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• Further demonstrated broad potential of novel genetic medicine platform with in vivo data in three diseases driven by different genetic mechanisms of disease
  
• Presented preclinical data showing compounds enabled with NeuBase’s proprietary delivery technology are well tolerated at pharmacologically active doses and are delivered beyond the liver after systemic administration
• Recent data support advancement of development of the myotonic dystrophy type 1 (DM1) program; IND filing expected in the fourth quarter of CY 2022
• Cash runway expected to fund currently planned operating and capital expenditures into the first quarter of CY 2023

PITTSBURGH, Aug. 12, 2021 (GLOBE NEWSWIRE) — NeuBase Therapeutics, Inc. (Nasdaq: NBSE) (“NeuBase” or the “Company”), a biotechnology platform company Drugging the Genome™ to address disease at the base level using a new class of precision genetic medicines, today reported its financial results for the three- and nine-month periods ended June 30, 2021.

“In June, we presented preclinical in vivo data of novel compounds demonstrating selective silencing of disease-causing mutations at the DNA or RNA level in three diseases, each of which is caused by a different underlying genetic mechanism. These new data further illustrate the broad applicability of our genetic medicine platform,” said Dietrich A. Stephan, Ph.D., Founder, CEO, and Chairman of NeuBase. “Following intravenous or subcutaneous dosing, these compounds were well tolerated at pharmacologically active doses. In addition, the compounds achieved targeted delivery into brain and muscle, which further support our claim of offering the unique ability to deliver genetic medicines throughout the body.”

“For our lead program in DM1, recent data support a differentiated therapeutic approach to maintain DMPK function while selectively silencing the disease-driving mutation. With these positive data in hand, we believe we have a clear path towards entering the clinic and are planning for an IND filing in the fourth quarter of calendar year 2022,” continued Dr. Stephan. “We are continuing to advance our therapeutic program for Huntington’s disease and we believe our proprietary delivery technology will allow our compounds to advance beyond intrathecal delivery, overcoming challenges seen with other programs.”

Dr. Stephan concluded, “Finally, we have shown that we can silence activating KRAS point mutations in vivo to inhibit protein production, which has the potential to target G12D and G12V, the two most common and historically ‘undruggable’ KRAS driver mutations that represent the majority of KRAS-driven tumors. This sets the stage for generating new precision genetic medicines capable of selectively targeting mutations at the single-base level to treat both rare and common diseases.”

Third Quarter of Fiscal Year 2021 and Recent Operating Highlights

• Completed an oversubscribed public offering led by noted fundamental healthcare investors for net proceeds of $42.6 million, providing a cash runway into CY 2023.
• Presented preclinical data demonstrating:
  • Proprietary genetic medicines platform generates novel compounds that selectively silence disease-driving genetic mutations in vivo without permanently modifying the genome
  • Functional rescue of myotonic dystrophy type 1 (DM1) phenotype in vivo after subcutaneous dosing, as well as tolerability at pharmacologically active doses
  • In vivo proof of concept in Huntington’s disease with allele-selective mutant protein knock-down after delivering compounds across the blood-brain barrier following subcutaneous dosing
  • Pharmacologic activity against historically ‘undruggable’ KRAS driver mutations in a variety of patient-derived tumor lines in xenograft models
  • Penetration of the blood-brain barrier with pharmacologic activity in the CNS and additional broad tissue distribution and activity of compounds after subcutaneous administration
  • Compounds are well tolerated, and consistent with historical data
• Expanded the executive management team with the appointment of Sandra Rojas-Caro, M.D., as Chief Medical Officer to oversee the preclinical and clinical development, medical, and regulatory strategy of the Company’s pipeline; and Kia Motesharei, Ph.D., as Chief Business and Strategy Officer to oversee business development and alliance management and work with the CEO on corporate strategy

Financial Results for the Third Fiscal Quarter Ended June 30, 2021

• As of June 30, 2021, the Company had cash and cash equivalents of approximately $58.8 million, compared with approximately $32.0 million as of September 30, 2020
• NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the first quarter of CY2023
• For the three-month period ended June 30, 2021, the Company reported a net loss of approximately $8.7 million, or a net loss of $0.29 per share, compared with a net loss of approximately $3.8 million, or a net loss of $0.18 per share, for the three-month period ended June 30, 2020
• For the three-month period ended June 30, 2021, total operating expenses were approximately $8.8 million, consisting of approximately $3.5 million in general and administrative expenses, $2.5 million of research and development expenses and $2.9 million in research and development- Vera acquisition expenses. This compares with total operating expenses of approximately $3.8 million for the three-month period ended June 30, 2020, consisting of approximately $2.3 million in general and administrative expenses, and $1.5 million in research and development expenses

Financial Results for the Nine-Month Period Ended June 30, 2021

• For the nine-month period ended June 30, 2021, the Company reported a net loss of approximately $18.3 million, or a net loss of $0.72 per share, compared with a net loss of approximately $12.7 million, or a net loss of $0.69 per share, for the same period last year
• For the nine-month period ended June 30, 2021, total operating expenses were approximately $19.4 million, consisting of approximately $8.8 million in general and administrative expenses, $7.7 million of research and development expenses, $2.9 million in research and development- Vera acquisition expenses. This compares with total operating expenses of approximately $12.0 million for the same period last year, consisting of approximately $7.6 million in general and administrative expenses and $4.3 million in research and development expenses

About NeuBase Therapeutics

NeuBase is accelerating the genetic revolution by developing a new class of precision genetic medicines which can be designed to increase, decrease, or change gene function, as appropriate, to resolve genetic defects that drive disease. NeuBase’s targeted PATrOL™ therapies are centered around its proprietary drug scaffold to address genetic diseases at the DNA or RNA level by combining the highly targeted approach of traditional genetic therapies with the broad organ distribution capabilities of small molecules. With an initial focus on silencing disease-causing mutations in debilitating neuromuscular, neurological and oncologic disorders, NeuBase is committed to redefining medicine for the millions of patients with both common and rare conditions. To learn more, visit www.neubasetherapeutics.com.

Use of Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements are distinguished by use of words such as “will,” “would,” “anticipate,” “expect,” “believe,” “designed,” “plan,” or “intend,” the negative of these terms, and similar references to future periods. These forward-looking statements include, among others, those related to the prospects of DM1 and the Company’s expectation to make an IND filing for DM1 in the fourth quarter of CY 2022, the Company’s therapeutic program for Huntington’s disease, the Company’s ability to target G12D and G12V and the Company’s expectation that its cash will fund currently planned operating and capital expenditures into the first quarter of CY 2023. These views involve risks and uncertainties that are difficult to predict and, accordingly, our actual results may differ materially from the results discussed in our forward-looking statements. Our forward-looking statements contained herein speak only as of the date of this press release. Factors or events that we cannot predict, including those risk factors contained in our filings with the U.S. Securities and Exchange Commission (the “SEC”), may cause our actual results to differ from those expressed in forward-looking statements. The Company may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release, including: the Company’s plans to develop and commercialize its product candidates; the timing of initiation of the Company’s planned clinical trials; the risks that prior data will not be replicated in future studies; the timing of any planned investigational new drug application or new drug application; the Company’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of the Company’s product candidates; the Company’s commercialization, marketing and manufacturing capabilities and strategy; global health conditions, including the impact of COVID-19; the Company’s ability to protect its intellectual property position; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all, as well as those risk factors contained in our filings with the SEC. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

NeuBase Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
OP: (617) 430-7576

NeuBase Media Contact:

Jessica Yingling, Ph.D.
Little Dog Communications Inc.
(858) 344-8091
[email protected]

 

BASEL, Switzerland, Aug. 12, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and men, today announced the appointment of Uneek Mehra as Chief Financial and Business Officer of Myovant Sciences, Inc.  Mr. Mehra will succeed Frank Karbe, who has decided to pursue other opportunities and will serve in an advisory capacity to support Mr. Mehra’s transition.   Beginning September 7, 2021, Mr. Mehra will lead Myovant’s finance, alliance partnerships, and business development functions and will be a member of Myovant’s Executive Committee, reporting to Dave Marek, Myovant’s Chief Executive Officer.

Mr. Mehra brings extensive financial leadership expertise supporting multi-billion dollar commercial-stage businesses in addition to deep experience successfully growing and scaling emerging companies.  He has over 25 years of experience in finance, corporate strategy, business development, and operations in the banking, technology, medical device, and pharmaceutical industries across global geographies, and within public and private organizations.

“We’re delighted to welcome Uneek to Myovant,” said Dave Marek, Myovant’s Chief Executive Officer.  As Myovant continues to build momentum with our launches of ORGOVYX^® and MYFEMBREE^®, we are seeking to build our pipeline and committed to adding key experience and capabilities to support our near and long-term success.  Uneek brings an uncommon breadth of successful leadership in commercial execution and a track-record of large-scale strategic business development that will be instrumental in driving Myovant’s future growth.  We thank Frank for his many contributions to the company over the past five years.  He has helped lead the company through clinical development, capital raising and partnerships, initial commercial launches, and has been an inspirational influence supporting our patient-centered culture.”

Mr. Mehra joins Myovant from PACT pharma, a personalized cell therapy company targeting solid cancers, where, as Chief Financial Officer and Corporate Treasurer, he successfully built partnerships, and raised capital to scale the emerging company.  Prior to joining PACT, Uneek was Chief Financial Officer at Proteus Digital Health, a digital medicines company, with responsibility for Finance, Tax, Treasury, IT, Facilities, and Human Resources.  Previously, Mr. Mehra spent more than 13 years at Novartis where he drove strategic investments and commercial financial performance for multi-billion dollar businesses.  He successfully led strategic portfolio prioritization and resource allocation across several business units and steered successful transactions across oncology and specialty pharma assets.  As Chief Financial Officer of the US Integrated Care and Critical Care Business Units, Mr. Mehra supported commercial excellence across multiple products; notably, driving the launch and execution of Cosentyx^® and Entresto^®.  Earlier in his career, Mr. Mehra held senior finance roles with International Business Machines(IBM) Corporation and Citibank.

Mr. Mehra obtained his Master’s in Business Administration in Strategy and Leadership from the International Institute for Management Development, Lausanne, Switzerland; Master’s of Science in Finance from the University of Mumbai, India; and Bachelor’s of Engineering in Electronics from the Birla Institute of Technology and Science, Pilani, India.

“I’m honored to join Myovant at this pivotal stage of growth for the company. I’m energized by Myovant’s completing its transition from a clinical stage company to a rapid-growth commercial organization, with two important therapies for women and men, and resources to secure the next generation of differentiated therapies,” said Mr. Mehra.  “I particularly admire Myovant’s purpose to make a difference in the lives of patients through a focus on placing patient care as the centerpiece of its mission.”

“I’m proud to have been part of Myovant since its beginning to help lead the organization through its IPO, the establishment of multiple partnerships and two product launches,” said Mr. Karbe.  “The Myovant team has accomplished a lot over the past five years, and I’m grateful for having been part of such an excellent group of people.  I’m confident the company is well-positioned to successfully execute on its product launches, pursue business development, and fulfill its mission of re-defining care and improving the lives of millions of women and men.”

About Myovant Sciences

Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy.  Founded in 2016, we have two FDA-approved products. ORGOVYX^® (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer.  Relugolix combination tablet (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) was approved in 2021 in the EU as RYEQO^® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, and in the U.S. as MYFEMBREE^® as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.  The therapy has also completed Phase 3 registration-enabling studies for women with endometriosis and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy.  We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction.  Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder.  For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

Investor Contact:

Ryan Crowe
Vice President, Investor Relations
Myovant Sciences, Inc.
+1 (650) 781-9106
[email protected]

Media Contact:

Albert Liao
Director, Corporate Communications
Myovant Sciences, Inc.
+1 (650) 410-3055
[email protected]

ESCONDIDO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) — One Stop Systems, Inc. (Nasdaq: OSS), a leader in AI Transportable solutions on the edge, reported results for the second quarter ended June 30, 2021. All quarterly comparisons are to the same year-ago period unless otherwise noted. The company will hold a conference call at 5:00 p.m. Eastern time today to discuss the results (see dial-in information below).  

Q2 2021 Financial Highlights

• Revenue totaled $14.9 million, up 12% sequentially and up 28% versus the same year-ago quarter.
• Gross margin was 31.2%, up 2.6 percentage points.
• GAAP net income totaled $1.7 million or $0.09 per diluted share versus a net loss of $12,000 or $(0.00) per diluted share in the year-ago quarter. GAAP net income includes forgiveness of PPP loan of approximately $1.5 million.
• Non-GAAP net income was $812,000 or $0.04 per basic and diluted share, versus $248,000 or $0.01 per diluted share in the same year-ago quarter. Non-GAAP net income excludes $1.5 million of PPP loan forgiveness (see definition of this and other non-GAAP measures and reconciliation to GAAP, below).
• Adjusted EBITDA was $1.4 million, up $1.3 million and reaching more than 9% of total revenue. Adjusted EBITDA excludes $1.5 million of PPP loan forgiveness.
• Cash, cash equivalents and short-term investments totaled $18.5 million on June 30, 2021.

First Half 2021 Financial Highlights

• Revenue totaled a record $28.2 million, up 13%.
• Gross margin was 32.2%, up 5.3 percentage points.
• GAAP net income totaled $1.7 million or $0.09 per share, up by $2.8 million. GAAP net income includes forgiveness of PPP loan of approximately $1.5 million.
• Non-GAAP net income was $1.5 million or $0.08 per basic and diluted share, up by $1.9 million. Non-GAAP net income excludes $1.5 million of PPP loan forgiveness.
• Adjusted EBITDA was $2.5 million, up by $3.3 million. Adjusted EBITDA excludes $1.5 million of PPP loan forgiveness.

Q2 2021 Operational Highlights

• Secured three major design wins, which included two AI on the Fly® applications, a transportable edge flash storage solution, an autonomous vehicle training system, and a high-performance computing medical controller system. Total major wins for the first half of the year totaled six wins. In addition to the confirmed wins, the company has 17 major pending opportunities.
• Operating expenses as a percentage of revenue decreased to 27.7% from 32.1% in the same year-ago quarter, which was primarily due to the company’s expense reduction program initiated in early 2020.

Management Commentary

“In Q2, we achieved strong top-line growth with revenue up 28% to $14.9 million, and this helped drive first half revenue up 13% to a record $28.2 million,” commented OSS president and CEO, David Raun. “The strong top-line performance reflects our broadening customer base and new wins with major accounts.

“We also drove down our operating expenses as a percentage of revenue. Together, these results generated solid bottom-line improvements with net income in the second quarter increasing $1.7 million versus the year-ago quarter and adjusted EBITDA up by $1.3 million, reaching more than 9% of total revenue.

“During the second quarter, we won three new major opportunities that included a medical control system, an edge flash storage program, and a GPU-accelerated training and inference system with a major vehicle supplier in Germany. The vehicle supplier win expanded our footprint in the autonomous vehicle market. Altogether, these successes brought our first half of the year major wins to six. We also shipped our latest SDS rugged server which was designed into a military mobile datacenter application.

“While we expect the effects of the pandemic to continue through the rest of the year, we are seeing improving customer demand. Even our commercial aerospace customers, which were severely affected by COVID, are re-engaging with us on new programs, as well as bringing back programs previously put on hold. We have now 17 major pending opportunities in our pipeline that we are focused on closing.

“Executing on our long-term strategic vision and product road map continues to be our top priority. This plan includes strengthening our value proposition in the fast-growing, edge-computing industry with the goal of becoming the market leader in the AI Transportables space. This target market requires the highest performance computing in a challenging mobile environment, which we believe to be one of our greatest strengths.

“We continue to proactively manage the challenges imposed by the pandemic, and in doing so, our team has become adept at optimizing engineering and manufacturing processes, shipping product on time, and not only protecting but increasing margins.

“While we are experiencing increased product demand, supply chain challenges such as price increases and long lead-times continue to be significant. However, our team is managing the fluid landscape on multiple fronts by qualifying additional vendors, implementing extended purchase planning, and focusing on other strategic and tactical activities.

“We believe our execution of our strategic plan, corporate reorganization, and improved board composition has contributed to a tripling of shareholder value over the past two years. So far this year, we have made better-than-expected top- and bottom-line progress.

“Given our adjusted EBITDA at 9% of total revenue in the first half of the year, we are well on our way to achieving our objective of it being no less than 10% of revenues. For the current third quarter, we believe we are on track to generate revenue of about $15.9 million, which would represent an increase of 23% over the same year-ago quarter and would exceed all historical third quarters.”

Q2 2021 Financial Summary

Revenue in the second quarter of 2021 increased 28% to $14.9 million, compared to $11.6 million in the same year-ago quarter. This growth was primarily driven by improvements in the sale of ruggedized servers in the media and entertainment markets, differentiated military AI Transportables data processing and storage products, as well as continued expansion of the company’s customer base and new applications within key accounts.

Gross profit was $4.7 million or 31.2% of revenue in the second quarter of 2021, up from $3.3 million or 28.6% of revenue in Q2 2020. The improvement in quarterly margin was attributed to changes in product mix and type of customer.

Operating expenses increased 11% to $4.1 million in the second quarter of 2021 compared to $3.7 million in the same year-ago quarter. Operating expenses as a percentage of revenue decreased to 27.7% in the second quarter of 2021 versus 32.1% in the year-ago quarter.

Net income on a GAAP basis totaled $1.7 million in the second quarter of 2021 or $0.09 per diluted share compared to a net loss of $12,000 or $(0.00) per diluted share in the year-ago period. This improvement was due to more favorable gross margins as well as debt and interest forgiveness on the company’s PPP loan of approximately $1.5 million.

Non-GAAP net income totaled $812,000 or $0.04 per basic and diluted share in the second quarter of 2021, as compared to a non-GAAP net income of $248,000 or $0.01 per diluted share in the same year-ago period. Non-GAAP net income excludes the $1.5 million PPP loan forgiveness.

Adjusted EBITDA, a non-GAAP term, totaled $1.4 million in the second quarter of 2021 as compared to $73,000 in the same year-ago period. Adjusted EBITDA excludes the $1.5 million PPP loan forgiveness.

Cash, cash equivalents and short-term investments totaled $18.5 million as of June 30, 2021, as compared to $19.6 million on March 31, 2021. The company believes its cash position and other available funds provide sufficient liquidity to meet its cash requirements for working capital and paying down debt, while supporting its strategic growth initiatives.

First Half 2021 Financial Summary

Total revenues increased 13% to a record $28.2 million compared to $25.0 million in the prior year. This growth was primarily driven by improvements in the sale of ruggedized servers in the media and entertainment markets, our differentiated military AI Transportables data processing and storage products, as well as continued expansion of our customer base and new applications within key accounts.

Gross profit for the first half of 2021 was $9.1 million or 32.2% of revenue, compared to $6.7 million or 26.9% of revenue in the same year-ago period. The improvements in quarterly margins were attributable to product mix, additional sales of high-value products, and increased efficiencies.

Total operating expenses decreased 4% to $8.3 million versus the first half of 2020. Operating expenses as a percentage of revenue improved to 29.4% during the first half of 2021 versus 34.6% in the same year-ago period.

Net income on a GAAP basis totaled $1.7 million or $0.09 per diluted share, as compared to a loss of $1.1 million or $(0.07) per share in the first half of 2020. Net Income includes the $1.5 million PPP loan forgiveness.

Non-GAAP net income totaled $1.5 million or $0.08 per diluted share, as compared to non-GAAP net loss of $466,000 or $(0.03) per share in the first half of 2020. Non-GAAP net income excludes the $1.5 million PPP loan forgiveness.

Adjusted EBITDA, a non-GAAP term, totaled $2.5 million as compared to negative $885,000 in the first half of 2020. Adjusted EBITDA excludes the $1.5 million PPP loan forgiveness.

Outlook

For the third quarter of 2021, OSS expects revenue of approximately $15.9 million which would be an increase of 7% sequentially and 23% versus the same year-ago quarter.

Conference Call

OSS management will hold a conference call to discuss its second quarter 2021 results later today, followed by a question-and-answer period.

Date: Thursday, August 12, 2021
Time: 5:00 p.m. Eastern time (2:00 p.m. Pacific time)
Toll-free dial-in number: 1-866-269-4260
International dial-in number: 1-786-204-3966
Conference ID: 1453156

The conference call will be webcast live and available for replay here as well as via a link in the Investors section of the company’s website at onestopsystems.com/pages/investors. OSS regularly uses its website to disclose material and non-material information to investors, customers, employees and others interested in the company.

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

A replay of the call will be available after 8:00 p.m. Eastern time on the same day through August 26, 2021.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 1453156

About One Stop Systems

One Stop Systems, Inc. (OSS) designs and manufactures innovative AI Transportable edge computing modules and systems, including ruggedized servers, compute accelerators, expansion systems, flash storage arrays and Ion Accelerator™ SAN, NAS and data recording software for AI workflows. These products are used for AI data set capture, training, and large-scale inference in the defense, oil and gas, mining, autonomous vehicles and rugged entertainment applications.
  
OSS utilizes the power of PCI Express, the latest GPU accelerators and NVMe storage to build award-winning systems, including many industry firsts, for industrial OEMs and government customers. The company enables AI on the Fly® by bringing AI datacenter performance to ‘the edge’, especially on mobile platforms, and by addressing the entire AI workflow, from high-speed data acquisition to deep learning, training and inference. OSS products are available directly or through global distributors. For more information, go to www.onestopsystems.com.

Non-GAAP Financial Measures

Management believes that the use of adjusted earnings before interest, taxes, depreciation and amortization, or adjusted EBITDA, is helpful for an investor to assess the performance of the Company. The Company defines adjusted EBITDA as income (loss) before interest, taxes, depreciation, amortization, acquisition expenses, impairment of long-lived assets, financing costs, fair value adjustments from purchase accounting, stock-based compensation expense and expenses related to discontinued operations. For this reporting period, it excludes PPP loan forgiveness, which the company does not anticipate will reoccur in the foreseeable future.
  
Adjusted EBITDA is not a measurement of financial performance under generally accepted accounting principles in the United States, or GAAP. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash operating expenses, management believes that providing a non-GAAP financial measure that excludes non-cash and non-recurring expenses allows for meaningful comparisons between the company’s core business operating results and those of other companies, as well as providing management with an important tool for financial and operational decision making and for evaluating the company’s own core business operating results over different periods of time.
  
The company’s adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in its industry, as other companies in the company’s industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. The Company’s adjusted EBITDA is not a measurement of financial performance under GAAP, and should not be considered as an alternative to operating income or as an indication of operating performance or any other measure of performance derived in accordance with GAAP. Management does not consider adjusted EBITDA to be a substitute for, or superior to, the information provided by GAAP financial results.

	For the Three Months Ended								For the Six Months Ended
	June 30,								June 30,
	2021				2020				2021				2020
Net income (loss)	$	1,697,122			$	(12,162	)		$	1,738,320			$	(1,108,194	)
Depreciation and amortization		394,794				402,385				775,572				798,210
Amortization of deferred gain		–				(12,359	)			–				(53,838	)
Stock-based compensation expense		465,336				85,378				903,730				293,139
Interest expense		169,031				150,186				319,013				218,970
Interest income		(61,798	)			(99,343	)			(67,098	)			(123,980	)
PPP loan and interest forgiveness		(1,514,354	)			–				(1,514,354	)			–
Provision (benefit) for income taxes		235,293				(441,511	)			295,815				(908,809	)
Adjusted EBITDA	$	1,385,424			$	72,574			$	2,450,998			$	(884,502	)

Adjusted EPS excludes the impact of certain items and therefore has not been calculated in accordance with GAAP. Management believes that exclusion of certain selected items assists in providing a more complete understanding of the company’s underlying results and trends and allows for comparability with its peer company index and industry. Management uses this measure along with the corresponding GAAP financial measures to manage the company’s business and to evaluate its performance compared to prior periods and the marketplace. The company defines Non-GAAP (loss) income as (loss) or income before amortization, stock-based compensation, expenses related to discontinued operations, impairment of long-lived assets and non-recurring acquisition costs. For this reporting period, it excludes PPP loan forgiveness, which the company does not anticipate will reoccur in the foreseeable future. Adjusted EPS expresses adjusted (loss) income on a per share basis using weighted average diluted shares outstanding.
  
Adjusted EPS is a non-GAAP financial measure and should not be considered in isolation or as a substitute for financial information provided in accordance with GAAP. These non-GAAP financial measures may not be computed in the same manner as similarly titled measures used by other companies. Management expects to continue to incur expenses similar to the adjusted income from continuing operations and adjusted EPS financial adjustments described above, and investors should not infer from the company’s presentation of these non-GAAP financial measures that these costs are unusual, infrequent or non-recurring.  

The following table reconciles net loss attributable to common stockholders and diluted earnings per share:

	For the Three Months Ended								For the Six Months Ended
	June 30,								June 30,
	2021				2020				2021				2020
Net income (loss)	$	1,697,122			$	(12,162	)		$	1,738,320			$	(1,108,194	)
Amortization of intangibles		163,901				174,525				327,801				349,051
Stock-based compensation expense		465,336				85,378				903,730				293,139
PPP loan and interest forgiveness		(1,514,354	)			–				(1,514,354	)			–
Non-GAAP net income (loss)	$	812,005			$	247,741			$	1,455,497			$	(466,004	)
Non-GAAP net income (loss) per share:
Basic	$	0.04			$	0.02			$	0.08			$	(0.03	)
Diluted	$	0.04			$	0.01			$	0.08			$	(0.03	)
Weighted average common shares outstanding:
Basic		18,513,620				16,488,325				17,934,022				16,410,660
Diluted		19,735,383				16,867,921				19,305,842				16,410,660

Forward-Looking Statements

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

Media Contact:

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

Investor Relations:

Ronald Both or Justin Lumley
CMA
Tel (949) 432-7557
Email contact

ONE STOP SYSTEMS, INC. (OSS)

UNAUDITED CONSOLIDATED BALANCE SHEETS

	Unaudited
	June 30,				December 31,
	2021				2020
ASSETS
Current assets
Cash and cash equivalents	$	3,975,069			$	6,316,921
Short-term investments		14,524,249				–
Accounts receivable, net		6,527,109				7,458,383
Inventories, net		12,411,490				9,647,504
Prepaid expenses and other current assets		996,801				655,708
Total current assets		38,434,718				24,078,516
Property and equipment, net		3,218,341				3,487,178
Deposits and other		48,155				81,709
Deferred tax assets, net		3,485,709				3,698,593
Goodwill		7,120,510				7,120,510
Intangible assets, net		334,456				662,257
	$	52,641,889			$	39,128,763
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	4,149,482			$	976,420
Accrued expenses and other liabilities		3,036,793				3,481,444
Current portion of notes payable, net of debt discount of $0 and
$2,047, respectively		1,777,715				1,365,204
Current portion of related party notes payable, net of debt discount
of $0 and $6,726, respectively		–				199,943
Current portion of senior secured convertible note, net of debt discounts of $74,458 and $256,242, respectively		2,516,451				1,789,212
Total current liabilities		11,480,441				7,812,223
Senior secured convertible note, net of current portion and debt discounts of $0 and $14,107, respectively		–				531,347
Paycheck protection program note payable		–				1,499,360
Total liabilities		11,480,441				9,842,930
Commitments and contingencies
Stockholders’ equity
Common stock, $.0001 par value; 50,000,000 shares authorized;
18,538,689 and 16,684,424 shares issued and outstanding, respectively		1,854				1,668
Additional paid-in capital		41,037,948				30,758,354
Accumulated other comprehensive income		145,062				287,547
Accumulated deficit		(23,416	)			(1,761,736	)
Total stockholders’ equity		41,161,448				29,285,833
	$	52,641,889			$	39,128,763

ONE STOP SYSTEMS, INC. (OSS)

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

	For the Three Months Ended June 30,								For the Six Months Ended June 30,
	2021				2020				2021				2020
Revenue	$	14,905,009			$	11,625,327			$	28,220,761			$	24,984,964
Cost of revenue		10,252,265				8,300,132				19,135,233				18,264,082
Gross profit		4,652,744				3,325,195				9,085,528				6,720,882
Operating expenses:
General and administrative		1,648,785				1,877,358				3,806,404				4,391,423
Marketing and selling		1,479,292				845,098				2,647,193				2,034,449
Research and development		1,008,017				1,008,625				1,840,250				2,212,050
Total operating expenses		4,136,094				3,731,081				8,293,847				8,637,922
Income (loss) from operations		516,650				(405,886	)			791,681				(1,917,040	)
Other income (expense), net:
Interest income		61,798				99,343				67,098				123,980
Interest expense		(169,031	)			(150,186	)			(319,013	)			(218,970	)
Other income (expense), net		1,522,998				3,056				1,494,369				(4,973	)
Total other income (expense), net		1,415,765				(47,787	)			1,242,454				(99,963	)
Income (loss) before income taxes		1,932,415				(453,673	)			2,034,135				(2,017,003	)
Provision (benefit) for income taxes		235,293				(441,511	)			295,815				(908,809	)
Net income (loss)	$	1,697,122			$	(12,162	)		$	1,738,320			$	(1,108,194	)
Net income (loss) per share:
Basic	$	0.09			$	(0.00	)		$	0.10			$	(0.07	)
Diluted	$	0.09			$	(0.00	)		$	0.09			$	(0.07	)
Weighted average common shares
outstanding:
Basic		18,513,620				16,488,325				17,934,022				16,410,660
Diluted		19,735,383				16,488,325				19,305,842				16,410,660

Received approval from Health Canada to initiate a clinical trial of AT-1501 in kidney transplantation; company expects to initiate trial in Q4 with initial data in late 2022

Reached agreement with the FDA to conduct a preclinical renal transplant study evaluating AT-1501 monotherapy in four non-human primates; launched academic collaboration to conduct the study with data expected mid-2022

Announces plans to develop AT-1501 as a therapy for IgA nephropathy (IgAN), the fourth potential indication for clinical development of AT-1501; company expects to initiate Phase 2 by year-end 2021

Conference call today at 4:30 PM ET

IRVINE, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc., (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today reported its second quarter 2021 operating and financial results.

“We have made significant progress since the announcement in April of our updated development strategy for AT-1501 in renal transplantation,” stated David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Enrollment in our ALS study is progressing well and we anticipate completing enrollment in the 4^th quarter. Separately, we received a No Objection Letter from Health Canada in response to our Clinical Trial Application proposing to initiate a clinical trial evaluating AT-1501, in 6 to 12 subjects, replacing tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation. We believe that replacing tacrolimus as an agent in renal transplantation can reduce immunosuppressive side effects and improve long-term graft survival. We look forward to reporting initial clinical data from the study late next year. In addition, we plan to initiate a preclinical renal transplant study evaluating AT-1501 monotherapy in four non-human primates, as requested by the U.S. Food and Drug Administration, with data expected in mid-2022.”

“In addition to our progress in ALS and renal transplant, we have selected IgA nephropathy as the fourth indication for the clinical development of AT-1501,” said Steven Perrin, Ph.D., President and Chief Scientific Officer of Eledon. “There is strong scientific rationale for this indication, as blocking CD40 ligand has been shown in preclinical studies to slow disease progression and improve renal function in animal models of autoimmune nephritis. We look forward to initiating a Phase 2 trial for this fourth indication in the coming months.”

Second Quarter 2021 and Recent Corporate Developments

• Completion of enrollment in third of four cohorts in the Phase 2 study of AT-1501 in ALS expected shortly with full enrollment of the trial expected to be completed by year end 2021.
• Received clearance from Health Canada in response to Clinical Trial Application to initiate a clinical trial of AT-1501 for the prevention of kidney transplant rejection.
• Reached agreement on the design of an FDA-requested preclinical renal transplant study in non-human primates (n = 4) evaluating AT-1501 monotherapy and launched academic collaboration to conduct the study.
• Announced selection of IgA nephropathy (IgAN) as fourth indication for clinical development of AT-1501.
• Presented two posters and two oral presentations at the American Society of Transplantation annual meeting held in June.
• Appointed leading immunology and rheumatology expert Dr. Jan Hillson to its Board of Directors.

Upcoming Anticipated Milestones

• Presentation at the International Pancreas and Islet Transplantation World Congress annual meeting, which is being held virtually October 20-23, 2021.
• Q4 2021: initiation of non-human primate renal transplant study of AT-1501 monotherapy.
• Q4 2021: initiation of clinical trial of AT-1501 for the prevention of kidney transplant rejection.
• Q4 2021: initiation of clinical trial of AT-1501 in IgAN.
• H1 2022: topline data from Phase 2 trial of AT-1501 in ALS.
• H1 2022: initial data from Phase 2 trial of AT-1501 in islet cell transplantation.
• Mid-2022: completion of non-human primate renal transplant study of AT-1501 monotherapy.
• Late 2022: initial data from clinical trial of AT-1501 in kidney transplantation.

Financial Results for the Three Months Ended June 30, 2021

• The company reported a net loss of $7.4 million, or $0.50 per share, for the three months ended June 30, 2021, compared to a net loss of $2.6 million, or $2.74 per share, for the same period in 2020.
• Research and development expenses were $4.2 million for the three months ended June 30, 2021, compared to $0.8 million for the comparable period in 2020, an increase of $3.4 million. The increase in research and development spend primarily reflects clinical and formulation costs associated with increased activity for our lead asset AT-1501.
• General and administrative expenses were $3.7 million for the three months ended June 30, 2021, compared to $1.3 million for the comparable period in 2020, an increase of $2.4 million. The increase in general and administrative spend primarily reflects increased personnel and stock-based costs, legal and other professional fees. 
• The company had approximately $101.1 million in cash and cash equivalents as of June 30, 2021, compared to $114.2 million in cash and cash equivalents as of December 31, 2020. The Company believes that it has sufficient financial resources to fund operations as currently planned well into 2023.

Conference Call

Eledon will hold a conference call today, August 12, 2021, at 4:30 pm Eastern Time to discuss second quarter results. The dial-in numbers are 877-407-9039 for domestic callers and 201-689-8470 for international callers. The conference ID is 13720793. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

About Eledon Pharmaceuticals and AT-1501

Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for patients living with an autoimmune disease, patients requiring an organ or cell-based transplant, and for patients living with ALS. The company’s lead compound in development is AT-1501, an anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential. AT-1501 is a humanized IgG1 antibody engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches. The CD40L/CD40 pathway is widely recognized for its prominent role in immune regulation. CD40L is primarily expressed on activated CD4⁺ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen presenting cells such as B cells, macrophages, and dendritic cells. By blocking CD40L and not the CD40 receptor, AT-1501 inhibits both the CD40 and CD11 costimulatory signaling pathways, providing the potential for improved efficacy compared to anti-CD40 receptor approaches. Blocking CD40L also increases polarization of CD4⁺ lymphocytes to Tregs, a specialized subpopulation of T cells that act to suppress an immune response, thus creating a more tolerogenic environment, which may also play a therapeutic role for autoimmune diseases and in the transplant setting. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: @Eledon_Pharma and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about a planned clinical trial in kidney transplant patients, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Corey Davis, Ph.D.
LifeSci Advisors, LLC
[email protected] 
212.915.2577

Source: Eledon Pharmaceuticals

PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited)
		June 30, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents		$	101,133			$	114,195
Prepaid expenses and other current assets			1,449				1,435
Total current assets			102,582				115,630
Operating lease asset, net			267				138
Goodwill			48,648				48,648
In-process research and development			32,386				32,386
Other assets			422				383
Total assets		$	184,305			$	197,185
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	857			$	1,366
Current operating lease liability			179				144
Accrued expenses and other liabilities			1,641				973
Total current liabilities			2,677				2,483
Deferred tax liabilities			3,017				4,106
Non-current operating lease liability			90				—
Total liabilities			5,784				6,589
Commitments and contingencies (Note 5)
Stockholders’ equity:
Series X1 non-voting convertible preferred stock, $0.001 par value, 515,000 shares
authorized; 108,070 shares issued and outstanding at June 30, 2021 and December 31, 2020			—				—
Series X preferred stock, $0.001 par value, 10,000 shares authorized; 6,204 and no shares
issued and outstanding at June 30, 2021 and December 31, 2020, respectively			—				—
Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2021
and December 31, 2020; 14,306,614 and 15,160,397 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively			14				15
Additional paid-in capital			274,783				270,974
Accumulated deficit			(96,276	)			(80,393	)
Total stockholders’ equity			178,521				190,596
Total liabilities and stockholders’ equity		$	184,305			$	197,185

ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) (Unaudited)
		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2021				2020				2021				2020
Operating expenses
Research and development		$	4,242			$	832			$	9,895			$	2,480
General and administrative			3,729				1,269				7,081				2,999
Restructuring expense			—				490				—				490
Total operating expenses			7,971				2,591				16,976				5,969
Loss from operations			(7,971	)			(2,591	)			(16,976	)			(5,969	)
Other income (expense), net			(1	)			5				4				35
Warrant inducement expense			—				—				—				(4,829	)
Loss before income tax benefit			(7,972	)			(2,586	)			(16,972	)			(10,763	)
Income tax benefit			588				—				1,089				—
Net loss and comprehensive loss		$	(7,384	)		$	(2,586	)		$	(15,883	)		$	(10,763	)
Net loss per share, basic and diluted		$	(0.50	)		$	(2.74	)		$	(1.07	)		$	(11.31	)
Weighted-average common shares outstanding,
basic and diluted			14,815,731				943,419				14,823,348				951,352

 

CAP-1002 – Capricor’s Cell Therapy Program for Duchenne Muscular Dystrophy


-Phase III Trial Protocol Submitted to FDA Following FDA Guidance-
-Commencing Start-Up Activities for Pivotal Trial-
-Phase II, HOPE-2 Final Data Submitted for Publication-

CAP-1002 – Capricor’s Cell Therapy Program for COVID-19


-Phase II INSPIRE Trial Enrollment Nearing Completion-

Capricor’s Exosomes Platform Technology


-Positioning Multivalent Exosome-mRNA Vaccine as Booster to Currently Available Vaccines-
-Completing Non-Clinical Studies for IND Submission-

-To Host Conference Call and Webcast Today at 4:30 p.m. ET-

LOS ANGELES, Aug. 12, 2021 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, today reported its financial results for the second quarter ended June 30, 2021, and provided an overview of its recent operational highlights. Management will host a webcast and conference call at 4:30 p.m. Eastern Time today.

“This has been a productive quarter for Capricor and I am pleased to report our progress across the organization as we have a busy back half of 2021 planned. We now have a clear path forward with CAP-1002 for DMD as we prepare to initiate a pivotal study later this year. The final data has been submitted for publication which shows that CAP-1002 has a significant impact on skeletal and cardiac muscle function in late-stage DMD patients, which we believe will further support the clinical path to potential approval. The positive momentum of this program has continued to advance our partnering discussions. Additionally, we have made progress in our exosome program, by expanding our team with seasoned biotechnology leaders who bring a wealth of experience in engineering exosomes for therapeutic use. We are now moving our multivalent exosome-mRNA vaccine towards the clinic, designed to be a booster to currently available vaccines. We believe that this multiple protein approach could potentially confer greater immune protection against variants of SARS-CoV-2,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Lastly, we have seen enrollment of our INSPIRE clinical trial for treating severe COVID-19 patients increase with the emerging prevalence of the Delta variant and we look forward to sharing top-line data in the near future.”

Second Quarter 2021 Highlights and Recent Corporate Developments:

• Completed an end-of-phase-II meeting with FDA and planning to move forward with start-up activities for a Phase III pivotal trial for CAP-1002 for the treatment of DMD.
• Completed GLP toxicology study and are nearing completion of IND-enabling studies for multivalent exosome-mRNA vaccine candidate.
• Presented preliminary findings from HOPE-2 open-label extension study in DMD at Parent Project Muscular Dystrophy (PPMD) 2021 Virtual Annual Conference
  • Presented comparative video of clinical subject improvement in patient that received CAP-1002
• Signed exclusive, worldwide licensing agreement with Johns Hopkins University to include engineered exosomes for vaccines and therapeutics as part of the Company’s exosome technology portfolio
• Appointed Karimah Es Sabar to its Board of Directors
  • Ms. Es Sabar brings over 35 years of biopharma leadership, drug development, venture investing and transactional experience to Capricor’s Board. She has extensive work experience and knowledge from biotech, specifically in the vaccine space as well as pharmaceuticals and the financial industry.
• Publication in conjunction with the US Army Institute of Surgical Research for Cardiosphere Derived Exosomes as a Potential Therapeutic for Shock
  • The preclinical data demonstrates Capricor’s exosome product as an antishock therapeutic, if delivered early. This further supports Capricor’s exosome platform advancement.
• Presented preclinical data for multivalent exosome-mRNA vaccine for SARS-CoV-2 at the International Society for Extracellular Vesicles (ISEV) Annual Meeting
  • The data demonstrated that Capricor’s exosome-based, multivalent mRNA vaccine elicited long-lasting cellular and humoral responses to both the N and S proteins. The data further supports new, tailored and targeted therapeutic approaches to a variety of diseases and disorders.
• Presented at the American Society of Gene and Cell Therapy’s (ASGCT) 24^th annual meeting

Financial Results for Second Quarter 2021

Revenues in conjunction with collaborations and grants: Capricor’s primary sources of revenues were from collaborative payments received from clinical trial arrangements and grant awards. For the three months ended June 30, 2021, the Company reported revenue of approximately $200,000 compared with approximately $50,000 for the three months ended June 30, 2020.

Operating expenses: Total operating expenses for the three months ended June 30, 2021, were approximately $5.3 million compared with approximately $3.5 million for the three months ended June 30, 2020.

The Company reported a net loss of approximately $4.7 million, or $0.21 per share, for the three months ended June 30, 2021, compared to a net loss of approximately $3.5 million, or $0.23 per share, for the three months ended June 30, 2020.

The Company’s cash and cash equivalents balance totaled approximately $38.1 million as of June 30, 2021, compared to approximately $32.7 million on December 31, 2020. Additionally, in the second quarter of 2021, Capricor raised approximately $1.0 million in net proceeds through issuances of common stock at an average price of approximately $5.41 per share under its at-the-market offering program.

Based on our current pipeline and operating plan, the Company’s cash position is expected to be sufficient to support operations for at least two years.

Conference Call: Thursday, August 12, 2021 at 4:30 p.m. ET

Domestic:	866-269-4264
International:	929-477-0577
Conference ID:	1169561
Webcast:	http://public.viavid.com/index.php?id=146080

The webcast will be archived for approximately 30 days and will be available at http://capricor.com/news/events/.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on developing transformative cell- and exosome-based therapeutics and vaccines for treating and preventing a broad spectrum of diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in clinical development for treating Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also developing its exosome technology as a next-generation therapeutic platform. The Company’s current focus is on developing exosomes loaded with nucleic acids, including mRNA, to treat or prevent a variety of diseases.

For more information, visit www.capricor.com, and follow the Company on Facebook, Instagram and Twitter.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the Securities and Exchange Commission on March 15, 2021 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 as filed with the Securities and Exchange Commission on May 14, 2021. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.

For more information, please contact:

Media Contact:

Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
[email protected] / [email protected]
212.896.1241 / 212.896.1204

Investor Contact:

Joyce Allaire
LifeSci Advisors, LLC
[email protected]
617.435.6602

Company Contact:

AJ Bergmann, Chief Financial Officer
[email protected]
310.358.3200

CAPRICOR THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

		Three months ended June 30,								Six months ended June 30,
			2021				2020				2021				2020
REVENUE
Revenue		$	204,082			$	49,864			$	244,898			$	235,557
TOTAL REVENUE			204,082				49,864				244,898				235,557
OPERATING EXPENSES
Research and development			3,497,275				1,927,473				6,793,597				3,082,629
General and administrative			1,789,974				1,610,237				3,695,556				2,748,282
TOTAL OPERATING EXPENSES			5,287,249				3,537,710				10,489,153				5,830,911
LOSS FROM OPERATIONS			(5,083,167	)			(3,487,846	)			(10,244,255	)			(5,595,354	)
OTHER INCOME (EXPENSE)
Investment income			16,741				3,692				25,906				26,382
Forgiveness of debt			318,160				—				318,160				—
TOTAL OTHER INCOME (EXPENSE)			334,901				3,692				344,066				26,382
NET LOSS			(4,748,266	)			(3,484,154	)			(9,900,189	)			(5,568,972	)
OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain on marketable securities			—				—				—				757
COMPREHENSIVE LOSS		$	(4,748,266	)		$	(3,484,154	)		$	(9,900,189	)		$	(5,568,215	)
Net loss per share, basic and diluted		$	(0.21	)		$	(0.23	)		$	(0.44	)		$	(0.51	)
Weighted average number of shares, basic and diluted			22,861,051				15,130,685				22,546,634				11,004,733

CAPRICOR THERAPEUTICS, INC.

SUMMARY BALANCE SHEETS

		June 30, 2021 (unaudited)				December 31, 2020
Cash, cash equivalents		$	38,077,964			$	32,665,874
Total assets		$	39,930,052			$	34,618,796
Total liabilities		$	6,549,922			$	6,419,012
Total stockholders’ equity – 22,998,434 and 20,577,123 common shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively			33,380,130				28,199,784
Total liabilities and stockholders’ equity		$	39,930,052			$	34,618,796

Announced successful completion of the validation study PRO-104 for the Preecludia™
 rule out test for preeclampsia and achievement of the primary endpoint of the study protocol

Recently achieved promising results with the prototype autonomous Oral Biotherapeutics Delivery System in a single oral dose study in a porcine model for lead candidate PGN-OB1

Implemented cost-cutting measures expected to result in approximately $97 million of cost savings on an annual run-rate basis

Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

SAN DIEGO, Aug. 12, 2021 (GLOBE NEWSWIRE) — Progenity, Inc. (Nasdaq: PROG), a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics, today provided a corporate update and reported financial results for the second quarter ended June 30, 2021.

In the second quarter Progenity initiated a strategic transformation directed at significantly reducing its cash burn rate whilst accelerating its transition to an innovation-led biotech company focused on its oral delivery of biomolecules and its GI-IBD platforms. The company has implemented cost-cutting measures that are expected to result in cost savings of approximately $97 million on an annual run-rate basis, and it plans to continue to evaluate and implement further cost-saving measures.

The company also recently announced the successful completion of the validation study, PRO-104, for its Preecludia™ rule out test for preeclampsia. Importantly, Preecludia™ achieved the primary endpoint of the study protocol and demonstrated strong performance consistent with what was achieved in the PRO-129 verification study and pre-validation set.

Separately, during the second quarter the company initiated preclinical studies of its lead candidates PGN-OB1 (adalimumab a monoclonal) and PGN-OB2 (liraglutide, a GLP 1 agonist) utilizing for the first time its prototype autonomous Oral Biotherapeutics Delivery System (OBDS) in a swine model. Data from a recent study demonstrated that, in animals with significant drug detected, average bioavailability levels were approximately 15% with maximum levels up to 44% of IV for adalimumab following a single dose, highlighting the vast potential for this program.

“Our GI innovation pipeline is progressing with both the Oral Biotherapeutics Delivery System and the Drug Delivery System now available as fully autonomous prototype devices that will enable key studies to be performed to advance our programs and provide potential partnership opportunities. I’m also excited by the successful outcome for the Preecludia™ PRO-104 validation study results, which we expect the independent PIs to publish soon, and we are making good progress with our single molecule platform. I’m also pleased with the implementation and execution of our company transformation with substantial costs savings already being achieved and with more anticipated in the coming months. We are projecting multiple key catalysts in the next quarter and beyond, and we look forward to sharing those results in the near future,” said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity.

Second Quarter 2021 Results and Other Corporate Highlights

• Successful completion of the validation study for the Preecludia™ rule-out test for preeclampsia. Achieved the primary endpoint of the study protocol. Demonstrated strong performance and a high NPV consistent with what was achieved in the PRO-129 verification study and pre-validation set.
• Completed closure of Ann Arbor laboratory and refocus of resources toward innovation pipeline. Operating expenses reduction plan is on track to achieve target.
• Initiated preclinical studies of PGN-OB1 (adalimumab + OBDS) and PGN-OB2 (GLP 1 agonist + OBDS). Initial data is promising with average bioavailability of approximately 15% in animals where significant drug was detected, and reaching up to 44%. Existing pharma partnerships advancing as expected.
• Announced the formation of its Inflammatory Bowel Disease Clinical Advisory Board. The advisory board includes respected researchers and clinicians who are thought leaders in the research and treatment of inflammatory bowel disease (IBD).
• Ongoing clinical study in ulcerative colitis patients using adalimumab delivered by enema as proxy for PGN-001 (adalimumab + Drug Delivery System (DDS)). First four subjects have completed dosage regimen with promising initial results Clinical advisory board to meet next month to review data and help finalize design of the first human feasibility study delivering Humira with the DDS.
• Announced the appointment of Surbhi Sarna to its board of directors effective July 1, 2021. Ms. Sarna’s medical device experience and her focus on development of strategic partnerships will prove valuable as the company advances its innovation pipeline.
• In June 2021, raised approximately $40.0 million in gross proceeds from a private placement with two leading healthcare-focused investment funds.

Second Quarter 2021 Financial Results

Comparison of Three Months Ended June 30, 2021 and March 31, 2021

Operating expenses were $36.1 million for the three months ended June 30, 2021, compared to $31.6 million for the three months ended March 31, 2021.

Net loss was $78.5 million for the three months ended June 30, 2021 and net loss per share was $1.23, compared to a net loss of $32.3 million and a net loss per share of $0.56 for the three months ended March 31, 2021.

Net loss from discontinued operations was $37.1 million for the three months ended June 30, 2021 and net loss per share for discontinued operations was $0.58, compared to a net loss from discontinued operations of $14.8 million and a net loss per share of $0.26 for the three months ended March 31, 2021.

Comparison of Three Months Ended June 30, 2021 and 2020

Operating expenses were $36.1 million for the three months ended June 30, 2021, compared to $26.5 million for the three months ended June 30, 2020.

Net loss was $78.5 million for the three months ended June 30, 2021 and net loss per share was $1.23, compared to a net loss of $53.1 million and a net loss per share of $6.11 for the three months ended June 30, 2020.

Net loss from discontinued operations was $37.1 million for the three months ended June 30, 2021 and net loss per share for discontinued operations was $0.58, compared to a net loss from discontinued operations of $20.1 million and a net loss per share of $2.31 for the three months ended June 30, 2020.

Webcast and Conference Call Information

Progenity will host a webcast and conference call to discuss the second quarter financial results and answer investment community questions today, Thursday, August 12, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 8635609. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

About Progenity

Progenity, Inc. is a biotechnology company innovating in the fields of women’s health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity’s vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company’s website at www.progenity.com.

Safe Harbor Statement or Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to develop and commercialize our testing products, our ability to innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding future test volumes and revenues, our expectations regarding our in network position, anticipated capacity for our tests, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Progenity’s Annual Report on Form 10-K for the period ended December 31, 2020 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.

Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:

Robert Uhl
Managing Director, Westwicke ICR
[email protected]
(619) 228-5886

Media Contact:

Kate Blom-Lowery
CG Life
[email protected]
(858) 457-2436

Progenity, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)


(In thousands, except share and per share amounts)

		Three Months Ended
		June 30, 2021				March 31, 2021
Revenues		$	463			$	167
Cost of sales			—				—
Gross profit			463				167
Operating expenses:
Research and development			13,401				11,673
Selling and marketing			2,006				1,858
General and administrative			20,709				18,100
Total operating expenses			36,116				31,631
Loss from operations			(35,653	)			(31,464	)
Interest expense			(3,502	)			(3,520	)
(Loss) gain on warrant liability			(5,146	)			2,650
Interest and other income, net			2,901				14,873
Loss from continuing operations			(41,400	)			(17,461	)
Loss from discontinued operations			(37,131	)			(14,803	)
Net loss		$	(78,531	)		$	(32,264	)
Net loss per share from continuing operations, basic and diluted		$	(0.65	)		$	(0.30	)
Net loss per share from discontinued operations, basic and diluted		$	(0.58	)		$	(0.26	)
Net loss per share, basic and diluted		$	(1.23	)		$	(0.56	)
Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted			63,942,298				57,493,800

Progenity, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)


(In thousands, except share and per share amounts)

		Three Months Ended June 30,
		2021				2020
Revenues		$	463			$	—
Cost of Sales			—				—
Gross profit			463				—
Operating Expenses:
Research and development			13,401				12,234
Selling and marketing			2,006				1,547
General and administrative			20,709				12,702
Total operating expenses			36,116				26,483
Loss from operations			(35,653	)			(26,483	)
Interest expense			(3,502	)			(2,489	)
Loss on warrant liability			(5,146	)			—
Interest and other income (expense), net			2,901				(3,751	)
Loss from continuing operations			(41,400	)			(32,723	)
Loss from discontinued operations			(37,131	)			(20,060	)
Net loss			(78,531	)			(52,783	)
Dividend paid to preferred shareholders			—				(268	)
Net loss attributable to common stockholders		$	(78,531	)		$	(53,051	)
Net loss per share from continuing operations, basic and diluted		$	(0.65	)		$	(3.77	)
Net loss per share from discontinued operations, basic and diluted		$	(0.58	)		$	(2.31	)
Net loss per share attributable to common stockholders, basic and diluted		$	(1.23	)		$	(6.11	)
Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted			63,942,298				8,687,250

Progenity, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)


(In thousands)

		June 30, 2021				December 31, 2020
						(1)
Assets
Current assets:
Cash and cash equivalents		$	65,991			$	91,520
Accounts receivable, net			5,047				6,634
Prepaid expenses and other current assets			13,107				8,107
Current assets of disposal group held for sale			30,181				20,077
Total current assets			114,326				126,338
Property and equipment, net			5,474				8,660
Other assets			146				169
Long-term assets of disposal group held for sale			—				19,273
Total assets		$	119,946			$	154,440
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable		$	14,560			$	12,657
Accrued expenses and other current liabilities			58,172				51,206
Current portion of mortgages payable and capital lease obligations			202				338
Current liabilities of disposal group held for sale			12,703				8,469
Total current liabilities			85,637				72,670
Mortgages payable and capital lease obligations, net of current portion			1,238				1,317
Convertible notes, net			157,533				158,886
Embedded derivative liability			388				18,370
Other long-term liabilities			14,759				8,239
Long-term liabilities of disposal group held for sale			—				1,952
Total liabilities		$	259,555			$	261,434
Stockholders’ deficit:
Common stock			82				59
Additional paid-in capital			531,156				452,992
Accumulated deficit			(652,069	)			(541,274	)
Treasury stock			(18,778	)			(18,771	)
Total stockholders’ deficit			(139,609	)			(106,994	)
Total liabilities and stockholders’ deficit		$	119,946			$	154,440

1. The condensed consolidated balance sheet data at December 31, 2020 has been derived from the audited consolidated financial statements, with adjustments to reflect the assets and liabilities held for sale.

EMERYVILLE, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) — Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health,” “Lucira” or the “Company”), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, today reported financial results for the second quarter ended June 30, 2021.

Recent Highlights

• Recorded record-high revenue of $12.4 million for the second quarter of 2021, representing 175% sequential growth from the previous quarter of 2021
• Commenced sale of LUCIRA CHECK IT COVID-19 Test Kit through OTC channels, which does not require a physician’s prescription
• International demand fueled by OTC indication
• New production center in the Dominican Republic became operational, and steps are underway to reach full manufacturing capacity
• LUCIRA CHECK IT COVID-19 Test Kit detects all current variants highlighted by the Centers of Disease Control and the World Health Organization, including the Delta variant

“We are excited that we are continuing to generate strong growth across all areas of the business,” said Erik Engelson, President and Chief Executive Officer of Lucira Health. “Our record-high quarterly revenue is a testament to our product and the strategic foundation that we have built. As the OTC EUA authorization for our LUCIRA CHECK IT COVID-19 Test Kit propelled sales, we continued to forge strategic partnerships, such as our relationship with Meenta which customized a workflow for the LUCIRA All-IN-ONE Test Kit, that was utilized by athletes and individuals traveling to Japan in the summer of 2021 and more recently, AZOVA, which negotiated authorization to sell the LUCIRA CHECK IT Test Kit with AZOVA’s video observation services for travel to Hawaii. We have also invested in establishing an infrastructure to support the accelerating demand for our test kits. We look forward to continuing to establish ourselves as market leaders in the at-home testing space in the second half of 2021 and beyond.”

Second Quarter 2021 Financial Results

The second quarter of 2021 represented Lucira’s second full quarter of commercial activity.

Net Revenue was $12.4 million for the second quarter of 2021. Net revenue was primarily driven by increased volume of LUCIRA CHECK IT COVID-19 Test Kit sales through the OTC indication, increased customer contracts, and international demand.

GAAP Gross Loss was approximately $70 thousand for the second quarter of 2021 or negative 1% of revenue. Non-GAAP gross profit and non-GAAP gross margin were $0.3 million and 3%, respectively. Gross loss and negative gross margin were primarily due to increased manufacturing production.

GAAP Operating Expenses were $16.2 million in the second quarter of 2021, compared to $5.5 million in the same period in 2020. Non-GAAP operating expenses were $15.1 million in the second quarter of 2021, compared to $5.4 million in the same period of 2020. The increase is primarily related to increased headcount and third-party services to facilitate commercial launch, validation of manufacturing activities, new product development, clinical studies, and public company compliance.

GAAP Net Loss was $16.2 million in the second quarter of 2021, compared to $6.6 million in the same period in 2020. Non-GAAP net loss was $14.7 million for the second quarter of 2021, compared to a non-GAAP net loss of $5.1 million for the same period in 2020.

Cash Balance as of June 30, 2021 was $161.7 million.

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Thursday, August 12, 2021, at 4:30 PM ET.

To participate in the call, please dial (833) 562-0151 (domestic) or (661) 567-1232 (international) and provide conference ID 4241018. A live and archived webcast of the event can be accessed through the following link ir.lucirahealth.com.

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. Lucira’s testing platform produces PCR quality molecular testing in a single-use, consumer-friendly, palm size test kit powered by two AA batteries. Lucira designed its test kits to provide accurate, reliable and on-the-spot molecular tests results anywhere and anytime. The LUCIRA CHECK IT COVID-19 Test Kits (OTC) and LUCIRA COVID-19 All-In-One Test Kits (Rx) provide PCR quality clinically relevant COVID-19 result within 30 minutes from sample collection. Lucira’s CHECK IT (OTC) also provides a SMS verified digital LUCI PASS test result back to a user’s phone for work, travel and other places where negative test verification may be required. For more information, visit www.lucirahealth.com.

Non-GAAP Financial Measures

In this press release, in order to supplement the Company’s condensed financial statements presented in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), management has disclosed certain non-GAAP financial measures for the Company’s statement of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance because Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP financial measures include gross loss, gross margin, operating expenses and net loss. Non-GAAP adjustments include stock-based compensation, depreciation and amortization, non-cash interest and other expense and preapproval inventories. From time to time in the future, there may be other items that the Company may include or exclude if the Company believes that doing so is consistent with the goal of providing useful information to investors and management. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure.

Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company’s non-GAAP financial measures as tools for comparison. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. The Company has provided at the end of this press release, following the accompanying financial data, reconciliations of its non-GAAP measures to their most directly comparable GAAP measures. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company’s business. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude the following:

Stock-based compensation expense. The Company has excluded the effect of stock-based compensation expenses in calculating the Company’s non-GAAP gross loss, operating expenses and net loss measures. Although stock-based compensation is a key incentive offered to employees, consultants and board members the Company continues to evaluate its business performance excluding stock-based compensation expenses. The Company records stock-based compensation expense related to grants of time-based options and restricted stock units. Depending upon the size, timing and terms of the grants, as well as the probability of achievement of performance-based awards, this expense may vary significantly but will recur in future periods. The Company believes that excluding stock-based compensation expense better allows for comparisons from period to period.

Depreciation and amortization. The Company has excluded depreciation and amortization expense in calculating its non-GAAP gross loss, operating expenses and net loss measures. Depreciation and amortization are non-cash charges to current operations.

Non-cash interest and other expense. The Company has excluded the effect of non-cash interest and remeasurement of derivative liabilities and convertible notes in calculating its non-GAAP net loss measure.

Preapproval inventories. The Company has included the effect of preapproval inventories. Preapproval inventories were previously recorded as research and development expense during the third quarter of 2020 and subsequently sold at zero cost of product and internally consumed in research and development and sales and marketing from the fourth quarter of 2020 through the second quarter of 2021.

Caution Regarding Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “believe,” “expect,” “continue,” “forecast,” “plan,” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of Lucira’s management. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, without limitation, our expectations around production capacity and our plans to gain market share and accelerate revenue growth. Important factors that could cause actual results to differ materially include: the evolution of the ongoing COVID-19 pandemic, including any impact on the demand for our products due to an increased vaccinated population or our manufacturing and supply chain; our ability to achieve or sustain profitability; our ability to gain market acceptance for our products and to accurately forecast and meet customer demand; our ability to compete successfully; our ability to enhance our product offerings; development and manufacturing problems, including capacity constraints or delays in production of our products; maintenance of coverage and adequate reimbursement for procedures using our products; and product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to updates forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Media Relations

Kevin Knight
[email protected]
206-451-4823

Investor Relations

Greg Chodaczek
[email protected]
347-620-7010

Lucira Health, Inc.

Condensed Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

		June 30,				December 31,
			2021				2020
Assets
Current assets:
Cash		$	161,662			$	58,212
Accounts receivable, net			3,392				293
Inventory			36,182				4,865
Grant income receivable			92				183
Prepaid expenses			6,164				3,496
Other current assets			6,099				844
Restricted cash equivalents			2,338				2,338
Total current assets			215,929				70,231
Property and equipment, net			28,153				19,408
Operating lease right-of-use assets			576				748
Other assets			31				2,316
Total assets		$	244,689			$	92,703
Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable		$	6,673			$	3,981
Accrued liabilities			18,672				4,445
Operating lease liabilities, current			374				431
Customer deposits			2,916				—
Total current liabilities			28,635				8,857
Convertible notes payable			—				24,694
Operating lease liabilities, net of current portion			254				380
Total liabilities			28,889				33,931
Commitments and contingencies
Redeemable convertible preferred stock $0.001 par value; 0 and 103,355,827 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 0 and 23,978,747 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively; aggregate liquidation preference of $0 as of June 30, 2021			—				121,080
Stockholders’ equity (deficit):
Preferred stock $0.001 par value; 10,000,000 and 0 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 0 shares issued and outstanding as of June 30, 2021 and December 31, 2020			—				—
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares authorized as of June 30, 2021 and December 31, 2020, respectively; 38,684,546 and 2,712,694 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively			39				3
Additional paid-in capital			308,991				1,403
Accumulated deficit			(93,230	)			(63,714	)
Total stockholders’ equity (deficit)			215,800				(62,308	)
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)		$	244,689			$	92,703

Lucira Health, Inc.

Condensed Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

		Three Months Ended June 30,								Six Months Ended June 30,
			2021				2020				2021				2020
Net sales		$	12,439			$	—			$	16,955			$	—
Cost of products sold			12,505				—				17,873				—
Gross loss			(66	)			—				(918	)			—
Operating expenses:
Research and development			10,117				4,574				16,399				7,315
Selling, general and administrative			6,100				931				12,200				1,559
Total operating expenses			16,217				5,505				28,599				8,874
Loss from operations			(16,283	)			(5,505	)			(29,517	)			(8,874	)
Other income (expense), net:
Grant income			79				335				281				1,977
Interest income (expense)			4				(10	)			1				(10	)
Remeasurement of derivative liabilities and convertible notes			—				(1,444	)			(281	)			(1,444	)
Total other income (expense), net			83				(1,119	)			1				523
Net loss		$	(16,200	)		$	(6,624	)		$	(29,516	)		$	(8,351	)
Net loss per share of common stock, basic and diluted		$	(0.42	)		$	(2.90	)		$	(0.96	)		$	(3.68	)
Weighted-average number of shares used in net loss per share of common stock, basic and diluted			38,483,766				2,282,024				30,688,349				2,270,130

Reconciliation of GAAP to Non-GAAP Financial Measures

The following table represents the reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures:
(In thousands)
(Unaudited)

		Three Months Ended June 30,								Six Months Ended June 30,
			2021				2020				2021				2020
Reconciliation of GAAP to non-GAAP Gross Profit (Loss):
GAAP Gross Loss		$	(66	)		$	—			$	(918	)		$	—
Less: Stock-based compensation expense			208				—				269				—
Less: Depreciation and amortization			268				—				335				—
Add: Preappoval inventories			(87	)			—				(1,089	)			—
Non-GAAP Gross profit (loss)		$	323			$	—			$	(1,403	)		$	—
		Three Months Ended June 30,								Six Months Ended June 30,
			2021				2020				2021				2020
Reconciliation of GAAP to non-GAAP Gross margin
GAAP Negative Gross margin			-1	%			–	%			-5	%			–	%
Less: Stock-based compensation expense			2	%			–				2	%			–
Less: Depreciation and amortization			2	%			–				2	%			–
Add: Preappoval Inventories			-1	%			–				-6	%			–
Non-GAAP Gross (negative) margin			3	%			–	%			-8	%			–	%
		Three Months Ended June 30,								Six Months Ended June 30,
			2021				2020				2021				2020
Reconciliation of GAAP to non-GAAP Operating expenses:
GAAP Operating expenses		$	16,217			$	5,505			$	28,599			$	8,874
Less: Stock-based compensation expense			(737	)			(59	)			(1,203	)			(117	)
Less: Depreciation and amortization			(408	)			(46	)			(548	)			(118	)
Add: Preappoval inventories			—				—				305				—
Non-GAAP Operating expenses		$	15,072			$	5,400			$	27,154			$	8,640
		Three Months Ended June 30,								Six Months Ended June 30,
			2021				2020				2021				2020
Reconciliation of GAAP to non-GAAP Net loss:
GAAP Net loss		$	(16,200	)		$	(6,624	)		$	(29,516	)		$	(8,351	)
Add: Stock-based compensation expense			945				59				1,472				117
Add: Depreciation and amortization			676				46				882				118
Add: Non-cash interest and other expense			(4	)			1,454				280				1,454
Less: Preapproval inventories			(87	)			—				(1,394	)			—
Non-GAAP Net loss		$	(14,670	)		$	(5,065	)		$	(28,276	)		$	(6,663	)

Additional Data Readouts and Initiation of Pivotal Trials for Inhaled Tacrolimus and Voriconazole Programs Expected in 2H 2021

Multiple Ascending Dose (MAD) Study Demonstrates Inhaled Tacrolimus Inhalation Powder Achieves Blood Levels Sufficient for Efficacious Immunosuppression

Formation of Scientific Advisory Board to Enable Continued Innovation and Clinical Development

Partnerships with Pharma, Academic Institutions and Government Continue to Advance

Conference Call and Webcast Scheduled Today, Thursday, August 12, 2021, 
at 4:30pm EDT

AUSTIN, Texas, Aug. 12, 2021 (GLOBE NEWSWIRE) — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the second quarter ended June 30, 2021, and also provided an update on recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference call and webcast, scheduled today, Thursday, August 12, 2021, at 4:30pm EDT.

“As we advance both our internal programs and external partnerships, TFF Pharmaceuticals continues to demonstrate the transformative potential of our proprietary Thin Film Freezing (TFF) drug delivery platform to improve upon pharmacokinetic and clinical profiles of currently approved therapies, while also formulating novel small molecule and biologic-based therapeutics that address serious unmet medical need,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals.

“During this quarter, we announced data from a multiple ascending dosing study showing that our Inhaled Tacrolimus Powder has superior bioavailability as compared to the oral dosage form of tacrolimus, and that relatively low doses as compared to the oral dosage form were able to generate blood concentration levels of tacrolimus known to be sufficiently immunosuppressive in preventing organ rejection following lung transplants. Our toxicology studies demonstrated that the lung concentrations are three- to four-fold higher than blood concentrations and together these data suggest that we can achieve sufficient drug levels in the lung to prevent rejection, while at the same time, mitigating the potential for renal toxicity. We believe this improved pharmacokinetic profile could result in superior safety compared to the oral product without sacrificing efficacy.”

Mr. Mattes continued, “I am also pleased to report that our internal CMC and drug manufacturing projects remain on track to fully support our product supply needs for our planned pivotal trials for Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder. Our TFF-TAC program represents a potential significant advancement in a field that has seen very little innovation in decades, and we look forward to presenting additional data for this program later in the year.”

“We are also excited to announce significant advances on the partnering front. Most recently, TFF and its partner, Augmenta Bioworks, announced the selection of a lead monoclonal antibody, AUG-3387, which is being developed for the prevention and treatment of COVID-19 and, importantly, has been shown to effectively neutralize the Delta variant in in vitro studies. The relationship with Augmenta is a prime example of how our Company’s Thin Film Freezing technology can be applied to proprietary, biologic-based therapeutics addressing a large unmet medical need in public health. This remains a highly active area of collaboration and partnerships for our company, as we now have in place several programs focused on the application of our TFF technology to biologic drugs.”

Importantly, all of our pharmaceutical company partnerships continue to advance, which include collaborations with Union Therapeutics Felix Therapeutics, GreenLight Biosciences, NeuroRx, PLUS Products, and Felix Biotechnology. In addition, we currently have ongoing projects with the majority of the top 20 pharmaceutical companies, where we are applying our thin film freezing technology to their products, and in some cases, working on multiple product formulation opportunities for individual companies. In addition, our academic and government partnerships and contracts are progressing and producing meaningful new data.”

“Results in the second half should further advance preclinical and clinical progress on both internal and partnered programs as well as generate material new business development opportunities. We believe these anticipated results will reinforce the applicability of TFF’s proprietary technology for the use in improving human health across a number of therapeutic areas.”

He continued, “As a result of our continued progress across these programs, we have also made key leadership appointments to support both our manufacturing operations and the expansion of our government/academic institution partnership team.

“I am also delighted to announce the formation of TFF’s Scientific Advisory Board, a group of extraordinarily accomplished individuals who will impart a wealth of invaluable scientific and medical expertise as we accelerate multiple programs from early-stage development to advanced clinical testing, both for our proprietary drug programs and our partnered opportunities.

“In the second half of the year, TFF will build on these significant accomplishments as we move our internal programs into pivotal testing. On the business development front, we expect to advance our programs with existing partners, while signing new licensing transactions with pharmaceutical and biotechnology companies.”   

Conference Call and Webcast Information

The Company will host a conference call today, Thursday, August 12, 2021, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

Domestic Dial-In Number: Toll-Free: (866) 269-4261
International Dial-In Number (323) 289-6581
Conference ID: 6229028

The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at http://public.viavid.com/index.php?id=146022. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Recent Clinical and Corporate Highlights: 

• Voriconazole Inhalation Powder (TFF VORI): As noted on the first quarter update, TFF has successfully completed the first of two dosing cohorts in a Phase 1b reactive airway study, which is evaluating safe dosing of TFF VORI in asthma patients with hyperreactive airways. The safety profile for TFF VORI continues to look favorable, with no serious adverse events reported in these cohorts. Top-line data from the study is expected in the third quarter of 2021. The Company continues preparations for an end of Phase 1 meeting with the FDA, and anticipates this meeting will also be held in the third quarter, after the dosing in this Phase 1b reactive airway study is complete.

  Earlier in the year, TFF announced the successful completion of the Phase 1 clinical trial and final data for Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA). Based on the results of the Phase 1 trial, the Company will study the 80 mg dose of Voriconazole Inhalation Powder for the upcoming pivotal trial where it will be compared to the oral form of voriconazole. The Company expects to initiate a pivotal trial of TFF VORI in the fourth quarter of 2021, which will be designed to assess efficacy for treating patients with IPA or for preventing infection in patients at high risk for developing IPA infections.

• Tacrolimus Inhalation Powder (TFF TAC)
  : In July, the Company announced completion of enrollment and preliminary data from its Phase 1 trial of Tacrolimus Inhalation Powder (TFF TAC). In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects. In the subjects that received inhaled tacrolimus in the low dose group, the mean trough blood levels reached 1.1 ng/mL, while blood levels in the highest dose group reached 10.0 ng/mL. Following lung transplant, it is desirable for patients to achieve maintenance tacrolimus blood levels from 5-15 ng/mL to prevent acute allograft rejection.

  In addition, when subjects received inhaled tacrolimus dosing at 2.5 mg while fasting or 30 minutes after a high-fat meal, there were no significant differences in systemic exposure demonstrating that delivery by inhalation was not associated with food effects in this cohort of subjects. By contrast, the rate and extent of absorption of tacrolimus is significantly decreased when tacrolimus is administered orally when taken with food, and this effect is most pronounced after a high-fat meal.

  In the Multiple Ascending Dose (MAD) phase, repeated dosing of inhaled tacrolimus every 12 hours over 7 days demonstrated that subjects receiving doses of 0.5 mg twice daily and 1.0 mg twice daily achieved 12-hour trough steady state blood levels that averaged 6.8 and 14.9 ng/mL, respectively. Importantly, these data demonstrate that low dosing of Tacrolimus Inhalation Powder (0.5-1.0 mg) can achieve blood levels that are believed to be sufficient for efficacious immunosuppression.

  TFF Pharmaceuticals expects to report top-line safety data in the third quarter of 2021 and believes the strong bioavailability data will enable initiation of a clinical trial in lung transplant patients in the second half of 2021. The Company expects that the dosing regimen for the study in lung transplantation will be tailored to potentially provide effective immunosuppression in the lung while reducing renal toxicities.

  In June, TFF Pharma held a Science Day for investors, featuring key opinion leader (KOL) perspectives on Thin Film Freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines. Deborah Jo Levine, M.D., from UT Health San Antonio, provided background on lung transplantation, the current toxicity limitation of oral tacrolimus for immunosuppression, and the potential improvements with an inhaled formulation of tacrolimus (TFF TAC). Kartik Chandran, Ph.D., from the Albert Einstein College of Medicine, discussed the benefits of using the TFF technology to create a dry powder pulmonary formulation for the rVSV vaccine against COVID-19. Ted Ross, Ph.D., from the University of Georgia, discussed his experience utilizing the TFF process for creating a universal influenza vaccine for pulmonary delivery and its potential benefit over the existing annual vaccination. TFF Pharma’s management team also provided an update on its internal pipeline and several upcoming planned clinical data releases for TFF TAC and TFF VORI (treatment of invasive fungal infections). The event and its presentation materials can be found on the TFF corporate website.

• Strategic Business Development and Partnership Activities – Governmental and Defense Contracting Agencies: Early in the second quarter, TFF announced that it is was awarded a contract with Leidos to participate in the Personalized Protective Biosystems (PPB) Program to develop next-generation chemical and biological protection for U.S. warfighters and stability operators. The PPB research program is overseen by the Defense Advanced Research Projects Agency (DARPA) and aims to develop an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. TFF Pharmaceuticals will utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, eyes and respiratory system.

  We continue to engage and collaborate with various government and defense contracting agencies in an effort to utilize the Company’s TFF technology platform to formulate dry powder vaccines and therapeutics for delivery via reconstitution for lung or nasal inhalation. This includes our 3-year Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for biodefense countermeasures, and our early-stage universal influenza work with the University of Georgia’s Center for Vaccines and Immunology, part of the NIH’s Collaborative Influenza Vaccine Innovation Centers (CIVICs).

• Strategic Business Development and Partnership Activities – Biopharmaceutical Companies and Research Institutions, Cannabis Development and Commercialization: During the second quarter, TFF Pharmaceuticals and its partner, Augmenta Bioworks, selected a lead monoclonal antibody candidate, AUG-3387, for COVID-19. More specifically, Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV2 who are at high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV2 infection for individuals who are at high-risk for severe disease.

  In vitro preclinical testing has demonstrated that AUG-3387 effectively neutralizes SARS-CoV2 and has activity against all variant strains tested to date, including major COVID variants of concern: Alpha (B.1.1.7 ), Beta (B1.1.351), Gamma (P.1) and Kappa (B.1.617.1) and Delta (B.1.617.2). TFF and Augmenta have an ongoing commitment to monitor activity of AUG-3387 against emerging SARS-CoV-2 variants and will be completing in vivo preclinical efficacy studies in the coming weeks. Continued scale-up manufacturing of AUG-3387 continues, and the Companies expect completion of toxicology studies to enable human clinical trials in the months ahead.

  TFF also continues to work with its partner, PLUS Products, to develop Thin Film Freezing versions of cannabinoid products. PLUS Products is currently conducting consumer testing of specific formulations.

Formation of Scientific Advisory Board

TFF Pharmaceuticals also announced the formation of a Scientific Advisory Board, comprised of globally-recognized thought leaders in their respective fields of study. The SAB will advise TFF Pharmaceuticals across a range of issues, including internally developed programs and select external projects. Below is a list of our advisors and their affiliated institutions:

• David N. Cornfield, M.D.
  Director of the Center for Excellence in Pulmonary Biology at Stanford, and Chief of the pediatric pulmonary, asthma, and sleep medicine divisions at Stanford University and Lucile Packard Children’s Hospital
• David Denning, FRCP, FRCPath, DCH, FMedSci
  Professor of Infectious Diseases in Global Health, University of Manchester
• Anthony Hickey, Ph.D.
  Professor Emeritus in Pharmacoengineering and Molecular Pharmaceutics at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill
• Jay Peters, M.D.
  
  Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center at San Antonio
• Ted M. Ross, Ph.D.
  
  Professor at the University of Georgia in the Animal Health Research Center, Center for Vaccines and Immunology, and the Department of Infectious Diseases
• Mike Saag, M.D.
  
  Professor of Medicine at UAB School of Medicine, Director of the UAB Center for AIDS Research and Associate Dean for Global Health.
• Drew Weismann, M.D., Ph.D.
  
  Roberts Family Professor in Vaccine Research at the Perelman School of Medicine at the University of Pennsylvania

Financial Results 

For the three months ended June 30, 2021, compared to the prior year: 

• Research and Development (R&D) expenses: R&D expenses for the second quarter of 2021 were $2.8 million, compared to $2.6 million for the same period in 2020. 

• General & Administrative (G&A) expenses: G&A expenses for the second quarter of 2021 were $2.4 million, compared to $1.3 million for the same period of 2020.  

• Net Loss: TFF Pharmaceuticals reported a net loss for the second quarter of 2021 of $4.7 million, compared to a net loss of $3.8 million for the same period of 2020. 

About TFF Pharmaceuticals’ Thin Film Freezing Technology Platform

TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 58 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.

SAFE HARBOR

This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder versions of Voriconazole and Tacrolimus, and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and Tacrolimus, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section “Risk Factors” included in the Company’s 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

TFF PHARMACEUTICALS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

		Three Months Ended June 30, 2021						Three Months Ended June 30, 2020							Six Months Ended June 30, 2021					Six Months Ended June 30, 2020
Grant revenue		$	1,850					$	—						$	26,165				$	—
Operating expenses:
Research and development			2,762,170						2,567,771							8,040,422					4,803,313
General and administrative			2,351,007						1,274,803							4,998,422					2,892,727
Total operating expenses			5,113,177						3,842,574							13,038,844					7,696,040
Loss from operations			(5,111,327			)			(3,842,574				)			(13,012,679		)			(7,696,040	)
Other income:
Other income			441,546						—							672,824					—
Interest income			14,069						25,995							29,568					82,263
Total other income			455,615						25,995							702,392					82,263
Net loss		$	(4,655,712			)		$	(3,816,579				)		$	(12,310,287		)		$	(7,613,777	)
Net loss per share, basic and diluted		$	(0.18			)		$	(0.20				)		$	(0.51		)		$	(0.40	)
Weighted average common shares outstanding, basic and diluted			25,369,144						19,071,658							24,261,032					19,040,134

TFF PHARMACEUTICALS, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

		June 30,				December 31,
		2021				2020
ASSETS
Current assets:
Cash and cash equivalents		$	52,067,339			$	35,300,805
Receivable due from collaboration agreement			489,221				—
Research and development tax incentive receivable			932,057				—
Prepaid assets and other current assets			1,968,726				2,258,229
Total current assets			55,457,343				37,559,034
Property and equipment, net			1,697,038				1,102,808
Total assets		$	57,154,381			$	38,661,842
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,509,224			$	1,297,725
Deferred research grant revenue			25,000				24,315
Total liabilities			1,534,224				1,322,040
Commitments and contingencies
Stockholders’ equity:
Common stock			25,372				22,535
Additional paid-in capital			102,301,550				71,648,453
Accumulated other comprehensive loss			(116,830	)			(51,538	)
Accumulated deficit			(46,589,935	)			(34,279,648	)
Total stockholders’ equity			55,620,157				37,339,802
Total liabilities and stockholders’ equity		$	57,154,381			$	38,661,842

Company Contacts:

Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
[email protected]                                                                                                
737-802-1973

Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
[email protected]                                                                                                
817-989-6358

Investor Relations Contact:  

Corey Davis, Ph.D. 
LifeSci Advisors 
212-915-2577 
[email protected] 

Media Contact:

Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
[email protected] 

• Closed merger transaction resulting in public listing (TPST)
• Closed $30M PIPE, extending runway into Q1’23
• Advancing TPST-1495 and TPST-1120 into targeted patient populations
• Advanced TREX-1 program to potent lead series with in vivo efficacy

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported financial results and provided a corporate update for the second quarter ended June 30, 2021.

“The second quarter of 2021 was an exciting period as Tempest became a public company and the team drove progress in all three of our novel programs,” said Steve Brady, chief executive officer of Tempest. “We look forward to the planned opening of the TPST-1120 randomized study in first line hepatocellular carcinoma in collaboration with Roche and the first combination study of TPST-1495, and remain focused on delivering potentially value-creating milestones over the next year and beyond.”

Recent Highlights

• Public Company Transition: successfully closed merger and concurrent PIPE financing, allowing Tempest to become a public company listed on the Nasdaq Capital Market, and extending runway into 2023 through multiple potential catalysts.
• TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose (“RP2D”).
• TPST-1120 (clinical PPARα antagonist): (i) completed monotherapy dose escalation and selected 600mg BID as RP2D; (ii) observed stable disease (“SD”) in 50% of the monotherapy-treated patients, including prolonged SD in patients with refractory cholangiocarcinoma; and (iii) observed a deep, confirmed partial response in a patient with checkpoint inhibitor-refractory fourth line renal cell carcinoma in the combination study with nivolumab (->60% by RECIST 1.1, durable through 4 scans and ongoing).
• TREX-1 Inhibitor (preclinical, tumor-selective STING pathway activator): (i) progressed lead series to picomolar IC₅₀ potency in biochemical assays; and (ii) demonstrated significant proof of concept in a mouse tumor model with systemic delivery of a lead series molecule.
• Board of Directors: Christine Pellizzari, J.D., Geoff Nichol, M.B., Ch.B., M.B.A., and Ronit Simantov, M.D., joined the Board of Directors, bringing deeper financial, legal, and clinical development expertise to Tempest.

Planned Near-Term Milestones

• TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with an anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
• TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) commencement of first line randomized Phase 1b/2 study in hepatocellular carcinoma patients, under a collaboration with F. Hoffman La Roche, expected within the third quarter.
• TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.

Financial Results

Second Quarter

• Tempest ended the second quarter of 2021 with $68.5 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
• Net loss and net loss per share for the second quarter of 2021 were $7.1 million and $7.63, respectively, compared to $5.2 million and $11.42, respectively, for the second quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
• Research and development expenses for the second quarter of 2021 were $4.2 million, compared to $4.1 million for the same period in 2020. The $0.1 million increase was primarily attributable to increased compensation expenses.
• For the three months ended June 30, 2021, general and administrative expenses were $2.6 million compared to $1.1 million for the same period in 2020. The increase was primarily due to growth in compensation expense and professional fees associated with the merger.

Year-to-Date

• Net cash used in operations for the six months ended June 30, 2021 was $6.2 million.
• Net loss and net loss per share for the six months ended June 30, 2021 were $12.4 million and $17.30, respectively, compared to $9.5 million and $21.28, respectively, for the same period in 2020.
• Research and development expenses for the six months ended June 30, 2021 were $7.8 million compared to $7.1 million for the same period in 2020. The $0.7 million increase was primarily due to increased compensation expenses and consulting services.
• For the six months ended June 30, 2021, general and administrative expenses were $4.1 million compared to $2.4 million for the same period in 2020.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage oncology company advancing small molecules that combine both targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s two novel clinical programs are TPST-1495 and TPST-1120, antagonists of EP2/EP4 and PPARα, respectively. Both TPST-1495 and TPST-1120 are advancing through Phase 1 studies designed to study both agents as monotherapies and in combination with other approved agents. Tempest is also developing an orally-available inhibitor of TREX-1 designed to activate selectively the cGAS/STING pathway, an innate immune response pathway important for the development of anti-tumor immunity. Tempest is headquartered in South San Francisco. More information about Tempest can be found on the company’s website at www.tempesttx.com.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. (“Tempest Therapeutics”). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. 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,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding the timing and selection of development candidates, dose selection or commencement of, or availability of data from, clinical trials, the company’s guidance regarding cash resources as well as our operational plans and the timing and ability to deliver on value-creating milestones. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement. These and other risks are described in greater detail in the Form 10-Q filed by Tempest Therapeutics with the Securities and Exchange Commission on August 12, 2021. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.

TEMPEST THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands)
		June 30, 2021				December 31, 2020
Assets
Current assets
Cash and cash equivalents		$	68,458			$	18,820
Prepaid expenses and other current assets			2,036				1,005
Total current assets			70,494				19,825
Property and equipment, net			1,218				1,110
Operating lease right-of-use assets			3,673				1,877
Other noncurrent assets			112				51
Total assets		$	75,497			$	22,863
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable		$	6,695			$	1,071
Accrued expenses and other			1,526				1,439
Current operating lease liabilities			1,484				712
Interest payable			89				–
Total current liabilities			9,794				3,222
Loan payable, net			14,915				–
Operating lease liabilities			2,674				1,727
Total liabilities			27,383				4,949
Convertible preferred stock			–				86,707
Stockholders’ equity
Common stock			7				15
Additional paid-in capital			132,281				2,953
Accumulated deficit			(84,174	)			(71,761	)
Total stockholders’ equity			48,114				(68,793	)
Total liabilities, convertible preferred stock and stockholders’ equity		$	75,497			$	22,863

TEMPEST THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands except per share amounts)
		Three months ended				Three months ended				Six months ended				Six months ended
		June 30, 2021				June 30, 2020				June 30, 2021				June 30, 2020
Expenses:
Research and development		$	4,229			$	4,094			$	7,821			$	7,121
General and administrative			2,556				1,144				4,091				2,420
Total expenses			6,785				5,238				11,912				9,541
Operating loss			(6,785	)			(5,238	)			(11,912	)			(9,541	)
Other income (expense), net:
Interest expense			(276	)			–				(507	)			–
Interest and other income, net			3				9				6				84
Net loss		$	(7,058	)		$	(5,229	)		$	(12,413	)		$	(9,457	)
Net loss per share		$	(7.63	)		$	(11.42	)		$	(17.30	)		$	(21.28	)

Investor Contacts:

Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]

Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]

REDWOOD CITY, Calif. and BEIJING, Aug. 12, 2021 (GLOBE NEWSWIRE) — Seer Inc. (NASDAQ: SEER), a life sciences company commercializing a disruptive new platform for proteomics, today announced it has signed an exclusive distribution agreement with Enlight Medical, a leading company in the development, production and distribution of innovative medical diagnostics and therapeutic devices in China. The agreement accelerates commercial availability of Seer’s Proteograph Product Suite to the rapidly expanding Chinese life sciences and clinical markets.

China’s life sciences, pharmaceutical and health care markets are among the largest and the fastest-growing in the world and hold enormous potential for proteomics. With the surging global health care needs in oncology, neurology, and immunology, new tools are needed to accelerate biological insights, identify biomarker targets, and develop novel therapies. Seer’s unbiased, deep, and scalable proteomics platform addresses this demand by enabling pharma and biomedical researchers to discover new biomarkers for the diagnosis and treatment of cancer and other diseases, and better understand how healthy cells function.

“We’re experiencing a major shift in how the Chinese population will receive care, which is driving the demand for more therapies to treat disease,” said Dr. Ruilin Zhao, CEO of Enlight Medical, and former China General Manager for Illumina. “Our management team has decades of industry experience and deep connections with leading hospitals and universities in China, so we are well positioned to bring Seer’s Proteograph Product Suite to this booming market of researchers, clinicians, and doctors to help Chinese people have longer and healthier lives.”

Through the partnership, Enlight’s experienced team will manage sales, marketing, and customer service for Seer’s Proteograph Product Suite and pave the way for expanding access to this disruptive platform in China. The Proteograph Product Suite, which leverages Seer’s proprietary engineered nanoparticle technology, empowers scientists and clinicians to obtain a clearer view of biology by enabling unbiased, deep access to the proteome at a scale never before possible.

“We are thrilled to partner with the highly-experienced and well-respected team at Enlight Medical to accelerate our entry into the Chinese market,” said Omead Ostadan, President and Chief Operating Officer at Seer. “China represents a significant opportunity for us and our partnership with Enlight will allow us to provide a broad range of customers — spanning academic institutions, commercial and pharmaceutical companies — access to the unique capabilities of our platform earlier than we had originally anticipated. We are excited to embark on this next phase of our commercial expansion and look forward to serving an expanding set of global customers in partnership with Enlight Medical.”

About Seer Bio

Seer is a life sciences company developing transformative products that open a new gateway to the proteome. Seer is commercializing its Proteograph Product Suite, an integrated solution that includes proprietary engineered nanoparticles, consumables, automation instrumentation and software to perform deep, unbiased proteomic analysis at scale in a matter of hours. Seer designed the Proteograph workflow to be efficient and easy to use, leveraging widely adopted laboratory instrumentation to provide a decentralized solution that can be incorporated by nearly any lab. Seer’s Proteograph Product Suite is for research use only and is not intended for diagnostic procedures. For more information, please visit www.seer.bio.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on Seer’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause Seer’s actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding Seer’s ability to successfully execute the development and commercialization of its Proteograph; or the combined solution offered by the commercial agreement, the ability of the combined product offering to enable labs to perform unbiased, deep proteomics studies at scale to deliver new levels of insight, speed, and sensitivity, to expand unbiased proteomics discovery efforts, expand application sets, and future collaborations. These and other risks are described more fully in Seer’s filings with the Securities and Exchange Commission (“SEC”) and other documents that Seer subsequently files with the SEC from time to time. Except to the extent required by law, Seer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

About Enlight Medical

Enlight Medical Technologies (Shanghai) Co., Ltd. is committed to the product development, production, and distribution of innovative medical diagnostics and therapeutic devices. The founding team of the company has successful experience and industry resources in R&D, sales, and marketing. The R&D team is composed of senior engineers graduated from top universities in both China and the United States. The company’s product pipeline has a wide layout, covering a variety of innovative products with huge market potential. The company will always take an international vision, uphold the heart of benevolence, based in China, to create a world-class technology provider and product manufacturer of innovative medical devices.

Seer Media Contact:

[email protected]

Enlight Medical Media Contact:

[email protected]