Market Newsdesk

– Strengthened leadership team with appointments of Andrew Hirsch as Chief Executive Officer, William McKee as Chief Financial Officer and Jolie M. Siegel as Chief Legal Officer –

– Completed upsized IPO in October 2020, raising $209.8 million in gross proceeds; cash runway extended into the second half of 2023 –

– Investigational New Drug (IND) submission for lead candidate, CFT7455, for hematologic malignancies anticipated by YE 2020; Phase 1/2 study expected to initiate in 1H 2021 –

WATERTOWN, Mass., Nov. 12, 2020 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule drugs that selectively destroys disease-causing proteins through degradation, today reported financial results for the third quarter ended September 30, 2020, highlighted recent progress and provided a business update.

“C4T’s recent IPO was a tremendous milestone for our team and an important accomplishment as the company advances our programs to the clinic. With a strong balance sheet and expanded senior team, we are well-positioned to execute against our pipeline and continue investing in our differentiated TORPEDO™ discovery platform,” said Andrew Hirsch, chief executive officer at C4 Therapeutics. “Looking ahead, we expect to have four clinical-stage programs by the end of 2022, including our lead candidate, CFT7455, for hematological malignancies, which is on track for an IND submission by the end of this year. We believe targeted protein degraders represent a novel class of medicines with distinctive benefits over traditional inhibitor drugs and look forward to exploring their potential in patients.”

THIRD QUARTER 2020 AND RECENT HIGHLIGHTS

• Amended the Amended and Restated Roche Collaboration Agreement: In November 2020, C4T entered into the First Amendment to its 2018 Amended and Restated License Agreement with F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc., which clarifies the rights and responsibilities of both parties in the event of a program termination. In addition, through this amendment, C4T and Roche mutually agreed to terminate the Amended and Restated Agreement with respect to the target epidermal growth factor receptor (EGFR). With this termination, C4T regains the right to pursue the target EGFR in products that use degradation as their mode of action.
• Presented at Scientific Conferences on Protein Structure and Degradation: In October 2020, C4T participated in the 3^rd Annual Targeted Protein Degradation Summit. Rhamy Zeid, Ph.D., Director of Target Biology at C4T, delivered a presentation highlighting CFT8634, a novel degrader of the protein BRD9. This case study showcased C4T’s TORPEDO platform’s capabilities to enable the development of novel, selective, orally bioavailable degraders. C4T’s Chief Scientific Officer, Stewart Fisher, Ph.D., also led a roundtable discussion on the pace of innovation in drug discovery and development. In November 2020, C4T participated in the 28^th Annual Protein Structure Determination in Industry (PSDI) Conference. Joe Patel, Ph.D., C4T’s Senior Director of Biochemistry, Biophysics and Crystallography, delivered a presentation demonstrating how C4T’s TORPEDO platform leverages HDX data and computational methods to design novel degrader candidates with predictable ternary complexes.
• Completed Upsized Initial Public Offering: In October 2020, C4T completed an upsized initial public offering of 11.0 million shares of common stock, including the full exercise of the underwriters’ over-allotment option, at a price of $19.00 per share. Net proceeds from the offering were $191.1 million.
• Strengthened Leadership Team: In September 2020, C4T announced the appointment of Andrew Hirsch as Chief Executive Officer. Additionally, in July 2020, the Company announced the appointments of William McKee as Chief Financial Officer and Jolie M. Siegel as Chief Legal Officer.

KEY UPCOMING MILESTONES

• Investigational New Drug (IND) submission planned for Q4 2020 for CFT7455, an orally bioavailable MonoDAC™ (Monofunctional Degradation Activating Compound) targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas (NHLs), including peripheral T cell lymphoma (PTCL) and mantle cell lymphoma (MCL). C4T anticipates initiating a Phase 1/2 clinical trial for this program in 1H 2021.
• IND submission expected in 2H 2021 for CFT8634, an orally bioavailable BiDAC™ (Bifunctional Degradation Activating Compound) targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors. C4T anticipates initiating a Phase 1/2 clinical trial for this program by 2H 2021.

UPCOMING INVESTOR EVENTS

• November 19, 2020 – C4T will present at the Jefferies Virtual London Healthcare Conference
• December 3, 2020 – C4T will hold a Fireside Chat/Panel discussion at the 3^rd Annual Evercore ISI HealthCONx Conference

THIRD QUARTER 2020 FINANCIAL RESULTS

Revenues: Total revenues for the third quarter of 2020 were $8.4 million, compared to $5.4 million for the third quarter of 2019. Total revenues reflect revenues recognized under our collaboration agreements with Roche, Biogen and Calico and increased by $3 million compared to the same period of 2019 primarily due to increased reimbursements from Biogen reflecting increase activities on collaboration projects and related activities.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2020 were $23.9 million, compared to $12.9 million for the third quarter of 2019. The increase in R&D expense was primarily attributable to increased third-party chemistry and biology costs, higher preclinical costs related to our lead programs and increased workforce expenses to support our growing clinical development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2020 were $2.9 million, compared to $2.4 million for the third quarter of 2019. The increase in G&A expense was primarily attributable to higher legal and professional costs supporting the company’s growth.

Net Loss: Net loss for the third quarter of 2020 was $21.8 million, compared to $10.1 million for the third quarter of 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and short-term investments as of September 30, 2020, were $199.4 million, compared to $90.5 million as of December 31, 2019. The September 30th balance does not include $191.1 million in net proceeds from our initial public offering, which was completed on October 6, 2020. We expect our cash, cash equivalents and short-term investments, including the net proceeds from our initial public offering and payments to be received under our existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures into the second half of 2023.

About C4 Therapeutics

C4 Therapeutics (C4T) is a biopharmaceutical company focused on harnessing the body’s natural regulation of protein levels to develop novel therapeutic candidates to target and destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases. This targeted protein degradation approach offers advantages over traditional therapies, including the potential to treat a wider range of diseases, reduce drug resistance, achieve higher potency, and decrease side effects through greater selectivity. To learn more about C4 Therapeutics, visit www.C4Therapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking statements” of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO™ platform in the development of novel, selective, orally bioavailable degraders; the potential timing and advancement of our preclinical studies and clinical trials; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our current resources and cash runway; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will not be successfully developed and commercialized; and the risk that the results of preclinical studies and clinical trials will be predictive of future results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause C4T’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics registration statement on Form S-1, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4T undertakes no duty to update this information unless required by law.

Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
		SEPTEMBER 30, 2020				DECEMBER 31, 2019
Cash, cash equivalents and short-term investments		$	199,413			$	90,549
Accounts Receivable			4,141				4,623
Total Assets			229,127				118,260
Deferred Revenue			84,997				93,423
Debt			9,877				–
Stockholders’ Deficit			(155,924	)			(111,963	)

 

Consolidated Statement of Operations Data
(in thousands, except share and per share data)
(Unaudited)
		THREE MONTHS ENDED SEPTEMBER 30,								NINE MONTHS ENDED SEPTEMBER 30,
			2020				2019				2020				2019
Revenue from collaboration agreements		$	8,447			$	5,364			$	24,933			$	13,172
Operating expenses:
Research and development			23,935				12,948				58,007				32,042
General and administrative			2,861				2,417				8,472				6,083
Total operating expenses			26,796				15,365				66,479				38,125
Loss from operations			(18,349	)			(10,001	)			(41,546	)			(24,953	)
Net loss			(21,835	)			(10,094	)			(44,540	)			(24,076	)
Accrual of preferred stock dividends			(5,212	)			(2,201	)			(10,363	)			(6,531	)
Net loss attributable to common stockholders			(27,047	)			(12,295	)			(54,903	)			(30,607	)
Net loss per share – basic and diluted		$	(17.55	)		$	(8.93	)		$	(36.76	)		$	(22.59	)
Weighted-average number of shares used in computing net loss per share – basic and diluted			1,540,902				1,376,365				1,493,521				1,354,734

Investor & Media Contact:
Kendra Adams
SVP, Communications & Investor Relations
[email protected]

C
omplete
s
e
nrollment of ATYR1923
c
linical
t
rial
in
patients with
COVID-19
s
evere
r
espiratory
c
omplications
.
Topline
data is expected at turn of calendar year.

Announce
s
Investigational New Drug
c
andidate
in oncology,
ATYR2810
,
f
rom its NRP2
a
ntibody
p
rogram
.

Company to host conference call and webcast today,
November 12,
at 5:00 p.m. E
S
T / 2:00 p.m. P
S
T
.

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced third quarter results and provided a corporate update.

“Throughout the third quarter, we remained focused on our clinical program for our lead therapeutic candidate, ATYR1923. We now have three active clinical trials as part of this program. Most notably, we have completed enrollment in our Phase 2 trial in COVID-19 patients with severe respiratory complications. We expect to report topline data from this study around the turn of the calendar year. In addition, amidst the ongoing pandemic, our pulmonary sarcoidosis trial sites have been reactivated to screen and dose patients and finish enrollment of the third and final cohort of our Phase 1b/2a study. Finally, our partner Kyorin Pharmaceutical is currently enrolling a Phase 1 study in healthy volunteers in Japan,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.

“While our clinical operations have expanded, so too has our pipeline. We have selected an Investigational New Drug (IND) candidate from our Neuropilin-2 (NRP2) antibody program, ATYR2810. This antibody, which has generated compelling data in pre-clinical cancer models, will be evaluated for the potential treatment of certain aggressive tumors where NRP2 is implicated.”

Third Quarter 2020 and Subsequent Period Highlights

• Completed enrollment in its Phase 2 randomized, double blind, placebo-controlled study of ATYR1923 in COVID-19 patients with severe respiratory complications. The study enrolled a total of 32 patients at hospitals in the U.S. and Puerto Rico, exceeding the target enrollment of 30 patients. Topline data is expected at the turn of the calendar year.
• Continued enrollment in the third and final cohort of its ongoing Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 36 patients with pulmonary sarcoidosis. The majority of sites have reactivated and are screening and dosing patients.
• Kyorin Pharmaceutical, Co., Ltd., aTyr’s partner in the development and commercialization of ATYR1923 for interstitial lung diseases in Japan, initiated and continues to enroll a Phase 1 study to evaluate the safety, pharmacokinetics and immunogenicity of ATYR1923 (known as KRP-R120 in Japan) in 32 Japanese healthy volunteers.
• Declared an IND candidate in oncology from its NRP2 antibody program, ATYR2810. This fully humanized monoclonal antibody will be evaluated for the potential treatment of certain aggressive tumors where NRP2 is implicated. NRP2 expression is associated with worsened patient outcomes in many cancers.
• Entered into a research collaboration with the Medical University of South Carolina (MUSC) to support the company’s NRP2 antibody program in oncology. Dr. Robert Gemmill, the former Melvyn Berlinksy Chair of Cancer Research and Professor of Medicine Emeritus in the Division of Hematology/Oncology at MUSC, will serve as the principal investigator for the collaboration, which aims to accelerate the development of therapeutic antibodies that selectively target specific NRP2 isoforms and validate their potential use in the treatment of lung cancer.
• Published a paper in the peer-reviewed journal mAbs titled, “Isolation of monoclonal antibodies from anti-synthetase syndrome patients and affinity maturation by recombination of independent somatic variants,” which highlighted novel technological advances to isolate, characterize and engineer high-affinity therapeutic antibodies.

Third Quarter 2020 Financial Results

Total revenues were $0.1 million and $0.2 million for the three months ended September 30, 2020 and 2019, respectively, consisting of license revenue. Research and development expenses were $4.6 million and $3.8 million for the three months ended September 30, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between the periods at $2.0 million and $1.9 million for the three months ended September 30, 2020 and 2019, respectively.

Total revenues were $8.4 million and $0.3 million for the nine months ended September 30, 2020 and 2019, respectively. Revenues for the nine months ended September 30, 2020 included $8.0 million from license revenue under the collaboration agreement with Kyorin. Research and development expenses were $12.6 million and $10.5 million for the nine months ended September 30, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between the periods at $6.8 million for each of the nine months ended September 30, 2020 and 2019.

As of September 30, 2020, aTyr had $36.1 million in cash, cash equivalents and investments. As of September 30, 2020, aTyr had $3.1 million of term loans. On November 3, 2020, aTyr fully repaid its term loans and retired its debt.

Conference Call and Webcast Details

aTyr Pharma will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 4549288. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: http://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr is currently enrolling a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr is conducting a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study is a randomized, double blind, placebo-controlled study that has been designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.

About aTyr

aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. For more information, please visit http://www.atyrpharma.com.

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 are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding the potential therapeutic benefits and applications of ATYR1923, ATYR2810 and our NRP2 antibody program; timelines and plans with respect to certain development activities (including the further development of ATYR9123, ATYR2810 and our NRP2 antibody program); expected activities under our collaboration agreements and certain development goals. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the fact that NRP2 biology is not fully understood, uncertainty regarding the COVID-19 pandemic, including the risk of delays in enrollment in our clinical trials, risks associated with the discovery, development and regulation of our product candidates, including the risk that results from clinical trials or other studies may not support further development, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons, the fact that our collaboration agreements are subject to early termination, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

ATYR PHARMA INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
	Three Months Ended								Nine Months Ended
	September   30,								September   30,
	2020				2019				2020				2019
	(unaudited)
Revenues:
License revenues	$	148			$	184			$	8,402			$	278
Total revenues		148				184				8,402				278
Operating expenses:
Research and development		4,616				3,799				12,593				10,458
General and administrative		2,044				1,883				6,780				6,836
Total operating expenses		6,660				5,682				19,373				17,294
Loss from operations		(6,512	)			(5,498	)			(10,971	)			(17,016	)
Total other expense, net		(88	)			(147	)			(324	)			(614	)
Consolidated net loss	$	(6,600	)		$	(5,645	)		$	(11,295	)		$	(17,630	)
Net loss attributable to noncontrolling interest in Pangu BioPharma Limited		1				—				3				—
Net loss attributable to aTyr Pharma, Inc.	$	(6,599	)		$	(5,645	)		$	(11,292	)		$	(17,630	)
Net loss per share, basic and diluted	$	(0.68	)		$	(1.47	)		$	(1.31	)		$	(5.55	)
Shares used in computing net loss per share, basic and diluted		9,648,534				3,846,249				8,632,972				3,175,177

ATYR PHARMA INC.
Condensed Consolidated Balance Sheets
(in thousands)
	September   30,				December   31,
	2020				2019
	(unaudited)
Cash, cash equivalents and available-for-sale investments	$	36,146			$	31,144
Other receivables		245				100
Property and equipment, net		1,004				1,270
Right-of-use assets		2,274				2,821
Prepaid expenses and other assets		1,967				853
Total assets	$	41,636			$	36,188
Accounts payable, accrued expenses and other liabilities	$	4,138			$	3,431
Current portion of operating lease liability		834				755
Term loans, net of debt issuance costs and discount		3,061				8,737
Long-term operating lease liability, net of current portion		1,605				2,239
Total Stockholders’ equity		31,998				21,026
Total liabilities and stockholders’ equity	$	41,636			$	36,188

Contact:

Ashlee Dunston

Director, Investor Relations and Corporate Communications

[email protected]

• 
  Third q
  
  
  uarter total revenues of $
  
  
  7.4
  
  
  million
  
  
  rebounding 46% from the second quarter
  
  
• 
  Continued expense reduction
  
  
  actions;
  
  
  third quarter operating costs decreased more than $1 million year-over-year
  
  
  and
  
  
  product sale
  
  
  margins improved by
  
  
  6
  
  
  %
  
• 
  GAAP
  
  
  n
  
  
  et loss of $
  
  
  0.
  
  
  5
  
  
  million, ($
  
  
  0.
  
  
  0
  
  
  2
  
  
  )
  
  
  per share
  
• 
  Non-GAAP
  
  
  net income of $0.8 million, $0.04 per share
  
• 
  Adjusted EBITDA of $1.
  
  
  4
  
  
  million
  
  

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company, today announced its financial results for the third quarter ended September 30, 2020.   

Robert W. D’Loren, Chairman and Chief Executive Officer of Xcel commented, “Despite the continued impact of the COVID-19 pandemic on our top and bottom line results, we are very pleased with our third quarter results and the rapid recovery of our Interactive TV business and improvement in our wholesale businesses.”

Third
Quarter 20
20
Financial
Results

Total revenue was $7.4 million, a decrease of $3.5 million compared to the prior year period, driven by lower product sales and lower licensing revenues of $2.3 million and $1.2 million, respectively. Our revenues primarily reflect lower sales by our licensees and retail partners as a result of an overall slowdown in economic activity related to the ongoing the COVID-19 pandemic. Despite the decrease in revenues and gross profit on an absolute dollar basis, overall gross profit margins increased from 73% in the prior year quarter to 83% in the current quarter.

GAAP net loss was approximately $0.5 million, or ($0.02) per diluted share, compared with a GAAP net loss of $0.1 million, or ($0.01) per diluted share, for the prior year quarter. After adjusting for certain cash and non-cash items, non-GAAP net income for the quarters ended September 30, 2020 and September 30, 2019, was approximately $0.8 million, or $0.04 per diluted share and approximately $1.2 million, or $0.06 per diluted share, respectively. Adjusted EBITDA was approximately $1.4 million and $1.8 million for the current quarter and the prior year quarter, respectively.      

Nine
Month
20
20
Financial Results

Total revenue was $22.0 million, a decrease of $8.4 million, driven by lower licensing revenues and lower product sales of $5.7 million and $2.7 million, respectively. Gross profit decreased by $5.8 million to $18.0 million from $23.8 million in the prior year nine months, but gross profit margins increased year-over-year. As with the quarter’s results, the decrease in our revenues was primarily caused by the COVID-19 pandemic, which included government ordered stay-at-home policies and retail store closures during the second quarter, as well as the continued overall slowdown in economic activity related to the pandemic.

GAAP net loss was approximately $2.6 million, or ($0.13) per diluted share, compared with GAAP net income of $1.9 million, or $0.10 per diluted share, for the prior year nine months. The prior year nine month’s GAAP net income notably included a $2.9 million gain on the reduction of contingent obligations. After adjusting for certain cash and non-cash items, non-GAAP net income for the nine months ended September 30, 2020 and September 30, 2019, was approximately $2.1 million, or $0.11 per diluted share, and approximately $3.8 million, or $0.20 per diluted share, respectively. Adjusted EBITDA was approximately $3.9 million and $5.6 million for the current nine months and the prior year nine months, respectively.       

See reconciliation tables below for non-GAAP metrics. These non-GAAP metrics may be inconsistent with similar measures presented by other companies and should only be used in conjunction with our results reported according to U.S. generally accepted accounting principles. Any financial measure other than those prepared in accordance with GAAP should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

The Company’s balance sheet at September 30, 2020 remained strong, with stockholders’ equity of approximately $97 million, cash and cash equivalents of approximately $4.8 million, and working capital, exclusive of the current portion of lease obligations, of approximately $8.7 million.

Conference Call and Webcast

The Company will host a conference call with members of the executive management team to discuss these results with additional comments and details at 5:00 p.m. Eastern Time on Thursday, November 12, 2020. A webcast of the conference call will be available live on the Investor Relations section of Xcel’s website at www.xcelbrands.com. Interested parties unable to access the conference call via the webcast may dial 1-877-300-8521. A replay of the conference call will be available on the Company website for 30 days following the event and can be accessed at 844-512-2921 using replay pin number 10149912.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ:XELB) is a media and consumer products company engaged in the design, production, marketing, wholesale, and direct-to-consumer sales of branded apparel, footwear, accessories, jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded by Robert W. D’Loren in 2011 with a vision to reimagine shopping, entertainment, and social as one. Xcel owns the Isaac Mizrahi, Judith Ripka, Halston, and C. Wonder brands, and it owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC, pioneering a ubiquitous sales strategy which includes the promotion and sale of products under its brands through interactive television, brick-and-mortar retail, e-commerce and peer to peer channels. Headquartered in New York City, Xcel Brands is led by an executive team with significant production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. With an experienced team of professionals focused on design, production, and digital marketing, Xcel maintains control of product quality and promotion across all of its product categories and distribution channels. Xcel differentiates by design. www.xcelbrands.com

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “ongoing,” “could,” “estimates,” “expects,” “intends,” “may,” “appears,” “suggests,” “future,” “likely,” “goal,” “plans,” “potential,” “projects,” “predicts,” “seeks,” “should,” “would,” “guidance,” “confident” or “will” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding our anticipated revenue, expenses, profitability, strategic plans and capital needs. These statements are based on information available to us on the date hereof and our current expectations, estimates and projections and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors, including, without limitation, the risks discussed in the “Risk Factors” section and elsewhere in the Company’s Annual Report on form 10-K for the year ended December 31, 2019 and its other filings with the SEC, which may cause our or our industry’s actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.

For further information please contact:

Andrew Berger
SM Berger & Company, Inc.
216-464-6400
[email protected]

Xcel Brands, Inc. and Subsidiaries
Unaudited Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
		September 30, 2020				December 31, 2019
		(Unaudited)
Assets
Current Assets:
Cash and cash equivalents		$	4,783			$	4,641
Accounts receivable, net			8,188				10,622
Inventory			723				899
Prepaid expenses and other current assets			1,426				1,404
Total current assets			15,120				17,566
Property and equipment, net			3,604				3,666
Operating lease right-of-use assets			9,019				9,250
Trademarks and other intangibles, net			107,675				111,095
Restricted cash			1,109				1,109
Other assets			297				505
Total non-current assets			121,704				125,625
Total Assets		$	136,824			$	143,191
Liabilities and Equity
Current Liabilities:
Accounts payable, accrued expenses and other current liabilities		$	2,908			$	4,391
Accrued payroll			618				1,444
Current portion of operating lease obligation			1,917				1,752
Current portion of long-term debt			2,850				2,250
Total current liabilities			8,293				9,837
Long-Term Liabilities:
Long-term portion of operating lease obligation			9,101				9,773
Long-term debt, less current portion			14,523				16,571
Contingent obligation			900				900
Deferred tax liabilities, net			7,165				7,434
Other long-term liabilities			224				224
Total long-term liabilities			31,913				34,902
Total Liabilities			40,206				44,739
Commitments and Contingencies
Equity:
Preferred stock, $.001 par value, 1,000,000 shares authorized, none issued and outstanding			–				–
Common stock, $.001 par value, 50,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively, and 19,231,040 and 18,866,417 issued and outstanding at September 30, 2020 and December 31, 2019, respectively			19				19
Paid-in capital			102,236				101,736
Accumulated deficit			(6,198	)			(3,659	)
Total Xcel Brands, Inc. stockholders’ equity			96,057				98,096
Noncontrolling interest			561				356
Total Equity			96,618				98,452
Total Liabilities and Equity		$	136,824			$	143,191

Xcel Brands, Inc. and Subsidiaries
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
		For the Three Months Ended								For the Nine Months Ended
		September 30,								September 30,
		2020				2019				2020				2019
Revenues
Net licensing revenue		$	5,236			$	6,428			$	15,378			$	21,094
Net sales			2,155				4,504				6,590				9,277
Net revenue			7,391				10,932				21,968				30,371
Cost of goods sold (sales)			1,270				2,950				3,923				6,549
Gross profit			6,121				7,982				18,045				23,822
Operating costs and expenses
Salaries, benefits and employment taxes			2,968				4,045				9,798				12,038
Other design and marketing costs			706				797				2,336				2,352
Other selling, general and administrative expenses			1,642				1,356				5,027				4,014
Costs in connection with potential acquisition			(189	)			126				(210	)			231
Stock-based compensation			49				295				780				777
Depreciation and amortization			1,437				991				4,069				2,939
Government assistance – Paycheck Protection Program			(176	)			–				(1,816	)			–
Property and equipment impairment			31				–				113				–
Total operating costs and expenses			6,468				7,610				20,097				22,351
Other Income			46								46				2,850
Operating (loss) income			(301	)			372				(2,006	)			4,321
Interest and finance expense
Interest expense and other finance charges			304				330				897				968
Loss on extinguishment of debt			0				0				0				189
Total interest and finance expense			304				330				897				1,157
(Loss) income before income taxes			(605	)			42				(2,903	)			3,164
Income tax ( benefit) provision			(145	)			137				(269	)			1,280
Net (loss) income			(460	)			(95	)			(2,634	)			1,884
Less: Net loss attributable to noncontrolling interest			(26	)			–				(95	)			–
Net (loss) income attributable to Xcel Brands, Inc. stockholders		$	(434	)		$	(95	)		$	(2,539	)		$	1,884
(Loss) earnings per share attributed to Xcel Brands, Inc. common stockholders:
Basic net (loss) income per share:		$	(0.02	)		$	(0.01	)		$	(0.13	)		$	0.10
Diluted net (loss) income per share:		$	(0.02	)		$	(0.01	)		$	(0.13	)		$	0.10
Weighted average number of common shares outstanding:
Basic weighted average common shares outstanding			19,231,040				18,975,265				19,078,453				18,839,424
Diluted weighted average common shares outstanding			19,231,040				18,975,265				19,078,453				18,840,149

Xcel Brands, Inc. and Subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
			For the Nine Months Ended
			September 30,
		2020				2019
Cash flows from operating activities
Net (loss) income		$	(2,634	)		$	1,884
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
Depreciation and amortization expense			4,069				2,939
Property and equipment impairment			113				–
Amortization of deferred finance costs			72				114
Stock-based compensation			780				777
Amortization of note discount			–				16
Allowance for doubtful accounts			1,054				(144	)
Loss on extinguishment of debt			–				189
Deferred income tax (benefit) provision			(269	)			1,280
Net Gain on sale of assets			(46	)			–
Gain on reduction of contingent obligation			–				(2,850	)
Changes in operating assets and liabilities:
Accounts receivable			1,380				1,182
Inventory			176				(87	)
Prepaid expenses and other assets			187				(14	)
Accounts payable, accrued expenses and other current liabilities			(2,403	)			(1,744	)
Cash paid in excess of rent expense			(276	)			(337	)
Other liabilities			–				(196	)
Net cash provided by operating activities			2,203				3,009
Cash flows from investing activities
Cash consideration for asset acquisition of the Halston Heritage assets			–				(8,830	)
Net proceeds from sale of assets			46
Purchase of property and equipment			(700	)			(918	)
Net cash used in investing activities			(654	)			(9,748	)
Cash flows from financing activities
Shares repurchased including vested restricted stock in exchange for witholdong taxes			(187	)			(24	)
Cash contribution from non-controling interest			300				–
Payment of deferred finance costs			(20	)			(315	)
Proceeds from long-term debt			–				7,500
Payment of long-term debt			(1,500	)			(3,742	)
Net cash (used in) provided by financing activities			(1,407	)			3,419
Net increase (decrease) in cash, cash equivalents, and restricted cash			142				(3,320	)
Cash, cash equivalents, and restricted cash at beginning of period			5,750				10,319
Cash, cash equivalents, and restricted cash at end of period		$	5,892			$	6,999
Reconciliation to amounts on consolidated balance sheets:
Cash and cash equivalents			4,783			$	5,890
Restricted cash			1,109				1,109
Total cash, cash equivalents, and restricted cash		$	5,892			$	6,999
Supplemental disclosure of non-cash activities:
Operating lease right-of-use asset		$	797			$	10,409
Operating lease obligation		$	797			$	13,210
Accrued rent offset to operating lease right-of-use assets		$	–			$	2,801
Settlement of seller note through offset to receivable		$	–			$	600
Settlement of contingent obligation through offset to note receivable		$	–			$	100
Issuance of common stock in connection with Halston Heritage assets acquisition		$	–			$	1,058
Contingent obligation related to acquisition of Halston Heritage assets at fair value		$	–			$	900
Liability for equity-based bonuses		$	93			$	168
Supplemental disclosure of cash flow information:
Cash paid during the period for income taxes		$	58			$	91
Cash paid during the period for interest		$	1,092			$	1,108

($ in thousands)	Three Months Ended								Nine Months Ended
	September 30,				September 30,				September 30,				September 30,
	2020				2019				2020				2019
	(Unaudited)				(Unaudited)				(Unaudited)				(Unaudited)
Net (loss) income attributed to Xcel Brands, Inc. stockholders	$	(434	)		$	(95	)		$	(2,539	)		$	1,884
Amortization of trademarks		1,107				786				3,323				2,309
Non-cash interest and finance expense		–				–				–				16
Stock-based compensation		49				295				780				777
Loss on extinguishment of debt		–				–				–				189
Costs in connection with potential acquisition		(189	)			126				(210	)			231
Certain adjustments to allowance for doubtful accounts		385				–				971				–
Property and equipment impairment		31				–				113				–
Gain on sale of assets		(46	)			–				(46	)			–
Gain on reduction of contingent obligation		–				–				–				(2,850	)
Deferred income tax provision (benefit)		(145	)			137				(269	)			1,280
Non-GAAP net income	$	758			$	1,249			$	2,123			$	3,836
	Three Months Ended								Nine Months Ended
	September 30,				September 30,				September 30,				September 30,
	2020				2019				2020				2019
	(Unaudited)				(Unaudited)				(Unaudited)				(Unaudited)
Diluted (loss) earnings per share	$	(0.02	)		$	(0.01	)		$	(0.13	)		$	0.10
Amortization of trademarks		0.06				0.04				0.17				0.12
Non-cash interest and finance expense		–				–				–				–
Stock-based compensation		–				0.01				0.04				0.04
Loss on extinguishment of debt		–				–				–				0.01
Costs in connection with potential acquisition		(0.01	)			0.01				(0.01	)			0.01
Certain adjustments to allowance for doubtful accounts		0.02				–				0.05				–
Property and equipment impairment		–				–				0.01				–
Gain on sale of assets		–				–				–				–
Gain on reduction of contingent obligation		–				–				–				(0.15	)
Deferred income tax provision (benefit)		(0.01	)			0.01				(0.02	)			0.07
Non-GAAP diluted EPS	$	0.04			$	0.06			$	0.11			$	0.20
Non-GAAP weighted average diluted shares		19,291,275				19,559,816				19,092,828				18,840,149
($ in thousands)	Three Months Ended								Nine Months Ended
	September 30,				September 30,				September 30,				September 30,
	2020				2019				2020				2019
	(Unaudited)				(Unaudited)				(Unaudited)				(Unaudited)
Net (loss) income attributed to Xcel Brands, Inc. stockholders	$	(434	)		$	(95	)		$	(2,539	)		$	1,884
Depreciation and amortization		1,437				991				4,069				2,939
Interest and finance expense		304				330				897				1,157
Income tax provision (benefit)		(145	)			137				(269	)			1,280
State and local franchise taxes		41				38				124				159
Stock-based compensation		49				295				780				777
Costs in connection with potential acquisition		(189	)			126				(210	)			231
Certain adjustments to allowance for doubtful accounts		385				–				971				–
Property and equipment impairment		31				–				113				–
Gain on sale of assets		(46	)			–				(46	)			–
Gain on reduction of contingent obligation		–				–				–				(2,850	)
Adjusted EBITDA	$	1,433			$	1,822			$	3,890			$	5,577

Non-GAAP net income and non-GAAP diluted EPS are non-GAAP unaudited terms. We define non-GAAP net income as net income (loss), exclusive of amortization of trademarks, stock-based compensation, non-cash interest and finance expense from discounted debt related to acquired assets, loss on extinguishment of debt, costs in connection with potential acquisitions, certain adjustments to allowances for doubtful accounts, asset impairments, gain on sale of assets, gain on reduction of contingent obligations, and deferred income taxes. Non-GAAP net income and non-GAAP diluted EPS measures do not include the tax effect of the aforementioned adjusting items, due to the nature of these items and the Company’s tax strategy.

Adjusted EBITDA is a non-GAAP unaudited measure, which we define as net income (loss) before depreciation and amortization, interest and finance expense (including loss on extinguishment of debt, if any), income taxes, other state and local franchise taxes, stock-based compensation, costs in connection with potential acquisitions, certain adjustments to allowances for doubtful accounts, asset impairments, gain on sale of assets, and gain on the reduction of contingent obligations.

Both non-GAAP net income and Adjusted EBITDA for the current quarter and current nine months include certain adjustments related to allowances for doubtful accounts for account debtors that have filed for bankruptcy protection triggered by the impact of COVID-19. In addition, included in net income was $1.8 million of government assistance received through the Paycheck Protection Program under the CARES Act, which was recognized as a reduction to current quarter and current nine months expenses for which the program was intended to compensate, in the amount of $0.2 million and $1.8 million, respectively. The expense reduction from the PPP is not considered a reconciling item for purposes of the computation of non-GAAP net income and Adjusted EBITDA due to the fact that the PPP represents a cash benefit and is directly related to the Company’s operating expenses incurred. Such treatment is also consistent with the calculation of EBITDA for financial covenant compliance purposes under the Company’s term debt.

Management uses non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA as measures of operating performance to assist in comparing performance from period to period on a consistent basis and to identify business trends relating to our results of operations. Management believes non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA are also useful because these measures adjust for certain costs and other events that management believes are not representative of our core business operating results, and thus these non-GAAP measures provide supplemental information to assist investors in evaluating our financial results. The Company has incurred certain costs which it could have eliminated but elected not to do so in light of government assistance received through the Paycheck Protection Program under the CARES Act (the “PPP Benefit”), which represents a cash benefit directly related to the Company’s operating expenses incurred. Accordingly, the PPP Benefit is not considered a reconciling item for purposes of the computation of non-GAAP net income and Adjusted EBITDA. Adjusted EBITDA is the measure used to calculate compliance with the EBITDA covenant under the Xcel Term Loan. Non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA should not be considered in isolation or as alternatives to net income, earnings per share, or any other measure of financial performance calculated and presented in accordance with GAAP. Given that non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA are financial measures not deemed to be in accordance with GAAP and are susceptible to varying calculations, our non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA may not be comparable to similarly titled measures of other companies, including companies in our industry, because other companies may calculate these measures in a different manner than we do. In evaluating non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA, you should be aware that in the future we may or may not incur expenses similar to some of the adjustments in this document. Our presentation of non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA does not imply that our future results will be unaffected by these expenses or any unusual or non-recurring items. When evaluating our performance, you should consider non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA alongside other financial performance measures, including our net income and other GAAP results, and not rely on any single financial measure.

REDWOOD CITY, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided an update on recent corporate developments and reported financial results for the three and nine months ended September 30, 2020.

“Graybug continues to make important progress in advancing its programs in retinal diseases and glaucoma. We have now completed our initial public offering, raising over $92 million in net proceeds, which provides us with significant financial strength to execute our business strategy,” said Frederic Guerard, PharmD, Chief Executive Officer of Graybug Vision. “We are particularly excited about our lead product candidate, GB-102, currently in Phase 2b clinical development, which seeks to reduce the current need for up to 12 intravitreal injections per year to two or, potentially, fewer treatments per year,” Fred concluded.

Recent Corporate
Developments

• Successfully completed initial public offering — On September 24, 2020, Graybug priced its upsized IPO of 5,625,000 shares of common stock at a public offering price of $16.00 per share, following which the underwriters exercised their option to purchase an additional 843,750 shares, resulting in total gross proceeds of $103.5 million.
• Completed GB-102 Phase 2a safety trial in macular edema — Final safety and tolerability results confirm the satisfactory safety profile of GB-102 1mg with no ocular serious adverse events or dose-limiting toxicity reported.
• Named three new members to the Board of Directors — Graybug appointed Christina Ackermann, Eric Bjerkholt, and Julie Eastland to its Board of Directors in September 2020. Each new member brings deep expertise as leaders in health care and biotechnology, as well as significant strategic and operational experience, to the board.
• Named Robert Breuil as Chief Financial Officer — In September 2020, Robert Breuil, joined Graybug. He brings over 20 years of experience in the biopharmaceutical and drug delivery sectors, as well as experience serving as the CFO of three public companies since 2003.
• L
  eading
  o
  phthalmologists and
  r
  etina
  e
  xperts
  joined
  Scientific Advisory Board — In August 2020, Graybug appointed a distinguished group of ophthalmic thought leaders to provide external scientific counsel on the company’s research and development programs aiming to address critical unmet medical needs in retinal diseases and glaucoma. Graybug’s Scientific Advisory Board members are David S. Boyer, M.D., Frederick L. Ferris III, M.D., Jeffrey S. Heier, M.D., Arshad M. Khanani, M.D., M.A., Carl D. Regillo, M.D., F.A.C.S., and Rishi P. Singh, M.D.

Anticipated Milestones
in 2021

• Complete GB-102 Phase 2b ALTISSIMO trial in patients with wet age-related macular degeneration (wet AMD), with topline data expected in the first half of 2021.
• Initiate two pivotal GB-102 Phase 3 trials in patients with wet AMD in the second half of 2021.
• Initiate GB-102 Phase 2b trial in patients with diabetic macular edema (DME) in the second half of 2021.
• Submit Investigational New Drug (IND) application for GB-401, an injectable depot formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, in the second half of 2021.

Financial Results for the
Three Months Ended September 30,
2020

As of September 30, 2020, Graybug’s cash and investments totaled $95.0 million, compared to $36.0 million as of December 31, 2019. The increase was due to the receipt of $79.5 million in net proceeds from Graybug’s IPO, completed in September 2020. In October 2020, the underwriters exercised their over-allotment option resulting in additional net proceeds of $12.6 million, resulting in total net proceeds from the offering of $92.1 million.

Net loss for the quarter ended September 30, 2020 was $4.7 million compared to $10.2 million for the third quarter ended September 30, 2019. Net loss for the quarter ended September 30, 2020 included a non-cash gain of $2.1 million resulting from the modification and expiration of the liability related to the preferred stock tranche obligation that was permanently eliminated in connection with the IPO. Excluding this amount, our net loss would have been $6.8 million.
      
Research and development expense for the third quarter of 2020 was $4.8 million compared to $8.4 million for the third quarter of 2019. The higher level of expense in the third quarter of 2019 was primarily due to the manufacturing of clinical supplies for the ALTISSIMO clinical trial that commenced later in the third quarter of 2019.

General and administrative expense for the third quarter of 2020 was $2.1 million compared to $2.0 million for the third quarter of 2019.

Financial Results for the Nine Months Ended September 30, 2020

Net loss for the nine months ended September 30, 2020 was $18.4 million, compared to $26.8 million for the same period in 2019. The decrease was primarily due to a $7.1 million decrease in research and development expense and the non-cash gain of $2.2 million resulting primarily from the modification and expiration of the liability related to the preferred stock tranche obligation, partially offset by a $0.8 million increase in general and administrative expense.

Research and development expense for the nine months ended September 30, 2020 was $15.5 million, compared to $22.6 million for the same period in 2019. The was primarily due to the completion of manufacturing of all clinical supplies required for the commencement of our Phase 2b, or ALTISSIMO, trial for GB-102 during 2019. We did not engage in any primary manufacturing activities in the nine-month period ended September 30, 2020.

General and administrative expenses for the nine months ended September 30, 2020 was $5.2 million, compared to $4.4 million for the same period in 2019. The increase was primarily due to additional professional services related in part to the preparation for our IPO.

The change in fair value of preferred stock tranche obligation for the nine months ended September 30, 2020 relates to the fair value adjustments of $2.2 million primarily due to the $2.1 million gain recognized in connection with our IPO. In September 2020, the preferred stock tranche obligation expired upon the effectiveness of the registration statement for our IPO, resulting in a corresponding elimination of the associated liability.

About
Graybug

Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a microparticle depot formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug is also using its proprietary technologies to develop GB-401, an injectable depot formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

Forward
–
L
ooking
S
tatement
s

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding the company’s clinical pipeline, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, the company’s operating results and cash positions, the company’s operations as a public company, the company’s management and board of directors, and the timing and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading “Risk Factors” in the company’s quarterly report on Form 10-Q for the three months ended September 30, 2020, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Investor Contact [email protected] (650) 487-2409	Media Contact [email protected] (404) 384-0067

GRAYBUG VISION, INC.

Condensed Statements of Operations

(in thousands, except share and per share amounts)

(Unaudited)

		Three Months Ended  September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Operating expenses:
Research and development		$	4,757			$	8,403			$	15,474			$	22,570
General and administrative			2,064				1,962				5,183				4,404
Total operating expenses			6,821				10,365				20,657				26,974
Loss from operations			(6,821	)			(10,365	)			(20,657	)			(26,974	)
Interest income		3				160				120				211
Change in fair value of preferred stock tranche obligation			2,102				—				2,158				—
Net loss			(4,716	)			(10,205	)			(18,379	)			(26,763	)
Cumulative dividends on convertible preferred stock			(2,396	)			(2,048	)			(7,189	)			(4,633	)
Net loss attributable to common stockholders		$	(7,112	)		$	(12,253	)		$	(25,568	)		$	(31,396	)
Net loss per common share—basic and diluted		$	(2.52	)		$	(9.30	)		$	(13.74	)		$	(24.10	)
Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted			2,818,349				1,317,497				1,861,229				1,302,687

GRAYBUG VISION, INC.

Condensed Balance Sheets

(in thousands)

(Unaudited
)

		September 30, 2020				December 31, 2019
Assets
Current assets:
Cash and cash equivalents		$	94,968			$	15,870
Short-term investments			—				20,086
Prepaid expenses and other current assets			138				315
Total current assets			95,106				36,271
Property and equipment, net			1,788				1,975
Prepaid expenses and other non-current assets			1,491				2,414
Total assets		$	98,385			$	40,660
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable		$	4,562			$	4,636
Accrued research and development			1,023				2,333
Other current liabilities			2,156				3,124
Preferred stock tranche obligation			—				2,158
Total current liabilities			7,741				12,251
Deferred rent, long term portion			10				—
Total liabilities			7,751				12,251
Commitments and contingencies
Convertible preferred stock			—				131,363
Stockholders’ Equity (Deficit):
Common stock			2				—
Additional paid-in capital			214,847				2,879
Accumulated deficit			(124,215	)			(105,836	)
Accumulated other comprehensive income			—				3
Total stockholders’ equity (deficit)			90,634				(102,954	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)		$	98,385			$	40,660

NEW YORK, NY, Nov. 12, 2020 (GLOBE NEWSWIRE) — HL Acquisitions Corp. (Nasdaq: HCCH) (“HL” or the “Company”) announced today that it has scheduled its annual general meeting of its shareholders (the “Meeting”) to vote on the proposed business combination with Fusion Fuel Green plc (“Fusion Fuel”), for 10:00 a.m., Eastern Time, on December 4, 2020.  In connection with the Meeting, HL filed its definitive proxy statement for the Meeting with the Securities and Exchange Commission and has commenced mailing proxy materials to its shareholders of record as of November 4, 2020, the record date for the Meeting.

Jeffrey Schwarz, CEO of HL, commented: “We are very pleased to finally be able to schedule the shareholder meeting to vote on the proposed business combination with Fusion Fuel. I want to thank our shareholders for their support and patience through this process, and also to remind them that their vote is important no matter how many shares they own. We look forward to closing the proposed business combination as soon as practicable following the Meeting.”

You are encouraged to submit your vote as soon as possible to ensure it is represented at the Meeting. If you hold your shares in an account at a brokerage firm, bank or other similar agent, you may vote prior to the Meeting by using your voting control number and instructions provided by your brokerage firm, bank or other similar agent. If you are a shareholder of record, you may also vote prior to the Meeting by signing, dating and mailing your proxy card in the return envelope provided with your proxy material.

If you have any questions relating to the Meeting, voting your shares, or need to request additional proxy materials, you may call our proxy solicitor Advantage Proxy toll-free at 1-877-870-8565 or collect at 1-206-870-8565 or by email to [email protected].

Additional Information and Where to Find It

HL and Fusion Fuel each filed a definitive proxy statement/prospectus with the SEC on November 10, 2020, and other relevant documents with the SEC. HL has commenced mailing the definitive proxy statement/prospectus to HL shareholders of record as of November 4, 2020. INVESTORS AND SECURITY HOLDERS OF HL ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS THAT HAVE BEEN FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus and other documents containing important information about HL, Fusion Fuel and Fusion Welcome – Fuel, S.A., through the website maintained by the SEC at http://www.sec.gov.

No Offer or Solicitation

This communication shall neither constitute an offer to sell nor the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Forward looking statements

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside HL’s or Fusion Fuel’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statement, including, among other things, the number of HL shareholders voting against the business combination proposals and/or seeking conversion, the occurrence of any event, change or other circumstances that could give rise to the termination of that certain Amended and Restated Business Combination Agreement, dated as of August 25, 2020, by and between HL, Fusion Fuel, Fusion Welcome – Fuel, S.A. and the other parties thereto, the ability to maintain the listing of Fusion Fuel’s securities on Nasdaq or another national securities exchange following the business combination, changes adversely affecting the businesses in which Fusion Fuel is engaged, management of growth, general economic conditions, including changes in the credit, debit, securities, financial or capital markets, the impact of COVID-19 or other adverse public health developments on Fusion Fuel’s business and operations, and the other risks and uncertainties set forth in the definitive proxy statement/prospectus filed by each of HL and Fusion Fuel on November 10, 2020. You are cautioned not to place undue reliance on these forward-looking statement, which speak only as of the date of this press release.

Contact:
Jeffrey E. Schwarz
Chief Executive Officer
HL Acquisitions Corp.
(212) 486-8100

 – LIFT-AD clinical trial evaluating ATH-1017, a once-daily investigational drug for the treatment of mild-to-moderate Alzheimer’s disease, actively enrolling 

 – Strong cash, cash equivalents and investments balance of $259.9 million as of September 30, 2020

SEATTLE, Nov. 12, 2020 (GLOBE NEWSWIRE) — Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

“At Athira, we are continuing to execute on our mission to restore neuronal health for those suffering from neurological diseases, including Alzheimer’s, and we have successfully begun enrollment in our Phase 2/3 clinical study, LIFT-AD, evaluating our lead product candidate ATH-1017 in individuals with mild-to-moderate Alzheimer’s disease,” said Leen Kawas, Ph.D., President and Chief Executive Officer at Athira. “Supported by a strong cash position from our Series B financing in June and our initial public offering in September, we remain focused on advancing the development of ATH-1017 and our other pipeline programs.”

Recent Business Highlights and Updates

Pipeline

• Initiated patient dosing for the LIFT-AD study. In September 2020, Athira initiated patient dosing in a randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating the safety, efficacy and tolerability of two dose levels of ATH-1017 in individuals with mild-to-moderate Alzheimer’s disease. Clinical efficacy will be measured by improvement in cognition and global/functional assessments comparing treatment arms to placebo. Up to approximately 300 patients will be randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a daily subcutaneous injection of ATH-1017 or placebo over a treatment course of 26 weeks.

Corporate

• Completed initial public offering (IPO). In September 2020, Athira Pharma completed its IPO of 12,000,000 shares of common stock at a public offering price of $17.00 per share, generating gross proceeds of $204.0 million before deducting underwriting discounts and commissions and estimated offering expenses. In October 2020, Athira sold an additional 1,397,712 shares of common stock to the underwriters of the IPO upon partial exercise of the underwriters’ option to purchase additional shares at the initial public offering price, resulting in gross proceeds of approximately $23.8 million before deducting underwriting discounts and commissions and estimated offering expenses.

Third Quarter 2020 Financial Results

• Liquidity Position. Cash, cash equivalents and investments were $259.9 million as of September 30, 2020, as compared to $85.2 million as of June 30, 2020.
• Research and Development (R&D) Expenses. R&D expenses were $5.8 million for the quarter ended September 30, 2020, as compared to $1.0 million for the same period in 2019. The increase was driven primarily by start-up activities by our clinical research organization and clinical drug supply manufacturers for Phase 2 Alzheimer’s clinical trials of ATH-1017.
• General and Administrative (G&A) Expenses. G&A expenses were $1.6 million for the quarter ended September 30, 2020, as compared to $0.5 million for the same period in 2019. The increase was primarily due to legal, accounting, technical and consulting services and personnel-related costs to support the increase in clinical activities.
• Net Loss. Net loss was $8.5 million, or $1.12 loss per share, for the quarter ended September 30, 2020, as compared to $1.5 million or $0.43 loss per share, for the same period in 2019.

About Athira Pharma, Inc.

Athira, headquartered in Seattle, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. We aim to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer’s and Parkinson’s dementia. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding ATH-1017 as a potential treatment for Alzheimer’s and other dementias; Athira’s platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof; anticipated design of planned clinical trials; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates, including ATH-1017; the anticipated presentation of data; the results of Athira’s research and development efforts and Athira’s ability to advance its product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” and other similar expressions among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary data for Athira’s ATH-1017 product candidate from the Phase 1a/b trials will not continue or persist; cessation or delay of any of the ongoing clinical trials and/or Athira’s development of ATH-1017 may occur; future potential regulatory milestones of ATH-1017, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; the impact of the COVID-19 pandemic on Athira’s business, research and clinical development plans and timelines and results of operations, including impact on our clinical trial sites and contractors who act for or on our behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of Athira’s product candidates; Athira’s assumptions regarding its planned expenditures and sufficiency of its cash, cash equivalents and investments to fund operations may be incorrect; Athira’s research and development efforts and its ability to advance product candidates into later stages of development may fail; any one or more of Athira’s product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets; political and regulatory uncertainty following the results of the U.S. election in November 2020; regulatory agencies may be delayed in reviewing, commenting on or approving any of Athira’s clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; impact of new or changing laws and regulations; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.

“Athira,” “Athira Pharma” and the Athira logo are registered trademarks or trademarks of Athira Pharma, Inc. in various jurisdictions. All other trademarks belong to their respective owner.

Investor & Media Contact:
Julie Rathbun
Athira Pharma
[email protected]
206-769-9219

Athira Pharma, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)
(Amounts in thousands)

		September   30,				December   31,
		2020				2019
Assets
Cash and cash equivalents		$	165,725			$	2,056
Short-term investments			60,547				0
Other short-term assets			5,994				104
Long-term investments			33,656				0
Other long-term assets			2,017				29
Total assets		$	267,939			$	2,189
Liabilities, Convertible preferred stock and stockholders’ equity (deficit)
Current liabilities		$	7,554			$	1,273
Long-term liabilities			915				3,588
Total liabilities			8,469				4,861
Convertible preferred stock			—				17,051
Stockholders’ equity (deficit)			259,470				(19,723	)
Total liabilities and stockholders’ equity (deficit)		$	267,939			$	2,189

Athira Pharma, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)
(Amounts in thousands, except share and per share data)

		Three Months Ended September   30,
		2020				2019
Operating expenses:
Research and development		$	5,830			$	1,026
General and administrative			1,567				509
Total operating expenses			7,397				1,535
Loss from operations			(7,397	)			(1,535	)
Other income (expense), net			(1,059	)			5
Net loss		$	(8,456	)		$	(1,530	)
Unrealized (loss)/gain on available-for-sale securities			7				—
Comprehensive loss attributable to common shareholders		$	(8,449	)		$	(1,530	)
Net loss per share attributable to common stockholders,    basic and diluted		$	(1.12	)		$	(0.43	)
Weighted-average shares used in computing net loss per    share attributable to common stockholders, basic    and diluted			7,564,538				3,554,345

 

• 
  Early Interim Data for TRIDENT-1 Phase 2 Study of
  
  
  Repotrectinib and Second Drug Candidate
  
  
  ,
  
  
  TPX-0022
  
  
  ,
  
  
  Recently
  
  
  Presented
  

• 
  Phase 2 TRIDENT-1 Registrational Study Full Site Activation and Timeline Update
  
  
  Anticipated
  
  
  in
  
  
  Early
  
  
  2021
  

• 
  Four Clinical Studies of Three Drug Candidates Ongoing; Three Additional Clinical Studies Planned in 2021
  

• 
  Cash
  
  
  ,
  
  
  Cash Equivalents
  
  
  , and
  
  
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  Securities
  
  
  of
  
  
  $
  
  
  7
  
  
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  million from Recent Stock Offering
  
  
  Expected to
  
  
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SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported financial results and operational updates for the third quarter ended Sept. 30.

“We made substantial progress in our repotrectinib and TPX-0022 programs since our last quarterly update — reporting early interim data from both the Phase 2 TRIDENT-1 registrational study of repotrectinib and the Phase 1 SHIELD-1 study of TPX-0022 – and raised net proceeds of approximately $434 million through our October stock offering to fund current operations into 2024,” said Athena Countouriotis, M.D., president and chief executive officer. “In addition, we continued to build a strong team to advance our pipeline of four drug candidates, with three new clinical trials planned for 2021, and importantly, to invest in earlier stage discovery. We look forward to completing our site activations in TRIDENT-1 and submitting our fourth IND in early 2021.”

Third
 quarter and recent highlights include
:

• Progress in the Phase 2 TRIDENT-1 registrational study of repotrectinib, where the company reported early interim data in August. Utilizing a July 10, 2020 data cutoff, the preliminary efficacy and safety in the first 39 treated patients across multiple Phase 2 cohorts demonstrated confirmed objective response rates (ORR) of 86 percent in TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC) patients (EXP-1: n=7); 40 percent in ROS1-positive NSCLC patients previously treated with a TKI and prior platinum-based chemotherapy (EXP2: n=5); 67 percent in ROS1-positive NSCLC patients previously treated with a TKI and no prior chemotherapy (EXP-4: n=6); and 50 percent in NTRK-positive TKI-pretreated patients (EXP-6: n=6), all by physician assessment. Repotrectinib was generally well tolerated, with the majority of treatment emergent adverse events reported as Grade 1 or 2.

  Turning Point has been granted three Fast Track designations by the Food and Drug Administration (FDA), in ROS1-positive advanced NSCLC patients who are TKI naïve, ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs.

  The company’s goal is to complete global activation of sites in the TRIDENT-1 study in early 2021, after which it plans to provide an update on the overall study timeline. Turning Point’s regional partner, Zai Lab, will continue to activate sites in 2021.

• Progress in the Phase 1 SHIELD-1 study of TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, where initial data reported in a late-breaker oral presentation at the EORTC-NCI-AACR symposium highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally tolerable safety profile.

  The company anticipates initiating Phase 1 dose expansion after determining the recommended Phase 2 dose. The company also plans to discuss the ongoing Phase 1 SHIELD-1 study with the FDA to potentially modify the trial into a registrational Phase 1/2 design with the goal to initiate the Phase 2 portion of the study in the second half of 2021, pending FDA feedback.

• Two additional trials ongoing, including the Phase 1/2 open-label study to assess repotrectinib in pediatric patients with ALK-, NTRK- or ROS1-positive advanced solid tumors; and the Phase 1/2 study of RET-inhibitor TPX-0046.
• Presenting preclinical data in a KRAS G12C NSCLC tumor xenograft model demonstrating repotrectinib significantly enhanced the efficacy of AMG-510 and showed a marked survival benefit when compared to AMG-510 alone. Repotrectinib has previously demonstrated synergy in preclinical models with AMG-510 and a MEK inhibitor. Based on these preclinical data, Turning Point plans to initiate a clinical combination study in KRAS mutant NSCLC in mid-2021.
• Completing a follow-on public stock offering generating net proceeds to Turning Point of approximately $434 million.

Third
Quarter Financial Update

Revenue of $25 million recorded in the quarter was the result of an upfront payment from Zai Lab under the company’s license agreement for repotrectinib in Greater China. Operating expenses for the third quarter totaled $43.5 million compared to $22.1 million in the third quarter of 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, TPX-0022, TPX-0046 and personnel expenses.

Excluding a one-time non-cash stock-based compensation charge in the first quarter, non-GAAP operating expenses for the first nine months totaled $107.5 million compared to $54.7 million in the prior-year period. Year-to-date net cash used in operating activities was $49.4 million.

Cash, cash equivalents and marketable securities at Sept. 30 totaled $711.4 million, an increase of $1 million from June 30 driven by the upfront payment from Zai Lab, partially offset by cash used in operating activities for the quarter. In addition, Turning Point completed a follow-on public stock offering in October that generated net proceeds of $433.6 million. Turning Point Therapeutics projects its cash position funds current operations into 2024.

Upcoming Milestones

Key milestones anticipated into 2021 include:

• TRIDENT-1 data presentation in a mini-oral session at the World Conference on Lung Cancer in January 2021.
• Achievement of full TRIDENT-1 global site activation in early 2021, excluding sites within China managed by the company’s partner Zai Lab, and an update on the overall study timeline in early 2021.
• Submitting an investigational new drug application to the FDA for ALK-inhibitor TPX-0131 in early 2021.
• Reporting early interim data from initial patients in the Phase 1 study of RET-inhibitor TPX-0046 in the first half of 2021.
• Initiation of TRIDENT-2, a planned Phase 2 combination study of repotrectinib in patients with KRAS mutant NSCLC in mid-2021.
• Initiation of the planned Phase 2 portion of the SHIELD-1 study of TPX-0022 in the second half of 2021, pending FDA feedback.
• Initiation of SHIELD-2, a planned Phase 2 study of TPX-0022 in combination with an inhibitor of epidermal growth factor receptor (EGFR), in the second half of 2021.

About Turning Point Therapeutics Inc.

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study called TRIDENT-1 in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is in a Phase 1 study called SHIELD-1 in patients with advanced or metastatic solid tumors harboring genetic alterations in MET; RET-inhibitor TPX-0046, which is in a Phase 1/2 study of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and ALK-inhibitor TPX-0131, which is in IND-enabling studies. Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

Non-GAAP Financial Measures

In addition to the financial results that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains a non-GAAP financial measure. When preparing our supplemental non-GAAP financial results, the Company excluded certain GAAP items that management does not consider to be normal. In particular, the non-GAAP measure excludes non-cash stock-based compensation expense relating to a one-time charge of $31.4 million associated with previously disclosed modifications to the vesting of existing stock options, pursuant to the transition agreement with the company’s scientific founder. This non-GAAP measure is provided as a complement to results provided in accordance with GAAP as management believes this non-GAAP financial measure is important in comparing current results with prior-period results. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidates, repotrectinib, TPX-0022, TPX-0046 and TPX-0131, the results, conduct, progress and timing of Turning Point Therapeutics’ development programs and clinical trials including the Phase 2 TRIDENT-1 clinical study, the Phase 1/2 pediatric clinical study of repotrectinib, the Phase 1 SHIELD-1 clinical study of TPX-0022 and the Phase 1/2 clinical study of TPX-0046, plans regarding future clinical trials and regulatory submissions, the regulatory approval path for repotrectinib, the potential to receive milestone and royalty payments from Zai Lab, the strength of Turning Point Therapeutics’ balance sheet and the adequacy of cash on hand. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point’s business and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

TURNING POINT THERAPEUTICS, INC.

Balance Sheet Data
(In thousands)
(unaudited)

		September 30,				December 31,
		2020				2019
Balance Sheet Data:
Cash, cash equivalents, and marketable securities		$	711,388			$	409,151
Working capital			697,907				400,915
Total assets			724,633				422,202
Accumulated deficit			(232,800	)			(122,884	)
Total stockholders’ equity			701,588				404,351

TURNING POINT THERAPEUTICS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Revenue		$	25,000				–			$	25,000			$	–
Operating expenses:
Research and development			32,213				16,640				79,136				40,802
General and administrative			11,326				5,500				59,761				13,857
Total operating expenses			43,539				22,140				138,897				54,659
Loss from operations			(18,539	)			(22,140	)			(113,897	)			(54,659	)
Other income, net			834				1,657				3,981				3,487
Net loss			(17,705	)			(20,483	)			(109,916	)			(51,172	)
Unrealized gain / (loss) on marketable securities, net of tax			(606	)			(24	)			141				322
Comprehensive loss		$	(18,311	)		$	(20,507	)		$	(109,775	)		$	(50,850	)
Net loss per share, basic and diluted		$	(0.42	)		$	(0.63	)		$	(2.82	)		$	(2.54	)
Weighted-average common shares outstanding, basic and diluted			42,185,824				32,312,814				38,914,789				20,178,979

TURNING POINT THERAPEUTICS, INC.
Reconciliation of GAAP to Non-GAAP Financial Results
(In thousands)
(unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
GAAP Operating Expenses		$	(43,539	)		$	(22,140	)		$	(138,897	)		$	(54,659	)
Adjustments:
Share-based compensation expense (1)			–				–				31,405				–
Non-GAAP Operating Expenses		$	(43,539	)		$	(22,140	)		$	(107,492	)		$	(54,659	)

(1)   During the first quarter of 2020, the Company recognized in non-cash stock-based compensation expense a one-time charge of $31.4 million associated with previously disclosed modifications to the vesting of existing stock options, pursuant to the transition agreement with the company’s scientific founder.

Contact:
Jim Mazzola
[email protected]
858-342-8272

WEST CHESTER, Pa., Nov. 12, 2020 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that Ted White, Verrica President and CEO, will present a business overview at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020, at 2:55 p.m. ET. A live webcast of the event can be accessed in the Investors/Presentations & Events section of the Verrica website at http://www.verrica.com. The webcast replay will be available shortly after conclusion of the event for 30 days.

About Verrica Pharmaceuticals
Inc.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. The Company’s late-stage product candidate, VP-102, is a potential first-in-class drug-device combination product containing a topical therapy for the treatment of molluscum contagiosum. Verrica submitted an NDA for VP-102 for the treatment of molluscum in September 2019. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on July 13, 2020. In October 2020, Verrica participated in a Type A meeting with the FDA. Verrica expects to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts. The Company is also developing VP-103, its third cantharidin-based product candidate, for the treatment of plantar warts. For more information, visit www.verrica.com.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

A. Brian Davis

Chief Financial Officer
484.453.3300 ext. 103
[email protected]

William Windham

Solebury Trout
646.378.2946
[email protected]

Media:

Zara Lockshin

Solebury Trout
646.378.2960
[email protected]

AUSTIN, Texas, Nov. 12, 2020 (GLOBE NEWSWIRE) — Ideal Power Inc. (Nasdaq: IPWR), pioneering the development and commercialization of highly efficient and broadly patented B-TRAN™ bi-directional power switches, reported results for its third quarter ended September 30, 2020.

“During the third quarter, we maintained our momentum toward our commercialization goals,” stated Dan Brdar, President and Chief Executive Officer of Ideal Power. “Recently, we completed our first milestone with United States Naval Sea Systems Command (NAVSEA) under our partnership with Diversified Technologies, Inc. (DTI) finishing the first wafer fabrication run with Teledyne. Devices are being packaged and will be tested and characterized under the NAVSEA program. We now have both initial driver and packaging designs through our collaboration with The University of Texas at Austin’s Microelectronics Research Center. Overall, we continue to make progress toward commercialization, and are excited about our prospects for B-TRAN™ as a differentiated technology that addresses a large and growing market.”

Key Recent
Operational Highlights

• Completed first major milestone under NAVSEA program in partnership with DTI to demonstrate B-TRAN™ enabled high efficiency direct current circuit breakers; received B-TRAN™ wafers from Teledyne’s first fabrication run under the program, which are being tested for selection and packaging into B-TRAN™ devices.
• In collaboration with The University of Texas at Austin’s Microelectronics Research Center:
  • Completed design and fabrication of initial version of our new B-TRAN™ driver
  • Under the NAVSEA program, completed the initial design of new B-TRAN™ device packaging
• Developed a new high power test rig to enable testing of packaged devices at high voltage and high current conditions as part of the device characterization required under the NAVSEA program and for the generation of a data sheet for the engineering sample program.
• B-TRAN™ Patent Estate: Currently have 57 issued B-TRAN™ patents with 21 of those issued outside of the United States and 25 pending B-TRAN™ patents. Current geographic coverage now includes North America, China, Japan and Europe, with potential to expand coverage into South Korea and India.
• As of September 30, 2020, and inclusive of the previously announced early warrant exercise transaction, we have raised $3 million in 2020 from warrant exercises.

Third


Quarter 2020 Financial Results

• Research and development expenses in the third quarter of 2020 were $0.5 million compared to $0.3 million in the third quarter of 2019. The increase was due to higher expenses related to B-TRAN wafer fabrication and driver development.
• General and administrative expenses in the third quarter of 2020 were $0.7 million compared to $0.5 million in the third quarter of 2019.
• In connection with the early warrant exercise transaction, we recorded a non-cash warrant inducement expense of $3.7 million within other expenses representing the estimated fair value of the new warrants issued in the transaction.
• Net loss in the third quarter of 2020 was $4.9 million, inclusive of the $3.7 million non-cash warrant inducement expense, compared to $0.8 million in the third quarter of 2019. The third quarter of 2019 included a $0.1 million loss from discontinued operations related to our PPSA operations which we sold in September 2019.
• Cash used in operating activities for the first nine months of 2020 was $2.3 million compared to $2.4 million in the first nine months of 2019.
• Cash and cash equivalents totaled $3.8 million at September 30, 2020. In August 2020, the Company raised net cash proceeds of $2.5 million from the early warrant exercise transaction.
• Long-term debt outstanding at September 30, 2020 was $0.1 million relating to a Payroll Protection Program loan received in the second quarter of 2020 to temporarily subsidize payroll and facilities costs in a business landscape impacted by the COVID-19 pandemic. We currently expect this loan to be forgiven.

Third


Quarter 2020


Conference Call Details

Ideal Power CEO and President Dan Brdar and CFO Tim Burns will host the conference call, followed by a question and answer period.

To access the call, please use the following information:

Date:		Thursday, November 12, 2020
Time:		4:30 p.m. EST, 1:30 p.m. PST
Toll-free dial-in number:		1-866-248-8441
International dial-in number:		1-323-289-6576
Conference ID:		8075834

Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact LHA Investor Relations at 1-212-838-3777.

The conference call will be broadcast live and available for replay at http://public.viavid.com/index.php?id=142114 and via the investor relations section of the Company’s website at www.IdealPower.com.

A replay of the conference call will be available after 7:30 p.m. Eastern time on November 12, 2020 through December 12, 2020.

Toll Free Replay Number:		1-844-512-2921
International Replay Number:		1-412-317-6671
Replay ID:		8075834

About Ideal Power Inc.
Ideal Power (Nasdaq: IPWR) is pioneering the development of its broadly patented bi-directional power switches, creating highly efficient and ecofriendly energy control solutions for industrial, alternative energy, military and automotive applications. The Company is focused on its patented Bi-directional, Bi-polar Junction Transistor (B-TRAN™) semiconductor technology. B-TRAN™ is a unique double-sided bi-directional AC switch able to deliver substantial performance improvements over today’s conventional power semiconductors. Ideal Power believes B-TRAN™ modules will reduce conduction and switching losses, complexity of thermal management and operating cost in medium voltage AC power switching and control circuitry. For more information, visit www.IdealPower.com.

Safe Harbor Statement        
All statements in this release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While Ideal Power’s management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, the impact of COVID-19 on our business, financial condition and results of operations, the success of our B-TRAN™ technology, including the success of our contract with DTI, whether the patents for our technology provide adequate protection and whether we can be successful in maintaining, enforcing and defending our patents and our inability to predict with precision or certainty the pace of development and commercialization of our B-TRAN™ technology, our ability to secure additional financing on commercially reasonable terms, or at all, especially in light of the market volatility uncertainty as a result of the COVID-19 pandemic and uncertainties set forth in our quarterly, annual and other reports filed with the Securities and Exchange Commission. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.

Ideal Power Investor Relations Contact: 
LHA Investor Relations
Carolyn Capaccio, CFA; Keith Fetter
T: 212-838-3777
[email protected]

 

 IDEAL POWER INC.
Balance Sheets

		September 30, 2020				December 31, 2019
			(unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	3,769,225			$	3,057,682
Accounts receivable, net			28,623				–
Prepayments and other current assets			138,436				248,148
Total current assets			3,936,284				3,305,830
Property and equipment, net			41,797				47,302
Intangible assets, net			1,583,523				1,634,378
Right of use asset			126,257				260,310
Other assets			–				17,920
Total assets		$	5,687,861			$	5,265,740
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	66,710			$	182,956
Accrued expenses			383,374				319,135
Current portion of lease liability			129,995				183,119
Total current liabilities			580,079				685,210
Long-term debt			91,407				–
Long-term lease liability			–				82,055
Other long-term liabilities			607,974				609,242
Total liabilities			1,279,460				1,376,507
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 50,000,000 shares authorized; 2,976,709 shares issued and 2,975,388 shares outstanding at September 30, 2020, and 2,101,272 shares issued and 2,099,951 shares outstanding at December 31, 2019, respectively			2,977				2,101
Additional paid-in capital			78,419,046				71,242,256
Treasury stock, at cost, 1,321 shares at September 30, 2020 and December 31, 2019			(13,210	)			(13,210	)
Accumulated deficit			(74,000,412	)			(67,341,914	)
Total stockholders’ equity			4,408,401				3,889,233
Total liabilities and stockholders’ equity		$	5,687,861			$	5,265,740

IDEAL POWER INC.

Statements of Operations

(unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Grant revenue		$	147,787			$	–			$	154,302			$	–
Cost of grant revenue			147,787				–				154,302				–
Gross profit			–				–				–				–
Operating expenses:
Research and development			494,548				250,773				1,161,537				804,741
General and administrative			677,967				471,272				1,773,615				1,520,325
Total operating expenses			1,172,515				722,045				2,935,152				2,325,066
Loss from continuing operations before interest			(1,172,515	)			(722,045	)			(2,935,152	)			(2,325,066	)
Other expenses:
Interest expense, net			1,358				2,763				2,480				3,072
Warrant inducement expense			3,720,866				–				3,720,866				–
Total other expenses			3,722,224				2,763				3,723,346				3,072
Loss from continuing operations			(4,894,739	)			(724,808	)			(6,658,498	)			(2,328,138	)
Loss from discontinued operations			–				(78,796	)			–				(768,047	)
Loss on sale of discontinued operations			–				(9,107	)			–				(9,107	)
Net loss		$	(4,894,739	)		$	(812,711	)		$	(6,658,498	)		$	(3,105,292	)
Loss from continuing operations per share – basic and fully diluted		$	(1.28	)		$	(0.49	)		$	(2.04	)		$	(1.60	)
Loss from discontinued operations per share – basic and fully diluted			–				(0.06	)			–				(0.53	)
Net loss per share – basic and fully diluted		$	(1.28	)		$	(0.55	)		$	(2.04	)		$	(2.13	)
Weighted average number of shares outstanding – basic and fully diluted			3,821,717				1,474,001				3,264,860				1,460,507

IDEAL POWER INC.

Statements of Cash Flows

(unaudited)

		Nine Months Ended September 30,
		2020				2019
Cash flows from operating activities:
Loss from continuing operations		$	(6,658,498	)		$	(2,328,138	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			86,368				82,913
Write-off of capitalized patents			18,235				–
Stock-based compensation			434,782				156,882
Stock issued for services			50,000				–
Warrant inducement expense			3,720,866				–
Decrease in operating assets:
Accounts receivable			(28,623	)			–
Prepayments and other current assets			127,632				204,530
Increase (decrease) in operating liabilities:
Accounts payable			(116,246	)			1,337
Accrued expenses			61,845				6,336
Net cash used in operating activities			(2,303,639	)			(1,876,140	)
Net cash used in operating activities – discontinued operations			–				(557,096	)
Cash flows from investing activities:
Purchase of property and equipment			(12,407	)			(4,253	)
Acquisition of intangible assets			(35,836	)			(74,342	)
Net cash used in investing activities			(48,243	)			(78,595	)
Net cash provided by investing activities – discontinued operations			–				23,587
Cash flows from financing activities:
Proceeds from loans			91,407				–
Proceeds from the exercise of warrants			2,972,018				–
Net cash provided by financing activities			3,063,425				–
Net increase (decrease) in cash and cash equivalents – continuing operations			711,543				(1,954,735	)
Net decrease in cash and cash equivalents – discontinued operations			–				(533,509	)
Cash and cash equivalents at beginning of period			3,057,682				3,258,077
Cash and cash equivalents at end of period		$	3,769,225			$	769,833

  IDEAL POWER INC.
Statement of Stockholders’ Equity
For the Three-Month Periods during the Nine Months Ended September 30, 2020 and 2019
(unaudited)

		Common Stock								Preferred Stock								Additional Paid-In Capital				Treasury Stock								Accumulated Deficit				Total Stockholders’ Equity
		Shares				Amount				Shares				Amount								Shares				Amount
Balances at December 31, 2018			1,404,479			$	1,404				1,518,430			$	1,518			$	68,022,484				1,321			$	(13,210	)		$	(63,414,252	)		$	4,597,944
Conversion of preferred stock to common stock			70,843				71				(708,430	)			(708	)			637				—				—				—				—
Stock-based compensation			—				—				—				—				(25,814	)			—				—				—				(25,814	)
Net loss for the three months ended March 31, 2019			—				—				—				—				—				—				—				(1,040,899	)			(1,040,899	)
Balances at March 31, 2019			1,475,322				1,475				810,000				810				67,997,307				1,321				(13,210	)			(64,455,151	)			3,531,231
Stock-based compensation			—				—				—				—				101,843				—				—				—				101,843
Net loss for the three months ended June 30, 2019			—				—				—				—				—				—				—				(1,251,682	)			(1,251,682	)
Balances at June 30, 2019			1,475,322			$	1,475				810,000			$	810			$	68,099,150				1,321			$	(13,210	)		$	(65,706,833	)		$	2,381,392
Stock-based compensation			—				—				—				—				16,692				—				—				—				16,692
Net loss for the three months ended September 30, 2019			—				—				—				—				—				—				—				(812,711	)			(812,711	)
Balances at September 30, 2019			1,475,322			$	1,475				810,000			$	810			$	68,115,842				1,321			$	(13,210	)		$	(66,519,544	)		$	1,585,373
Balances at December 31, 2019			2,101,272			$	2,101				—			$	—			$	71,242,256				1,321			$	(13,210	)		$	(67,341,914	)		$	3,889,233
Stock-based compensation			—				—				—				—				116,497				—				—				—				116,497
Net loss for the three months ended March 31, 2020			—				—				—				—				—				—				—				(930,501	)			(930,501	)
Balances at March 31, 2020			2,101,272				2,101				—				—				71,358,753				1,321				(13,210	)			(68,272,415	)			3,075,229
Stock-based compensation			—				—				—				—				109,671				—				—				—				109,671
Stock issued for services			26,316				26				—				—				49,974				—				—				—				50,000
Exercise of warrants			225,718				226				—				—				175,590				—				—				—				175,816
Net loss for the three months ended June 30, 2020			—				—				—				—				—				—				—				(833,258	)			(833,258	)
Balances at June 30, 2020			2,353,306			$	2,353				—			$	—			$	71,693,988				1,321			$	(13,210	)		$	(69,105,673	)		$	2,577,458
Stock-based compensation			—				—				—				—				208,614				—				—				—				208,614
Exercise of warrants			250,566				251				—				—				248,365				—				—				—				248,616
Early warrant exercise transaction			372,837				373				—				—				2,547,213				—				—				—				2,547,586
Warrant inducement expense			—				—				—				—				3,720,866				—				—				—				3,720,866
Net loss for the three months ended September 30, 2020			—				—				—				—				—				—				—				(4,894,739	)			(4,894,739	)
Balances at September 30, 2020			2,976,709			$	2,977				—			$	—			$	78,419,046				1,321			$	(13,210	)		$	(74,000,412	)		$	4,408,401