximately 8,100 real estate transactions, a 56% increase from approximately 5,200 transactions during the same period last year. Average revenue per transaction expanded 12% to $6,895, from $6,171 for last year’s third quarter. Fathom’s real estate agent network grew to 5,026 agents as of September 30, 2020, up 38% from 3,629 one year ago.

GAAP net loss for the 2020 third quarter narrowed to $184,000, or a loss of $0.02 per share, compared with a GAAP net loss of $239,000, or a loss of $0.02 per share, for last year’s third quarter. Adjusted EBITDA, a non-GAAP measure, increased to $5,800 for the third quarter of 2020, from an adjusted EBITDA loss of $170,000 for the same period last year. Fathom is providing adjusted EBITDA, a non-GAAP financial measure, because it provides additional information for monitoring the company’s performance. A table providing a reconciliation of adjusted EBITDA to its most comparable GAAP measure, as well as an explanation of this non-GAAP measure, is included in the tables at the end of this press release.

“By all accounts, the third quarter was a resounding success. Our significant revenue growth reflected our expanded agent network, focus on increasing agent productivity, and improving market conditions, including continued rising home prices both in our mature and newer markets,” said Fathom CEO Joshua Harley. “I’m especially proud of our results, which exceeded expectations, as we were only public and funded for a little over half of the quarter. Clearly, our growth is a result of our tenacity, amazing team, and disruptive model that is attracting hundreds of agents each month.

“We are prudently and strategically using our IPO funds to accelerate growth, including our planned acquisition of Verus Title, which we announced earlier this month, hiring new leaders to accelerate our growth, and geographic expansion into the Oklahoma and West Virginia markets. We are continuing to identify additional opportunities to give us the ability to better serve our agents, including expanding our footprint and increasing our revenue through vertical integration,” Harley continued. “Fathom has built what we believe is an exceptional company dedicated to serving others, which is one of our key missions, and is reflected in both our agent and transaction growth. Fathom is founded on a culture of service, which assists with our agent recruiting and retention efforts. I believe our future is very bright. Our team remains dedicated to proving that out, and we look forward to continued growth and sharing our progress with you.”

First Nine Months 2020 Financial Results

Total revenue for the first nine months of 2020 increased 58% to $123.4 million, from $78.0 million for the same period of 2019. GAAP net loss for the first nine months of 2020 was $66,000, or a loss of $0.01 per share, compared with a GAAP net loss of $2.7 million, or a loss of $0.28 per share, for the first nine months of last year. Adjusted EBITDA totaled $469,000 for the 2020 period, versus an adjusted EBITDA loss of $1.1 million for the 2019 period.

The company had cash and cash equivalents of $31.0 million at September 30, 2020, up from $579,000 at December 31, 2019, primarily reflecting the completion of the company’s initial public offering on August 4, 2020, which resulted in the issuance and sale of approximately 3.4 million shares at an offering price of $10.00 per share, providing net proceeds of $31.1 million, net of offering costs.

“Our balance sheet is strong and flexible, providing us the opportunity to execute our growth plans,” added Fathom President and CFO Marco Fregenal. “Despite the pandemic-related challenges of 2020, Fathom’s market remains strong, we are recruiting new agents at a rapid pace, and at the same time, we are working to solidify and expand our market position.”

Fiscal 2020 Third Quarter Financial Results Conference Call

Date:	Wednesday, November 11, 2020
Time:	5:00 p.m. ET/2:00 p.m. PT
Phone:	877-270-2148 (domestic); 412-902-6510 (international)
Replay:	Accessible through November 18, 2020; 877-344-7529 (domestic);
	412-317-0088 (international); replay access code 10149556
Webcast:	Accessible at www.FathomRealty.com; archive available for
	approximately one year

About Fathom Holdings Inc.

Fathom Holdings Inc. is the parent company of Fathom Realty Holdings, LLC, a national, virtual, full-service real estate brokerage that leverages proprietary cloud-based software called intelliAgent to operate a Platform as a Service model (PaaS) for the residential real estate industry. Fathom offers real estate professionals 100% commission, small flat-fee transaction costs, support, technology, and training, all powered by best in class operational efficiencies. For more information visit www.fathomrealty.com.

Cautionary Note Concerning Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such “forward-looking statements” include, but are not limited to, accelerating growth. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including: risks associated with the COVID pandemic; competition; management of growth; risks associated with making and integrating acquisitions; the costs and distractions of operating as a public company; and the others set forth in the Risk Factors section of the Company’s registration statement for its initial public offering filed with the SEC, copies of which are available on the SEC’s website at www.sec.gov, along with other Company filings made with the SEC made from time to time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Investor Relations and Media Contacts:

Roger Pondel/Laurie Berman
PondelWilkinson Inc.
[email protected]
(310) 279-5980

Marco Fregenal
President and CFO
Fathom Holdings Inc.
[email protected]
(888) 455-6040

(Financial tables follow)

FATHOM HOLDINGS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019

Revenue	$	55,847,915	$	32,089,978	$	123,375,490	$	78,017,017
Cost of revenue		52,871,073		30,318,582		115,915,107		73,197,739

Gross profit		2,976,842		1,771,396		7,460,383		4,819,278

General and administrative		2,895,055		1,927,407		6,835,350		7,332,891
Marketing		217,931		55,483		586,595		159,432
Total operating expenses		3,112,986		1,982,890		7,421,945		7,492,323

Income (loss) from operations		(136,144)		(211,494)		38,438		(2,673,045)

Other expense (income), net
Interest expense, net		16,103		27,385		80,658		81,816
Other income, net		–		–		(10,000)		–
Other expense (income), net		16,103		27,385		70,658		81,816

Loss from operations before income taxes		(152,247)		(238,879)		(32,220)		(2,754,861)
Income tax (expense) benefit		(31,500)		–		(33,500)		7,980
Net loss	$	(183,747)	$	(238,879)	$	(65,720)	$	(2,746,881)

Net loss per share
Basic and Diluted	$	(0.02)	$	(0.02)	$	(0.01)	$	(0.28)

Weighted average common shares outstanding
Basic and Diluted		12,156,111		9,888,462		10,721,917		9,793,727

FATHOM HOLDINGS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS


	September 30, 2020		December 31, 2019
ASSETS	(Unaudited)
Current assets:
Cash and cash equivalents	$	30,993,116	$	579,416
Accounts receivable		1,398,123		304,769
Agent annual fees receivable, net of allowance for doubtful accounts of $455,551 and $349,420		744,929		356,131
Due from affiliates		–		2,561
Prepaid and other current assets		1,031,851		411,202
Total current assets		34,168,019		1,654,079
Property and equipment, net		107,549		105,972
Capitalized software, net		721,786		464,842
Lease right of use assets		249,075		265,140
Total assets	$	35,246,429	$	2,490,033

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable and accrued liabilities	$	4,233,501	$	2,806,228
Due to affiliates		–		23,658
Loan payable – current portion		17,319		17,095
Notes payable – current portion		186,978		–
Lease liability – current portion		78,531		89,566
Total current liabilities		4,516,329		2,936,547
Loan payable, net of current portion		22,076		35,093
Notes payable, net of current portion		266,603		500,000
Lease liability, net of current portion		174,163		177,578
Total liabilities		4,979,171		3,649,218

Commitments and contingencies

Stockholders’ Equity (Deficit)
Common stock, $0.00 par value, 100,000,000 authorized and 13,638,049 and 10,211,658 issued and outstanding as of September 30, 2020 and December 31, 2019		–		–
Treasury Stock, at cost, 5,683 and 0 shares as of September 30, 2020 and December 31, 2019		(30,000)		–
Additional paid-in capital		36,510,545		4,988,382
Accumulated deficit		(6,213,287)		(6,147,567)
Total stockholders’ equity (deficit)		30,267,258		(1,159,185)
Total liabilities and stockholders’ equity (deficit)	$	35,246,429	$	2,490,033

FATHOM HOLDINGS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

	Nine months ended September 30,
	2020		2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(65,720)	$	(2,746,881)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization		108,457		41,519
Bad debt expense		106,131		110,451
Share based compensation		322,433		1,579,099
Change in operating assets and liabilities:
Accounts receivable		(1,093,354)		987,819
Agent annual fees receivable		(494,929)		(531,911)
Due from affiliates		2,561		575,029
Prepaid and other assets		(620,649)		31,379
Accounts payable and accrued liabilities		1,427,273		(325,894)
Operating lease right of use assets		16,065		63,061
Operating lease liabilities		(14,450)		(61,694)
Due to affiliates		(23,658)		13,594
Net cash used in operating activities		(329,840)		(264,429)

CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		(25,878)		(19,728)
Purchase of capitalized software		(341,100)		(232,780)
Net cash used in investing activities		(366,978)		(252,508)

CASH FLOWS FROM FINANCING ACTIVITIES:
Principal payments on loan payable		(12,793)		(12,573)
Proceeds from issuance of common stock		83,014		576,000
Proceeds from the issuance of common stock in connection with public offering		34,300,000		–
Payment of offering cost in connection with issuance of common stock in connection with pubic offering		(3,183,284)		–
Purchase of treasury stock		(30,000)		–
Extinguishment of note payable		(500,000)		–
Proceeds from note payable		453,581		–
Net cash provided by financing activities		31,110,518		563,427

Net increase in cash and cash equivalents		30,413,700		46,490
Cash and cash equivalents at beginning of period		579,416		1,008,538
Cash and cash equivalents at end of period	$	30,993,116	$	1,055,028

Supplemental disclosure of cash and non-cash transactions:
Cash paid for interest	$	81,803	$	81,945
Income taxes paid	$	5,361	$	12,505
Right of use assets obtained in exchange for lease liabilities	$	–	$	261,814
Issuance of common stock warrants as offering costs in connection with public offering of common stock	$	677,082	$	–

FATHOM HOLDINGS INC.
RECONCILIATION OF NON-GAAP TO GAAP FINANCIAL MEASURES
(Unaudited)

	Three months ended September 30,				Nine months ended September 30,
	2020		2019		2020		2019

Net loss	$	(183,747)	$	(238,879)	$	(65,720)	$	(2,746,881)
Other expense (income), net		16,103		27,385		70,658		81,816
Income tax expense (benefit)		31,500		–		33,500		(7,980)
Depreciation & amortization		44,686		17,886		108,457		41,519
Restricted stock award compensation expense		97,219		2,942		298,239		1,546,247
Stock option compensation expense		–		21,033		24,194		32,852
Adjusted EBITDA	$	5,761	$	(169,633)	$	469,328	$	(1,052,427)

Note about Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), the Company uses Adjusted EBITDA, a non-GAAP financial measure, to understand and evaluate its core operating performance. This non-GAAP financial measure, which may be different than similarly titled measures used by other companies, is presented to enhance investors’ overall understanding of the Company’s financial performance and should not be considered a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP.

Fathom defines Adjusted EBITDA as net income (loss), excluding other expense (income), net, income tax expense (benefit), depreciation and amortization, and share-based compensation expense.

Fathom believes that Adjusted EBITDA provides useful information about the Company’s financial performance, enhances the overall understanding of our past performance and future prospects, and allows for greater transparency with respect to a key metric used by management for financial and operational decision-making. The Company believes that Adjusted EBITDA helps identify underlying trends in its business that otherwise could be masked by the effect of the expenses excluded in Adjusted EBITDA. In particular, Fathom believes the exclusion of share-based compensation expense related to restricted stock awards and stock options provides a useful supplemental measure in evaluating the performance of its operations and provides better transparency into its results of operations.

Adjusted EBITDA is being presented to assist investors in seeing the Company’s financial performance through the eyes of management, and because it believes this measure provides an additional tool for investors to use in comparing Fathom’s core financial performance over multiple periods with other companies in its industry.

Adjusted EBITDA should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. There are a number of limitations related to the use of Adjusted EBITDA compared to net income (loss), the closest comparable GAAP measure, including:

Adjusted EBITDA excludes share-based compensation expense related to restricted stock awards and stock options, which have been, and will continue to be for the foreseeable future, significant recurring expenses in the Company’s business and an important part of its compensation strategy; and
Adjusted EBITDA excludes certain recurring, non-cash charges such as depreciation and amortization of property and equipment and, although these are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future.

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SOURCE Fathom Realty

November 11, 2020 4:08 pm

BioHiTech Global to Report Third Quarter 2020 Financial Results on Monday, November 16, 2020 and Provide Corporate Update

Conference call to be held Monday, November 16, at 4:30 p.m. Eastern Time

PR Newswire

CHESTNUT RIDGE, N.Y., Nov. 11, 2020 /PRNewswire/ — BioHiTech Global, Inc. (“BioHiTech” or the “Company”) (NASDAQ: BHTG), a sustainable technology and services company, announces today that it will report third quarter 2020 financial results on Monday, November 16, 2020 after the market close.

Management will host a conference call at 4:30 p.m. ET on Monday, November 16, 2020 to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question and answer session.

Participants are asked to pre-register for the call via the following link:
https://dpregister.com/sreg/10150010/dd340fff34

Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. Those without Internet access or who are unable to pre-register may dial in by calling 1-866-652-5200 (domestic) or 1-412-317-6060 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioHiTech Global call.

The conference call will be available through a live webcast found here:
https://services.choruscall.com/links/bhtg201116.html

It will also be broadcast live through the Company’s website with the following link:
http://investors.biohitechglobal.com/events-and-webcasts

A webcast replay of the call will be available approximately one hour after the end of the call through February 16, 2021. The webcast replay can be accessed through the above links or by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10150010. A telephonic replay of the call will be available through November 30, 2020.

About BioHiTech Global
BioHiTech Global, Inc. (NASDAQ: BHTG), is a technology services company focused on providing cost-effective solutions that improve environmental outcomes. Our technologies for waste management include the patented processing of municipal solid waste into a valuable renewable fuel, biological disposal of food waste on-site, and proprietary real-time data analytics tools to reduce food waste generation. When used individually or in combination, our solutions lower the carbon footprint associated with waste transportation and can reduce or virtually eliminate landfill usage. In addition, we distribute a patented technology that achieves high-level disinfection of spaces such as classrooms, hotel or hospital rooms and other enclosed areas to combat the spread of viruses and bacteria without the use of harsh chemicals. Our unique solutions enable businesses, educational institutions and municipalities of all sizes to solve everyday problems in a smarter and more cost-effective way while reducing their impact on the environment. For more information, please visit www.biohitech.com.

Forward Looking Statements
Statements in this press release contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. Without limiting the foregoing, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. These statements are also based on many assumptions and estimates and are not guarantees of future performance. These statements are estimates, based on information available to management as of the date of this release, and are subject to further changes. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of BioHiTech Global, Inc. to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. BioHiTech Global, Inc. assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future in these forward-looking statements, even if new information becomes available in the future. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation those set forth as “Risk Factors” in our filings with the Securities and Exchange Commission (“SEC”). There may be other factors not mentioned above or included in the BioHiTech’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. BioHiTech Global, Inc. assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

Company Contact:
BioHiTech Global, Inc.
Richard Galterio
Executive Vice President
Direct: 845.367.0603
[email protected]
www.biohitech.com
Investors:
[email protected]

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SOURCE BioHiTech Global, Inc.

November 11, 2020 4:08 pm

SenesTech Announces Third Quarter 2020 Financial and Operational Results

PR Newswire

PHOENIX, Nov. 11, 2020 /PRNewswire/ — SenesTech, Inc. (NASDAQ: SNES), a developer of proprietary, next generation technologies for managing animal pest populations through fertility control, today announced financial and operational results for the third quarter of fiscal year 2020, which ended on September 30, 2020.

Ken Siegel, CEO of SenesTech, commented, “We continued to achieve traction during the third quarter in the awareness and deployment of ContraPest, which resulted in a 114% increase in sales over the prior year period. Perhaps most notable during the quarter, was the passing of the California Ecosystems Protection Act of 2020, otherwise known as AB 1788, which will prohibit the use of the four major Second Generation Anticoagulant Rodenticides (SGARs) commonly used in rodent pest control under many circumstances. SenesTech’s ContraPest provides pest management professionals (PMP) with an alternative and complementary non-lethal approach to managing rodents through fertility control, and may be increasingly used to replace the SGARs. We are working closely with the PMPs in California to ensure continuity of service to their customers by offering ContraPest as part of their IPM programs once the bill goes effective on January 1, 2021.”

“While we are increasingly focusing efforts within California, we continue to make progress on other key initiatives we set forth at the beginning of the year to drive long-term adoption of ContraPest. These include finalizing data sets within key industries, including poultry and municipal areas, driving pull through demand through a refocused sales and marketing program , as well as direct sales efforts through our e-commerce platform. As budgets become less encumbered by the effects of COVID-19, we believe these efforts, coupled with our repositioning of ContraPest as a component of an overall integrated pest management strategy, will increasingly gain traction,” concluded Mr. Siegel.

Third Quarter 2020 Highlights

Revenue during the third quarter of 2020 was approximately $77,000 compared to approximately $36,000 in the third quarter of 2019.
The California Ecosystems Protection Act of 2020 (AB 1788) was signed by California’s Governor and goes into effect January 1, 2021. AB 1788 will prohibit the use of the four major Second Generation Anticoagulant Rodenticides (SGARs) commonly used in rodent pest control under many circumstances, which opens up a potential $100 million annual market opportunity to alternative solutions, which includes ContraPest.
San Francisco added ContraPest to the Reduced Risk Pesticide List, which now permits ContraPest’s expanded use in San Francisco.
On a GAAP basis, net loss for the third quarter of 2020 was $(1.9) million, compared with a net loss of $(2.6) million for third quarter of 2019.
Adjusted EBITDA loss, which is a non-GAAP measure of operating performance, for the third quarter of 2020 was $(1.7) million versus $(2.3) million in the third quarter of 2019.
In October 2020, the Company entered into an inducement agreement with an existing warrant holder to exercise certain outstanding warrants, which provided gross proceeds to the Company of approximately $2.9 million.
Cash balance at the end of the third quarter of 2020, together with the net proceeds of the inducement agreement, was approximately $5.3 million.

Use of Non-GAAP Measure

Adjusted EBITDA is a non-GAAP measure. However, this measure is not intended to be a substitute for those financial measures reported in accordance with GAAP. Adjusted EBITDA has been included because management believes that, when considered together with the GAAP figures, it provides meaningful information related to our operating performance and liquidity and can enhance an overall understanding of financial results and trends. Adjusted EBITDA may be calculated by us differently than other companies that disclose measures with the same or similar term. See our attached financials for a reconciliation of this non-GAAP measure to the nearest GAAP measure.

Conference Call Details

Date and Time: Wednesday, November 11, 2020 at 5:00 pm ET (2:00 pm PT)

Call-in Information: Interested parties can access the conference call by dialing (844) 308-3351 or (412) 317-5407.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at http://senestech.investorroom.com/.

Replay: A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation #10149685. A webcast replay will be available in the Investor Relations section of the Company’s website at http://senestech.investorroom.com/ for 90 days.

About SenesTech
SenesTech is changing the model for pest management by targeting one of the root causes of the problem: reproduction.

ContraPest® is an innovative technology with an approach that targets the reproductive capabilities of both sexes in rat populations, inducing egg loss in female rats and impairing sperm development in males. Using a proprietary bait delivery method, ContraPest® is dispensed in a highly palatable liquid formulation that promotes sustained consumption by rat communities. ContraPest® is designed, formulated and dispensed to be low hazard for handlers and non-target species such as wildlife, livestock and pets, where the active ingredients break down rapidly.

We believe ContraPest® will establish a new paradigm in rodent control, resulting in a decreased reliance on lethal options. For more information visit the SenesTech website at www.senestech.com.

Safe Harbor Statement

The foregoing paragraphs contain forward-looking statements that involve estimates, assumptions, risks and uncertainties. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking. “Forward-looking statements” may be preceded by words such as “may,” “future,” “plan” or “planned,” “will,” “should,” “expected,” “anticipates,” “continue,” “eventually,” “believes,” or “projected.” Forward-looking statements include statements concerning continued or additional success of deployments and success of our products; the continued potential impact and effects of the COVID-19 pandemic on the Company’s business; the Company’s strategy and target marketing and markets; continuing the Company’s vision; expected benefits of the Company’s initiatives and continuation of those initiatives; the continuation or expansion of the use of ContraPest, including as a replacement for SGARs; demand for ContraPest; the Company’s expectation regarding costs, expenses and cash and continuing its cost improvement plan; future financial results; and the Company’s execution of its strategic business plan.

Investors should not unduly rely on forward-looking statements. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those made in the forward-looking statements, including as a result of various factors and other risks, such as market acceptance and demand for the Company’s products, customers completing order commitments, the Company’s ability to reduce costs and execute on its plans and continuing to believe it is following the best strategy, the Company having sufficient financing, and other factors identified in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and quarterly reports filed on Form 10-Q. All forward-looking statements speak only as of the date on which they were made based on management’s assumptions as of such date. The Company does not undertake any obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACT:
Investors: Robert Blum, Joe Dorame, Joe Diaz, Lytham Partners, LLC,
602-889-9700, [email protected]

Company: Tom Chesterman, Chief Financial Officer, SenesTech, Inc.,
928-779-4143

SENESTECH, INC.
CONDENSED BALANCE SHEETS
(In thousands, except shares and per share data)

	September 30,	December 31,
	2020	2019
ASSETS	(Unaudited)

Current assets:
Cash	$ 2,717	$ 1,936
Accounts receivable trade, net	30	26
Accounts receivable-other	–	123
Prepaid expenses	281	257
Inventory	1,102	1,180
Deposits	28	20
Total current assets	4,158	3,542

Right to use asset-operating leases	726	699
Property and equipment, net	541	738
Total assets	$ 5,425	$ 4,979


LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
Short-term debt	$ 105	$ 123
Accounts payable	444	265
Accrued expenses	316	1,193
Total current liabilities	865	1,581

Long-term debt, net	695	137
Operating lease liability	731	694
Total liabilities	2,291	2,412

Commitments and contingencies (See note 12)	–	–

Stockholders’ equity:
Common stock, $0.001 par value, 100,000,000 shares authorized, 3,398,832 and 1,414,671
shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	3	1
Additional paid-in capital	105,277	98,433
Accumulated deficit	(102,146)	(95,867)
Total stockholders’ equity	3,134	2,567

Total liabilities and stockholders’ equity	$ 5,425	$ 4,979

SENESTECH, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except shares and per share data)
(Unaudited)

	For the Three Months		For the Nine Months
	Ended September 30,		Ended September 30,
	2020	2019	2020	2019

Revenue:
Sales	$ 77	$ 36	$ 185	$ 79
Cost of sales	41	25	106	58
Gross profit	36	11	79	21

Operating expenses:
Research and development	380	432	902	1,359
Selling, general and administrative	1,568	2,173	5,040	5,908
Total operating expenses	1,948	2,605	5,942	7,267

Net operating loss	(1,912)	(2,594)	(5,863)	(7,246)

Other income (expense):
Interest income	–	19	2	45
Interest expense	(7)	(10)	(22)	(34)
Other income (expense)	–	–	18	(3)
Total other income (expense)	(7)	9	(2)	8

Net loss and comprehensive loss	(1,919)	(2,585)	$ (5,865)	$ (7,238)
Deemed dividend-warrant price protection-revaluation adjustment	–	–	414	–
Net loss attributable to common shareholders	$ (1,919)	$ (2,585)	$ (6,279)	$ (7,238)


Weighted average common shares outstanding – basic and fully diluted	3,398,832	1,394,575	2,593,288	1,266,842

Net loss per common share – basic and fully diluted	$ (0.56)	$ (1.85)	$ (2.42)	$ (5.71)

SenesTech Inc.
Itemized Reconciliation Between Net Loss and Non-GAAP Adjusted EBITDA
For the Three and Nine Months Ended September 30, 2020 and 2019
(Unaudited)

(in thousands)			For the Three Months		For the Nine Months
			Ended September 30,		Ended September 30,
			2020	2019	2020	2019
Net Loss (As Reported, GAAP)			(1,919)	(2,585)	(5,865)	(7,238)

Non-GAAP Adjustments:
	Interest and dividends		7	(9)	20	(11)
	Stock-based compensation		162	204	453	675
	Reserve for future severance payments		–	–	(51)	–
	Loss (gain) on sale of assets		–	1	(18)	3
	Amortization and accretion:
	Depreciation expense		71	101	219	314
		Total of non-GAAP adjustments	240	297	623	981

Adjusted EBITDA Loss (Non-GAAP)			(1,679)	(2,288)	(5,242)	(6,257)

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SOURCE SenesTech, Inc.

November 11, 2020 4:08 pm

Manning & Napier, Inc. Reports October 31, 2020 Assets Under Management

PR Newswire

FAIRPORT, N.Y., Nov. 11, 2020 /PRNewswire/ — Manning & Napier, Inc. (NYSE: MN), (“Manning & Napier” or “the Company”) today reported preliminary assets under management (“AUM”) as of October 31, 2020 of $18.5 billion compared with $19.2 billion at September 30, 2020. AUM by investment vehicle and by portfolio are set forth in the table below.

	Assets Under Management
	(in millions)

		October 31, 2020		September 30, 2020

By investment vehicle:
Separate accounts		$	13,317.5	$	13,626.7
Mutual funds and collective investment trusts		5,138.2		5,618.4
Total		$	18,455.7	$	19,245.1

By portfolio:
Blended Asset		$	12,732.4	$	13,367.7
Equity		4,729.3		4,872.6
Fixed Income		994.0		1,004.8
Total		$	18,455.7	$	19,245.1

About Manning & Napier, Inc.
Manning & Napier (NYSE: MN) provides a broad range of investment solutions through separately managed accounts, mutual funds, and collective investment trust funds, as well as a variety of consultative services that complement our investment process. Founded in 1970, we offer equity, fixed income and alternative strategies, as well as a range of blended asset portfolios, including life cycle funds. We serve a diversified client base of high-net-worth individuals and institutions, including 401(k) plans, pension plans, Taft-Hartley plans, endowments and foundations. For many of these clients, our relationship goes beyond investment management and includes customized solutions that address key issues and solve client-specific problems. We are headquartered in Fairport, NY.

Safe Harbor Statement
This press release and other statements that the Company may make may contain forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which reflect the Company’s current views with respect to, among other things, its operations and financial performance. Words like “believes,” “expects,” “may,” “estimates,” “will,” “should,” “intends,” “plans,” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, are used to identify forward-looking statements, although not all forward-looking statements contain these words. Although the Company believes that it is basing its expectations and beliefs on reasonable assumptions within the bounds of what it currently knows about its business and operations, there can be no assurance that its actual results will not differ materially from what the Company expects or believes. Some of the factors that could cause the Company’s actual results to differ from its expectations or beliefs include, without limitation: changes in securities or financial markets or general economic conditions; a decline in the performance of the Company’s products; client sales and redemption activity; changes of government policy or regulations; and other risks discussed from time to time in the Company’s filings with the Securities and Exchange Commission.

Contacts

Investor Relations Contact

Sean Silva

Prosek Partners
646-818-9122
[email protected]

Public Relations Contact

Nicole Kingsley Brunner

Manning & Napier, Inc.
585-325-6880
[email protected]

View original content:http://www.prnewswire.com/news-releases/manning–napier-inc-reports-october-31-2020-assets-under-management-301171309.html

SOURCE Manning & Napier, Inc.

November 11, 2020 4:08 pm

Heron Therapeutics to Present at Several Upcoming Virtual Investor Conferences

PR Newswire

SAN DIEGO, Nov. 11, 2020 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron Therapeutics, will present at the following virtual investor conferences:

Stifel 2020 Virtual Healthcare Conference: Tuesday, November 17, 2020 at 3:20 pm ET
Jefferies Virtual London Healthcare Conference: Thursday, November 19, 2020 at 1:30 pm GMT
3^rd Annual Evercore ISI HealthCONx Conference: Tuesday, December 1, 2020 at 4:20 pm ET

A live webcast of each presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of each presentation will be archived on the site for 60 days.

About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

Forward-Looking Statements
This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to, risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Investor Relations and Media Contact:

David Szekeres

Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
[email protected]
858-251-4447

View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-to-present-at-several-upcoming-virtual-investor-conferences-301171239.html

SOURCE Heron Therapeutics, Inc.

November 11, 2020 4:08 pm

PDS Biotechnology Reports Financial Results for the Third Quarter 2020 and Provides Business Update

FLORHAM PARK, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.

Third Quarter 2020 and Recent Business Highlights

Successfully raised approximately $19 million via a public offering of common stock.
Initiated VERSATILE-002, a Phase 2 trial of PDS0101, our investigational drug candidate, in combination with standard of care KEYTRUDA^® for first-line treatment of patients with metastatic or recurrent HPV-positive head and neck cancer.
Initiated a Phase 2 study of PDS0101 in combination with standard of care chemoradiotherapy at the MD Anderson Cancer Center for treatment of locally advanced cervical cancer.
Continued development of PDS0103 in partnership with the National Cancer Institute.
Advanced co-development program with Farmacore with plans to move the PDS0203 COVID-19 vaccine into clinical development with the support of the Brazilian government.
Expanded Board of Directors with appointment of preeminent oncologist, Otis Brawley, M.D.

“As a result of our team’s dedicated efforts during the third quarter and our clinical partnerships with leading institutions in immuno-oncology, today PDS0101 is being evaluated in three phase 2 clinical trials for multiple HPV-associated cancers,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotechnology. “Furthermore, the successful equity raise we completed in August strengthened our balance sheet, ensuring we can continue to progress the clinical development of our oncology programs as well as expand both our oncology and infectious disease programs despite the challenges posed by the COVID-19 pandemic.”

Third
Quarter 2020 Financial Review

For the third quarter of 2020, net loss was approximately $3.9 million, or $0.23 per basic share and diluted share, compared to a net loss of approximately $5.8 million, or $1.10 per basic share and diluted share for the third quarter of 2019.

Research and development expenses totaled approximately $2.1 million for the third quarter of 2020, compared to approximately $1.8 million for the same period in 2019, an increase of 12%. The increase was primarily attributable to an increase of $0.1 million in technical operations (manufacturing) and $0.3 million in clinical studies, offset by a decrease of $0.1 million in professional fees and $0.1 million in regulatory expenses.

For the third quarter of 2020, general and administrative expenses were approximately $1.8 million compared with approximately $3.0 million during the third quarter of 2019, a decrease of 40%. The decrease was primarily attributable to a decrease of $0.2 million in salary and benefits, $0.1 million in facilities and office expense, $0.3 million in insurance expense, $0.6 million in professional fees, and $0.1 million in legal fees offset by an increase of $0.1 million in licenses, taxes and fees.

Total operating expenses for the third quarter of 2020 were approximately $3.9 million, compared to total operating expenses of approximately $5.8 million during the same period of 2019, a decrease of 33%.

As of September 30, 2020, the Company’s cash balance was approximately $33.5 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Thursday, November 12, 2020. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13712632.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Versamune^® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for its lead asset PDS0101 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotechnology
Phone: +1 (908) 517-3613
Email: [email protected]

Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: [email protected]

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

Condensed Consolidated
Balance Sheets

	September 30, 2020			December 31, 2019
ASSETS	(unaudited)
Current assets:
Cash and cash equivalents	$	33,468,935		$	12,161,739
Prepaid expenses and other		373,395			2,308,462
Total current assets		33,842,330			14,470,201

Property and equipment, net		9,345			21,051
Operating lease right-to-use asset		593,580			–

Total assets	$	34,445,255		$	14,491,252

LIABILITIES AND STOCKHOLDERS’ EQUITY
LIABILITIES
Current liabilities:
Accounts payable	$	1,559,591		$	1,197,720
Accrued expenses		1,222,773			1,097,640
Restructuring reserve		–			498,185
Operating lease obligation – short term		116,240			–
Total current liabilities		2,898,604			2,793,545

Noncurrent liability:
Operating lease obligation – long term		521,692			–

STOCKHOLDERS’ EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2020 and December 31, 2019, 22,261,619 shares and 5,281,237 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		7,346			1,742
Additional paid-in capital		70,775,892			40,633,670
Accumulated deficit		(39,758,279	)		(28,937,705	)
Total stockholders’ equity		31,024,959			11,697,707

Total liabilities and stockholders’ equity	$	34,445,255		$	14,491,252

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

Condensed Consolidated
Statements of Operations and Comprehensive
Loss

(Unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Operating expenses:
Research and development expenses	$	2,060,815		$	1,834,371		$	5,446,718		$	4,751,308
General and administrative expenses		1,846,214			3,068,581			5,428,098			9,358,429
Lease termination costs		–			944,445			–			944,445

Total operating expenses		3,907,029			5,847,397			10,874,816			15,054,182

Loss from operations		(3,907,029	)		(5,847,397	)		(10,874,816	)		(15,054,182	)

Other income (expense):
Gain on bargain purchase upon merger		–			–			–			11,939,331
Interest income		1,207			95,787			54,242			294,694
Interest expense		–			–			–			(606	)

Net loss and comprehensive loss		(3,905,822	)		(5,751,610	)		(10,820,574	)		(2,820,763	)
Per share information:
Net loss per share, basic and diluted	$	(0.23	)	$	(1.10	)	$	(0.73	)	$	(0.60	)

Weighted average common shares outstanding, basic and diluted	$	17,169,257		$	5,246,829		$	14,892,764		$	4,729,153

November 11, 2020 4:08 pm

Kinsale Capital Group Announces Dividend Declaration

RICHMOND, Va., Nov. 11, 2020 (GLOBE NEWSWIRE) — Kinsale Capital Group, Inc. (Nasdaq: KNSL) today announced that its Board of Directors declared a cash dividend of $0.09 per share of common stock. This dividend is payable on December 11, 2020 to all stockholders of record as of the close of business on November 30, 2020.

About Kinsale Capital Group, Inc.

Kinsale Capital Group, Inc. is a specialty insurance group headquartered in Richmond, Virginia, focusing on the excess and surplus lines market.

Contact

Kinsale Capital Group, Inc.
Bryan Petrucelli
Executive Vice President, Chief Financial Officer and Treasurer
804-289-1272
[email protected]

November 11, 2020 4:08 pm

Arcutis Biotherapeutics to Present at the Stifel 2020 Virtual Healthcare Conference

WESTLAKE VILLAGE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced that Frank Watanabe, President and CEO, will present a corporate overview during the Stifel 2020 Virtual Healthcare Conference taking place November 16-18, 2020.

Details for the presentation are as follows:
Stifel 2020 Virtual Healthcare Conference
Presentation Date: Wednesday, November 18, 2020
Presentation Time: 12:20 p.m. PST / 3:20 p.m. EST

The presentation will be webcast and may be accessed at the “Events & Presentations” section of the Company’s website at https://investors.arcutis.com/events-and-presentations. Arcutis will maintain an archived replay of the webcast on its website for 30 days after the conference.

About Arcutis – Bioscience, applied to the skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis’ robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The company’s lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow the company on LinkedIn and Twitter.

Investor
Contact
:

Heather Rowe Armstrong
Vice President, Investor Relations & Corporate Communications
[email protected]
805-418-5006, Ext. 740

November 11, 2020 4:08 pm

Stifel Announces a Three-for-Two Stock Split & Intention to Increase its Common Stock Dividend by 32%

Represents Fourth Consecutive Annual Dividend Increase Delivered to Shareholders

ST. LOUIS, Nov. 11, 2020 (GLOBE NEWSWIRE) — Stifel Financial Corp. (NYSE: SF) today announced that its Board of Directors has approved a three-for-two stock split of the Company’s common stock, which will be made in the form of a 50% stock dividend. Shareholders of record at the close of business on December 2, 2020 will receive one additional share of Stifel Financial common stock for every two shares owned. These additional shares will be distributed beginning December 16, 2020. Cash will be distributed in lieu of fractional shares based on the closing price on the record date. The Company has approximately 68.7 million shares outstanding and, after the split, the Company will have approximately 103.0 million shares outstanding.

Following the stock split, the current quarterly dividend equates to $0.1133 per common share, which the firm intends to increase in 2021 to $0.15 per common share, subject to board approval. This action would represent Stifel’s fourth consecutive annual increase of its common stock dividend.

“Our stock split and the board’s intention to increase our common dividend are the result of our company’s strong market performance, continuing growth prospects, and our desire to reward existing and long-term investors. Additionally, these actions reflect the board’s confidence in our ability to drive long-term shareholder value by focusing on the fundamentals of our company,” commented Ronald J. Kruszewski, Chairman & Chief Executive Officer of Stifel Financial Corp.

For additional information, please visit the Stifel Investor Relations page at:
https://www.stifel.com/docs/pdf/investorrelations/stock-split-faq.pdf .

Stifel Company Information

Stifel Financial Corp. (NYSE: SF) is a financial services holding company headquartered in St. Louis, Missouri, that conducts its banking, securities, and financial services business through several wholly owned subsidiaries. Stifel’s broker-dealer clients are served in the United States through Stifel, Nicolaus & Company, Incorporated, including its Eaton Partners business division; Keefe, Bruyette & Woods, Inc.; Miller Buckfire & Co., LLC and Century Securities Associates, Inc. The Company’s broker-dealer affiliates provide securities brokerage, investment banking, trading, investment advisory, and related financial services to individual investors, professional money managers, businesses, and municipalities. Stifel Bank and Stifel Bank & Trust offer a full range of consumer and commercial lending solutions. Stifel Trust Company, N.A. and Stifel Trust Company Delaware, N.A. offer trust and related services. To learn more about Stifel, please visit the Company’s website at www.stifel.com. For global disclosures, please visit https://www.stifel.com/investor-relations/press-releases.

Investor Relations Contact
Joel Jeffrey, (212) 271-3610
[email protected]

Media Relations Contact

Neil Shapiro, (212) 271-3447
[email protected]

November 11, 2020 4:08 pm

Trevi Therapeutics Announces Third Quarter 2020 Financial Results and Business Update

PRISM Trial of
Haduvio
™ for Severe Pruritus in Patients with Prurigo
Nodularis

Exceeds Halfway Enrollment Milestone

Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject
Post-
COVID
-19
Restrictions

Cash Position Expected to Fund Operations into the First Half of 2022

NEW HAVEN, Conn., Nov. 11, 2020 (GLOBE NEWSWIRE) — Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2020, as well as business updates.

“We are pleased with the continued progress of our clinical development programs,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “We recently announced significant developments in both of our ongoing clinical trials by surpassing halfway enrollment in our PRISM trial and enrolling the first new subject in our chronic cough trial in IPF since the study resumed after pausing due to COVID restrictions. We are focused on completing enrollment in both trials and preparing for the next steps in the development of Haduvio.”

Key Business Updates

Phase 2b/3 PRISM trial of
Haduvio
for severe pruritus in patients with prurigo
nodularis
: The Company has enrolled approximately 190 subjects in the trial and reaffirms its guidance that it expects to complete enrollment in the third quarter of 2021 and to report top-line data in the fourth quarter of 2021.
Phase 2 trial of
Haduvio
for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Company resumed screening and enrolling patients in the trial following the pause in the trial due to COVID-19. The Company amended the study protocol to require fewer in-person visits by subjects as well as fewer procedures in order to facilitate the completion of the trial in an at-risk patient population for COVID-19. Additionally, the Company is assessing additional study sites in Germany which could potentially accelerate enrollment and reduce the risks inherent with single-country recruitment during the COVID-19 pandemic.

Third Quarter 2020 Financial Highlights

Cash position: As of September 30, 2020, the Company had total cash and cash equivalents of $53.3 million, compared to $57.3 million as of December 31, 2019. During the third quarter of 2020, the Company received $14.0 million in proceeds from a term loan with Silicon Valley Bank and sold approximately $2.5 million of common stock under the Company’s ATM program. The Company expects its cash position will fund operations into the first half of 2022.

Research and development (R&D) expenses: R&D expenses for the third quarter of 2020 were $4.8 million compared to $5.7 million in the same period in 2019. The decrease was primarily due to decreased activity in the Company’s Phase 2 trial in chronic cough in patients with IPF due to the pausing of enrollment and treatment of patients as a result of the COVID-19 pandemic as well as decreased activity with the completion of the Company’s Phase 1b trial in patients with chronic liver disease.

General and administrative (G&A) expenses: G&A expenses for the third quarter of 2020 were $2.4 million compared to $2.0 million in the same period in 2019. The increase was primarily due to an increase in stock-based compensation expenses and an increase in consulting fees.

Net loss: For the third quarter of 2020, the Company reported a net loss of $7.4 million, compared to a net loss of $7.4 million in the same period in 2019.

Conference Call

As previously announced, the Company will host a conference call and webcast today, November 11, 2020 at 4:30 p.m. ET. To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News’ section on the Company’s website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company’s website following the event.

About
Trevi
Therapeutics, Inc.

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

About HADUVIO

Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on Trevi’s clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from, Trevi’s Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi’s business plans and objectives, including future plans or expectations for Trevi’s product candidates and expectations regarding Trevi’s uses and sufficiency of capital; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi’s clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi’s ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating Trevi’s cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Trevi
Therapeutics, Inc.

Selected Balance Sheet Data

(unaudited)

(amounts in thousands)

	September 30, 2020		December 31, 2019

Cash and cash equivalents	$	53,293	$	57,313
Working capital		49,106	54,353
Total assets		55,879	60,001
Total debt		13,798	──
Stockholders’ equity		35,618	54,545

Trevi
Therapeutics, Inc.

Selected Statement of Operations Data

(unaudited)

(amounts in thousands)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019

Operating expenses:
Research and development	$	4,828		$	5,650		$	15,768		$	14,516
General and administrative		2,416			2,000			7,528			5,363
Total operating expenses		7,244			7,650			23,296			19,879
Loss from operations		(7,244	)		(7,650	)		(23,296	)		(19,879	)
Other income (expense), net		(145	)		280			26			352
Loss before income tax benefit		(7,389	)		(7,370	)		(23,270	)		(19,527	)
Income tax benefit		11			5			35			14
Net loss	$	(7,378	)	$	(7,365	)	$	(23,235	)	$	(19,513	)

Investor Contact

Chris Seiter, Chief Financial Officer
Trevi Therapeutics, Inc.
203-304-2499
[email protected]

Media
Contact
Rosalia Scampoli
914-815-1465
[email protected]