IO Biotech Announces 2023 First-Quarter Results

  • The company expects to enroll 225 patients in its Phase 3 pivotal trial (IOB-013/KN-D18) in advanced melanoma by mid-2023 and to fully enroll the trial by the end of 2023.
  • The Phase 3 trial protocol calls for an interim analysis of overall response rate (ORR) one year after 225 patients have been randomized; data obtained from this analysis could allow for submission of a Biologics License Application for an accelerated approval in the United States.
  • Enrollment in the company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, or metastatic bladder cancer is continuing. The company anticipates reporting additional data from this trial over the course of 2023.
  • The company’s investigational new drug (IND) application for its IOB-032 trial to evaluate the use of IO102-IO103 in combination with pembrolizumab in the neo-adjuvant/adjuvant treatment of patients with solid tumors was cleared by the US Food and Drug Administration (FDA).
  • The company is executing from a strong financial position with approximately $128.5 million in cash and equivalents as of March 31, 2023, which will support operations through the third quarter of 2024.

NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® technology platform, today announced financial results for the first quarter ended March 31, 2023. The company continues to advance its lead cancer vaccine candidate, IO102-IO103, with two company-sponsored clinical trials currently recruiting, as well as five investigator-initiated trials contracted with leading cancer institutions in the United States and Europe.

“Our team remains keenly focused on advancing the development of IO102-IO103, our novel, investigational immune-modulating cancer vaccine, across multiple programs,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “As anticipated, enrollment in our global Phase 3 pivotal trial for patients with advanced melanoma has accelerated, and we expect to reach 225 patients randomized by mid-2023 and expect full enrollment in the trial by the end of 2023. Importantly, the protocol calls for an interim analysis to be conducted one year after 225 patients have been randomized. If these data are supportive, we could then prepare and submit a Biologics License Application for accelerated approval in the US.

Dr. Zocca continued, “Additionally, we are pleased that the FDA has cleared our IND to study the use of IO102-IO103 for the neo-adjuvant/adjuvant treatment of solid tumors in patients with melanoma and head and neck cancers. We plan to initiate this Phase 2 trial in the second half of 2023.”

Highlights for First Quarter 2023 and Recent Weeks

  • The company’s Phase 3 trial (IOB-013/KN-D18) is evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients. The company continues to expect to enroll 225 patients by mid-2023 and fully enroll the trial by the end of 2023. The Phase 3 trial protocol calls for an interim analysis of overall response rate one year after 225 patients have been randomized; if these data are supportive this interim analysis could allow for submission of a Biologics License Application for an accelerated approval in the US.
  • The company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, or metastatic bladder cancer showed encouraging initial data from 10 lung cancer patients; of the 10 patients, 9 were efficacy evaluable per protocol having received at least one full cycle of treatment. Among the 9 evaluable patients, 4 patients had a partial response while 4 had stable disease; one patient had progressive disease. The safety profile observed at the time of the interim readout is consistent with prior clinical experience with IO102-IO103. The trial continues to recruit patients and the company expects to report additional data from this trial this year.
  • The FDA has cleared the company’s IND for the evaluation of IO102-IO103 in the neo-adjuvant / adjuvant treatment of solid tumors. The company plans to initiate a Phase 2 basket trial evaluating the use of IO102-IO103 in combination with pembrolizumab in the neo-adjuvant/adjuvant setting in patients with melanoma and head and neck cancer.

First Quarter 2023 Financial Results

  • Net loss for the three months ended March 31, 2023 was $17.0 million, compared to $17.2 million for the three months ended March 31, 2022.
  • Research and development expenses were $11.9 million for the three months ended March 31, 2023, compared to $10.3 million for the three months ended March 31, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 product candidate, including the continued execution of our Phase 3 clinical trial. The Company recognized $0.7 million in research and development equity-based compensation for both the three months ended March 31, 2023 and 2022.
  • General and administrative expenses were $6.0 million for the three months ended March 31, 2023, compared to $6.7 million for the three months ended March 31, 2022. The decrease was related to lower professional services and consulting costs, offset by an increase in headcount. The Company recognized $1.2 million in general and administrative equity-based compensation for the three months ended March 31, 2023, compared to $0.9 million for the three months ended March 31, 2022.
  • Cash and cash equivalents as of March 31, 2023 were $128.5 million, compared to $142.6 million at December 31, 2022. During the three months ended March 31, 2023, the Company used cash, cash equivalents and restricted cash of $14.8 million from operating and investing activities that was offset by an increase of $0.7 million in cash due to the effects of foreign currency exchange rates.
  • Cash on hand is expected to support operations through the third quarter of 2024.

About IO102-IO103

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.

About the IOB-013/KN-D18 Phase 3 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment is 300 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line advanced cancers: non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC). The clinical trial is sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® vaccine platform. The T-win platform is a novel approach to cancer vaccines designed to activate T cells to target the most important immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing in clinical studies its lead cancer vaccine candidate, IO102-IO103, targeting IDO and PD-L1, and through preclinical development its other pipeline candidates. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

For further information, please visit www.iobiotech.com.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the interim analysis of our Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Company Contact:

Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
[email protected]
Investor Contact:

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



IO BIOTECH, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(unaudited)

     
  For the Three Months

Ended March 31,
 
  2023     2022  
Operating expenses          
Research and development $ 11,900     $ 10,306  
General and administrative   6,024       6,704  
Total operating expenses   17,924       17,010  
Loss from operations   (17,924 )     (17,010 )
Other income (expense)          
Currency exchange gain (loss), net   258       (20 )
Interest income   1,028       15  
Interest expense         (123 )
Total other income (expense), net   1,286       (128 )
Loss before income tax expense   (16,638 )     (17,138 )
Income tax expense   406       66  
Net loss   (17,044 )     (17,204 )
Net loss attributable to common shareholders   (17,044 )     (17,204 )
Net loss per common share, basic and diluted $ (0.59 )   $ (0.60 )
Weighted-average number of shares used in computing net loss per common share, basic and diluted   28,815,267       28,815,267  
Other comprehensive loss          
Net loss   (17,044 )     (17,204 )
Foreign currency translation   517       (2,647 )
Total comprehensive loss   (16,527 )     (19,851 )
               
               

IO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(unaudited)

           
  March 31,

2023
    December 31,

2022
 
Assets          
Current assets          
Cash and cash equivalents $ 128,527     $ 142,590  
Prepaid expenses and other current assets   3,739       5,629  
Total current assets   132,266       148,219  
Restricted cash   268       268  
Property and equipment, net   842       741  
Right of use lease asset   2,592       2,493  
Other non-current assets   876       84  
Total non-current assets   4,578       3,586  
Total assets $ 136,844     $ 151,805  
Liabilities, convertible preference shares and stockholders’ equity          
Current liabilities          
Accounts payable $ 4,260     $ 4,004  
Lease liability – current   559       515  
Accrued expenses and other current liabilities   5,538       6,157  
Total current liabilities   10,357       10,676  
Lease liability – noncurrent   2,272       2,275  
Total non-current liabilities   2,272       2,275  
Total liabilities   12,629       12,951  
Commitments and contingencies          
Stockholders’ equity          
Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively          
Common stock, par value of $0.001 per share; 300,000,000 shares authorized, 28,815,267 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively   29       29  
Additional paid-in capital   328,593       326,705  
Accumulated deficit   (194,783 )     (177,739 )
Accumulated other comprehensive loss   (9,624 )     (10,141 )
Total stockholders’ equity   124,215       138,854  
Total liabilities, convertible preference shares and stockholders’ equity $ 136,844     $ 151,805  



Shift Announces First Quarter Results and Review of Strategic Alternatives

SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) — Shift Technologies, Inc. (Nasdaq: SFT), a consumer-centric omnichannel retailer for buying and selling used cars, today reported first quarter financial results for the period ended March 31, 2023. Management’s commentary on first quarter financial results can be found by accessing the Company’s prepared remarks on investors.shift.com, or by listening to today’s conference call. A live audio webcast will also be available on Shift’s Investor Relations website.

First
Quarter
2023
Operating Results

  • Total revenue for the quarter was $57.7 million.
  • Total retail units sold were 2,396.
  • Gross profit per unit was $1,477; Adjusted gross profit per unit1 (“Adjusted GPU”) was $1,777.
  • Net loss and comprehensive loss was $48.1 million or 83% of revenue, compared to net income of $13.0 million or 20% of revenue in Q4’22 (net income for the fourth quarter included a gain on bargain purchase of $76.7 million related to the acquisition of CarLotz, Inc.)
  • Adjusted EBITDA1 loss was $24.0 million or 41.7% of revenue, compared to $25.5 million or 38.9% of revenue in Q4’22.
  • Cash and cash equivalents totaled $68 million at March 31, 2023

“While making significant progress in managing our cost structure, our team has shown improvement in the execution of our omni-channel strategy as evidenced by the sequential improvement of total adjusted GPU to $1,777 in the first quarter, a 71% increase compared to fourth quarter 2022. In addition to our omni-channel strategy, our tech team is highly focused on preparing to launch the dealer marketplace in the third quarter 2023. I want to thank everyone for all of their hard work,” said CEO Jeff Clementz. “Simultaneously, in order to maximize shareholder value, the Board of Directors, alongside management and advisors, is evaluating strategic alternatives for the business.”

Review of Strategic Alternatives

Shift Technologies’ Board of Directors, together with management and in consultation with our financial and legal counsels, is conducting a process to explore and evaluate strategic alternatives, including exploring a potential sale of certain operating businesses, third party investment or partnership opportunities and/or funding alternatives for our marketplace business, to further enhance value for all stakeholders. The Board expects to proceed in a timely manner, but has not set a definitive timetable for completion of this process. There can be no assurance that this review process will result in a transaction or other strategic alternative of any kind. The Company does not intend to disclose developments or provide updates on the progress or status of this process or discuss with investors the Company’s results of operations until it deems further disclosure is appropriate or required.

_________________________________


1

Adjusted Gross Profit, Adjusted Gross Profit per Unit (GPU), Adjusted EBITDA, and Adjusted EBITDA Margin are non-GAAP financial measures. Please see the discussion in the section “Explanation of Non-GAAP Measures” and the reconciliations included at the end of this press release.

Shift
First
Quarter
2023
Results Summary

                                                                                

  Three Months Ended March 31,
    2023       2022     Change (%)
 
(in thousands, except per unit and per share amounts)
Revenue $ 57,693     $ 219,580     (74 )%
Gross profit   3,538       10,788     (67 )%
Adjusted gross profit   4,258       11,286     (62 )%
Net loss and comprehensive loss   (48,097 )     (57,048 )   (16 )%
Net loss and comprehensive loss per share, basic and diluted   (2.84 )     (6.97 )   (59 )%
Adjusted EBITDA loss   (24,044 )     (46,588 )   (48 )%
           
Gross profit per unit $ 1,477     $ 1,607     (8 )%
Adjusted gross profit per unit $ 1,777     $ 1,681     6 %
Average selling price per retail unit $ 21,298     $ 27,269     (22 )%
Retail units sold   2,396       6,714     (64 )%

Share and per-share amounts have been adjusted to give effect to the Company’s 10 for 1 reverse stock split effective March 8, 2023 



Conference Call Information

Shift senior management will host a conference call today to discuss the Company’s Q1’23 financial results. This call is scheduled to begin at 2:00 pm PT / 5:00 pm ET and can be accessed by dialing (833) 634-1255 or (412) 317-6015. To listen to a live audio webcast, please visit Shift’s Investor Relations website at investors.shift.com. A telephonic replay of the conference call will be available until Thursday, May 18, 2023, and can be accessed by dialing (877) 344-7529 or (412) 317-0088 and entering the passcode 5267882.

About Shift

Shift is a consumer-centric omnichannel retailer transforming the used car industry by leveraging its end-to-end ecommerce platform and retail locations to provide a technology-driven, hassle-free customer experience. Shift’s mission is to make car purchase and ownership simple — to make buying or selling a used car fun, fair, and accessible to everyone. Shift provides comprehensive, digital solutions throughout the car ownership lifecycle: finding the right car, a seamless digitally-driven purchase transaction including financing and vehicle protection products, an efficient, digital trade-in/sale transaction, and a vision to provide high-value support services during car ownership. For more information, visit www.shift.com. The contents of our website are not incorporated into this press release.

Forward-Looking Statements

This document includes “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward looking statements include estimated financial information. Such forward looking statements with respect to revenues, earnings, performance, strategies, prospects and other aspects of Shift’s business are based on current expectations that are subject to risks and uncertainties. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward looking statements. These factors include, but are not limited to: (1) Shift’s ability to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees; (2) changes in applicable laws or regulations; (3) the possibility that Shift may be adversely affected by other economic, business, and/or competitive factors; (4) the operational and financial outlook of Shift; (5) the ability for Shift to execute its strategy; (6) Shift’s ability to purchase sufficient quantities of vehicles at attractive prices; (7) legislative, regulatory and economic developments and (8) other risks and uncertainties indicated from time to time in other documents filed or to be filed with the SEC by Shift. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Shift undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Key Operating Metrics


Retail Units Sold

We define retail units sold as the number of vehicles sold to customers in a given period, net of returns. We currently have a seven-day, 200 mile return policy. The number of retail units sold is the primary driver of our revenues and, indirectly, gross profit, since retail unit sales enable multiple complementary revenue streams, including all financing and protection products. We view retail units sold as a key measure of our growth, as growth in this metric is an indicator of our ability to successfully scale our operations while maintaining product integrity and customer satisfaction.


Wholesale Units Sold

We define wholesale units sold as the number of vehicles sold through wholesale channels in a given period. While wholesale units are not the primary driver of revenue or gross profit, wholesale is a valuable channel as it allows us to be able to purchase vehicles regardless of condition, which is important for the purpose of accepting a trade-in from a customer making a vehicle purchase from us, and as an online destination for consumers to sell their cars even if not selling us a car that meets our retail standards.


Retail Average Sale Price

We define retail average sale price (“ASP”) as the average price paid by a customer for an retail vehicle, calculated as retail revenue divided by retail units. Retail average sale price helps us gauge market demand in real-time and allows us to maintain a range of inventory that most accurately reflects the overall price spectrum of used vehicle sales in the market. We believe this metric provides transparency and is comparable to our peers.


Wholesale Average Sale Price

We define wholesale average sale price as the average price paid by a customer for a wholesale vehicle, calculated as wholesale revenue divided by wholesale units. We believe this metric provides transparency and is comparable to our peers.


Gross Profit per Unit

We define gross profit per unit as the gross profit for retail, other, and wholesale, each of which divided by the total number of retail units sold in the period. We calculate gross profit as the revenue from vehicle sales and services less the costs associated with acquiring and reconditioning the vehicle prior to sale. Gross profit per unit is primarily driven by retail vehicle revenue, which generates additional revenue through attachment of our financing and protection products, and gross profit generated from wholesale vehicle sales. We present gross profit per unit from our three revenues streams as Retail gross profit per unit, Wholesale gross profit per unit and Other gross profit per unit.


Average Monthly Unique Visitors

We define a monthly unique visitor as an individual who has visited our website within a calendar month, based on data collected on our website. We calculate average monthly unique visitors as the sum of monthly unique visitors in a given period, divided by the number of months in that period. To classify whether a visitor is “unique”, we dedupe (a technique for eliminating duplicate copies of repeating data) each visitor based on email address and phone number, if available, and if not, we use the anonymous ID which lives in each user’s internet cookies. This practice ensures that we do not double-count individuals who visit our website multiple times within any given month. We view average monthly unique visitors as a key indicator of the strength of our brand, the effectiveness of our advertising and merchandising campaigns and consumer awareness.


Average Days to Sale

We define average days to sale as the number of days between Shift’s acquisition of a vehicle and sale of that vehicle to a customer, averaged across all retail units sold in a period. We view average days to sale as a useful metric in understanding the health of our inventory.


Retail Vehicles Available for Sale

We define retail vehicles available for sale as the number of retail vehicles in inventory on the last day of a given reporting period. Until we reach an optimal pooled inventory level, we view retail vehicles available for sale as a key measure of our growth. Growth in retail vehicles available for sale increases the selection of vehicles available to consumers, which we believe will allow us to increase the number of vehicles we sell. Moreover, growth in retail vehicles available for sale is an indicator of our ability to scale our vehicle purchasing, inspection and reconditioning operations.

Explanation Of Non-GAAP Measures

In addition to our GAAP results, we review certain non-GAAP financial measures to help us evaluate our business, measure our performance, identify trends affecting our business, establish budgets, measure the effectiveness of investments in our technology and sales and marketing, and assess our operational efficiencies. These non-GAAP measures include Adjusted Gross Profit, Adjusted gross profit per unit (“Adjusted GPU”), and Adjusted EBITDA, each of which is discussed below.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitutes for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. You are encouraged to evaluate these adjustments, and review the reconciliation of these non-GAAP financial measures to their most comparable GAAP measures, and the reasons we consider them appropriate. It is important to note that the particular items we exclude from, or include in, our non-GAAP financial measures may differ from the items excluded from, or included in, similar non-GAAP financial measures used by other companies. See “Reconciliation of gross profit to Adjusted Gross Profit,” “Reconciliation of gross profit per unit to Adjusted gross profit per unit” and “Reconciliation of net loss to Adjusted EBITDA” included as part of this shareholder letter.


Adjusted Gross Profit

Management evaluates our business based on an adjusted gross profit calculation that removes the financial impact associated with milestones achieved under our Lithia warrant arrangement and depreciation related to reconditioning facilities that is included in cost of sales. These items resulted in reductions in gross profit in our consolidated financial statements as applicable to the periods presented. These are non-cash adjustments, and we do not expect any material future non-cash gross profit adjustments related to the Lithia warrant agreement. We also excluded non-recurring losses incurred to liquidate inventories as part of the Project Focus Restructuring Plan. We examine adjusted gross profit in aggregate as well as for each of our revenue streams: retail, other, and wholesale.


Adjusted Gross Profit per Unit

We define adjusted gross profit per unit (“Adjusted GPU”) as the adjusted gross profit for retail, other and wholesale, each of which divided by the total number of retail units sold in the period. Adjusted GPU is driven by retail vehicle revenue, which generates additional revenue through attachment of our financing and protection products, and gross profit generated from wholesale vehicle sales. We present Adjusted GPU from our three revenues streams, as Retail Adjusted GPU, Wholesale Adjusted GPU and Other Adjusted GPU. We believe Adjusted GPU is a key measure of our growth and long-term profitability.


Adjusted EBITDA and Adjusted EBITDA Margin

We define Adjusted EBITDA as net loss adjusted to exclude stock-based compensation expense, depreciation and amortization, net interest income or expense, impact of warrant remeasurement, warrant milestone impact, and other cash and non-cash based income or expenses that we do not consider indicative of our core operating performance. Adjusted EBITDA Margin is defined as Adjusted EBITDA divided by revenue. We believe Adjusted EBITDA is useful to investors in evaluating our performance for the following reasons:

  • Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s performance without regard to items such as those we exclude in calculating this measure, which can vary substantially from company to company depending upon their financing, capital structures, and the method by which assets were acquired.
  • Our management uses Adjusted EBITDA in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of performance and the effectiveness of our business strategies, and in communications with our board of directors concerning our performance.
  • Adjusted EBITDA provides a measure of consistency and comparability with our past performance that many investors find useful, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.

Although Adjusted EBITDA is frequently used by investors and securities analysts in their evaluations of companies, Adjusted EBITDA has limitations as an analytical tool, and should not be considered in isolation or as a substitute for analysis of our results of operations as reported under GAAP. These limitations include but are not limited to:

  • Stock-based compensation is a non-cash charge and will remain an element of our long-term incentive compensation package, although we exclude it as an expense when evaluating our ongoing operating performance for a particular period.
  • Depreciation and amortization are non-cash charges, and the assets being depreciated or amortized will often have to be replaced in the future, but Adjusted EBITDA does not reflect any cash requirements for these replacements.
  • Change in fair value of financial instruments is a non-cash gain or loss. Liability-classified financial instruments represent potential future obligations to settle liabilities by issuing the Company’s common stock. Adjusted EBITDA does not reflect changes in the fair value of these obligations.
  • Adjusted EBITDA does not reflect changes in our working capital needs, capital expenditures, or contractual commitments.
  • Adjusted EBITDA does not reflect cash requirements for income taxes and the cash impact of other income or expense.
  • Other companies may calculate Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.

Our Adjusted EBITDA is influenced by fluctuations in our revenue and the timing and amounts of our investments in our operations. Adjusted EBITDA should not be considered as an alternative to net income (loss), income (loss) from operations, or any other measure of financial performance calculated and presented in accordance with GAAP.


Adjusted Selling, General and Administrative Expenses

We define Adjusted selling, general and administrative expenses (“Adjusted SG&A”) as Selling, General and Administrative Expenses (“SG&A”) adjusted to exclude those SG&A items that are excluded from Adjusted EBITDA. These items included but are not limited to stock-based compensation expense, transaction costs, and other cash and non-cash based expenses that we do not consider indicative of our core operating performance. We believe Adjusted SG&A is useful to investors in evaluating our performance for the following reasons:

  • Adjusted SG&A is widely used by investors and securities analysts to measure a company’s performance without regard to items such as those we exclude in calculating this measure, which can vary substantially from company to company depending upon their financing, capital structures, and the method by which assets were acquired.
  • Our management uses Adjusted SG&A in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of performance and the effectiveness of our business strategies, and in communications with our board of directors concerning our performance.
  • Adjusted SG&A provides a measure of consistency and comparability with our past performance that many investors find useful, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.

Although Adjusted SG&A is frequently used by investors and securities analysts in their evaluations of companies, Adjusted SG&A has limitations as an analytical tool, and should not be considered in isolation or as a substitute for analysis of our results of operations as reported under GAAP. These limitations include but are not limited to:

  • Stock-based compensation is a non-cash charge and will remain an element of our long-term incentive compensation package, although we exclude it as an expense when evaluating our ongoing operating performance for a particular period.
  • Adjusted SG&A does not reflect changes in our working capital needs, capital expenditures, or contractual commitments.
  • Other companies may calculate Adjusted SG&A differently than we do, limiting its usefulness as a comparative measure.

Our Adjusted SG&A is influenced by fluctuations in the timing and amounts of our investments in our operations. Adjusted SG&A should not be considered as an alternative to SG&A or any other measure of financial performance calculated and presented in accordance with GAAP.

Investor Relations Contact:

[email protected]

Media Contact:

[email protected]

Source: Shift Technologies, Inc.



SHIFT TECHNOLOGIES, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets


(in thousands, except share and per share amounts)



(unaudited)

  As of March 31, 2023   As of December 31, 2022
ASSETS      
Current assets:      
Cash and cash equivalents $ 58,784     $ 96,159  
Restricted cash, current   7,907       10,632  
Marketable securities at fair value         1,264  
Accounts receivable, net of allowance for doubtful accounts of $603 and $93   4,393       4,558  
Inventory   34,019       40,925  
Prepaid expenses and other current assets   6,257       7,657  
Operating and finance lease assets, property and equipment, accounts receivable, and other assets held for sale   12,749       17,226  
Total current assets   124,109       178,421  
Restricted cash, non-current   1,030       1,055  
Marketable securities at fair value, non-current         707  
Property and equipment, net   2,012       6,797  
Operating lease assets   28,365       44,568  
Finance lease assets, net   113       152  
Capitalized website and internal use software costs, net   9,633       10,657  
Goodwill   2,070       2,070  
Deferred borrowing costs   193       268  
Other non-current assets   1,971       3,323  
Total assets $ 169,496     $ 248,018  
       
LIABILITIES AND STOCKHOLDERS’ DEFICIT      
Current liabilities:      
Accounts payable $ 14,280     $ 12,085  
Accrued expenses and other current liabilities   23,136       33,872  
Operating lease liabilities, current   5,490       8,865  
Finance lease liabilities, current   50       271  
Flooring line of credit   22,165       24,831  
Operating and finance lease liabilities and other liabilities associated with assets held for sale   18,159       15,432  
Total current liabilities   83,280       95,356  
Long-term debt, net   163,879       163,363  
Operating lease liabilities, non-current   27,245       44,985  
Finance lease liabilities, non-current   1,496       3,989  
Other non-current liabilities   65       111  
Total liabilities   275,965       307,804  
       
Stockholders’ deficit:      
Preferred stock – par value $0.0001 per share; 1,000,000 shares authorized at March 31, 2023 and December 31, 2022, respectively          
Common stock – par value $0.0001 per share; 500,000,000 shares authorized at March 31, 2023 and December 31, 2022, respectively; 17,227,910 and 17,212,134 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively   2       2  
Additional paid-in capital   554,379       552,968  
Accumulated other comprehensive loss         (3 )
Accumulated deficit   (660,850 )     (612,753 )
Total stockholders’ deficit   (106,469 )     (59,786 )
Total liabilities and stockholders’ deficit $ 169,496     $ 248,018  

Share and per-share amounts have been adjusted to give effect to the Company’s 10 for 1 reverse stock split effective March 8, 2023





SHIFT TECHNOLOGIES INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss


(in thousands, except share and per share amounts)



(unaudited)

  Three Months Ended

March 31,
  2023   2022
Revenue      
Retail revenue, net $ 51,031     $ 183,081  
Other revenue, net   1,922       8,712  
Wholesale vehicle revenue   4,740       27,787  
Total revenue   57,693       219,580  
Cost of sales   54,155       208,792  
Gross profit   3,538       10,788  
Operating expenses:      
Selling, general and administrative expenses   43,435       63,537  
Depreciation and amortization   4,419       1,680  
Loss on impairment   931        
Total operating expenses   48,785       65,217  
Loss from operations   (45,247 )     (54,429 )
Interest and other expense, net   (2,795 )     (2,578 )
Loss before income taxes   (48,042 )     (57,007 )
Provision for income taxes   55       41  
Net loss and comprehensive loss $ (48,097 )   $ (57,048 )
Net loss and comprehensive loss per share, basic and diluted $ (2.84 )   $ (6.97 )
Weighted-average number of shares outstanding used to compute net loss per share, basic and diluted   16,920,600       8,182,525  

Share and per-share amounts have been adjusted to give effect to the Company’s 10 for 1 reverse stock split effective March 8, 2023





SHIFT TECHNOLOGIES INC. AND SUBSIDIARIES


Condensed Consolidated Statements of Cash Flows


(in thousands)



(unaudited)

  Three Months Ended

March 31,
  2023   2022
CASH FLOWS FROM OPERATING ACTIVITIES      
Net loss $ (48,097 )   $ (57,048 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization   4,467       2,019  
Stock-based compensation expense   1,233       4,192  
Amortization of operating lease right-of-use assets   3,388       2,162  
Contra-revenue associated with milestones   601       159  
Amortization of debt discounts   591       365  
Loss on impairment and non-cash restructuring expenses   931        
Loss on disposal of long-lived assets   3,439        
Changes in operating assets and liabilities:      
Accounts receivable   845       130  
Inventory   6,906       (37,762 )
Prepaid expenses and other current assets   1,437       (2,179 )
Other non-current assets   101       (27 )
Accounts payable   1,842       (543 )
Accrued expenses and other current liabilities   (9,780 )     (6,243 )
Operating lease liabilities   (3,746 )     (1,925 )
Other non-current liabilities   (38 )     (1,670 )
Net cash, cash equivalents, and restricted cash used in operating activities   (35,880 )     (98,370 )
       
CASH FLOWS FROM INVESTING ACTIVITIES      
Purchases of property and equipment   (390 )     (1,444 )
Proceeds from sale of property and equipment   9        
Proceeds from sales of marketable securities   806        
Proceeds from commutation of reinsurance contracts   187        
Capitalized website internal-use software costs   (1,991 )     (2,328 )
Net cash, cash equivalents, and restricted cash used in investing activities   (1,379 )     (3,772 )
       
CASH FLOWS FROM FINANCING ACTIVITIES      
Proceeds from flooring line of credit facility   33,229       126,903  
Repayment of flooring line of credit facility   (35,895 )     (110,150 )
Principal payments on finance leases   (180 )      
Proceeds from stock option exercises, including from early exercised options         3  
Payment of tax withheld for common stock issued under stock-based compensation plans   (19 )     (2,162 )
Repurchase of shares related to early exercised options   (1 )     (10 )
Net cash, cash equivalents, and restricted cash provided by (used in) financing activities   (2,866 )     14,584  
Net decrease in cash, cash equivalents and restricted cash   (40,125 )     (87,558 )
Cash, cash equivalents and restricted cash, beginning of period   107,846       194,341  
Cash, cash equivalents and restricted cash, end of period $ 67,721     $ 106,783  





SHIFT TECHNOLOGIES, INC. AND SUBSIDIARIES


Key Operating Metrics


(unaudited)

  Three Months Ended

March 31,
  2023   2022
Units:      
Retail units   2,396       6,714  
Wholesale units   344       1,975  
Total units sold   2,740       8,689  
       
Retail ASP $ 21,298     $ 27,269  
Wholesale ASP $ 13,779     $ 14,069  
       
Gross Profit per Unit      
Retail gross profit per unit $ 951     $ 330  
Other gross profit per unit   802       1,298  
Wholesale gross profit per unit   (276 )     (21 )
Total gross profit per unit $ 1,477     $ 1,607  
       
Average monthly unique visitors   543,911       822,856  
Average days to sale   78       56  
Retail vehicles available for sale   1,650       5,464  





SHIFT TECHNOLOGIES, INC. AND SUBSIDIARIES


Reconciliation of Gross Profit to Adjusted Gross Profit

(In thousands)

(unaudited)

  Three Months Ended

March 31,
    2023       2022  
Total gross profit:      
GAAP total gross profit $ 3,538     $ 10,788  
Warrant impact adjustment (1)   106       159  
Closed location inventory costs (2)   571        
Depreciation in cost of sales (3)   43       339  
Adjusted total gross profit $ 4,258     $ 11,286  
       
Retail gross profit:      
GAAP retail gross profit $ 2,278     $ 2,214  
Warrant impact adjustment (1)          
Closed location inventory costs (2)   571        
Depreciation in cost of sales (3)   43       339  
Adjusted retail gross profit $ 2,892     $ 2,553  
       
Other gross profit:      
GAAP other gross profit $ 1,922     $ 8,712  
Warrant impact adjustment (1)   106       159  
Closed location inventory costs (2)          
Depreciation in cost of sales (3)          
Adjusted other gross profit $ 2,028     $ 8,871  
       
Wholesale gross profit:      
GAAP wholesale gross profit $ (662 )   $ (138 )
Warrant impact adjustment (1)          
Closed location inventory costs (2)          
Depreciation in cost of sales (3)          
Adjusted wholesale gross profit (loss) $ (662 )   $ (138 )

(1)   Includes non-cash charges related to the Lithia warrants and recorded as contra-revenue on the consolidated statements of operations and comprehensive loss.

(2)   Includes non-recurring losses on inventory incurred related to the closure of the Downers Grove, IL location.

(3)   Includes depreciation expense attributed to reconditioning facilities included in cost of sales on the condensed consolidated statements of operations and comprehensive loss.

SHIFT TECHNOLOGIES, INC. AND SUBSIDIARIES

Reconciliation of Gross Profit Per Unit To Adjusted Gross Profit Per Unit

(unaudited)

  Three Months Ended

March 31,
    2023       2022  
Total gross profit per unit:      
GAAP total gross profit per unit $ 1,477     $ 1,607  
Warrant impact adjustment per unit (1)   44       24  
Closed location inventory costs (2)   238        
Depreciation adjustment per unit (3)   18       50  
Adjusted total gross profit per unit $ 1,777     $ 1,681  
       
Retail gross profit per unit:      
GAAP retail gross profit per unit $ 951     $ 330  
Warrant impact adjustment per unit (1)          
Closed location inventory costs (2)   238        
Depreciation adjustment per unit (3)   18       50  
Adjusted retail gross profit per unit $ 1,207     $ 380  
       
Other gross profit per unit:      
GAAP other gross profit per unit $ 802     $ 1,298  
Warrant impact adjustment per unit (1)   44       24  
Closed location inventory costs (2)          
Depreciation adjustment per unit (3)          
Adjusted other gross profit per unit $ 846     $ 1,322  
       
Wholesale gross profit per unit:      
GAAP wholesale gross profit per unit $ (276 )   $ (21 )
Warrant impact adjustment per unit (1)          
Closed location inventory costs (2)          
Depreciation adjustment per unit (3)          
Adjusted wholesale gross profit (loss) per unit $ (276 )   $ (21 )

(1)   Includes non-cash charges related to the Lithia warrants and recorded as contra-revenue on the consolidated statements of operations and comprehensive loss.

(2)   Includes non-recurring losses on inventory incurred related to the closure of the Downers Grove, IL location.

(3)   Includes depreciation expense attributed to reconditioning facilities included in cost of sales on the condensed consolidated statements of operations and comprehensive loss.





SHIFT TECHNOLOGIES, INC. AND SUBSIDIARIES


Reconciliation of Net Loss to Adjusted EBITDA

(In thousands)

(unaudited)

  Three Months Ended

March 31,

Adjusted EBITDA Reconciliation
  2023       2022  
Net Loss $ (48,097 )   $ (57,048 )
(+) Interest and other expense, net   2,795       2,578  
(+) Stock-based compensation   1,233       4,192  
(+) Depreciation & amortization   4,462       2,019  
(+) Warrant impact adjustment – contra-revenue (1)   106       159  
(+) Merger and acquisition transaction and integration costs (2)   1,451       1,471  
(+) Provision for income taxes   55       41  
(+) Costs related to closed locations excluding severance (3)   6,561        
(+) Severance, retention, and CEO costs (4)   1,441        
(+) Facility closure costs from inventory, and property and equipment (5)   4,328        
(+) Impairment expense   931        
(+) F&I Milestone prepaid asset termination(1)   495        
(+) Capital markets costs(6)   195        
Adjusted EBITDA $ (24,044 )   $ (46,588 )
EBITDA Margin (%) (41.7)        %   (21.2)        %

(1)   Includes non-cash charges related to the Lithia warrants and recorded as contra-revenue on the consolidated statements of operations and comprehensive loss, as well as a one-time non-cash charge related to the termination of the underlying contract.
(2)   Includes transaction costs for the Carlotz merger continuing into the first quarter.
(3)   Includes non-cash lease expense related to the continued closures of the Company’s facilities. Includes fulfillment, lease, payroll, facilities, and other operating expenses related to the process of closing facilities.
(4)   Includes severance and retention amounts related employees, executives, and the CEO transition.
(5)   Includes net losses on inventory liquidated as part of the aforementioned facility closures. Includes losses on property sold or disposed from closing facilities.    
(6)   Includes one-time costs associated with the conversion of the Company’s Form S-3 registration statement to Form S-1.





SHIFT TECHNOLOGIES, INC. AND SUBSIDIARIES


Reconciliation of Selling, General and Administrative Expenses to Adjusted Selling, General and Administrative Expenses

(In thousands)

(unaudited)

  Three Months Ended

March 31,

Adjusted Selling, General and Administrative Expenses Reconciliation
  2023       2022  
Selling, general and administrative expenses $ 43,435     $ 63,537  
(-) Stock-based compensation   (1,233 )     (4,192 )
(-) Merger and acquisition transaction and integration costs   (1,451 )     (1,471 )
(-) Costs related to closed locations excluding severance   (6,561 )      
(-) Severance, retention, and CEO costs   (1,441 )      
(-) Facility closure costs from property and equipment (1)   (3,757 )      
(-) F&I Milestone prepaid asset termination(2)   (495 )      
(-) Capital markets costs(3)   (195 )      
Adjusted selling, general and administrative expenses $ 28,302     $ 57,874  

(1)   Included in Facility closure costs from inventory, and property and equipment in the Adjusted EBITDA Reconciliation table above.
(2)   Includes non-cash charges related to the Lithia warrants and recorded as contra-revenue on the consolidated statements of operations and comprehensive loss, as well as a one-time non-cash charge related to the termination of the underlying contract.
(3)   Includes one-time costs associated with the conversion of the Company’s Form S-3 registration statement to Form S-1.



Viracta Therapeutics to Present at the RBC Capital Markets Global Healthcare Conference

SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) — Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that Mark Rothera, its President and Chief Executive Officer, and Dan Chevallard, its Chief Operating Officer and Chief Financial Officer, are scheduled to participate in a fireside chat at the RBC Capital Markets Global Healthcare Conference on Wednesday, May 17, 2023, at 4:05 p.m. EDT.

A live webcast of the fireside chat will be available on the Investors section of the Viracta website under “Events and Webcasts” and archived for 90 days.

About Viracta Therapeutics, Inc.

Viracta is a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed/refractory Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 trial for the treatment of EBV+ recurrent or metastatic nasopharyngeal carcinoma and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers.

For additional information please visit www.viracta.com.

Investor Relations Contact:

Ashleigh Barreto
Head of Investor Relations & Corporate Communications
Viracta Therapeutics, Inc.
[email protected]

SOURCE Viracta Therapeutics, Inc.



Kinnate Biopharma Inc. Reports First Quarter 2023 Financial Results and Recent Corporate Updates

  • Presented positive monotherapy dose escalation data for exarafenib, an investigational pan-RAF inhibitor, at the 2023 AACR Annual Meeting

  • Provided update on ongoing exarafenib monotherapy dose expansion; data-informed strategy prioritizes enrollment in BRAF Class II-driven solid tumors

  • Disclosed early, compelling responses with exarafenib plus binimetinib from the ongoing dose escalation combination arm, primarily in NRAS mutant melanoma

  • Announced the addition of two new development candidates to its pipeline, a MEK inhibitor and a c-MET inhibitor

  • Upcoming poster presentation on genomic landscape analysis in FGFR2 at the 2023 American Society of Clinical Oncology Annual Meeting

  • Cash, cash equivalents and investments of $231.2 million as of March 31, 2023 anticipated to fund operations into early 2025

SAN FRANCISCO and SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) — Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage precision oncology company, today announced financial results for the first quarter of 2023 and recent corporate updates.

“Kinnate continues to make demonstrable progress with its pipeline of highly selective compounds designed with optimized drug properties and the ability to address a broad set of alterations, overcome resistance mechanisms and/or achieve brain penetrance,” said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. “At AACR this year, we presented the first clinical data for the company from our RAF program, showing exarafenib, the lead product candidate, was well-tolerated, achieved substantial, dose proportional and therapeutically meaningful exposures with objective measures of response supporting its best-in-class profile. Building on this momentum, we look forward to several additional catalysts in the second half of the year, including dose selection for the exarafenib and binimetinib combination where we’ve also observed early responses, initial dose escalation data for KIN-3248, our investigational pan-FGFR inhibitor, and entering the clinic with our third internally developed product candidate, a brain-penetrant MEK inhibitor. With a strong balance sheet, we believe our current capital will fund operations into early 2025, enabling our continued growth as a global company.”

Pipeline Updates

  • The company will have a poster presentation at the 2023 American Society of Clinical Oncology Annual Meeting on circulating tumor DNA-based genomic landscape analysis to evaluate molecular brake and gatekeeper mutations in FGFR2. (View Poster Details) Initial dose escalation data from the ongoing global Phase 1 clinical trial, KN-4802, evaluating the pan-FGFR inhibitor, KIN-3248, in patients with FGFR2/3 alterations is expected in the second half of 2023.
  • Presented exarafenib monotherapy dose escalation data from KN-8701, a global Phase 1 clinical trial, during an oral presentation at the American Association for Cancer Research (AACR) 2023 Annual Meeting. In addition, the company provided an update on the monotherapy dose expansion strategy and announced preliminary findings from the combination arm of KN-8701, evaluating exarafenib plus binimetinib. The company expects to provide an update in the second half of 2023 on the dose selection and additional escalation data for exarafenib plus binimetinib, and initial exarafenib monotherapy dose expansion data in the first half of 2024. (View Release)
  • Presented preclinical data for exarafenib monotherapy and in combination with a MEK inhibitor in human NRAS mutant melanoma models in a poster session at the AACR 2023 Annual Meeting. (View Poster)
  • Announced the addition of two next-generation development candidates to the pipeline – a brain penetrant mitogen-activated protein kinase (MEK) inhibitor (KIN-7136), expected to enter the clinic in the second half of 2023, and a highly selective mesenchymal epithelial transition (c-MET) inhibitor (KIN-8741), expected to enter the clinic in the first half of 2024. (View Release)
  • Announced the company will evaluate strategic alternatives for its Cyclin-Dependent Kinase (CDK12) program. (View Release)

Financial Results

  • As of March 31, 2023, total cash, cash equivalents and investments were $231.2 million, which is expected to fund current operations into early 2025.
  • First quarter research and development expenses for 2023 were $26.5 million, compared to $19.6 million for the same period in 2022.
  • First quarter general and administrative expenses for 2023 were $8.1 million, compared to $7.4 million for the same period in 2022.
  • First quarter net loss for 2023 was $32.9 million, compared to $26.9 million for the same period in 2022.

About Kinnate Biopharma Inc.

Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer. The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such as non-responsiveness or acquired and intrinsic resistance. Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine. The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. For more information, visit Kinnate.com and follow us on LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation, the timing and presentation of clinical data and dose selection; statements regarding the potential benefits and properties of the company’s product candidates; the timing for initiation of clinical trials for KIN-7136 and KIN-8741; the sufficiency of our funding to continue to operate, support long term growth and progress our pipeline; our anticipated cash runway; and statements by our Chief Executive Officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors, including, among other things: operating as a clinical-stage biopharmaceutical company with a limited operating history; the timing, progress and results of ongoing and planned preclinical studies and clinical trials for our current product candidates; that continued dose escalation in our clinical trials could increase the risk of the occurrence of adverse events; the potential for future clinical trial results to differ from initial results or from our preclinical studies; our ability to timely enroll a sufficient number of patients in our clinical trials; our ability to raise additional capital to finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs; our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; negative impacts of the COVID-19 pandemic on our business, including ongoing and planned clinical trials and preclinical studies; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property; reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our product candidates; general economic and market conditions; and other risks. These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 that we are concurrently filing with the Securities and Exchange Commission (SEC), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.

Investor & Media Contact:

Priyanka Shah | [email protected] | +1-908-447-6134

Kinnate Biopharma Inc.    
Condensed Consolidated Balance Sheets    
(in thousands, except share and par value amounts)    
             
         
    March 31, 2023   December 31, 2022  
Assets            
Current assets:            
Cash and cash equivalents   $ 73,570     $ 29,261      
Cash at consolidated joint venture           25,725      
Short-term investments     127,411       172,214      
Prepaid expenses and other current assets     4,307       3,637      
Total current assets     205,288       230,837      
Property and equipment, net     2,877       3,071      
Right-of-use lease assets     3,170       3,377      
Long-term investments     30,203       39,139      
Restricted cash     371       371      
Other non-current assets     1,971       2,031      
Total assets   $ 243,880     $ 278,826      
             
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Equity        
Current liabilities:            
Accounts payable   $ 4,451     $ 2,970      
Accrued expenses     12,721       13,206      
Current portion of operating lease liabilities     983       991      
Total current liabilities     18,155       17,167      
Operating lease liabilities, long-term     2,963       3,191      
Total liabilities     21,118       20,358      
Redeemable convertible noncontrolling interests           35,000      
Stockholders’ equity:            
Preferred stock, $0.0001 par value; 200,000,000 shares authorized at            
    March 31, 2023 and December 31, 2022; 0 shares outstanding at            
    March 31, 2023 and December 31, 2022                
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at            
    March 31, 2023 and December 31, 2022; 46,569,648 and 44,342,292 shares            
    issued and outstanding at March 31, 2023 and December 31, 2022 , respectively     5       4      
Additional paid-in capital     515,524       484,237      
Accumulated other comprehensive loss     (464 )     (1,410 )    
Accumulated deficit     (292,303 )     (259,363 )    
Total stockholders’ equity     222,762       223,468      
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ equity   $ 243,880     $ 278,826      
             
Kinnate Biopharma Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
             
      Three Months Ended March 31,  
        2023       2022    
             
Operating expenses:            
Research and development     $ 26,559     $ 19,647    
General and administrative       8,094       7,412    
Total operating expenses       34,653       27,059    
Loss from operations       (34,653 )     (27,059 )  
Other income, net       1,713       157    
Net loss     $ (32,940 )   $ (26,902 )  
             
Weighted-average shares outstanding, basic and diluted       45,409,572       43,882,920    
Net loss per share, basic and diluted     $ (0.73 )   $ (0.61 )  
             
             
Comprehensive loss:            
Net loss     $ (32,940 )   $ (26,902 )  
Other comprehensive loss:            
Unrealized gain (loss) on investments       946       (1,656 )  
Total comprehensive loss     $ (31,994 )   $ (28,558 )  
             

 



ImmuCell Announces Unaudited Financial Results for the Quarter Ended March 31, 2023

PORTLAND, Maine, May 11, 2023 (GLOBE NEWSWIRE) — ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced its unaudited financial results for the quarter ended March 31, 2023.


Management’s Discussion:


“Our unaudited, preliminary product sales were first reported on April 5, 2023,” commented Michael F. Brigham, President and CEO of ImmuCell. “We have no changes to those figures.”

“We have just persevered through the most difficult quarter in the history of the Company,” continued Mr. Brigham. “As previously disclosed, we made the strategic decision to significantly reduce production output to remediate a production contamination event. We believe that the operational improvements we have implemented throughout the production process as part of this remediation will help us run more effectively at a higher output level going forward.”

This production slowdown, in part, contributed to an increase in the order backlog to approximately $8 million as of May 3, 2023 from $2.5 million as of December 31, 2022. Due to the loss in earned gross margin that was incurred during the first quarter of 2023, the Company has made the decision to defer, for the time being, completion of certain capital expenditure investments.

The Company is being driven by data as it resolves this temporary production problem. Product is tested at the beginning, middle and end of the production process. From February 1, 2023 through May 3, 2023, the incoming quality control test has met standards 88% of the time, and the mid-process and end-process tests have both consistently passed. This improvement from the depth of the contamination problem in January is allowing the Company to come back into full production.

“As we recover and resume full production, our goal is to produce more product quarter after quarter than we did during the first quarter of 2023,” added Mr. Brigham. “When this contamination event is fully behind us, our goal is to be able to produce at least $6 million worth of product per quarter, which would annualize to about 80% of our $30 million full production capacity annually.”

“The increase in sales demand for the First Defense® product line leading up to the contamination events is both exciting and difficult for us. The 2023 supply shortage may prove to be more detrimental to our growth curve than any other supply shortage because it impacted so many customers during peak calving season. We are doing the necessary work to stabilize supply, regain lost business and reestablish our growth objectives,” concluded Mr. Brigham. “At the same time, we are preparing all the data required to make our third submission of the CMC Technical Section for Re-Tain® during the second quarter of 2023, and we remain poised and excited to revolutionize the way that subclinical mastitis is treated in today’s dairy market with a novel alternative to traditional antibiotics.”


Certain Financial Results:

  • Product sales decreased by 43%, or $2.6 million, to $3.4 million during the three-month period ended March 31, 2023 compared to $6.0 million during the three-month period ended March 31, 2022.
  • Product sales decreased by 24%, or $5.1 million, to $16.0 million during the trailing twelve-month period ended March 31, 2023 compared to $21.1 million during the trailing twelve-month period ended March 31, 2022.
  • Gross margin earned was 9% and 52% of product sales during the three-month periods ended March 31, 2023 and 2022, respectively. The less than normal gross margin during 2023 was largely the result of product contamination events in the production processes that resulted in a slowdown in production output and a write-off of the affected inventory. Remediation measures are being implemented to reduce the opportunity for recurrence.
  • Net operating (loss) was ($2.3) million during the three-month period ended March 31, 2023 in contrast to a net operating income of $571,000 during the three-month period ended March 31, 2022.
  • Net (loss) was ($2.3) million, or ($0.30) per basic share, during the three-month period ended March 31, 2023 in comparison to net income of $513,000, or $0.07 per diluted share, during the three-month period ended March 31, 2022.
  • EBITDA (a non-GAAP financial measure described on page 5 of this press release) decreased to approximately ($1.6) million during the three-month period ended March 31, 2023 from $1.2 million during the three-month period ended March 31, 2022.


Balance Sheet Data as of March 31, 2023:

  • Cash and cash equivalents decreased to $3.1 million as of March 31, 2023 from $5.8 million as of December 31, 2022.
  • Net working capital decreased to approximately $8.4 million as of March 31, 2023 from $10.9 million as of December 31, 2022.
  • Stockholders’ equity decreased to $28.2 million as of March 31, 2023 from $30.4 million as of December 31, 2022.


Cautionary Note Regarding Forward-Looking Statements (Safe


Harbor


Statement):

This Press Release and the statements to be made in the related earnings conference call referenced herein contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and will often include words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. Such statements include, but are not limited to, any forward-looking statements relating to: our plans and strategies for our business; projections of future financial or operational performance; the timing and outcome of pending or anticipated applications for regulatory approvals; future demand for our products; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis and producers’ level of interest in treating subclinical mastitis given the current economic and market conditions; the expected efficacy of new products; estimates about the market size for our products; future market share of and revenue generated by current products and products still in development; our ability to increase production output and reduce costs of goods sold per unit; the adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the impacts of backlogs on customer relationships; the efficacy or timeline to complete our contamination remediation efforts; the likelihood, severity or impact of future contamination events; the anticipated costs of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity, efficiency and yield; future regulatory requirements relating to our products; future expense ratios and margins; the efficacy of our investments in our business; anticipated changes in our manufacturing capabilities and efficiencies; projections about depreciation expense and its impact on income for book and tax return purposes; and any other statements that are not historical facts. These statements are intended to provide management’s current expectation of future events as of the date of this earnings release, are based on management’s estimates, projections, beliefs and assumptions as of the date hereof; and are not guarantees of future performance. Such statements involve known and unknown risks and uncertainties that may cause the Company’s actual results, financial or operational performance or achievements to be materially different from those expressed or implied by these forward-looking statements, including, but not limited to, those risks and uncertainties relating to: difficulties or delays in development, testing, regulatory approval, production and marketing of our products (including the First Defense® product line and Re-Tain®), competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand (including the consequences of backlogs), uncertainty associated with the timing and volume of customer orders as we come out of a prolonged backlog, adverse impacts of supply chain disruptions on our operations and customer and supplier relationships, commercial and operational risks relating to our current and planned expansion of production capacity, and other risks and uncertainties detailed from time to time in filings we make with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements involve risks and uncertainties and are based on our current expectations, but actual results may differ materially due to various factors. In addition, there can be no assurance that future risks, uncertainties or developments affecting us will be those that we anticipate. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 
Condensed Statements of Operations (Unaudited)
 
  During the Quarters Ended March 31,
(In thousands, except per share amounts)   2023     2022
       
Product sales $3,447     $6,000
Costs of goods sold   3,146       2,897
Gross margin   301       3,103
       
Product development expenses   1,110       1,036
Sales, marketing and administrative expenses   1,447       1,497
Operating expenses   2,557       2,533
       
NET OPERATING (LOSS) INCOME   (2,256 )     570
       
Other expenses, net   57       56
       
(LOSS) INCOME BEFORE INCOME TAXES   (2,313 )     514
       
Income tax expense   2       1
       
NET (LOSS) INCOME ($2,315 )   $513
       
Basic weighted average common shares            
outstanding   7,747       7,742
Basic net (loss) income per share ($0.30 )   $0.07
       
Diluted weighted average common shares            
outstanding   7,747       7,789
Diluted net (loss) income per share ($0.30 )   $0.07
       

Selected Balance Sheet Data (In thousands) (Unaudited)
       
  As of

March 31, 2023
  As of

December 31, 2022
Cash and cash equivalents $3,096   $5,792
Net working capital 8,410   10,923
Total assets 43,123   44,861
Stockholders’ equity $28,161   $30,380
       


Non-GAAP Financial Measures:


Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flow that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP measures included in this press release should be considered in addition to, and not as a substitute for or superior to, the comparable measure prepared in accordance with GAAP. We believe that considering the non-GAAP measures of Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) assists management and investors by looking at our performance across reporting periods on a consistent basis excluding these certain charges that are not uses of cash from our reported (loss) income before income taxes. We calculate EBITDA as described in the following table:

  During the Quarters Ended March 31,
(In thousands)   2023     2022
       
(Loss) Income before income taxes ($2,313 )   $514
Interest Expense (excluding debt issuance costs)   88       73
Depreciation   652       617
Amortization   7       7
EBITDA ($1,566 )   $1,211
             

During the three-month periods ended March 31, 2023 and 2022, EBITDA included approximately $96,000 and $54,000 of stock-based compensation expense, respectively, which is a non-cash expense that we add back to EBITDA when assessing our cash flows.


Conference Call:


The Company will host a conference call on Friday, May 12, 2023 at 9:00 AM ET to discuss the full unaudited financial results for the quarter ended March 31, 2023. Interested parties can access the conference call by dialing (844) 855-9502 (toll free) or (412) 317-5499 (international). A teleconference replay of the call will be available until May 19, 2023 at (877) 344-7529 (toll free) or (412) 317-0088 (international), utilizing replay access code #3163870. Investors are encouraged to review the Company’s updated Corporate Presentation slide deck that provides an overview of the Company’s business and is available under the “Investors” tab of the Company’s website at www.immucell.com, or by request to the Company.


About ImmuCell:


ImmuCell Corporation’s (Nasdaq: ICCC) purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell manufactures and markets First Defense®, providing Immediate Immunity™ to newborn dairy and beef calves, and is in the late stages of developing Re-Tain®, a novel treatment for subclinical mastitis in dairy cows without a milk discard requirement that provides an alternative to traditional antibiotics. Press releases and other information about the Company are available at: http://www.immucell.com.

Contacts: Michael F. Brigham, President and CEO
  ImmuCell Corporation
  (207) 878-2770
   
  Joe Diaz, Robert Blum and Joe Dorame
  Lytham Partners, LLC 
  (602) 889-9700
  [email protected] 



Iridex Reports First Quarter 2023 Financial Results

MOUNTAIN VIEW, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Iridex Corporation (Nasdaq: IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, today reported financial results for the first quarter ended April 1, 2023.

First Quarter 2023 Highlights

  • Generated total revenue of $13.7 million, an increase of 2% year-over-year
  • Cyclo G6® product family revenue of $3.7 million increased 4% year-over-year
    • 61 Cyclo G6 Glaucoma Laser Systems sold, compared to 56 in the prior year period
    • Cyclo G6 probe revenue increased 6% year-over-year on decreased unit sales of 13,800 probes
  • Retina product revenue of $7.2 million was essentially flat year-over-year
  • Received FDA clearance in February for the new single-spot laser platform for the Iridex 532 and Iridex 577 systems
  • Cash and cash equivalents totaled approximately $11.0 million as of April 1, 2023

“In addition to receiving FDA clearance in February for our second key laser platform, we were pleased to achieve 19% year-over-year growth in U.S. G6 probe revenue,” said David Bruce, President and CEO. “Although we experienced a modest decline in year-over-year glaucoma probe unit sales resulting from continued international distributor order volatility after a record fourth quarter, we saw strength in international purchases of glaucoma systems. We remain confident in our activities to drive adoption and utilization of our Cyclo G6 glaucoma treatment platform. By leveraging our Sweep Management software and increasing awareness of effective dosing recommendations, we expect clinicians to experience strong clinical outcomes and consistency, leading to increased utilization throughout the year.”

First Quarter 2023 Financial Results

Revenue for the three months ended April 1, 2023 was $13.7 million compared to $13.4 million during the same period of the prior year. Total product revenue from the Cyclo G6 glaucoma product group was $3.7 million, an increase of 4% compared to the first quarter of 2022, driven by strong probe ASP growth in the U.S. Retina product revenue in the first quarter was $7.2 million compared to $7.3 million in the prior year, a decrease of 1%. Other revenue, which includes royalties, services, and other legacy products, increased 11% to $2.8 million in the first quarter of 2023 compared to the prior year, primarily driven by higher revenue from Other legacy products.

Gross profit for the first quarter of 2023 remained essentially unchanged at $5.9 million or a 43.3% gross margin, compared to $6.0 million, or a 44.6% gross margin, in the same period of the prior year. The lower gross margin was the result of higher production overhead.

Operating expenses for the first quarter of 2023 were flat at $8.3 million for both the first quarter of 2023 and in the same period of the prior year.

Net loss for the first quarter of 2023 was $2.1 million, or $0.13 per share, compared to a net loss of $2.4 million, or $0.15 per share, in the same period of the prior year.

Cash and cash equivalents totaled $11.0 million as of April 1, 2023. Cash use of $2.9 million in the first quarter included items unique to the first quarter and cash usage is expected to decrease significantly in the remaining quarters of 2023 as inventory levels decrease.

Guidance for Full Year 2023

Iridex reiterated its financial outlook for 2023, expecting Cyclo G6 probe sales of 65,000 to 67,000 representing approximately 9% to 12% growth over 2022 and to expand the Cyclo G6 systems installed base by 225 to 250 systems. Total revenue for the full year is expected to be $57 million to $59 million. 2023 total revenue guidance represents growth of approximately 3% to 6% after adjusting for an approximate $1.5 million reduction of Other Revenue royalty income resulting from the expiration of licensed patents.

Webcast and Conference Call Information

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

About Iridex

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

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical and commercial momentum, market adoption and expansion, demand for and utilization of the Company’s products, financial guidance and results and expected sales volumes. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the fiscal year ended December 31, 2022. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

Investor Relations Contact

Philip Taylor
Gilmartin Group
[email protected]

IRIDEX Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share data)
(unaudited)

    Three Months Ended  
    April 1,     April 2,  
    2023     2022  
                 
Total revenues   $ 13,706     $ 13,387  
Cost of revenues     7,768       7,410  
Gross profit     5,938       5,977  
                 
Operating expenses:                
Research and development     1,749       2,116  
Sales and marketing     4,283       4,300  
General and administrative     2,250       1,838  
Total operating expenses     8,282       8,254  
                 
Loss from operations     (2,344 )     (2,277 )
Other income (expense), net     266       (94 )
Loss from operations before provision for income taxes     (2,078 )     (2,371 )
Provision for income taxes     12       20  
Net loss   $ (2,090 )   $ (2,391 )
                 
Net loss per share:                
Basic   $ (0.13 )   $ (0.15 )
Diluted   $ (0.13 )   $ (0.15 )
                 
Weighted average shares used in computing net loss per share                
Basic     16,001       15,881  
Diluted     16,001       15,881  

IRIDEX Corporation

Condensed Consolidated Balance Sheets

(In thousands and unaudited)

    April 1,     December 31,  
    2023     2022  

Assets
               
Current assets:                
Cash and cash equivalents   $ 11,048     $ 13,922  
Accounts receivable, net     10,759       9,768  
Inventories     11,241       10,608  
Prepaid expenses and other current assets     1,650       1,468  
Total current assets     34,698       35,766  
Property and equipment, net     449       462  
Intangible assets, net     1,894       1,977  
Goodwill     965       965  
Operating lease right-of-use assets, net     1,423       1,665  
Other long-term assets     1,551       1,455  
Total assets   $ 40,980     $ 42,290  


Liabilities and Stockholders’ Equity

               
Current liabilities:                
Accounts payable   $ 3,669     $ 3,873  
Accrued compensation     2,813       2,448  
Accrued expenses     2,132       1,548  
Other current liabilities     882       968  
Accrued warranty     196       168  
Deferred revenue     2,424       2,411  
Operating lease liabilities     1,046       1,037  
Total current liabilities     13,162       12,453  
                 
Long-term liabilities:                
Accrued warranty     124       106  
Deferred revenue     11,312       11,742  
Operating lease liabilities     472       732  
Other long-term liabilities     26       26  
Total liabilities     25,096       25,059  
                 
Stockholders’ equity:                
Common stock     169       169  
Additional paid-in capital     87,312       86,802  
Accumulated other comprehensive loss     (35 )     (24 )
Accumulated deficit     (71,562 )     (69,716 )
Total stockholders’ equity     15,884       17,231  
Total liabilities and stockholders’ equity   $ 40,980     $ 42,290  

 



Phunware Reports First Quarter 2023 Financial Results

AUSTIN, Texas, May 11, 2023 (GLOBE NEWSWIRE) — Phunware, Inc. (NASDAQ: PHUN) (“Phunware” or the “Company”), the pioneer of Location Based SaaS and offers the only fully integrated enterprise cloud platform for mobile that enables brands to engage, manage and monetize their anytime, anywhere users worldwide, today announced financial results for the quarter ended March 31, 2023.

“This past quarter we expanded our breadth of reach and depth of engagement with major brands for our market-leading Location Based Platform,” said Russ Buyse, CEO of Phunware. “We are thrilled to add Siemens as a channel partner through their Siemens Connect Ecosystem. Partners like Siemens are a prime example of the types of relationships we intend to forge and will be a key accelerator for bookings on our Platform in 2023 and beyond. I’m also encouraged by the progress made by major brands moving deeper through our sales pipeline. At the same time, our product team made huge strides in realizing our vision for Contextual Engagement on our Platform. Phunware gives brands the tools and reach to enhance the consumer experience, increase customer satisfaction and provide a strong return on investment. Looking ahead, we intend to continue ramping our go-to-market efforts to capture as much market share as possible.”


First Quarter 2023 Financial Results

  • Net revenues for the quarter totaled $4.7 million
  • Platform revenues were $1.3 million
  • Hardware revenues were $3.4 million
  • Net loss was $(4.3) million
  • Net loss per share was $(0.04)
  • Non-GAAP Adjusted EBITDA loss was $(5.6) million


Recent Business Highlights


Conference Call Information

Phunware management will host a conference call today (May 11, 2023) at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its financial results for the quarter ended March 31, 2023.

Interested parties may access the conference call by dialing 888-506-0062 in the United States, or 973-528-0011 from international locations with access code: 196075. The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at investors.phunware.com.

Safe Harbor Clause and Forward-Looking Statements

This press release includes forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “expose,” “intend,” “may,” “might,” “opportunity,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments and their potential effects on us. Future developments affecting us may not be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission (the “SEC”), including our reports on Forms 10-K, 10-Q, 8-K and other filings that we make with the SEC from time to time. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. These risks and others described under “Risk Factors” in our SEC filings may not be exhaustive.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and developments in the industry in which we operate may differ materially from those made in or suggested by the forward-looking statements contained in this press release. In addition, even if our results or operations, financial condition and liquidity, and developments in the industry in which we operate are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in subsequent periods.

Disclosure Information

Phunware uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations and webcasts.

About Phunware, Inc.

Everything You Need to Succeed on Mobile — Transforming Digital Human Experience

Phunware, Inc. (NASDAQ: PHUN), the pioneer of Location Based SaaS and offers the only fully integrated enterprise cloud platform for mobile that enables brands to engage, manage and monetize their anytime, anywhere users worldwide. Phunware’s Software Development Kits (SDKs) include location-based services, mobile engagement, content management, messaging, advertising, loyalty (PhunCoin & PhunToken) and analytics, as well as a mobile application framework of pre-integrated iOS and Android software modules for building in-house or channel-based mobile application and vertical solutions. Phunware helps the world’s most respected brands create category-defining mobile experiences, with approximately one billion active devices touching its platform each month when operating at scale. For more information about how Phunware is transforming the way consumers and brands interact with mobile in the virtual and physical worlds, visit https://phunware.com and follow @phunware on all social media platforms.

Phunware PR & Media Inquiries:

Email: [email protected]
Phone: (512) 693-4199

Phunware Investor Relations:

Matt Glover and John Yi
Gateway Investor Relations
Email: [email protected]
Phone: (949) 574-3860

 
Condensed Consolidated Balance Sheets
(In thousands, except share and per share information)
 
  March 31, 2023   December 31, 2022
  (Unaudited)    
Assets      
Current assets:      
Cash $ 694     $ 1,955  
Accounts receivable, net of allowance for doubtful accounts of $198 at March 31, 2023 and December 31, 2022, respectively   1,200       958  
Inventory   2,671       2,780  
Digital assets   2,530       10,137  
Prepaid expenses and other current assets   807       1,033  
Total current assets   7,902       16,863  
Property and equipment, net   206       221  
Goodwill   31,136       31,113  
Intangible assets, net   2,357       2,524  
Right-of-use asset   3,489       3,712  
Other assets   367       402  
Total assets $ 45,457     $ 54,835  
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $ 7,765     $ 7,699  
Accrued expenses   2,506       2,895  
Lease liability   961       954  
Deferred revenue   1,512       2,904  
PhunCoin deposits   1,202       1,202  
Current maturities of long-term debt, net   5,687       9,667  
Warrant liability   3       256  
Total current liabilities   19,636       25,577  
Deferred revenue   1,072       1,274  
Lease liability   2,848       3,103  
Total liabilities   23,556       29,954  
Commitments and contingencies (Note 8)      
Stockholders’ equity      
Common stock, $0.0001 par value; 1,000,000,000 shares authorized; 104,469,310 shares issued and 104,007,810 shares outstanding as of March 31, 2023 and 103,153,337 shares issued and outstanding as of December 31, 2022, respectively   10       10  
Treasury stock at cost; 461,500 and 0 shares at March 31, 2023 and December 31, 2022, respectively   (475 )      
Additional paid-in capital   277,303       275,562  
Accumulated other comprehensive loss   (449 )     (472 )
Accumulated deficit   (254,488 )     (250,219 )
Total stockholders’ equity   21,901       24,881  
Total liabilities and stockholders’ equity $ 45,457     $ 54,835  
               

Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share information)
(Unaudited)
 
  Three Months Ended

March 31,
    2023       2022  
Net revenues $ 4,747     $ 6,778  
Cost of revenues   4,386       5,007  
Gross profit   361       1,771  
       
Operating expenses:      
Sales and marketing   1,128       1,485  
General and administrative   4,712       4,305  
Research and development   1,772       1,003  
Total operating expenses   7,612       6,793  
Operating loss   (7,251 )     (5,022 )
       
Other income (expense):      
Interest expense   (537 )     (381 )
Impairment of digital assets   (50 )     (9,353 )
Gain on sale of digital assets   3,214       26  
Fair value adjustment of warrant liability   253       (213 )
Other income, net   102       26  
Total other income (expense)   2,982       (9,895 )
Loss before taxes   (4,269 )     (14,917 )
Income tax expense          
Net loss   (4,269 )     (14,917 )
Other comprehensive income (loss):      
Cumulative translation adjustment   23       (32 )
Comprehensive loss $ (4,246 )   $ (14,949 )
       
Loss per share, basic and diluted $ (0.04 )   $ (0.15 )
       
Weighted-average common shares used to compute loss per share, basic and diluted   103,169       96,844  

Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
 
  Three Months Ended

March 31,
    2023       2022  
Operating activities      
Net loss $ (4,269 )   $ (14,917 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Amortization of debt discount and deferred financing costs   289       155  
(Gain) loss on change in fair value of warrant liability   (253 )     213  
Gain on sale of digital assets   (3,214 )     (26 )
Impairment of digital assets   50       9,353  
Stock-based compensation   1,362       564  
Other adjustments   357       (71 )
Changes in operating assets and liabilities:      
Accounts receivable   (245 )     (248 )
Inventory   241       (2,063 )
Prepaid expenses and other assets   261       (687 )
Accounts payable   67       219  
Accrued expenses   (89 )     (1,489 )
Lease liability payments   (345 )     (173 )
Deferred revenue   (1,594 )     (1,001 )
Net cash used in operating activities   (7,382 )     (10,171 )
Investing activities      
Proceeds received from sale of digital assets   10,790        
Purchase of digital assets         (489 )
Capital expenditures   (6 )     (80 )
Net cash provided by (used in) investing activities   10,784       (569 )
Financing activities      
Payments on borrowings   (4,270 )     (1,566 )
Proceeds from exercise of options to purchase common stock   58       16  
Payment for stock repurchase   (475 )      
Net cash used in financing activities   (4,687 )     (1,550 )
Effect of exchange rate on cash and restricted cash   24       (32 )
Net decrease in cash   (1,261 )     (12,322 )
Cash at the beginning of the period   1,955       23,137  
Cash at the end of the period $ 694     $ 10,815  

  Three Months Ended

March 31,
  2023   2022
Supplemental disclosure of cash flow information:      
Interest paid $ 434   $ 204
Income taxes paid $   $
Supplemental disclosures of non-cash financing activities:      
Issuance of common stock in connection with acquisition of Lyte Technology, Inc. $   $ 1,125
Issuance of common stock for payment of bonuses previously accrued $ 347   $
           

Non-GAAP Financial Measures and Reconciliation

Our non-GAAP financial measures include adjusted gross profit, adjusted gross margin and adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”) (our “non-GAAP financial measures”). Our non-GAAP financial measures should be considered in addition to, not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. They are not measurements of our financial performance under GAAP and should not be considered as alternatives to revenue or net loss, as applicable, or any other performance measures derived in accordance with GAAP and may not be comparable to other similarly titled measures of other businesses. Our non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of our operating results as reported under GAAP. Some of these limitations include: (i) non-cash compensation is and will remain a key element of our overall long-term incentive compensation package, although we exclude it as an expense when evaluating its ongoing operating performance for a particular period, (ii) our non-GAAP financial measures do not reflect the impact of certain charges resulting from matters we consider not to be indicative of ongoing operations, and (iii) other companies in our industry may calculate our non-GAAP financial measures differently than we do, limiting their usefulness as comparative measures.

We compensate for these limitations to our non-GAAP financial measures by relying primarily on our GAAP results and using our non-GAAP financial measures only for supplemental purposes. Our non-GAAP financial measures include adjustments for items that may not occur in future periods. However, we believe these adjustments are appropriate because the amounts recognized can vary significantly from period to period, do not directly relate to the ongoing operations of our business and complicate comparisons of our internal operating results and operating results of other peer companies over time. Each of the normal recurring adjustments and other adjustments described in this paragraph help management with a measure of our operating performance over time by removing items that are not related to day-to-day operations or are non-cash expenses.

 
Reconciliation of GAAP to Non-GAAP Financial Measures
(In thousands, except percentages)
 
  Three Months Ended March 31,
(in thousands)   2023       2022  
Net loss $ (4,269 )   $ (14,917 )
Add back:  Depreciation and amortization   188       186  
Add back:  Interest expense   537       381  
EBITDA   (3,544 )     (14,350 )
Add Back: Stock-based compensation   1,362       564  
Add Back: Impairment of digital currencies   50       9,353  
(Less)/Add back: Fair value adjustment for warrant liabilities   (253 )     213  
Less: Gain on sale of digital assets   (3,214 )     (26 )
Adjusted EBITDA $ (5,599 )   $ (4,246 )

  Three Months Ended March 31,
(in thousands, except percentages) 2023   2022
Gross profit $ 361     $ 1,771  
Add back:  Stock-based compensation   253       46  
Adjusted gross profit $ 614     $ 1,817  
Adjusted gross margin   12.9 %     26.8 %

Supplemental Information
(In thousands, except percentages)
     
  Three Months Ended March 31,   Change  
(in thousands, except percentages) 2023   2022   Amount   %  
Net Revenues                
Platform revenue $ 1,345     $ 2,492     $ (1,147 )   (46.0 )%
Hardware revenue   3,402       4,286       (884 )   (20.6 )%
Net revenues $ 4,747     $ 6,778     $ (2,031 )   (30.0 )%
Platform revenue as percentage of total revenue   28.3 %     36.8 %          
Hardware revenue as percentage of total revenue   71.7 %     63.2 %          



Cyclacel Pharmaceuticals Reports First Quarter Financial Results and Provides Business Update


– Key Catalysts ahead with multiple Value Generating Readouts –



– Expects to Report Phase 1/2 Data Releases with Oral Fadraciclib




– Advancing single-agent Efficacy with Differentiated Oral Plogosertib –



– Adds to Balance Sheet with non-dilutive $4.7 million from R&D Tax Credit –



– Management to Host Conference Call at 4:30 pm EDT Today –

BERKELEY HEIGHTS, N.J., May 11, 2023 (GLOBE NEWSWIRE) — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical leader in cell cycle checkpoint control developing innovative medicines based on cancer cell biology, announced today first quarter financial results and provided a business update.

“We are on track to deliver on key readouts this year. For fadraciclib, our oral CDK2/9 inhibitor, we plan to report pharmacokinetic (PK), pharmacodynamic (PD), safety and activity data from the dose escalation stage of our 065-101 study followed by initial clinical activity data from the Phase 2 proof of concept (PoC) stage. We also expect to report PK, PD, safety and activity data from the dose escalation part of our 140-101 Phase 1/2 study of plogosertib, our oral PLK1 inhibitor,” said Spiro Rombotis, President and Chief Executive Officer. “Data collected to date suggest that fadraciclib and plogosertib are differentiated from other molecules in their respective classes. Furthermore, the receipt of $4.7 million in non-dilutive capital from the R&D tax credit along with existing resources supports our ongoing clinical programs.”

“Both clinical programs with fadraciclib and plogosertib are progressing well and are approaching important data readouts,” said Mark Kirschbaum, M.D., Chief Medical Officer. “In 065-101, we are currently recruiting patients at dose level 6A of fadraciclib with the aim of optimizing the recommended Phase 2 dosing schedule before opening the PoC stage. Our Phase 2 clinical sites are ready to enroll patients with the tumor types that appear to be most sensitive to fadraciclib treatment. With plogosertib we are recruiting patients at dose level 4. After observing unexpected efficacy at lower dose levels with three patients on treatment for three to eight cycles, we are investigating the biological rationale for this effect and how we could exploit these findings in subsequent studies. We remain enthusiastic about our clinical stage pipeline and look forward to presenting emerging data from these two programs during the year.“

Key Upcoming Milestones for 2023

  • Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
  • First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
  • Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
  • Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2023, pro forma cash and cash equivalents totaled $16.1 million, including the $4.7 million of United Kingdom research & development tax credits received after the end of the quarter. Cash and cash equivalents as of March 31, 2023 was $11.4 million, compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $6.9 million for the three months ended March 31, 2023 compared to $6.8 million for the same period of 2022. The Company estimates that its available cash will fund currently planned programs into the first quarter of 2024.

Research and development (R&D) expenses were $5.7 million for the three months ended March 31, 2023, as compared to $5.0 million for the same period in 2022. R&D expenses relating to fadraciclib were $4.1 million for the three months ended March 31, 2023, as compared to $3.6 million for the same period in 2022 due to increased non-clinical expenditures. R&D expenses related to plogosertib were $1.4 million for the three months ended March 31, 2023, as compared to $1.1 million for the same period in 2022 due to clinical trial costs associated with the progression of the Phase 1/2 study.

General and administrative expenses for the three months ended March 31, 2023 and 2022, remained relatively flat at $1.6 million. 

Total other income, net, for the three months ended March 31, 2023, was $0.2 million compared to an income of $1.3 million for the same period of the previous year. The decrease of $1.1 million for the three months ended March 31, 2023, is primarily related to royalty income received in the previous year.

United Kingdom research & development tax credits for the three months ended March 31, 2023 were $1.3 million compared to $1.1 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended March 31, 2023, was $5.8 million, compared to $4.1 million for the same period in 2022.  

Conference call information:

US/Canada call: (800) 274-8461 / international call: (203) 518-9783

US/Canada archive: (800) 839-6975 / international archive: (402) 220-6061 

Code for live and archived conference call is CYCCQ123. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days. 

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, the potential effects of the COVID-19 pandemic, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Company: Paul McBarron, (908) 517-7330, [email protected]
Investor Relations: Grace Kim, [email protected]
   

© Copyright 2023 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

SOURCE: Cyclacel Pharmaceuticals, Inc.

 
CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)

(In $000s, except share and per share amounts)
         
        Three Months Ended
        March 31,
        2023   2022
             
Revenues   $     $  
             
Operating expenses:        
  Research and development     5,674       4,954  
  General and administrative     1,645       1,605  
Total operating expenses     7,319       6,559  
Operating loss     (7,319 )     (6,559 )
Other income (expense):        
  Foreign exchange gains (losses)     (87 )     29  
  Interest income     116       4  
  Other income, net     166       1,280  
    Total other income (expense), net     195       1,313  
Loss before taxes     (7,124 )     (5,246 )
Income tax benefit     1,320       1,138  
Net loss     (5,804 )     (4,108 )
Dividend on convertible exchangeable preferred shares     (50 )     (50 )
Net loss applicable to common shareholders   $ (5,854 )   $ (4,158 )
Basic and diluted earnings per common share:        
Net loss per share – basic and diluted   $ (0.47 )   $ (0.42 )
Weighted average common shares outstanding     12,539,189       9,993,135  
             

 
CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEET

(In $000s, except share, per share, and liquidation preference amounts)
             
        March 31,


  December 31,


        2023


  2022


             
ASSETS        
Current assets:        
  Cash and cash equivalents   $ 11,435     $ 18,345  
  Prepaid expenses and other current assets     7,539       6,066  
    Total current assets     18,974       24,411  
             
  Property and equipment, net     31       32  
  Right-of-use lease asset     139       142  
  Non-current deposits     2,916       2,916  
    Total assets   $ 22,060     $ 27,501  
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
  Accounts payable   $ 2,509     $ 2,561  
  Accrued and other current liabilities     4,829       4,831  
    Total current liabilities     7,338       7,392  
Lease liability     80       106  
    Total liabilities     7,418       7,498  
             
Redeemable common stock     4,494       4,494  
             
Stockholders’ equity     10,148       15,509  
  Total liabilities and stockholders’ equity   $ 22,060     $ 27,501  
             



Enliven Therapeutics Highlights Business Achievements and Reports First Quarter 2023 Financial Results

Successfully completed merger with Imara Inc., trading under the new ticker symbol on Nasdaq, “ELVN”

Dosed first patient in Phase 1 study of ELVN-002 in patients with HER2-altered non-small cell lung cancer (NSCLC) and other solid tumors

Enrollment progressing in Phase 1 trial with ELVN-001 in chronic myeloid leukemia (CML)

Ended the first quarter 2023 with cash and cash equivalents of approximately $292 million, which is expected to provide cash runway into early 2026

BOULDER, Colo., May 11, 2023 (GLOBE NEWSWIRE) — Enliven Therapeutics, Inc. (Enliven) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the first quarter ended March 31, 2023 and provided a business update.

“2023 is off to a strong start with the successful completion of our merger with Imara Inc. and the concurrent private financing, dosing of the first patient in the Phase 1 study of ELVN-002, continued progression of enrollment in our Phase 1 trial for ELVN-001, and good progress on our discovery pipeline,” said Sam Kintz, MBA, Enliven’s Co-founder and President and Chief Executive Officer. “2023 is a critical year of execution for us as our parallel lead programs advance ahead of expected Phase 1a data for both programs in 2024.”

Recent Business Highlights and Upcoming Milestones

Research and Development Highlights

  • ELVN-002: Dosed the first patient in the Phase 1 clinical trial evaluating ELVN-002 in people with cancers harboring an abnormal HER2 gene (NCT05650879). ELVN-002 is a CNS penetrant, selective and irreversible HER2 inhibitor with activity against various HER2 mutations, including Exon 20 insertion mutations (E20IMs) in NSCLC, for which there are currently no approved small molecule inhibitors. The Company expects to share initial safety and efficacy data from the Phase 1a study in 2024.

  • ELVN-001: Continued progress in the dose escalation portion of the Phase 1 clinical trial evaluating ELVN-001 in adults with CML (NCT05304377). The Company expects to share initial safety and efficacy data from the Phase 1a study in 2024.

  • Pipeline: Progress toward nominating a product candidate for a third program, which is expected in the second quarter of this year. Enliven is also actively pursuing multiple additional early-stage discovery programs.

Corporate and Business Highlights

  • In February 2023, Enliven successfully completed the merger with Imara Inc. and concurrent private financing, and the combined company’s shares commenced trading under the new ticker “ELVN” on February 24, 2023. The Company’s cash and cash equivalents, including proceeds from the merger and the concurrent private financing, are expected to fund the Company’s planned operations into early 2026.

First Quarter 2023 Financial Results

  • Cash Position: As of March 31, 2023, the Company had cash and cash equivalents totaling $292.1 million.
  • Research and development (R&D) expenses: R&D expenses were $11.9 million for the first quarter of 2023, compared to $7.1 million for the first quarter of 2022.
  • General and administrative (G&A) expenses: G&A expenses for the first quarter of 2023 were $4.5 million, compared to $1.6 million for the first quarter of 2022.
  • Net Loss: Enliven reported a net loss of $14.7 million for the first quarter of 2023, compared to a net loss of $8.7 million for the first quarter of 2022.

About Enliven Therapeutics

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help patients with cancer not only live longer, but better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall patient well-being. Enliven’s discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado.

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 (Securities Act)) concerning Enliven and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans and expectations regarding, Enliven’s programs, including ELVN-001, ELVN-002 and its early-stage discovery programs; the expected timing of Phase 1a data for ELVN-001 and ELVN-002 and timing for making a product candidate nomination for Enliven’s third program; expectations regarding the sufficiency of Enliven’s capital resources and cash runway; and statements by Enliven’s Co-founder, President and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the limited operating history of Enliven; the significant net losses incurred since its inception; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; Enliven’s limited resources;  Enliven’s ability to obtain additional capital to finance its operations; the decision to develop or seek strategic collaborations to develop Enliven’s current or future product candidates in combination with other therapies; Enliven’s lack of experience in commercializing a product candidate; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven’s patent protection; developments relating to Enliven’s competitors and its industry, including competing product candidates and therapies; reliance on third parties, including contract manufacturing organizations, and contract research organizations; general economic and market conditions; and other risks and uncertainties, including those more fully described in Enliven’s filings with the Securities and Exchange Commission (SEC), including Enliven’s Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023 and in Enliven’s future reports to be filed with the SEC. Except as required by applicable law, Enliven 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.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Contact:

Enliven Investors & Media:

Argot Partners
[email protected]

Enliven Therapeutics, Inc.

Selected Condensed Consolidated Financial Information
(in thousands, except per share data)
(unaudited)

             
Statements of Operations     Three Months Ended March 31,  
        2023       2022    
Operating expenses:            
    Research and development     $ 11,880     $ 7,059    
    General and administrative       4,538       1,619    
Total operating expenses       16,418       8,678    
Loss from operations       (16,418 )     (8,678 )  
Other income (expense), net       1,694       9    
Net loss     $ (14,724 )   $ (8,669 )  
Net loss per share, basic and diluted     $ (0.80 )   $ (3.01 )  
Weighted-average shares outstanding, basic and diluted       18,515       2,877    
             
Balance Sheets   March 31,   December 31,  
      2023       2022    
Assets            
Current assets:            
    Cash and cash equivalents   $ 292,102     $ 75,536    
    Prepaid expenses and other current assets       5,901       2,217    
Total current assets       298,003       77,753    
Property and equipment, net       853       890    
Right-of-use asset       551       626    
Deferred offering costs             3,975    
Restricted cash       54       54    
Other long-term assets       3,405          
Total assets     $ 302,866     $ 83,298    
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)            
Current liabilities:            
    Accounts payable     $ 5,860     $ 3,438    
    Accrued expenses and other current liabilities       5,082       6,277    
Total current liabilities       10,942       9,715    
Long-term liabilities       508       659    
Total liabilities       11,450       10,374    
Convertible preferred stock             149,749    
Stockholders’ equity (deficit)       291,416       (76,825 )  
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)     $ 302,866     $ 83,298    
             



Telesis Bio Reports First Quarter 2023 Financial Results

— Total revenue of $6.3M in 1QFY23

— BioXp® franchise revenue increased by 28%

SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) — Telesis Bio Inc. (NASDAQ: TBIO), a leader in automated multi-omic and synthetic biology solutions, today reported financial results for the first quarter of 2023.

“We are pleased with our company’s performance this quarter where we delivered 28% growth year over year in BioXp franchise revenue while improving gross margins and holding operating expenses steady,” said Todd R. Nelson, PhD, CEO, and founder of Telesis Bio. “We believe we are still in the early stages of adoption within our targeted workflows and our value proposition to researchers will continue to increase. Our positive results are a testament to the thoughtful planning and the steady execution of our team. We remain laser focused on operating expenses as we move towards a time where we can become a profitable company.”

Highlights

Continued to execute its commercial strategy:

  • Successful on-time launch of three novel BioXp® Select kits providing scientists the flexibility to adapt the BioXp System to their process and begin with their own materials. 
    • BioXp® Select mRNA Synthesis Kit allows customers to synthesize mRNA in just hours using DNA that they bring to the system to streamline and accelerate discovery workflows in mRNA therapeutics, vaccines, and precision medicine.
    • BioXp® Select DNA Cloning and Amplification Kit and the BioXp® Select Plasmid Amplification Kit provide scientists the ability to initiate experiments with their own plasmid or linear DNA fragments and perform automated cell-free DNA amplification and scale-up, particularly in antibody engineering, protein engineering, and cellular immunotherapy.
  • Progress on development of other higher margin products previously announced.

Delivered operational milestones, including:

  • Relocation to consolidated headquarters in San Diego to execute programs to expand gross margin including insourcing initiatives related to raw materials and vertical Integration of instrument manufacturing.
  • Commercial delivery of BioXp kits incorporating oligos from our in-house proprietary oligo production operation.
  • Accomplishments to support the shipping of its first internally manufactured BioXp system in the third quarter.

The company’s expectation is that these insourcing efforts will be substantially completed by year-end and that full financial benefit will be realized in 2024.

First Quarter 2023 Financial Results

Revenue was $6.3 million for the first quarter 2023, a 12.1% increase from $5.6 million for the same period in the prior year. This growth was primarily driven by product sales from new product introductions, including the BioXp 9600.

Cost of revenue for the first quarter 2023 was $2.81 million, compared to $2.86 million for the same period in the prior year. The decrease of $0.05 million, despite the increase in revenues was primarily driven by a change in product mix with the launch of the higher margin 9600 system during the latter half of 2022, and the sale of kits with higher average margins.

Gross margin for the first quarter 2023 was 55.6%, compared to 49.3% for the same period in the prior year. The favorable change reflects the positive mix shift in revenue from recently launched products including the BioXp 9600 system, as well as new kits for mRNA, long fragment builds, and cell free DNA scale-up.

Operating expenses were $14.5 million for the first quarter 2023, compared to $15.6 million for the same period in the prior year. This decrease is primarily a result of prudent cost-cutting decisions made a year ago in Q2 2022 to focus the team on the most profitable and near-term opportunities.

Net loss was $11.1 million for the first quarter 2023, compared to a loss of $13.2 million in the same period in the prior year. Net loss per share was $0.37 for the fourth quarter of 2022, compared to $0.45 for the corresponding prior year period.

Cash and cash equivalents were $32.2 million as of March 31, 2023.

Webcast and Conference Call Information

Company management will host a conference call today, Thursday, May 11, 2023, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

The press release and live audio webcast can be accessed via the Investor section of Telesis Bio’s website at ir.telesisbio.com and the conference call can be accessed live by pre-registering here: https://register.vevent.com/register/BIf9b7641fab2948fca7b1ec1d400ceec4. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on our website for 30 days.

About Telesis Bio

Telesis Bio is empowering scientists with the ability to create novel, synthetic biology-enabled solutions for many of humanity’s greatest challenges. As inventors of the industry-standard Gibson Assembly® method and the first commercial automated benchtop DNA and mRNA synthesis system, Telesis Bio is enabling rapid, accurate and reproducible writing of DNA and mRNA for numerous downstream markets. The award-winning BioXp® system consolidates, automates, and optimizes the entire synthesis, cloning and amplification workflow. As a result, it delivers virtually error-free synthesis of DNA and RNA at scale within days and hours instead of weeks or months. Scientists around the world are using the technology in their own laboratories to accelerate the design-build-test paradigm for novel, high-value products for precision medicine, biologics drug discovery, vaccine and therapeutic development, genome editing, and cell and gene therapy. Telesis Bio is a public company based in San Diego. For more information, visit www.telesisbio.com.

Telesis Bio, the Telesis Bio logo, Gibson Assembly, and BioXp are trademarks of Telesis Bio Inc.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include statements and guidance regarding Telesis Bio’s future financial performance as well as statements regarding the future release and success of new and existing products and services. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled Risk Factors and elsewhere in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on
March 22, 2023, as amended on May 1, 2023. These
forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Telesis Bio disclaims any obligation to update these forward-looking statements.

Contact:
Jen Carroll
Vice President of Investor Relations
[email protected]

Telesis Bio Inc.   
Selected Statements of Operations Financial Data   
(in thousands, except per share amounts)   
 (unaudited)
 
  Three Months Ended 

March 31,
   2023     2022 
Revenue:      
Product sales $ 3,001     $ 2,423  
Service revenue   1,674       1,705  
Collaboration revenue   962       962  
Royalties and other revenue   679       546  
Total revenue   6,316       5,636  
Cost of revenue   2,805       2,858  
Gross Profit   3,511       2,778  
Operating expenses:      
Research and development   5,121       6,305  
Sales and marketing   3,807       3,546  
General and administrative   5,554       5,790  
Total operating expenses   14,482       15,641  
Loss from operations   (10,971 )     (12,863 )
Interest expense, net   (249 )     (336 )
Change in fair value of derivative liabilities   140       23  
Other expense, net   (36 )     (12 )
Provision for income taxes   (3 )     (6 )
Net loss $ (11,119 )   $ (13,194 )
Net loss per share, basic and diluted $ (0.37 )   $ (0.45 )
Weighted average common shares used to compute net loss per share, basic and diluted   29,663,006       29,331,325  
 

Telesis Bio Inc.   
Selected Balance Sheet Financial Data   
(in thousands)   
(unaudited)   
       
  March 31,   December 31,
   2023     2022 
Balance Sheet Data:      
Cash, restricted cash, cash equivalents and short-term investments $ 32,242     $ 43,753  
Working capital   31,699       41,594  
Total assets   89,162       81,362  
Total liabilities   52,543       34,797  
Accumulated deficit   (124,860 )     (113,741 )
Total stockholders’ equity   36,619       46,565