Market Newsdesk

November 12, 2020 4:08 pm

Aurinia Pharmaceuticals to Present at the 2020 Jefferies Virtual London Healthcare Conference

Aurinia Pharmaceuticals to Present at the 2020 Jefferies Virtual London Healthcare Conference

VICTORIA, British Columbia–(BUSINESS WIRE)–
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the “Company”) today announced that members of the senior management team will participate in a fireside chat during the 2020 Jefferies Virtual London Healthcare Conference on November 19, 2020 at 11:25 a.m. ET.

In order to participate in the audio webcast, interested parties can register and access the live webcast under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

ABOUT AURINIA

Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company’s head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006061/en/

Investor & Corporate Contact:

Glenn Schulman, PharmD, MPH

SVP, Corporate Communications & IR

[email protected]

KEYWORDS: United States North America Canada Maryland

INDUSTRY KEYWORDS: Professional Services Health Finance Clinical Trials Pharmaceutical Banking Biotechnology

MEDIA:

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November 12, 2020 4:08 pm

ALX Oncology Reports Third Quarter 2020 Financial Results and Provides Clinical Development and Operational Highlights

BURLINGAME, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the third quarter ended September 30, 2020, and clinical development and operational highlights.

“We are very pleased to report that during the third quarter we continued to make substantial progress in advancing our next generation anti-CD47 therapeutic, ALX148, in clinical trials in advanced gastric/gastroesophageal junction cancer and head and neck squamous cell cancers, as well as securing a clinical trial collaboration with Merck to study the combination of ALX148 with KEYTRUDA^® in the setting of first line, metastatic or unresectable, recurrent head and neck squamous cell cancer,” said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. “In addition, subsequent to the third quarter, we announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148 with azacitidine for the treatment of patients with higher-risk myelodysplastic syndromes. We also recently presented further encouraging data for ALX148 from the ASPEN-01 Phase 1b Study at the 35^th Annual SITC meeting, including a 64% ORR in advanced gastric cancer patients treated with ALX148 in combination with trastuzumab and the current chemotherapeutic standard of care. We look forward to providing further updates as we continue to advance ALX148 as a potential treatment for a range of solid tumor indications and hematologic malignancies.”

Recent Clinical Developments for ALX148

Presented New Data from the ASPEN-01 Phase 1b Study of ALX148 in Combination with Standard Chemotherapy and Antibody Regimens in Patients with Gastric/Gastroesophageal Junction Cancer (“GC”) and Head and Neck Squamous Cell Carcinoma (“HNSCC”) at the SITC 35
^th
Anniversary Annual Meeting [Abstract #404].
- In November 2020, ALX Oncology reported new preliminary data from the GC patient cohort receiving ALX148 plus trastuzumab plus chemotherapy. In patients with >2L HER2 positive GC (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrated an initial objective response rate (“ORR”) of 64% in combination with trastuzumab plus ramucirumab and paclitaxel that compares favorably with historical data. In addition, updated data from patients with >2L HER2 positive GC receiving ALX148 plus trastuzumab suggested promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.
- ALX Oncology also reported new preliminary data from the HNSCC patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In initial patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=4), ALX148 demonstrated an initial ORR of 75%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum. In addition, updated data from patients who have never been treated with a PD-1/PD-L1 inhibitor for their >2L HNSCC and who received ALX148 plus pembrolizumab suggested clinical activity beyond that expected from pembrolizumab monotherapy.
Collaboration Initiated with Merck on Phase 2 Immuno-Oncology Studies Evaluating ALX148, Targeting CD47, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Head & Neck Cancer. In September 2020, ALX Oncology entered into a clinical trial collaboration with Merck to evaluate the combination of ALX148 and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with HNSCC. ALX Oncology will conduct a Phase 2 program comprising two separate Phase 2 studies. The first study will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study will evaluate ALX148 in combination with KEYTRUDA and standard chemotherapy for the first line treatment of patients with metastatic or unresectable, recurrent HNSCC.
Announced the first patient has been dosed in the Phase 1/2 ASPEN-02 study evaluating the combination of ALX148 with
azacitidine
for the treatment of patients with higher-risk myelodysplastic syndromes (“MDS”). With the first patient dosed in October 2020, the Phase 1 part of the study is expected to characterize the safety of ALX148 in combination with azacitidine in patients with relapsed/refractory or previously untreated higher-risk MDS. Upon completion of the Phase 1, the Phase 2 component of the study will be initiated to evaluate the efficacy of the combination in patients with previously untreated higher-risk MDS.

Operational Highlights:

Named Leading Oncology Experts to Scientific Advisory Board. In October 2020, ALX Oncology announced the formation of the Company’s Scientific Advisory Board (“SAB”) with three leading oncology experts. The members of the ALX Oncology SAB include Keith Flaherty, M.D. (Chair), Charles M. Baum, M.D., Ph.D. and Kipp Weiskopf, M.D., Ph.D.
Added to Russell 2000
^®
and 3000
^®
Indexes. In September 2020, ALX Oncology was added as a member of the Russell 2000® and 3000® Indexes effective as of September 18, 2020, as part of Russell’s quarterly additions of select initial public offering (“IPO”) companies.

Conference Call on November 16
^th
at 5:00 p.m. EST

New ALX148 Data from the Phase 1b GC Expansion Cohort in ASPEN-01

ALX Oncology will host a conference call on Monday, November 16, 2020 at 5:00 p.m. EST to discuss the updated results from the GC expansion cohort in ASPEN-01, the ALX148 Phase 1b study, which was presented at the SITC 35^th Anniversary Annual Meeting. In addition to ALX Oncology’s executive management team, Dr. Yung-Jue Bang, Professor Emeritus and former Director of Cancer Research Institute, Seoul National University College of Medicine and Hospital, South Korea, will be featured on the call to discuss the latest ALX148 clinical data in patients with GC.

To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4766826. Presentation slides will be available to download under “News & Events” (see “Events”) in the Investors section of the ALX Oncology website at www.alxoncology.com.

Third Quarter 2020 Financial Results:

Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2020 were $259.5 million. ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through 2023.
Related-party Revenue: There was no related-party revenue for the quarter ended September 30, 2020, compared to $1.3 million for the corresponding period in 2019. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac Therapeutics, Inc. in July 2020.
Research and Development (“R&D”) Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148. These expenses for the three months ended September 30, 2020, were $5.3 million, compared to $2.2 million for the three months ended September 30, 2019. The increase of $3.1 million was primarily due to an increase of $2.9 million in clinical and development costs due to higher expenses associated with increased pre-clinical, clinical and other research costs in advancement of our current lead product candidate, ALX148 and an increase of $0.6 million in personnel-related costs, partially offset by a decrease of $0.4 million in stock-based compensation expense.
General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended September 30, 2020, were $4.5 million, compared to $0.9 million for the prior-year period. This increase of $3.5 million was primarily due to an increase in stock-based compensation expense of $1.0 million, an increase in professional service costs of $0.6 million, additional $0.4 million in directors and officers liability insurance premium, increased personnel-related costs of $1.2 million due to higher headcount and additional other G&A costs of $0.3 million.
Net loss: Net loss attributable to common stockholders was $10.8 million and $4.1 million for the three months ended September 30, 2020, and 2019, respectively. Included in the $10.8 million loss for the three months ended September 30, 2020, was $0.6 million related to cumulative dividends allocated to preferred shareholders, which, along with prior cumulative dividends, were converted into 2.6 million shares of common stock at the IPO. Non-GAAP net loss was $9.1 million and $3.0 million for the three months ended September 30, 2020, and 2019, respectively. A reconciliation of GAAP to non-GAAP financial results can be found in a table at the end of this press release.

About ALX Oncology

ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes. For more information, please visit ALX Oncology’s website at www.alxoncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding ALX Oncology’s financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology’s clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

ALX ONCOLOGY HOLDINGS INC.

Condensed Consolidated Statements of
Operations and Comprehensive Loss

(unaudited)
(in thousands)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Related-party revenue	$	—		$	1,256		$	1,182		$	3,583
Operating expenses:
Research and development		5,328			2,210			16,819			9,571
General and administrative		4,481			938			9,126			2,205
Cost of services for related-party revenue		—			1,142			1,075			3,257
Total operating expenses		9,809			4,290			27,020			15,033
Loss from operations		(9,809	)		(3,034	)		(25,838	)		(11,450	)
Interest expense		(226	)		—			(660	)		—
Other expense, net		(111	)		(2	)		(409	)		(4	)
Loss before income taxes		(10,146	)		(3,036	)		(26,907	)		(11,454	)
Income tax provision		(35	)		(8	)		(59	)		(25	)
Net loss and comprehensive loss		(10,181	)		(3,044	)		(26,966	)		(11,479	)
Cumulative dividends allocated to preferred stockholders		(578	)		(1,071	)		(5,202	)		(2,957	)
Net loss attributable to common stockholders	$	(10,759	)	$	(4,115	)	$	(32,168	)	$	(14,436	)

Condensed Consolidated Balance Sheet Data

(unaudited)
(in thousands)

		September 30, 2020		December 31, 2019
Cash and cash equivalents	$	259,484	$	9,017
Total assets	$	262,449	$	10,676
Total liabilities	$	10,433	$	10,952
Convertible preferred stock	$	—	$	70,363
Total stockholders’ equity/(deficit)	$	252,016	$	(70,639	)

GAAP to Non-GAAP Reconciliation

(unaudited)
(in thousands)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
GAAP net loss, as reported	$	(10,181	)	$	(3,044	)	$	(26,966	)	$	(11,479	)
Adjustments:
Stock-based compensation expense		689			86			3,693			222
Accretion of term loan		118			—			339			—
Mark-to-market adjustment on financial instruments		242			—			650			—
Total adjustments		1,049			86			4,682			222
Non-GAAP net loss	$	(9,132	)	$	(2,958	)	$	(22,284	)	$	(11,257	)

Use of Non-GAAP Financial Measures

We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

“Non-GAAP net loss“ is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) debt offering costs (interest expense related to ALX Oncology’s term loan offering costs) and (3) mark-to market adjustment on financial instruments (which include preferred stock warrants and derivatives) within our reconciliation of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

Investor Contact:

Peter Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
[email protected]

Argot Partners
(212)-600-1902
[email protected]

Media Contact:

Karen Sharma
MacDougall
(781) 235-3060
[email protected]

November 12, 2020 4:08 pm

Alta Equipment Group Inc. Reports Third Quarter 2020 Financial Results

Alta Equipment Group Inc. Reports Third Quarter 2020 Financial Results

Net revenues increased 47.3% to $220.6 million year over year
Industrial and Construction revenue increased to $115.0 million and $105.6 million, respectively
Gross profit increased 28.3% to $56.7 million compared to $44.2 million a year ago
Net income of $0.3 million improved from a net loss of $(27.4) million last year
Adjusted EBITDA* grew to $21.9 million compared to $21.7 million last year
Completed two acquisitions in Midwest region, expanding product lines and manufacturing relationships

LIVONIA, Mich.–(BUSINESS WIRE)–
Alta Equipment Group Inc. (“Alta” or the “company”) (NYSE: ALTG), a leading provider of premium industrial and construction equipment and related services, today announced financial results for the third quarter and nine months ended September 30, 2020.

CEO Comment:

Ryan Greenawalt, Chief Executive Officer of Alta, said “Alta’s solid third quarter results reflect increased customer demand from the prior quarter in both our material handling and construction businesses. As business conditions improved, we returned to close to our pre-pandemic levels of operation and labor utilization, and judiciously expanded our skilled labor force during the quarter in key areas across the Alta network. The addition of our two recent acquisitions in the Midwest, Martin Implement Sales and Howell Tractor & Equipment, will provide further penetration into a strategic growth market and further expand our product lines and OEM relationships.”

Mr. Greenawalt continued, “We anticipate a strong finish to the year and are excited to enter next year with momentum as we further differentiate and integrate our dealership and rental model, and capitalize on the investments we made in 2020. We believe this momentum paired with diligent execution will enable us to emerge as a stronger company as business conditions continue to improve.”

Third Quarter 2020 Financial Highlights:

Net revenue increased to $220.6 million from $149.8 million in the third quarter of 2019
Gross profit grew to $56.7 million compared to $44.2 million
Parts and Service revenue of $71.0 million compared to $56.5 million in the second quarter of 2020
Adjusted EBITDA* was $21.9 million in the third quarter of 2020 compared to $21.7 million same period in 2019

	Three months ended September 30,						Increase (Decrease) 2020 versus 2019						Nine months ended September 30,						Increase (Decrease) 2020 versus 2019
	2020			2019									2020			2019
Revenues:
New and used equipment sales	$	97.9		$	61.1		$	36.8			60.2	%	$	275.2		$	167.1		$	108.1			64.7	%
Parts sales		35.5			22.9			12.6			55.0	%		92.3			60.0			32.3			53.8	%
Service revenue		35.5			27.3			8.2			30.0	%		94.1			67.2			26.9			40.0	%
Rental revenue		32.2			27.8			4.4			15.8	%		83.4			66.9			16.5			24.7	%
Rental equipment sales		19.5			10.7			8.8			82.2	%		48.2			26.8			21.4			79.9	%
Net revenue	$	220.6		$	149.8		$	70.8			47.3	%	$	593.2		$	388.0		$	205.2			52.9	%

Cost of revenues:
New and used equipment sales		84.4			53.4			31.0			58.1	%		240.3			146.6			93.7			63.9	%
Parts sales		24.3			14.9			9.4			63.1	%		63.3			39.4			23.9			60.7	%
Service revenue		13.5			10.0			3.5			35.0	%		35.9			24.3			11.6			47.7	%
Rental revenue		5.4			4.3			1.1			25.6	%		14.8			11.4			3.4			29.8	%
Rental depreciation and amortization		19.2			13.7			5.5			40.1	%		47.1			32.9			14.2			43.2	%
Rental equipment sales		17.1			9.3			7.8			83.9	%		41.7			23.1			18.6			80.5	%
Cost of revenue	$	163.9		$	105.6		$	58.3			55.2	%	$	443.1		$	277.7		$	165.4			59.6	%
Gross profit	$	56.7		$	44.2		$	12.5			28.3	%	$	150.1		$	110.3		$	39.8			36.1	%
Total general and administrative expenses		60.2			38.0		$	22.2			58.4	%		157.7			97.4		$	60.3			61.9	%
(Loss) income from operations	$	(3.5	)	$	6.2		$	(9.7	)		(156.5	)%	$	(7.6	)	$	12.9		$	(20.5	)		(158.9	)%
Total other income (expense)	$	1.9		$	(33.6	)	$	35.5			(105.7	)%	$	(16.6	)	$	(42.5	)	$	25.9			(60.9	)%
Loss before taxes	$	(1.6	)	$	(27.4	)		25.8			(94.2	)%	$	(24.2	)	$	(29.6	)		5.4			(18.2	)%
Income tax benefit		(1.9	)		—			(1.9	)	NA				(3.4	)		—			(3.4	)	NA
Net income (loss)	$	0.3		$	(27.4	)	$	27.7			(101.1	)%	$	(20.8	)	$	(29.6	)	$	8.8			(29.7	)%

Recent Acquisitions:

Howell Tractor and Equipment – Completed on September 1, 2020. Howell Tractor was a privately held heavy equipment dealer serving Northern Illinois and Northwest Indiana with an expansive range of heavy construction, mining, material handling, and crane equipment available for sale or rent to its premium customer base. As an equipment industry leader in the area since opening in 1943, Howell Tractor provides around the clock professional service, with an experienced and knowledgeable staff operating out of two fully equipped, state-of-the-art facilities.
Martin Implement Sales, Inc. – Completed on October 30, 2020. Martin was a privately held premium equipment distributor with three branches in the Chicago metro area. Martin has an expansive range of new and used equipment available for sale or rental to construction and municipal customers. Martin sells primarily construction and agricultural equipment in partnership with industry leading manufacturers including New Holland, Kubota, Hyundai and Toro, and offers any equipment service that a customer needs, along with a 24/7 service hotline.

Conference Call Information:

Alta will discuss its third quarter 2020 results via live webcast and teleconference today at 5:00 p.m. Eastern Time. A live webcast of the call can be found on the investor relations portion of the company’s website at https://Investors.altaequipment.com. For a live audio teleconference, please dial (844) 543-5487 (domestic), or (825) 312-2330 (international), with conference ID # 8905858 to access the conference call at least five minutes prior to the 5:00 p.m. Eastern Time start time. Once connected with the operator, request access to the Alta Equipment Group Third Quarter 2020 Earnings Call.

A live replay of the call will also be available on the investor relations portion of the company’s website at https://Investors.altaequipment.com. An audio replay will be available between 8:00 p.m. Eastern Time, November 12, 2020, and 12:59 p.m. Eastern Time, November 26, 2020, by calling (800) 585-8367, or (416) 621-4642, with conference ID # 8905858.

Additionally, supplementary presentation slides will be accessible on the “Investor Relations” section of the Company’s website at https://Investors.altaequipment.com.

About Alta Equipment Group Inc.

Alta owns and operates one of the largest integrated equipment dealership platforms in the U.S. Through its branch network, the Company sells, rents, and provides parts and service support for several categories of specialized equipment, including lift trucks and aerial work platforms, cranes, earthmoving equipment and other industrial and construction equipment. Alta has operated as an equipment dealership for 35 years and has developed a branch network that includes 51 total locations across Michigan, Illinois, Indiana, New England, New York, Virginia and Florida. Alta offers its customers a one-stop-shop for most of their equipment needs by providing sales, parts, service, and rental functions under one roof. More information can be found at www.altaequipment.com.

Forward Looking Statements

This presentation includes certain statements that may constitute “forward-looking statements” for purposes of the federal securities laws. Forward-looking statements include, but are not limited to, statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: our future financial performance; our plans for expansion and acquisitions; and changes in our strategy, future operations, financial position, estimated revenues, and losses, projected costs, prospects, plans and objectives of management. These forward-looking statements are based on information available as of the date of this presentation, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing the parties’ views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. You should not place undue reliance on these forward-looking statements. As a result of a number of known and unknown risks and uncertainties, actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against us relating to the business combination and related transactions; (2) the ability to maintain our listing of shares of common stock on the New York Stock Exchange; (3) the risk that integrating our acquisitions disrupts our current plans and operations; (4) the ability to recognize the anticipated benefits of our business combination and acquisitions, which may be affected by, among other things, competition, our ability to grow and manage growth profitably, our ability to maintain relationships with customers and suppliers and retain our management and key employees; (5) changes in applicable laws or regulations; (6) the possibility that we may be adversely affected by other economic, business, and/or competitive factors; (7) disruptions in the political, regulatory, economic and social conditions domestically or internationally; (8) major public health issues, such as an outbreak of a pandemic or epidemic (such as the novel coronavirus COVID-19), which could cause disruptions in our operations, supply chain, or workforce; and (9) and other risks and uncertainties identified in this presentation or indicated from time to time in the section entitled “Risk Factors” in our annual report on Form 10-K and other filings with the U.S. Securities and Exchange Commission (the “SEC”). The company cautions that the foregoing list of factors is not exclusive, and readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. We do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

*Use of Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with accounting principles generally accepted in the United States (“GAAP”), Alta discloses non-GAAP financial measures, including Adjusted EBITDA, in this press release because Alta believes they are useful performance measures because they allow for an effective evaluation of Alta’s operating performance when compared to its peers, without regard to financing methods or capital structure. Alta believes such measures are useful for investors and others in understanding and evaluating Alta’s operating results in the same manner as its management. However, such measures are not financial measures calculated in accordance with GAAP and should not be considered as a substitute for, or in isolation from, net income (loss), revenue, operating profit, or any other operating performance measures calculated in accordance with GAAP.

Alta defines Adjusted EBITDA as net income (loss) before interest expense, income taxes, depreciation and amortization, adjustments for certain one-time or non-recurring items and other adjustments. Alta excludes these items from net income (loss) in arriving at Adjusted EBITDA because these amounts are either non-recurring or can vary substantially within the industry depending upon accounting methods and book values of assets, capital structures and the method by which the assets were acquired. Certain items excluded from Adjusted EBITDA are significant components in understanding and assessing a company’s financial performance, such as a company’s cost of capital and tax structure, as well as the historic costs of depreciable assets, none of which are reflected in Adjusted EBITDA. Alta’s presentation of Adjusted EBITDA should not be construed as an indication that results will be unaffected by the items excluded from Adjusted EBITDA. Alta’s computation of Adjusted EBITDA may not be identical to other similarly titled measures of other companies. For a reconciliation of non-GAAP measures to their most comparable measures under GAAP, please see the table entitled “Reconciliation of Non-GAAP Financial Measures” at the end of this press release.

ALTA EQUIPMENT GROUP INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS

*(in millions, except share and per share amounts)*	September 30, 2020			December 31, 2019
ASSETS
CURRENT ASSETS
Cash	$	0.1		$	—
Accounts receivable, net of allowances of $6.2 and $4.4 as of September 30, 2020 and December 31, 2019, respectively		122.8			101.2
Inventories, net		221.1			137.2
Prepaid expenses and other current assets		13.2			5.7
Total current assets		357.2			244.1
PROPERTY AND EQUIPMENT, NET		293.7			196.5
OTHER ASSETS
Goodwill		22.8			8.6
Intangible assets, net		24.2			3.0
Other assets		1.9			2.0
Total other assets		48.9			13.6
TOTAL ASSETS	$	699.8		$	454.2
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
CURRENT LIABILITIES
Lines of credit, net	$	139.0		$	72.5
Floor plan payable – new equipment		118.6			87.7
Floor plan payable – used and rental equipment		36.3			112.5
Current portion of long-term debt		7.8			7.1
Accounts payable		62.8			31.1
Customer deposits		6.8			7.2
Accrued expenses		26.8			16.0
Other current liabilities		13.3			9.3
Total current liabilities		411.4			343.4
LONG-TERM LIABILITIES
Long-term debt, net of current portion		136.4			86.5
Capital lease obligations, net of current portion		0.8			1.4
Buyback residual obligations, net of current portion		0.8			0.7
Guaranteed purchase obligation, net of current portion		7.4			9.0
Lease liability, net of current portion		2.7			3.7
Deferred tax liability		15.6			—
Other liabilities		10.0			3.1
Warrant liability		—			29.6
TOTAL LIABILITIES	$	585.1		$	477.4
CONTINGENCIES – NOTE 11
STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred stock, $0.0001 par value, 1,000,000 authorized and no shares outstanding at September 30, 2020	$	—		$	—
Common stock, $0.0001 par value, 29,511,359 and 7,300,000 shares issued and outstanding at September 30, 2020 and December 31, 2019		—			—
Additional paid-in capital		183.6			—
Treasury stock		(5.9	)		—
Retained deficit		(63.0	)		(23.2	)
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)		114.7			(23.2	)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	699.8		$	454.2

ALTA EQUIPMENT GROUP INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS

	Three Months Ended September 30,						Nine Months Ended September 30,
*(in millions, except share and per share amounts)*	2020			2019			2020			2019
Revenues:
New and used equipment sales	$	97.9		$	61.1		$	275.2		$	167.1
Parts sales		35.5			22.9			92.3			60.0
Service revenue		35.5			27.3			94.1			67.2
Rental revenue		32.2			27.8			83.4			66.9
Rental equipment sales		19.5			10.7			48.2			26.8
Net revenue	$	220.6		$	149.8		$	593.2		$	388.0
Cost of revenues:
New and used equipment sales		84.4			53.4			240.3			146.6
Parts sales		24.3			14.9			63.3			39.4
Service revenue		13.5			10.0			35.9			24.3
Rental revenue		5.4			4.3			14.8			11.4
Rental depreciation		19.2			13.7			47.1			32.9
Rental equipment sales		17.1			9.3			41.7			23.1
Cost of revenue	$	163.9		$	105.6		$	443.1		$	277.7
Gross profit	$	56.7		$	44.2		$	150.1		$	110.3
General and administrative expenses		58.4			37.5			153.2			95.6
Depreciation and amortization expense		1.8			0.5			4.5			1.8
Total general and administrative expenses		60.2			38.0			157.7			97.4
(Loss) income from operations	$	(3.5	)	$	6.2		$	(7.6	)	$	12.9
Other income (expense)
Interest expense, floor plan payable – new equipment		(0.5	)		(0.9	)		(1.8	)		(2.4	)
Interest expense – other		(5.6	)		(4.7	)		(15.9	)		(12.7	)
Other income		8.0			0.3			8.7			0.9
Change in fair market of warrants		—			(28.3	)		—			(28.3	)
Loss on extinguishment of debt		—			—			(7.6	)		—
Total other income (expense)	$	1.9		$	(33.6	)	$	(16.6	)	$	(42.5	)
Loss before taxes	$	(1.6	)	$	(27.4	)	$	(24.2	)	$	(29.6	)
Income tax benefit		(1.9	)		—			(3.4	)		—
Net income (loss)	$	0.3		$	(27.4	)	$	(20.8	)	$	(29.6	)
Basic and diluted income (loss) per share	$	0.01		$	(3.74	)	$	(0.81	)	$	(4.05	)
Basic and diluted weighted average common shares outstanding		29,221,460			7,300,000			25,689,145			7,300,000

ALTA EQUIPMENT GROUP INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS

	Nine Months Ended September 30,
*(amounts in millions)*	2020			2019
OPERATING ACTIVITIES
Net loss	$	(20.8	)	$	(29.6	)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation and amortization		51.6			34.9
Amortization of debt discount and debt issuance costs		1.2			0.8
Inventory obsolescence		1.3			0.6
Gain on sale of rental equipment		(6.5	)		(3.7	)
Provision for bad debt		2.8			1.3
Loss on debt extinguishment		7.6			—
(Repayment) accrual of paid-in-kind interest		(11.2	)		4.7
Change in fair value of warrants		—			28.3
Share-based payment		6.3			—
Changes in deferred taxes		(3.4	)		—
Changes in:
Accounts receivable		6.2			(14.2	)
Inventories		(102.8	)		(53.2	)
Proceeds from sale of rental equipment		48.2			26.8
Prepaid expenses and other assets		(5.5	)		(1.3	)
Proceeds from floor plans with manufacturers		240.5			183.1
Payments under floor plans with manufacturers		(273.1	)		(188.4	)
Accounts payable, accrued expenses, customer deposits, and other current liabilities		16.0			5.1
Leases and other liabilities		(3.1	)		0.8
Net cash used in operating activities	$	(44.7	)	$	(4.0	)
INVESTING ACTIVITIES
Proceeds from the sale of assets		1.0			—
Expenditures for rental equipment		(34.5	)		(18.0	)
Expenditures for property and equipment		(4.0	)		(2.1	)
Expenditures for acquisitions, net of cash acquired		(128.8	)		(65.6	)
Net activity on notes and land contract receivable		—			0.1
Net cash used in investing activities	$	(166.3	)	$	(85.6	)
FINANCING ACTIVITIES
Expenditures for debt issuance costs		(2.7	)		(0.1	)
Extinguishment of floor plans and line of credit		(132.9	)		—
Extinguishment of long-term debt		(82.0	)		—
Redemption of former shareholder notes payable		(6.7	)		—
Extinguishment of warrant liability		(29.6	)		—
Proceeds from lines of credit		334.5			137.4
Payments under lines of credit		(187.1	)		(88.0	)
Proceeds from floor plans with unaffiliated source		63.5			81.4
Payments under floor plans with unaffiliated source		(61.3	)		(50.7	)
Proceeds from issuance of long-term debt, net		149.4			20.0
Payments on long-term debt		(4.8	)		(9.1	)
Payments on capital lease obligations		(0.6	)		(0.7	)
Equity proceeds from reverse recapitalization, net		175.7			—
Proceeds from disgorgement of short swing profits		1.6			—
Repurchases of common stock		(5.9	)		—
Net cash provided by financing activities	$	211.1		$	90.2
NET CHANGE IN CASH		0.1			0.6
Cash, Beginning of year		—			1.5
Cash, End of period	$	0.1		$	2.1
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid for interest	$	26.0		$	9.7

ALTA EQUIPMENT GROUP INC. AND SUBSIDIARIES RECONCILIATION OF NON-GAAP FINANCIAL MEASURES

	Nine months ended September 30,						Three months ended September 30,
*(amounts in millions)*	2020			2019			2020			2019
Net (loss) income	$	(20.8	)	$	(29.6	)	$	0.3		$	(27.4	)
Depreciation and amortization		51.6			34.9			21.0			14.4
Interest expense		17.7			15.1			6.1			5.6
Income tax benefit		(3.4	)		—			(1.9	)		—
EBITDA (1)	$	45.1		$	20.4		$	25.5		$	(7.4	)
Change in fair value of warrants (2)		—			28.3			—			28.3
One-Time Transaction Costs (3)		3.9			0.4			1.2			0.2
Loan Administration Fees (4)		0.3			0.3			0.1			—
Non-Cash Adjustments (5)		0.7			1.5			0.3			1.1
Loss on Debt Extinguishment (6)		7.6			—			—			—
Equity-linked Incentives (7)		9.8			—			3.2			—
Other expenses (8)		0.4			0.1			—			—
Insurance proceeds (9)		(8.0	)		—			(8.0	)		—
Showroom-Ready Floorplan Interest Expense (10)		(1.4	)		(1.6	)		(0.4	)		(0.5	)
Adjusted EBITDA (1)	$	58.4		$	49.4		$	21.9		$	21.7
Pro Forma EBITDA—Acquisitions (11)		6.9			27.1			0.5			7.3
Adjusted Pro Forma EBITDA (1)	$	65.3		$	76.5		$	22.4		$	29.0

(1)		Represents Non-GAAP measure
(2)		Represents mark to market valuation for warrants
(3)		Includes expenses related to the acquisitions, both completed and pending, and public company preparation costs
(4)		Debt administration expenses associated with debt refinancing activities in May 2019 and February 2020 in connection with the business combination
(5)		Non-cash adjustments related to deferred rent expenses
(6)		Represents expenses of debt extinguishments related to refinancing activities relating to the business combination in February 2020
(7)		Reflects equity-based compensation expenses related to refinancing activities in February 2020 and Restricted Stock Unit expense in September 2020
(8)		Other non-recurring expenses primarily related to severance payments
(9)		Key-man life insurance proceeds
(10)		Represents interest expense associated with showroom-ready new and used floorplan equipment interest included in total interest expense above
(11)		Pro forma EBITDA of NITCO, Flagler, Liftech, PeakLogix, Hilo and Martin for periods in 2019 and forward, assuming each was acquired as of January 1, 2019

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006042/en/

Investors:

Bob Jones / Taylor Krafchik

Ellipsis

[email protected]

(646) 776-0886

Media:

Glenn Moore

Alta Equipment

[email protected]

(248) 305-2134

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: Other Transport Trucking Construction & Property Automotive General Automotive Transport Building Systems Other Construction & Property Fleet Management

MEDIA:

November 12, 2020 4:08 pm

IntelGenx Reports Third Quarter 2020 Financial Results

SAINT LAURENT, Quebec, Nov. 12, 2020 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX V:IGX)(OTCQB:IGXT) (the “Company” or “IntelGenx”) today reported financial results for the third quarter ended September 30, 2020. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

20

20

Thir

d

Quarter Financial

Summary

:

Revenue was $510,000, compared to $61,000 in the 2019 third quarter
Adjusted EBITDA loss was ($1.2 million), compared to ($2.3 million) in Q3-2019

Recent

Development

s:

Issued U.S. Patent 10,828,254 entitled “Oral film formulation for modulating absorption profile,” which covers a novel oral film dosage technology platform for modulating the in vivo absorption profile of a sublingually- or buccally-administered active ingredient.
Announced the publication of a study in the peer-reviewed International Journal of Clinical Pharmacy evaluating Montelukast’s effect on neurological aging.
Closed a private placement in two tranches, raising a total of $1.8 million principal amount of 8% convertible notes due October 15, 2024.
Signed a binding letter of intent (“LOI”) with Heritage Cannabis Holdings Corp. (CSE:CANN; OTCQX:HERTF) (“Heritage”) for the supply of filmstrip products containing CBD for the Canadian and Australian markets.
Entered into an amended and restated license agreement, granting Tetra Bio-Pharma (TSX:TBP; OTCQB:TBPMF) (“Tetra”) additional exclusive worldwide rights, including the right to manufacture, IntelGenx’s Adversa^® mucoadhesive delivery technology.
Expanded its RIZAPORT^®commercialization agreement with Exeltis Healthcare S.L. (“Exeltis”) to include the European Union.
Entered into a feasibility agreement with ATAI Life Sciences (“ATAI’) for the development of novel formulations of pharmaceutical-grade psychedelics.
Amended the exclusivity terms of its November 2018 license, development and supply agreement with Tilray, Inc. to allow for IntelGenx’s co-development and commercialization of CBD products with additional partners.
Entered into a feasibility agreement with Cybin Corp. for the development of an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin.

“We began to see the results of our performance improvement program being reflected in our financial results this quarter,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We have also continued to execute on our business development strategy by granting Tetra additional exclusive worldwide rights to our Adversa^® technology, and entering into a feasibility agreement and a LOI with ATAI and Heritage, respectively, related to our filmstrip technology. In addition, we added 26 European countries to our existing RIZAPORT^® commercialization partnership with Exeltis, and are looking forward to their launch of the product in at least one major market early next year.”

Financial Results:

Total revenues for the three-month period ended September 30, 2020 amounted to $510,000, an increase of $449,000, or 736%, compared to $61,000 for the three-month period ended September 30, 2019. The increase is mainly attributable to a $308,000 and $141,000 increase in licensing agreement and research and development revenues, respectively.

Operating costs and expenses were $1.9 million for the third quarter of 2020, versus $2.6 million for the corresponding three-month period of 2019. The decrease for the three-month period ended September 30, 2020 is mainly attributable to a $691,000 decrease in selling, general and administrative expenses.

For the third quarter of 2020, the Company had an operating loss of $1.4 million, compared to an operating loss of $2.5 million for the comparable period of 2019.

Net comprehensive loss for the three-month period ended September 30, 2020 was $1.6 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $2.9 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

As at September 30, 2020, the Company’s cash and short-term investments totalled $1.5 million, which did not include gross proceeds of $1.8 million raised by the Company in its October 2020 convertible notes offering.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 third quarter financial results today, Thursday, November 12, 2020, at 4:30 p.m. ET.

Live Call:	1-800‑459‑5346 (Canada and the United States)
	1-203‑518‑9544 (International)

The call will be also be webcast live and archived for twelve months at www.intelgenx.com.

About
IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm^® and VetaFilm™, as well as its transdermal development and manufacturing capabilities, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

Forward Looking Statements:

This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions, including, without limitation, anticipated commencement of commercial production of cannabis-infused VersaFilm® and how long operations can be funded based on current assets. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx’s operations, the demand for its products, global supply chains and economic activity in general. IntelGenx assumes no obligation to update any such forward-looking statements.

Each of the TSX Venture Exchange and OTCQB has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source: IntelGenx Technologies Corp.

For
IntelGenx
:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
[email protected]

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
[email protected]

November 12, 2020 4:08 pm

Taysha Gene Therapies Reports Third Quarter 2020 Financial Results and Provides Business Update

Taysha Gene Therapies Reports Third Quarter 2020 Financial Results and Provides Business Update

Successfully raised $96 million in Series B financing and completed $181 million IPO

Established management team with successful track record of developing and commercializing AAV9-based gene therapies for monogenic diseases of the central nervous system

Company on track to initiate a Phase 1/2 clinical trial of TSHA-101 in GM2 gangliosidosis by the end of 2020 and plans to submit four INDs in 2021

DALLAS–(BUSINESS WIRE)–Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today reported its financial results for the third quarter of 2020 and provided a business update.

“Just over a year ago, we founded Taysha in partnership with UT Southwestern with a mission to develop gene therapies to address monogenic diseases of the central nervous system, and to that end we have made significant progress in building a talented team that can advance our broad portfolio,” said RA Session, II, President, Founder and CEO of Taysha. “During the third quarter, we raised over $275 million between our Series B financing and our IPO, providing the capital resources to support our industry-leading pipeline of 18 gene therapy programs. We have also bolstered our GMP manufacturing capabilities to ensure we have the capacity to support our development plans for multiple programs by utilizing the UTSW vector core, our internal Taysha manufacturing facility that is currently in development and our newly announced partnership with Catalent.”

Program Highlights

TSHA-101 for GM2 gangliosidosis – Taysha secured rare pediatric disease designation and orphan drug designation from the U.S. Food and Drug Administration (FDA) for TSHA-101, its bicistronic vector designed to treat GM2 gangliosidosis, also known as Tay-Sachs and Sandhoff disease. Taysha anticipates initiating a Phase 1/2 clinical trial of TSHA-101 in Canada by end of 2020.

TSHA-102 for Rett syndrome –Taysha announced that FDA has granted rare pediatric disease and orphan drug designation for TSHA-102, which is under development for the treatment of Rett syndrome, one of the most common genetic causes of severe intellectual disability. TSHA-102 utilizes the miRARE platform, which is designed to regulate the expression of therapeutic transgenes on a cellular basis. Taysha remains on track to file an Investigational New Drug (IND) application for the program in 2021.

TSHA-118 for CLN1 – Taysha announced the in-licensing of an AAV9-based gene therapy program for the treatment of CLN1. TSHA-118 was originally developed in the academic lab of Steven Gray, Ph.D., Taysha’s Chief Scientific Advisor. CLN1 Batten disease is a rapidly progressive rare lysosomal storage disease with no approved treatments. The company intends to initiate a Phase 1/2 clinical trial of TSHA-118 in 2021 under a currently open IND.

Recent Business Highlights

In October, Taysha announced a partnership with Invitae to support two different screening programs to enable rapid identification of patients with genetic disorders. DETECT Lysosomal Storage Diseases provides genetic testing for lysosomal storage disorders, including GM2 gangliosidosis and CLN1. The Behind the Seizures® program supports the diagnosis of patients with genetic epilepsies.

In November, Taysha announced a development and manufacturing partnership with Catalent to support future preclinical and clinical supply for several of Taysha’s gene therapy programs, including CLN1 and Rett syndrome.

Taysha has also invested in building its internal management team to advance the development of its broad gene therapy pipeline. The company anticipates more than tripling its headcount from its IPO by the end of 2020 across all areas of the organization.

Financial Results

As of September 30, 2020, cash and cash equivalents totaled $279 million, which includes gross proceeds of $181 million from Taysha’s IPO and $96 million from its Series B financing. Taysha was incorporated in September of 2019 and thus has no previous nine-month results for comparison.

Taysha reported R&D expenses for the nine months ended September 30, 2020 of $19.6 million. The $19.6 million was primarily attributable to $10.0 million of expenses recognized pursuant to the Queen’s University Agreement and the Abeona CLN1 Agreement, $4.1 million related to the manufacture of clinical trial material and $3.9 million in other sponsored research agreements for the Company’s various product candidates. Additionally, Taysha incurred regulatory and clinical consulting expenses of $0.8 million and employee compensation and benefits expenses of $0.8 million, which included $0.4 million of non-cash stock-based compensation.

Taysha reported G&A expenses of $5.0 million for the nine months ended September 30, 2020. The $5.0 million was primarily attributable to $2.7 million of compensation and benefits related to new hires, which included $0.9 million of non-cash stock-based compensation, $1.7 million in consulting fees, $0.5 million of legal expenses related to general corporate matters and $0.1 million related to insurance and other administrative expenses.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed and the success of our partnerships with Invitae and Catalent. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which we intend to file shortly hereafter and will be available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

Taysha Gene Therapies
Selected Condensed Consolidated Financial Information
(In thousands, except share and per share data)
(Unaudited)

Statements of Operations

	For the Three Months Ended September 30, 2020			For the Nine Months Ended September 30, 2020			For the Period from September 20, 2019 (date of inception) to September 30, 2019

Operating expenses:
Research and development	$	11,057		$	19,633		$	–
General and administrative		3,984			5,002			31
Total operating expenses		15,041			24,635			31
Loss from operations		(15,041	)		(24,635	)		(31	)
Other expense:
Change in fair value of preferred stock tranche liability		–			(17,030	)		–
Interest expense		(1	)		(28	)		–
Total other expense		(1	)		(17,058	)		–
Net loss	$	(15,042	)	$	(41,693	)	$	(31	)

Net loss per common share, basic and diluted	$	(1.28	)	$	(3.73	)	$	(0.00	)
Weighted average common shares outstanding, basic and diluted		11,733,170			11,176,429			8,715,999

Balance Sheet

	September 30, 2020	December 31, 2019

ASSETS
Current assets:
Cash and cash equivalents	$ 278,634	$ –
Prepaid expenses	604	–
Deferred offering costs	–	15
Total current assets	279,238	15
Property and equipment, net	28	–
Total assets	$ 279,266	$ 15

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable	$ 8,837	$ –
Accrued expenses	2,727	150
Due to related party	60	–
Total current liabilities	11,624	150
Total liabilities	11,624	150


Stockholders’ equity (deficit)
Preferred stock, $0.00001 par value per share; 10,000,000 shares authorized and no shares issued and outstanding as of September 30, 2020; no shares authorized, issued and outstanding as of December 31, 2019	–	–
Common stock, $0.00001 par value per share; 200,000,000 shares authorized and 37,761,435 issued and outstanding as of September 30, 2020; 10,895,000 shares authorized, 10,894,999 issued and outstanding as of December 31, 2019	–	–
Additional paid-in capital	310,450	980
Accumulated deficit	(42,808)	(1,115)
Total stockholders’equity (deficit)	267,642	(135)
Total liabilities and stockholders’ equity (deficit)	$ 279,266	$ 15

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006028/en/

Company Contact:

Niren Shah, PharmD, MBA

Taysha Gene Therapies

[email protected]

Media Contact:

Carolyn Hawley

Canale Communications

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Health Infectious Diseases Genetics Research Science Pharmaceutical Biotechnology

MEDIA:

Logo

November 12, 2020 4:08 pm

Applied Molecular Transport Reports Third Quarter 2020 Financial Results and Provides Corporate Update

– Company on track with comprehensive AMT-101 Phase 2 clinical program across multiple indications, including inflammatory bowel diseases and rheumatoid arthritis –

– Announced dosing of first patient in Phase 2 monotherapy trial (LOMBARD) evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe ulcerative colitis –

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020.

“We continue to make important progress in the development of our differentiated oral biologic drug candidates in a number of indications,” said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. “We recently advanced oral AMT-101 into a Phase 2 monotherapy trial in patients with ulcerative colitis (UC). In addition, we continue the planned expansion of this comprehensive clinical program with two additional Phase 2 trials of AMT-101 in combination with anti-TNFα therapy in biologic-naïve patients with moderate to severe UC and as a monotherapy in patients with pouchitis, both initiating by year-end. We are also looking forward to the initiation of the fourth Phase 2 trial for AMT-101 in combination with anti-TNFα in rheumatoid arthritis patients who are partially responding to anti-TNFα therapy. Furthermore, given the broad potential of our technology platform as an engine for the development of novel oral biologics, we continue to work on expanding our deep pipeline into additional indications and therapeutic areas and look forward to sharing updates on our progress.”

Recent Business Highlights

Announced dosing of the first patient in the LOMBARD Phase 2 monotherapy trial evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe UC
Successfully manufactured AMT-101 and AMT-126 clinical biologic drug supply at AMT’s internal GMP manufacturing facility
Announced publication of preclinical data demonstrating potential of AMT-101 for inflammatory diseases in The Journal of Immunology (November 2020 issue)

Anticipated Upcoming
Milestones

Initiate the remaining Phase 2 trials for oral AMT-101:
- MARKET clinical trial of oral AMT-101 in combination with anti-TNFα, in biologic-naïve, moderate to severe UC patients by year-end
- FILLMORE clinical trial of oral AMT-101 for the treatment of pouchitis by year-end
- CASTRO clinical trial of oral AMT-101 in combination with anti-TNFα for the treatment of rheumatoid arthritis in 1H 2021
- Anticipate top-line data readouts from the four AMT-101 Phase 2 trials beginning in 2H 2021 and into 1H 2022
File IND/CTA for AMT-126, a gastrointestinal (GI)-selective oral fusion of hIL-22, to treat serious diseases associated with intestinal epithelial (IE) barrier defects by year-end

Financial Results for the
Third
Quarter Ended
September
30, 2020

Research and development (R&D) expenses. Total R&D expenses for the third quarter of 2020 were $13.4 million, compared to $6.9 million for the same period in 2019. The increase was primarily due to higher expenses associated with clinical trials, preclinical studies, materials, compensation, and facilities related expenses, offset by a decrease in contract manufacturing due to internal capabilities.

General and administrative (G&A) expenses. Total G&A expenses for the third quarter of 2020 were $3.4 million, compared to $1.0 million for the same period in 2019. The increase was primarily due to an increase in personnel costs and professional fees.

Net loss. Net loss for the third quarter of 2020 was $16.8 million, compared to $7.9 million for the third quarter of 2019.

Cash, cash equivalents
, and investments. As of September 30, 2020, cash, cash equivalents, and investments were $147.3 million.

About Applied Molecular Transport Inc.

Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT’s proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that uses the cell’s own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly tablet and capsule forms that are designed to either target local GI tissue or enter systemic circulation to precisely address the relevant biology of a disease.

AMT’s headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT’s plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT’s technology platform, statements regarding AMT’s Phase 2 clinical trials for AMT-101 including the timing of such trials, the timing of the filing of IND/CTA for AMT-126, AMT’s ability to leverage its technology to expand its pipeline, presentations regarding AMT-101’s Phase 1b dataset, and AMT-101 top-line data readouts including the timing of such readouts. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our technology platform to build a pipeline of product candidates; uncertainty of developing biologic therapeutics; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; potential delays and disruption resulting from the COVID-19 pandemic; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in AMT’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2020, and AMT’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Applied Molecular Transport Inc.

Condensed Bal
ance Sheets

(unaudited)

(in thousands, except share and per share amounts)

	September 30,			December 31,
	2020			*2019()**
Assets
Current assets:
Cash and cash equivalents	$	11,314		$	12,727
Short-term investments		135,940			19,676
Prepaid expenses		1,816			532
Deferred offering costs		—			366
Other current assets		79			152
Total current assets		149,149			33,453
Property and equipment, net		8,437			4,091
Long-term investments		—			249
Restricted cash		108			108
Other assets		127			632
Total assets	$	157,821		$	38,533
Liabilities, convertible preferred stock and stockholders’ equity (deficit)
Current liabilities:
Accounts payable	$	2,705		$	2,666
Accrued expenses		4,692			1,315
Deferred rent, current		65			13
Capital lease obligations, current		229			42
Total current liabilities		7,691			4,036
Deferred rent		473			526
Capital lease obligations		463			58
Total liabilities		8,627			4,620
Commitments and contingencies
Series A convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 5,157,213 shares authorized, issued and outstanding, as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $33,000 as of December 31, 2019		—			32,826
Series B convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 3,992,919 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $31,025 as of December 31, 2019		—			30,921
Series C convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 4,816,160 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $41,949 as of December 31, 2019		—			41,868
Stockholders’ equity (deficit):
Common stock, $0.0001 par value, 450,000,000 and 32,000,000 shares authorized as of September 30, 2020, and December 31, 2019, respectively; 34,880,411 and 7,360,738 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively		3			1
Additional paid-in capital		269,437			1,078
Accumulated other comprehensive income		31			13
Accumulated deficit		(120,277	)		(72,794	)
Total stockholders’ equity (deficit)		149,194			(71,702	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)	$	157,821		$	38,533

(*) Derived from audited Financial Statements.

Applied Molecular Transport Inc.

Condensed Statements of Opera
tions and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
Operating expenses:
Research and development	$	13,395		$	6,890		$	39,185		$	17,756
General and administrative		3,428			1,008			8,404			2,510
Total operating expenses		16,823			7,898			47,589			20,266
Loss from operations		(16,823	)		(7,898	)		(47,589	)		(20,266	)
Interest income, net		59			36			187			107
Other expense, net		(29	)		(3	)		(81	)		(15	)
Net loss	$	(16,793	)	$	(7,865	)	$	(47,483	)	$	(20,174	)
Net loss per share, basic and diluted	$	(0.48	)	$	(1.07	)	$	(2.53	)	$	(2.74	)
Weighted-average shares of common stock outstanding, basic and diluted		34,767,308			7,360,738			18,770,153			7,360,738
Comprehensive loss:
Net loss	$	(16,793	)	$	(7,865	)	$	(47,483	)	$	(20,174	)
Other comprehensive income (loss):
Unrealized gains on investments		29			3			37			3
Amounts recognized for net realized gains included in net loss		—			—			(19	)		—
Total comprehensive loss	$	(16,764	)	$	(7,862	)	$	(47,465	)	$	(20,171	)

Investor Relations Contact:

Andrew Chang
Head, Investor Relations & Corporate Communications
[email protected]

Media Contacts:

Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]

Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]

November 12, 2020 4:08 pm

Kezar Life Sciences to Present During Upcoming Virtual Investor Conferences

Kezar Life Sciences to Present During Upcoming Virtual Investor Conferences

SOUTH SAN FRANCISCO–(BUSINESS WIRE)–
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced members of the executive team will present during upcoming virtual investor conferences. The details of the presentations are as follows:

Jefferies Virtual London Healthcare Conference

Wednesday, November 18, 2020, 1:10pm EST (Fireside Chat)

Presenters: John Fowler, Chief Executive Officer; Christopher Kirk, PhD, Chief Scientific Officer, and Noreen R. Henig, MD, Chief Medical Officer

2020 Evercore ISI HealthCONx Conference

Thursday, December 3, 2020, 1:00pm EST (Presentation)

Presenter: John Fowler, Chief Executive Officer

The presentations will be webcast live and may be accessed in the “Investors and News” section of the Company’s website at www.kezarlifesciences.com. Kezar Life Sciences will maintain an archived replay of the webcasts on its website for 90 days after the conference.

About Kezar Life Sciences

Based in South San Francisco, Kezar Life Sciences is combining courage, conviction, and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function and inhibit multiple drivers of disease via a single target. KZR-616, a first-in-class selective immunoproteasome inhibitor, is being evaluated in severe and underserved autoimmune diseases. Additionally, KZR-261, the first clinical candidate for the treatment of cancer from the company’s protein secretion program targeting the Sec61 translocon, is undergoing IND-enabling activities.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006003/en/

Celia Economides

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Oncology Health Research Pharmaceutical Science Biotechnology

MEDIA:

November 12, 2020 4:08 pm

Ra Medical Systems Reports 2020 Third Quarter Financial Results

Ra Medical Systems Reports 2020 Third Quarter Financial Results

Conference call begins at 4:30 p.m. Eastern time today

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, reports financial results for the three and nine months ended September 30, 2020 and provides a business update.

Recent Operational Highlights

Twelve subjects enrolled in the Company’s atherectomy pivotal clinical trial, for a total of 13 subjects enrolled to date
Positive test results support the path to extend the shelf life of future DABRA catheters
Next-generation DABRA catheter projects are advancing on or ahead of schedule with prototypes available for in vitro testing
The quality improvement program initiated in late 2019 is substantially complete

“I’m encouraged by the progress we’ve made during the third quarter and in recent weeks, in particular with patient enrollment in our atherectomy pivotal trial and with improvements and enhancements to the DABRA catheter,” said Will McGuire, Ra Medical Systems CEO. “We are executing well on our engineering, clinical and quality initiatives, and I am confident that we will deliver on our milestones.”

Third Quarter Financial Highlights

Net revenue for the third quarter of 2020 was $0.9 million, which consisted of product sales of $0.2 million and service and other revenue of $0.7 million. This compares with net revenue of $1.9 million for the third quarter of 2019, which consisted of product sales of $1.1 million and service and other revenue of $0.8 million.

Net revenue from the vascular segment for the third quarter of 2020 was $0.1 million, compared with $0.2 million for the third quarter of 2019. Net revenue from the dermatology segment was $0.8 million for the third quarter of 2020, compared with $1.7 million for the third quarter of 2019.

Total cost of revenue for the third quarter of 2020 was $1.4 million, compared with $2.4 million for the third quarter of 2019.

Selling, general and administrative expenses for the third quarter of 2020 were $4.9 million, which included $0.8 million in stock-based compensation, compared with $15.9 million for the third quarter of 2019, which included $6.6 million in stock-based compensation. Research and development expenses for the third quarter of 2020 were $2.3 million, compared with $1.2 million for the third quarter of 2019. Research and development expenses for the third quarters of 2020 and 2019 included $0.1 million and $0.3 million of stock-based compensation, respectively.

The net loss for the third quarter of 2020 was $7.8 million, or $0.13 per share, compared with a net loss for the third quarter of 2019 of $17.4 million, or $1.30 per share.

Adjusted EBITDA for the third quarter of 2020 was negative $6.2 million, compared with negative $9.9 million for the third quarter of 2019. Adjusted EBITDA is a non-GAAP measure presented as net loss before depreciation and amortization expense, interest income, interest expense, income taxes and stock-based compensation. For additional information regarding the non-GAAP financial measures discussed in this news release, please see “Non-GAAP Reconciliations” below.

Ra Medical reported cash and cash equivalents of $33.6 million as of September 30, 2020.

Nine Month Financial Highlights

Net revenue for the first nine months of 2020 was $3.2 million, which consisted of product sales of $0.9 million and service and other revenue of $2.3 million. This compares with net revenue of $5.8 million for the first nine months of 2019, which consisted of product sales of $3.3 million and service and other revenue of $2.5 million.

Net revenue from the vascular segment was $0.3 million for the first nine months of 2020, compared with $1.1 million for the first nine months of 2019. Net revenue from the dermatology segment was $2.9 million for the first nine months of 2020, compared with $4.7 million for the first nine months of 2019.

Total cost of revenue for the first nine months of 2020 was $4.2 million, compared with $7.1 million for the first nine months of 2019.

Selling, general and administrative expenses for the first nine months of 2020 were $19.1 million, which included $2.5 million in stock-based compensation, compared with $42.9 million for the first nine months of 2019, which included $19.3 million in stock-based compensation. Research and development expenses for the first nine months of 2020 were $5.6 million, which included $0.3 million in stock-based compensation, compared with $3.7 million for the first nine months of 2019, which included $1.4 million in stock-based compensation.

The net loss for the first nine months of 2020 was $25.6 million, or $0.79 per share, compared with a net loss for the first nine months of 2019 of $47.2 million, or $3.63 per share.

Adjusted EBITDA for the first nine months of 2020 was negative $20.8 million, compared with negative $24.4 million for the first nine months of 2019.

Conference Call and Webcast

Ra Medical will hold a conference call and audio webcast to discuss this announcement and answer questions at 4:30 p.m. Eastern time today. The conference call dial-in numbers are 866-777-2509 for domestic callers and 412-317-5413 for international callers, and the passcode is 10149446. A live webcast of the call will be available on the Investor Relations section of www.ramed.com.

A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing 877-344-7529 for domestic callers, 855-669-9658 for Canadian callers or 412-317-0088 for international callers. Please use the passcode 10149446. A webcast replay will be available on the Investor Relations section of www.ramed.com for 30 days, beginning approximately two hours after the completion of the call.

Non-GAAP Financial Measures

Ra Medical has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis for the three- and nine-month periods ended September 30, 2020 and September 30, 2019. EBITDA and Adjusted EBITDA are performance measures that provide supplemental information management believes is useful to analysts and investors to evaluate Ra Medical’s ongoing results of operations, when considered alongside other GAAP measures. These measures are intended to aid investors in better understanding Ra Medical’s current financial performance and prospects for the future as seen through management. Management uses non-GAAP measures to compare the company’s performance relative to forecasts and strategic plans and to benchmark the company’s performance externally against competitors. Management believes that these non-GAAP financial measures facilitate comparisons with Ra Medical’s historical results and with the results of peer companies who present similar measures (although other companies may define non-GAAP measures differently than we define them, even when similar terms are used to identify such measures). Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company’s operating results as reported under U.S. GAAP. Ra Medical encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the accompanying tables of this release.

Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business. Ra Medical defines EBITDA as our GAAP net loss as adjusted to exclude depreciation and amortization, interest income, interest expense and income tax expense. Ra Medical defines Adjusted EBITDA as our GAAP net loss as adjusted to exclude depreciation and amortization, interest income, interest expense, income tax expense and stock-based compensation.

About Ra Medical Systems

Ra Medical Systems commercializes excimer lasers and catheters for the treatment of vascular and dermatological diseases. In May 2017, the DABRA excimer laser system received FDA 510(k) clearance in the U.S. for crossing chronic total occlusions, or CTOs, in patients with symptomatic infrainguinal lower extremity vascular disease with an intended use for ablating a channel in occlusive peripheral vascular disease. The Pharos excimer laser system is FDA-cleared and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. DABRA and Pharos are both based on Ra Medical’s core excimer laser technology platform and deploy similar mechanisms of action. Ra Medical manufactures DABRA and Pharos excimer lasers and catheters in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in controlled environments.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Ra Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Ra Medical’s future expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements regarding Ra Medical’s business strategy. Ra Medical’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks associated with acceptance of DABRA and Pharos and procedures performed using such devices by physicians, payors, and other third parties; development and acceptance of new products or product enhancements; clinical and statistical verification of the benefits achieved via the use of Ra Medical’s products; the results from our clinical trials, which may not support intended indications or may require Ra Medical to conduct additional clinical trials or modify ongoing clinical trials; challenges related to commencement, patient enrollment, completion, an analysis of clinical trials; Ra Medical’s ability to manage operating expenses; Ra Medical’s ability to effectively manage inventory; Ra Medical’s ability to recruit and retain management and key personnel; Ra Medical’s need to comply with complex and evolving laws and regulations; intense and increasing competition and consolidation in Ra Medical’s industry; the impact of rapid technological change; costs and adverse results in any ongoing or future legal proceedings; adverse outcome of regulatory inspections; and the other risks and uncertainties described in Ra Medical’s news releases and filings with the Securities and Exchange Commission. Information on these and additional risks, uncertainties, and other information affecting Ra Medical’s business and operating results is contained in Ra Medical’s Annual Report on Form 10-K for the year ended December 31, 2019 and in its other filings with the Securities and Exchange Commission. Additional information will also be set forth in Ra Medical’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 to be filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Ra Medical as of the date hereof, and Ra Medical disclaims any obligation to update any forward-looking statements, except as required by law.

Ra Medical investors and others should note that we announce material information to the public about the company through a variety of means, including our website (www.ramed.com), our investor relations website (https://ir.ramed.com/), press releases, SEC filings and public conference calls in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.

Ra Medical Systems, Inc.
Condensed Balance Sheets
(Unaudited)
(in thousands)

	September 30, 2020		December 31, 2019
ASSETS
Current Assets
Cash and cash equivalents	$	33,646	$	14,584
Short-term investments		—		15,993
Accounts receivable, net		475		786
Inventories		2,592		2,777
Prepaid expenses and other current assets		466		1,860
Total current assets		37,179		36,000
Property and equipment, net		3,581		5,050
Operating lease right-of-use-assets		2,574		2,835
Other non-current assets		120		196
TOTAL ASSETS	$	43,454	$	44,081

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable	$	899	$	1,532
Accrued expenses		4,591		2,642
Current portion of deferred revenue		1,729		2,029
Current portion of equipment financing		306		293
Current portion of promissory note		168		—
Current portion of operating lease liabilities		346		318
Total current liabilities		8,039		6,814
Deferred revenue		656		1,232
Equipment financing		34		265
Promissory note		1,832		—
Operating lease liabilities		2,355		2,620
Total liabilities		12,916		10,931
Total stockholders’ equity		30,538		33,150
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	43,454	$	44,081

Ra Medical Systems, Inc.

Condensed Statements of Operations

(Unaudited)

(in thousands, except per share data)

Three Months Ended September 30, Nine Months Ended September 30,

2020

2019

2020

2019

Net revenue

Product sales
$

183

$

1,078

$

923

$

3,256

Service and other

731

830

2,265

2,553

Total net revenue

914

1,908

3,188

5,809

Cost of revenue

Product sales

670

1,518

2,258

4,848

Service and other

748

907

1,911

2,252

Total cost of revenue

1,418

2,425

4,169

7,100

Gross loss

(504

)

(517

)

(981

)

(1,291

)

Operating expenses

Selling, general and administrative

4,933

15,889

19,114

42,907

Research and development

2,332

1,182

5,580

3,692

Total operating expenses

7,265

17,071

24,694

46,599

Operating loss

(7,769

)

(17,588

)

(25,675

)

(47,890

)

Other income (expense), net

(10

)

173

74

684

Loss before income tax expense

(7,779

)

(17,415

)

(25,601

)

(47,206

)

Income tax expense

—

3

—

8

Net loss
$

(7,779

)

$

(17,418

)

$

(25,601

)

$

(47,214

)

Basic and diluted net loss per share
$

(0.13

)

$

(1.30

)

$

(0.79

)

$

(3.63

)

Basic and diluted weighted average common shares outstanding

59,638

13,370

32,443

13,023

Ra Medical Systems, Inc.

Non-GAAP Reconciliations

(Unaudited)

(in thousands)

Three Months Ended September 30, Nine Months Ended September 30,

2020

2019

2020

2019

Statements of Operations Data:

Net loss
$

(7,779

)

$

(17,418

)

$

(25,601

)

$

(47,214

)

Depreciation and amortization

631

460

1,845

1,291

Interest income

(4

)

(245

)

(128

)

(870

)

Interest expense

14

72

54

186

Income tax expense

—

3

—

8

EBITDA

(7,138

)

(17,128

)

(23,830

)

(46,599

)

Stock-based compensation

964

7,277

3,044

22,154

Adjusted EBITDA
$

(6,174

)

$

(9,851

)

$

(20,786

)

$

(24,445

)

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005978/en/

At the Company:

Jeffrey Kraws

President, Ra Medical Systems

760-496-9008

[email protected]

Investors:

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Posted on November 12, 2020 4:08 pm
Retrophin Completes Acquisition of Orphan Technologies

Addition of OT-58 strengthens pipeline of potential first-in-class therapies targeting rare diseases

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Retrophin, Inc. (NASDAQ: RTRX) today announced the completion of its previously announced acquisition of Orphan Technologies Limited, a privately held, clinical-stage biopharmaceutical company focused on the development of product candidate OT-58 for the treatment of classical homocystinuria (HCU). OT-58 is a novel investigational human enzyme replacement therapy being evaluated in Phase 1/2 development for the treatment of classical HCU, a rare metabolic disorder characterized by elevated levels of plasma homocysteine that can lead to life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay.

“We are excited to begin working with the HCU community to develop a deeper understanding of how we can continue to integrate their perspectives into the development of OT-58, and help address their unmet needs,” said Eric Dube, Ph.D., chief executive officer of Retrophin. “We look forward to building upon the promising potential of OT-58 with the goal of developing and ultimately delivering the first disease modifying therapy for people living with HCU.”

Under the terms of the agreement, Retrophin made an upfront payment of $90 million in cash at closing of the transaction. Orphan Technologies shareholders will remain eligible to receive up to $427 million in additional cash payments contingent upon the achievement of key milestones in the development and commercialization of OT-58. Retrophin will also pay a tiered mid-single digit royalty on future net sales of OT-58 in the US and Europe, and potentially make a milestone payment in the event a rare pediatric disease priority review voucher is granted.

Barclays acted as financial advisor, and Cooley LLP acted as legal counsel to Retrophin. Cantor Fitzgerald & Co. acted as financial advisor, and Hogan Lovells US LLP acted as legal counsel to Orphan Technologies.

About
Classical Homocystinuria

Classical homocystinuria (HCU) is a rare genetic metabolic disorder caused by a deficiency in the enzyme cystathionine beta synthase (CBS). CBS is a pivotal enzyme that is essential for the management of methionine and cysteine in the body. Classical HCU leads to toxic levels of homocysteine that can result in life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay. Current treatment options are limited to protein-restricted diet and supplemental use of vitamin B6 and betaine.

About Retrophin

Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company’s approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin’s R&D efforts are supported by revenues from the Company’s commercial products Chenodal^®, Cholbam^®, Thiola^® and Thiola EC^®.

Retrophin.com

About
Orphan Technologies

Orphan Technologies is a clinical-stage biopharmaceutical company focused on the development of OT-58. OT-58 is an investigational human enzyme replacement therapy being evaluated in Phase 1/2 development for the treatment of classical homocystinuria (HCU). HCU is a rare metabolic disorder characterized by elevated levels of plasma homocysteine that can lead to life-threatening thrombotic events such as stroke and heart attacks, ophthalmologic and skeletal complications, as well as developmental delay.

Forward-Looking Statements

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words “may”, “might”, “believes”, “thinks”, “anticipates”, “plans”, “expects”, “intends” or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references related to; the potential impact upon and benefits to Retrophin from the acquisition of Orphan Technologies; the potential for OT-58 to ultimately become the first disease modifying therapy for HCU; and references to the achievement of future potential development and commercialization milestones for the OT-58 program, including, without limitation, the potential future issuance of a rare pediatric disease priority review voucher. Such forward-looking statements are based on current information available to Retrophin and involve inherent risks and uncertainties, including factors that could delay, divert or change any such forward-looking statements, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Retrophin faces risks associated with, but not limited to: Retrophin’s ability to realize the anticipated benefits of the proposed transaction, including the potential developmental and commercial success of the OT-58 product candidate; significant and unknown transaction costs; actual or contingent liabilities; the risk of litigation and/or regulatory actions related to the transaction; other business effects outside of Retrophin’s control, including the effects of industry, market, economic, political or regulatory conditions or the ongoing COVID-19 pandemic; as well as negative impacts that could result from changes in tax and other laws, regulations, rates and policies. In addition, such risks and uncertainties may include those described in Retrophin’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission, which are available at Retrophin’s website (www.retrophin.com) under “Investors & Media”. You are cautioned not to place undue reliance on any forward-looking statements as there are important factors that could cause actual results to differ materially from those in any forward-looking statements, many of which are beyond our control. Except to the extent required by law, Retrophin undertakes no obligation to publicly update any forward-looking statement.

Contact:
Chris Cline, CFA
Senior Vice President, Investor Relations & Corporate Communications
888-969-7879
[email protected]

Posted on November 12, 2020 4:08 pm
Realize the Full Potential of the NextSeq 2000 with the Power of the P3 Reagent Kit

Realize the Full Potential of the NextSeq 2000 with the Power of the P3 Reagent Kit

Now Commercially Available, Both NextSeq 1000 and NextSeq 2000 Sequencers Include Integrated Informatics and Loss-less Compression Technology, Creating an Intuitive User Experience

SAN DIEGO–(BUSINESS WIRE)–
. Illumina, Inc. (NASDAQ: ILMN) is further extending the reach of the NextSeq™ 2000 Sequencing System with the commercial availability of the P3 high-output flow cell. The P3 flow cell offers 1.1 billion reads in a single sequencing run, almost three times more than previously available on Illumina’s mid-throughput NextSeq sequencing portfolio, expanding the range of applications that run on the system.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201112005974/en/

Now commercially available, Illumina’s NextSeq 1000 and NextSeq 2000 (shown here) Sequencers include integrated informatics and loss-less compression technology, creating an intuitive user experience. (Photo: Business Wire)

“The advanced yet affordable P3 flow cell for the NextSeq 2000 gives customers more capacity to increase the depth and breadth of their projects and the ability to stretch their project budgets, yielding deeper insights,” said Susan Tousi, Chief Product Officer of Illumina. “We’re pleased to further instill customer confidence with the highest data quality ever achieved at commercial launch. Together with the on-instrument integration of our award-winning informatics solution and loss-less compression software, customers can extract actionable insights with a seamless user interface.”

“At University of Edinburgh, our genomics work includes single cell RNA sequencing projects which are often limited by cost,” said Lee Murphy, Head of the Genetics Core at the Edinburgh Clinical Research Facility. “With the NextSeq 2000 and P3 kits, we are experiencing higher output enabling more complex, informative studies which increases the value of our offerings to our world class researchers.”

“The NextSeq 2000 has enabled us to bring sequencing in-house that we would otherwise have to outsource,” said Bryan Venters, Director of Genomic Technologies at EpiCypher, an epigenetic technology company located in North Carolina. “This is critical because it gives us control over our development pipeline. With the release of the P3 cartridge, it will enable higher throughput sequencing and faster turnaround times.”

The P3 flow cell is available in four configurations, including 100-, 200- and 300-cycles, delivering 110 Gb, 220 Gb, and 330 Gb per run, respectively. In response to customer feedback, Illumina is also launching a 50-cycle kit, targeting infectious disease, small RNA, and spatial transcriptomics applications. Additionally, at the outset of 2021, the NextSeq1000 and NextSeq 2000 platforms will come with a tool designed to allow easy recycling of >60% of the reagent cartridge used in each sequencing run.

Illumina also announced the commercial availability of the NextSeq 1000, with an even more accessible price point for sequencing up to 400 million reads per run. Like the NextSeq 2000, the NextSeq 1000 offers onboard informatics for rapid secondary analysis and cloud-based, loss-less compression technology – the first of its kind to offer genomic compression technology built-in. The systems were designed with customers in mind, offering not only a clearer path to deep, actionable insights, but also our most intuitive user experience yet.

“Both the NextSeq 1000 and NextSeq 2000 are designed to simplify workflows and empower labs of any size with the economy of scale to sequence more, more frequently,” said Mark Van Oene, Chief Commercial Officer of Illumina. “With lower run costs, we’re empowering our customers to more freely pursue their research ideas and drive genomics forward.”

The NextSeq 1000 and NextSeq 2000, as well as the P2 and P3 flow cells, are now shipping.

To learn more, visit our website.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties, including the expectation for lower costs related to the storing and managing of genomic data costs. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services; (ii) our ability to deploy new products, services, and applications, and to expand the markets for our technology platforms; and (iii) the acceptance by customers of our newly launched products, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005974/en/

Media:

Karen Birmingham, PhD

646-355-2111

[email protected]

Investors:

Juliet Cunningham

858-882-2171

[email protected]

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Now commercially available, Illumina’s NextSeq 1000 and NextSeq 2000 (shown here) Sequencers include integrated informatics and loss-less compression technology, creating an intuitive user experience. (Photo: Business Wire)

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