Adverum Biotechnologies Reports First Quarter 2023 Financial Results

– Full enrollment of the Phase 2 LUNA trial in
wet age-related macular degeneration (wet AMD) is
anticipated in the second half of 2023 –

– LUNA 14-week data, including initial aflibercept protein levels anticipated in the third quarter 2023 and preliminary efficacy and safety data anticipated in the fourth quarter of 2023 –

REDWOOD CITY, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the first quarter ended March 31, 2023 and provided an update on its ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD).

“We are pleased to be the only ocular gene therapy company in wet AMD to have been granted Fast Track Designation by the U.S. FDA, PRIME designation by the European Medicines Agency and most recently the Innovation Passport under the Innovative Licensing and Access Pathway from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “These three global regulatory designations will allow us to have thoughtful and robust engagements as we gather data from LUNA and plan for pivotal trials of potentially the first intravitreal gene therapy for a highly prevalent disease globally.”

“The excitement we are hearing from the investigators and their study teams in our Phase 2 LUNA trial of Ixo-vec is highly encouraging. We are on track to finish enrolling the study in the second half of 2023,” said Star Seyedkazemi, PharmD, chief development officer of Adverum Biotechnologies. “We plan to provide interim datasets for a percentage of participants at 14 weeks, including aflibercept protein levels, in the third quarter of 2023, as well as preliminary efficacy and safety data in the fourth quarter of 2023. Early aflibercept protein levels have been found to be therapeutic and sustained through three years in subjects dosed with Ixo-vec in the Phase 1 OPTIC trial. The 14-week data from the new, lower 6×10^10 vg/eye dose in LUNA may be indicative of future efficacy and long term aflibercept protein levels.”

Recent Highlights

  • Enrollment in the Phase 2 LUNA trial evaluating Ixo-vec in subjects with wet AMD is expected to be completed during the second half of 2023. Participants are being randomized equally across two doses, the 2×10^11 vg/eye (2E11) dose and a new, lower 6×10^10 vg/eye (6E10) dose. Four prophylactic corticosteroid regimens are being studied that cover the period of peak immunogenicity observed in nonclinical studies and in the OPTIC study.
  • In April 2023, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency granted Ixo-vec an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP.) This designation is intended to accelerate the regulatory and market access interactions in the United Kingdom.
  • In April 2023, Adverum presented nonclinical data in non-human primates supporting the feasibility of staggered, bilateral administration of Ixo-vec at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting. Wet AMD is a bilateral disease and incidence of neovascularization (nAMD) in the second eye is up to 42% in the first two to three years following diagnosis in the primary eye.
  • In May 2023, Adverum announced that it will unveil new nonclinical data on the development of an intravitreal (IVT) gene therapy for the treatment of dry age-related macular degeneration (dry AMD) and geographic atrophy (GA) through the overexpression of Complement Factor I (CFI) to inhibit the complement cascade during the American Society of Gene & Cell Therapy (ASGCT) 2023 Annual Meeting.

Anticipated LUNA 2023 Milestones

  • 2H 2023 – Anticipate full enrollment of the Phase 2 LUNA trial
  • Q3 2023 – Anticipate LUNA 14-week data, including aflibercept protein levels for a percentage of the cohort
  • Q4 2023 – Anticipate LUNA preliminary efficacy and safety data

Financial Results for the Three Months Ended March 31, 2023

  • Cash, cash equivalents and short-term investments were $164.3 million as of March 31, 2023, compared to $185.6 million as of December 31, 2022. Adverum expects the March 31, 2023 cash position to fund operations into 2025.
  • Research and development expenses were $21.1 million for the three months ended March 31, 2023, compared to $23.0 million for the same period in 2022. Research and development expenses decreased due to lower compensation and laboratory expense; partially offset by higher material production and bioanalytic expenses and license costs. Stock-based compensation expense included in research and development expenses was $1.4 million for the first quarter of 2023.
  • General and administrative expenses were $12.8 million for the three months ended March 31, 2023, compared to $15.2 million for the same period in 2022. General and administrative expenses decreased due to lower compensation, professional services expenses and recruiting costs. Stock-based compensation expense included in general and administrative expenses was $3.2 million for the first quarter of 2023.
  • Net loss was $29.1 million, or $0.29 per basic and diluted share, for the three months ended March 31, 2023, compared to $37.9 million, or $0.38 per basic and diluted share, for the same period in 2022.

About Wet Age-Related Macular Degeneration

Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD affecting approximately 10% of patients living with AMD. Wet AMD is a leading cause of blindness in people over 65 years of age, with approximately 20 million individuals worldwide living with this condition. New cases of wet AMD are expected to grow significantly worldwide as populations age. AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases. Additionally, wet AMD is a bilateral disease and incidence of nAMD in the second eye is up to 42% in the first two to three years.

About Ixo-vec in Wet AMD

Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), its clinical-stage gene therapy product candidate, for the treatment of wet AMD. Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require surgery to administer the gene therapy under the retina (sub-retinal approach), Ixo-vec is designed to be administered as a one-time IVT injection in the physician’s office, deliver long-term efficacy, reduce the burden of frequent anti-vascular endothelial growth factor (VEGF) injections, optimize patient compliance and improve vision outcomes for patients with wet AMD. In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation for Ixo-vec for the treatment of wet AMD. Ixo-vec also received PRIME designation from the European Medicines Agency and the Innovation Passport from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for the treatment of wet AMD.

About LUNA Trial of Ixo-vec in Wet AMD

The LUNA trial is a double-masked, randomized, Phase 2 trial being conducted at approximately 40 sites in the U.S. and Europe. LUNA will evaluate Ixo-vec in subjects with wet AMD who are 50 years or older and have demonstrated a response to anti-VEGF treatment. Up to 72 subjects will be randomized equally between the previously evaluated 2E11 vg/eye dose and a new, lower 6E10 vg/eye dose. Four prophylactic corticosteroid regimens will be studied with the aim of establishing a prophylactic corticosteroid regimen with minimal need for inflammation management post prophylaxis. Prophylactic regimens being evaluated include 22 weeks of a tapered regimen of topical difluprednate (Durezol®), a single administration of IVT dexamethasone (Ozurdex®), and a combination of either topical Durezol® or IVT Ozurdex® with up to 10 weeks of a tapered regimen of oral prednisone. All four prophylactic corticosteroid regimens in LUNA cover the period of peak immunogenicity observed in nonclinical studies and in the Phase 1 OPTIC study.

The LUNA trial primary endpoints are mean change in best corrected visual acuity (BCVA) from baseline to one year, as well as the incidence and severity of adverse events. Important secondary endpoints in LUNA include the mean change in central subfield thickness (CST) from baseline to one year and assessing the effectiveness of prophylactic corticosteroid regimens on minimizing inflammation. Additionally, LUNA will assess aflibercept protein levels starting at Week 14 and include an interim analysis at Week 26. Study participants will have the option to enroll in a long-term extension study.

About Adverum Biotechnologies

Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit www.adverum.com.

Forward-looking Statements

Statements contained in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding the potential benefits of Ixo-vec in the treatment of wet AMD, the design of and enrollment in the LUNA trial, including the prophylactic corticosteroid regimens, and anticipated preliminary and interim data from the LUNA trial. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverum’s novel technology, which makes it difficult to predict the timing of commencement and completion of clinical trials; regulatory uncertainties; enrollment uncertainties; the results of early clinical trials not always being predictive of future clinical trials and results; and the potential for future complications or side effects in connection with use of Ixo-vec. Additional risks and uncertainties facing Adverum are set forth under the caption “Risk Factors” and elsewhere in Adverum’s Securities and Exchange Commission (SEC) filings and reports, including Adverum’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 30, 2023. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Corporate, Investor and Media Inquiries

Anand Reddi
Vice President, Head of Corporate Strategy, External Affairs and Engagement
Adverum Biotechnologies, Inc.
T: 650-649-1358
E: [email protected]

Adverum Biotechnologies, Inc.
Consolidated Balance Sheets
(In thousands)
         
    March 31   December 31


 
      2023       2022  
    (Unaudited)     (1)  
Assets        
Current assets:        
Cash and cash equivalents   $ 67,552     $ 68,431  
Short-term investments     96,733       117,158  
Prepaid expenses and other current assets   4,588       5,006  
Total current assets     168,873       190,595  
Property and equipment, net     33,347       34,927  
Operating lease right-of-use asset     69,503       78,934  
Restricted cash     2,503       2,503  
Deposit and other long-term assets     1,351       1,413  
Total assets   $ 275,577     $ 308,372  
         
Liabilities and stockholders’ equity        
Current liabilities:        
Accounts payable   $ 2,863     $ 2,238  
Lease liability, current portion     26,265       13,241  
Accrued expenses and other current liabilities     17,344       16,767  
Total current liabilities     46,472       32,246  
Lease liability, net of current portion     71,348       93,561  
Other noncurrent liabilities           1,047  
Total liabilities     117,820       126,854  
Stockholders’ equity:        
Common stock     10       10  
Additional paid-in capital     990,214       985,651  
Accumulated other comprehensive loss     (799 )     (1,531 )
Accumulated deficit     (831,668 )     (802,612 )
Total stockholders’ equity     157,757       181,518  
Total liabilities and stockholders’ equity $ 275,577     $ 308,372  
         
(1) Derived from Adverum’s annual audited consolidated financial statements.
         

Adverum Biotechnologies, Inc.
Consolidated Statements of Operations
(In thousands except per share data)
         
    Three months ended March 31,
      2023       2022  
    (Unaudited)
         
License revenue   $ 3,600     $  
         
Operating expenses:        
Research and development     21,059       22,964  
General and administrative     12,780       15,169  
Total operating expenses     33,839       38,133  
Operating loss     (30,239 )     (38,133 )
Other income, net     1,200       244  
Net loss before income taxes     (29,039 )     (37,889 )
Income tax provision     (17 )     (19 )
Net loss     (29,056 )     (37,908 )
Net loss per share — basic and diluted   $ (0.29 )   $ (0.38 )
Weighted-average common shares outstanding – basic and diluted     100,304       98,596  
         
         
(1) Derived from Adverum’s annual audited consolidated financial statements.



Rain Oncology Reports First Quarter 2023 Financial Results and Highlights Recent Progress

– Quarter-end cash position of $110 million provides runway to complete all ongoing and planned clinical trials of milademetan, including the Phase 3 MANTRA trial in liposarcoma, Phase 2 MANTRA-2 basket trial, and planned Phase 1/2 MANTRA-4 basket trial –

– Required number of progression events achieved in the Phase 3 pivotal MANTRA trial to trigger the primary analysis of progression free survival (PFS) in patients with dedifferentiated liposarcoma (DDLPS) –

– Topline data for the MANTRA trial expected this quarter –

– Phase 2 MANTRA-2 trial continues to enroll across MDM2-amplified advanced solid tumor types –

– Phase 1/2 MANTRA-4 trial in advanced solid tumors exhibiting loss of the CDKN2A gene on track to commence in mid-2023 –

– Management to host conference call and webcast today at 5:00 PM Eastern Time –

NEWARK, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today reports financial results for the first quarter ended March 31, 2023, along with an update on the Company’s key corporate highlights and upcoming milestones.

“We remain excited for MANTRA’s topline data readout, which we continue to anticipate in the second quarter. We are hopeful these data will support a potential new therapeutic option for patients with dedifferentiated liposarcoma, and also assert the importance of p53’s role in the regulation of cancer,” said Avanish Vellanki, co-founder and chief executive officer of Rain. “We continue to maintain strong fiscal prudence with tightly controlled cash burn on top of continued enrollment in MANTRA-2, and the anticipated, imminent start of the MANTRA-4 clinical trial.”

First Quarter 2023 Key Research and Development (R&D) Highlights and Upcoming Milestones

  • Phase 3 Dedifferentiated Liposarcoma (DDLPS) Trial (MANTRA)

    • Trial achieved required number of at least 105 progression events
    • Company expects to announce topline data in the second quarter of 2023
    • Company anticipates filing regulatory applications in the United States and other regions globally, subject to supportive clinical topline data readout
  • Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors (n=65)

    • Clinical trial continues to enroll across solid tumors with MDM2 copy number greater than or equal to 8
  • Phase 1/2 Basket Trial (MANTRA-4) in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene

    • Company expects to commence trial in mid-2023, which will evaluate the combination of milademetan with Roche’s FDA-approved immune-oncology therapy, atezolizumab in 30 patients who have previously failed or progressed on immunotherapy

Our updated corporate presentation is available at the “Corporate Presentation” section of the Rain website.

First Quarter 2023 Financial Results

For the three months ended March 31, 2023, Rain reported a net loss of $20.5 million, as compared to a net loss of $17.4 million for the same period in 2022. Net loss per share for the three months ended March 31, 2023, was $0.56, as compared to a net loss per share of $0.66 for the same period in 2022.

Research and development (R&D) expenses were $16.7 million for the three months ended March 31, 2023, as compared to $13.6 million for the same period in 2022. The increase was primarily related to clinical trial costs for milademetan, higher payroll-related costs for our R&D personnel, and various other R&D costs for milademetan. Non-cash stock-based compensation expenses included in R&D expenses were approximately $1.1 million in the three months ended March 31, 2023, as compared to $0.9 million in the same period in 2022.

General and administrative (G&A) expenses were $5.1 million for the three months ended March 31, 2023, as compared to $3.9 million for the same period in 2022. The increase was primarily due to higher professional services costs and legal costs, as well as higher payroll-related costs. Non-cash stock-based compensation expense included in G&A expenses was approximately $0.4 million for each of the three months ended March 31, 2023 and 2022.

Total non-cash stock-based compensation expenses were approximately $1.6 million for the three months ended March 31, 2023, as compared to $1.2 million for the same period in 2022.

As of March 31, 2023, Rain had $109.8 million in cash, cash equivalents and short-term investments. Consistent with the prior quarter, Rain will not provide guidance on cash runway at this time. Rain will continue to assess its cash runway and provide further guidance in the next quarter, if appropriate, after the release of MANTRA topline results in this quarter.

As of March 31, 2023, Rain had approximately 36.4 million shares of common stock outstanding.

First Quarter 2023 Results Conference Call and Webcast Details

The management of Rain Oncology will host a conference call and webcast for the investment community today, May 11, 2023 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here: https://viavid.webcasts.com/starthere.jsp?ei=1610065&tp_key=22d79acd4c. The conference call can be accessed by dialing (877) 704-4453 (domestic) or (201) 389-0920 (international). The passcode for the conference call is 13738120.

Replay of the call will be available by visiting the “Events” section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

About Milademetan

Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the MDM2-p53 complex that reactivates p53. Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally designed dosing schedule to mitigate safety concerns and widen the potential therapeutic window of inhibition of the p53-MDM2 complex. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS and anticipates topline data this quarter. In addition, milademetan is being evaluated in a Phase 2 tumor-agnostic basket trial in certain solid tumors with MDM2 amplification (MANTRA-2). Rain anticipates commencing a Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in mid-2023. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS.

About Rain Oncology Inc.

Rain Oncology Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors’ underlying genetics rather than histology. Rain’s lead product candidate, milademetan, is a small molecule, oral inhibitor of the p53-MDM2 complex that reactivates p53.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy and safety profile of milademetan, Rain’s ongoing and planned trials for milademetan, patient enrollment, timing for topline data, including anticipated timing for topline data in the Phase 3 MANTRA trial, timing for the commencement of planned trials, including anticipated commencement of Phase 1/2 MANTRA-4 trial, expected trial designs, and the timing for the filing of potential regulatory applications in the United States and Europe, and expectations regarding the time period over which Rain’s capital resources will be sufficient to fund its anticipated operations. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will”, “anticipates,” “goal,” “potential,” “expects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rain’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rain’s business in general and limited operating history, Rain’s ability to execute on its strategy; Rain’s reliance on third parties to conduct and support its preclinical studies and clinical trials, positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical studies; the effect of public health crises on Rain’s clinical trials and business operations, the impact of general economic, health, industrial or political conditions in the United States or internationally, the sufficiency of Rain’s capital resources and its ability to raise additional capital, and the other risks described in Rain’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

     
Investor Contact
Daniel Ferry
LifeSci Advisors
+1.617.430.7576
[email protected]

Media Contact

Jordyn Temperato
LifeSci Communications
[email protected]



RAIN ONCOLOGY INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
     
     
  Three Months Ended March 31,
    2023       2022  
  (unaudited)
     
Operating expenses:    
Research and development $ 16,677     $ 13,555  
General and administrative   5,066       3,895  
Total operating expenses   21,743       17,450  
Loss from operations   (21,743 )     (17,450 )
Other income:    
Interest income   1,259       56  
Total other income   1,259       56  
Net loss $ (20,484 )   $ (17,394 )
Net loss per share, basic and diluted $ (0.56 )   $ (0.66 )
Weighted-average shares used in computing net loss per share, basic and diluted   36,339,851       26,511,743  

SUMMARY CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
     
  March 31, December 31,
    2023     2022

(1)
  (unaudited)  
Cash, cash equivalents and short-term investments $ 109,770     $ 130,454  
Total assets   114,178       135,180  
Stockholders’ equity   94,557       113,036  

(1) Derived from audited financial statements

 



Athira Pharma Reports First Quarter 2023 Financial Results and Recent Pipeline and Business Updates

Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease to focus on 40 mg dose

Open label extension trial to be extended, providing up to 36 months of long-term exposure data

ATH-1105 significantly prolongs survival and improves motor function in a mouse model of ALS; Strongly supports development as a treatment for ALS

Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points

BOTHELL, Wash., May 11, 2023 (GLOBE NEWSWIRE) — Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced the company’s financial results for the first quarter ended March 31, 2023, and reviewed recent pipeline and business updates.

“We continue to advance the Phase 2/3 LIFT-AD trial of fosgonimeton as a treatment for mild-to-moderate Alzheimer’s disease and will focus on the 40 mg dose, as the totality of the data supports the selection of this dose to enhance both our chances for success and the trial’s potential to be a registrational study,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira.

“Throughout the first quarter and in the recent months, we presented supportive preclinical and clinical data describing the therapeutic potential of enhancing the HGF/MET system to protect and repair neuronal networks in neurodegenerative diseases such as Alzheimer’s (AD), Parkinson’s and amyotrophic lateral sclerosis (ALS). Clinical data recently presented at AAN showed a statistically significant improvement in Mini-Mental State Exam (MMSE) scores in the participants treated with fosgonimeton without concomitant acetylcholinesterase inhibitors (AChEIs) in a post-hoc analysis of the exploratory six-month Phase 2 ACT-AD trial. These data, along with a statistically significant improvement in a plasma biomarker of neurodegeneration (neurofilament light chain, NfL), and directional improvements in biomarkers of neuroinflammation and AD protein pathology continue to give us confidence in the potential for fosgonimeton to become a meaningful therapy for people living with Alzheimer’s.

“We have a strong balance sheet that enables us to continue to advance fosgonimeton in Alzheimer’s and ATH-1105 in ALS, through key inflection points,” concluded Dr. Litton.

Clinical Development & Pipeline Programs

Fosgonimeton (ATH-1017) – Small molecule designed to enhance the HGF/MET system with the potential to protect and repair neuronal networks.

  • The Company has selected the 40 mg dose for further development and potential regulatory approval for mild to moderate AD.
  • Fosgonimeton continues to demonstrate a favorable safety profile in patients on both the 40 mg and 70 mg doses in all completed and ongoing clinical studies.
  • The dose selection was based on a review of the totality of the data across preclinical and clinical studies and in consultation with independent regulatory and biostatistical experts.
  • This decision was based on supportive data from participants treated with 40 mg fosgonimeton without concomitant acetylcholinesterase inhibitors (AChEIs):
    • Phase 1b trial results showed 73 milliseconds improvement in P300 latency from baseline compared with placebo at eight days (p=0.027);
    • Post-hoc analyses of the Phase 2 ACT-AD trial of the 40 mg arm at 6 months showed:
      • P300 latency improvement of 37 milliseconds (p=0.050) compared to placebo;
      • ADAS-Cog11 improvement of – 2.6 points (n.s.) compared to placebo; and
      • NfL, improvement of 8.15 pg/mL (p=0.019) compared to placebo.
  • A higher number of participants from the ACT-AD trial receiving the 40 mg dose transitioned into the OLEX trial compared to those receiving the 70 mg dose.

LIFT-AD Phase 2/3 trial in mild-to-moderate Alzheimer’s disease (

NCT04488419

)

  • In September 2022, an independent, unblinded interim efficacy and futility analysis was performed on 100 patients without concomitant AChEIs who completed the trial. The positive outcome from the independent data monitoring committee supports the potential clinically meaningful activity of fosgo and its potential to achieve the primary endpoint, which is a composite score of cognition and function.
  • The Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease will now focus enrollment and the primary analysis on 40 mg dosing and will discontinue enrollment of the 70 mg arm going forward.
  • The Company was granted an end of Phase 2 meeting with the U.S. Food and Drug Administration this summer. The timeline for LIFT-AD will be updated following this meeting.

Open Label Extension (OLEX) trial (

NCT04886063

)

  • The Company plans to further extend the current OLEX for the Phase 2/3 LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton for the treatment of mild-to-moderate AD by an additional 12 months. Following this extension, eligible participants who have completed the LIFT-AD or ACT-AD trials and elect to participate in the ongoing OLEX will be able to receive up to 30 months of open-label treatment.   This extension is intended to address investigator and patient interest in continuing treatment with fosgonimeton beyond 18 months. We believe it will also further enhance our long-term safety database and provide insights into fosgonimeton’s long-term effects for up to 3 years.
  • The OLEX continues to enroll with greater than 85% of participants who have completed either study having elected to enroll in the OLEX trial.

The ACT-AD trial and the related open-label extension for ACT-AD participants was supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.

Presentations and Publications

  • The Company presented preclinical and clinical data in support of its small molecule pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system:
    • Delivered an oral presentation at the American Association of Neurology (AAN) 2023 Annual Meeting that highlighted data from additional post hoc analyses from the completed, exploratory Phase 2 ACT-AD trial of fosgonimeton in mild-to-moderate AD, which included statistically significant improvements in MMSE scores following fosgonimeton treatment without concomitant AChEIs. This is in line with previously reported findings showing directional changes in improvements in measures of cognition and plasma biomarkers of neuroinflammation and protein pathology, as well as a statistically significant improvement in Nfl, an established biomarker of neurodegeneration, following fosgonimeton treatment without concomitant AChEIs. 
    • Presented an oral presentation at AAN 2023 that reviewed compelling preclinical data that continue to elucidate fosgonimeton’s multimodal mechanism of action and therapeutic potential in neurodegenerative diseases.
    • Reported new data at AAN 2023 that provided further insights into the interaction of fosgonimeton with donepezil. Preclinical data presented suggested that the neuroprotective effects of fosgonimeton are muted in combination with donepezil, which we believe to be due, in part, to an interference on neuroprotective AKT signaling, one of the multimodal mechanisms enhanced by targeting the HGF/MET system. 
    • Presented three posters at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD) that highlighted the potential neuroprotective, neurotrophic and anti-inflammatory effects of enhancing the HGF/MET system.

ATH-1105 – A novel, orally available, small molecule designed to be a positive modulator of the HGF/MET system as a potential treatment candidate for amyotrophic lateral sclerosis (ALS).

  • Presented preclinical findings for ATH-1105 at AAN that demonstrated statistically significant improvements on multiple measures of nerve and motor function, biomarkers of inflammation and neurodegeneration, and survival in an animal model of amyotrophic lateral sclerosis (ALS), including prolonged survival and delayed time to first mortality (p=0.0035); improvement in balance, coordination, and muscle strength in motor function tests (p<0.0001); protection against body weight reduction (p<0.01); preservation of nerve function and structure (p<0.001); and reduction of plasma biomarkers of systemic inflammation and neurodegeneration (p<0.0001).
  • Completing IND-enabling work throughout 2023 in order to initiate first-in-human studies in 2024 to evaluate this promising product candidate as a treatment for ALS.

Financial Results

  • Cash Position. Cash, cash equivalents and investments were $219.9 million as of March 31, 2023, compared with $245.2 million as of December 31, 2022. Net cash used in operations was $26.2 million for the quarter ended March 31, 2023, compared with $16.6 million for the quarter ended March 31, 2022.

  • Research and Development (R&D) Expenses. R&D expenses were $21.3 million for the quarter ended March 31, 2023, compared with $14.5 million for the quarter ended March 31, 2022. The increase was driven primarily by costs related to increased clinical trial activities, headcount and increased preclinical research and development expenses.
      
  • General and Administrative (G&A) Expenses. G&A expenses were $8.5 million for the quarter ended March 31, 2023, compared with $8.9 million for the quarter ended March 31, 2022. The decrease was primarily due to a decrease in legal and other general corporate expenses, partially offset by increases in personnel expenses as the Company’s headcount expanded to support its continued growth.

  • Net Loss. Net loss was $27.8 million, or $0.73 per share, for the quarter ended March 31, 2023, compared with a net loss of $21.0 million, or $0.56 per share, for the quarter ended March 31, 2022.

About Athira Pharma, Inc.

Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease, Dementia with Lewy bodies and ALS. For more information, visit www.athira.com. You can also follow Athira on FacebookLinkedIn, Twitter and @athirapharma on Instagram.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: product candidates as a potential treatment for Alzheimer’s disease, Parkinson’s disease dementia, Dementia with Lewy bodies, neuropsychiatric diseases, and other neurodegenerative diseases, such as amyotrophic lateral sclerosis; Athira’s platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof; expectations regarding the safety, potential efficacy and commercial potential of Athira’s product candidates; the anticipated reporting of data; the potential learnings from the LIFT-AD unblinded interim efficacy and futility analysis and their ability to inform and improve future clinical development plans; Athira’s plans to further extend the open label extension trial for its LIFT-AD and ACT-AD clinical trials; and Athira’s ability to advance its product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” “suggest,” “potential,” and other similar expressions, among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the data for our product candidates from our preclinical and clinical trials not supporting the safety, efficacy and tolerability of our product candidates; cessation or delay of Athira’s development of product candidates may occur; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for product candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; the impact of the COVID-19 pandemic on Athira’s business, research and clinical development plans and timelines, and the regulatory process for Athira product candidates; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that have been or may in the future be instituted against us and certain of our directors and officers; clinical trials may not demonstrate safety and efficacy of any of Athira’s product candidates; possible negative interactions of Athira’s product candidates with other treatments; Athira’s assumptions regarding the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets; the impact of competition; regulatory agencies may be delayed in reviewing, commenting on or approving any of Athira’s clinical development plans as a result of the COVID-19 pandemic, which could further delay development timelines; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.

Investor & Media Contact

Julie Rathbun
Athira Pharma
[email protected]
206-769-9219

Athira Pharma, Inc.
Condensed Consolidated Balance Sheets
(Amounts in thousands)
 
    March 31,     December 31,  
    2023     2022  
    (unaudited)        
Assets                
Cash and cash equivalents   $ 105,182     $ 95,966  
Short-term investments     80,799       104,378  
Other short-term assets     6,915       7,189  
Long-term investments     33,903       44,829  
Other long-term assets     5,973       5,791  
Total assets   $ 232,772     $ 258,153  
Liabilities and stockholders’ equity                
Current liabilities   $ 20,150     $ 21,431  
Long-term liabilities     1,497       1,585  
Total liabilities     21,647       23,016  
Stockholders’ equity     211,125       235,137  
Total liabilities and stockholders’ equity   $ 232,772     $ 258,153  

Athira Pharma, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
(Unaudited)
 
    Three Months Ended

March 31,
      2023       2022  
Operating expenses:        
Research and development   $ 21,293     $ 14,460  
General and administrative     8,477       8,927  
Total operating expenses     29,770       23,387  
Loss from operations     (29,770)       (23,387)  
Grant income     157       2,234  
Other income, net     1,793       173  
Net loss   $ (27,820)     $ (20,980)  
Unrealized gain (loss) on available-for-sale securities     927       (1,068)  
Comprehensive loss attributable to common stockholders   $ (26,893)     $ (22,048)  
Net loss per share attributable to common stockholders,
basic and diluted
  $ (0.73)     $ (0.56)  
Weighted-average shares used in computing net loss per
share attributable to common stockholders, basic
and diluted
    37,923,402       37,593,328  

 



Inotiv, Inc. Announces Second Quarter Fiscal 2023 Financial Results

Updates Select Full Year Fiscal 2023 Financial Guidance

WEST LAFAYETTE, Ind., May 11, 2023 (GLOBE NEWSWIRE) — Inotiv, Inc. (Nasdaq: NOTV) (the “Company”, “We”, “Our” or “Inotiv”), a leading contract research organization specializing in nonclinical and analytical drug discovery and development services and research models and related products and services, today announced financial results for the three months (“Q2 FY 2023”) and six months (“YTD FY 2023”) ended March 31, 2023.


Financial Highlights

Q2 FY 2023 Highlights

  • Revenue grew to $151.5 million in Q2 FY 2023 from $140.3 million during the three months ended March 31, 2022 (“Q2 FY 2022”), driven by a $7.9 million, or 20.2%, increase in Discovery and Safety Assessment (“DSA”) revenue and a $3.3 million, or 3.3%, increase in Research Models and Services (“RMS”) revenue.
  • Consolidated net loss for Q2 FY 2023 was $(9.6) million, or (6.4)% of total revenue, compared to consolidated net loss of $(6.7) million, or (4.7)% of total revenue, in Q2 FY 2022.
  • Adjusted EBITDA1 was $17.1 million, or 11.3% of total revenue, compared to $25.3 million, or 18.0% of total revenue, in Q2 FY 2022.
  • Book-to-bill ratio was 0.95x for the DSA services business.
  • DSA backlog was $145.7 million, up from $133.6 million at March 31, 2022.

YTD FY 2023 Highlights

  • Revenue grew to $274.2 million in YTD FY 2023 from $224.5 million during the six months ended March 31, 2022 (“YTD FY 2022”), driven by a $16.2 million, or 22.5%, increase in DSA revenue and a $33.5 million, or 22.0%, increase in RMS revenue.
  • Consolidated net loss for YTD FY 2023 was $(96.6) million, or (35.2)% of total revenue, compared to consolidated net loss of $(90.1) million, or (40.1)% of total revenue, in YTD FY 2022. The YTD FY 2023 consolidated net loss included a $66.4 million non-cash goodwill impairment charge related to our RMS segment.
  • Adjusted EBITDA1 was $11.6 million, or 4.2% of total revenue, compared to $35.3 million, or 15.7% of total revenue, in YTD FY 2022.
  • Book-to-bill ratio was 0.98x for the DSA services business.

1 This is a non-GAAP financial measure. Refer to “Non-GAAP to GAAP Reconciliation” in this release for further information.


Updating Select Financial Guidance for the Full Fiscal Year Ending September 30, 2023 (“FY 2023”)

The Company’s guidance takes into account a number of factors, including existing DSA backlog, current sales pipeline, trends in cancellations and delays, trends in pricing, the impact of new products and services and efficiency initiatives including the recent and planned facility consolidations in the U.S. and globally. In addition, the guidance presented below represents the Company’s best efforts to estimate the impact of the NHP supply disruption that was identified and disclosed in the first quarter of fiscal 2023. For FY 2023, we are confirming guidance of at least $580 million of revenue and capital expenditures of no more than 5% of revenue during FY 2023. However, as a result of the increased legal and third party fees incurred during YTD FY 2023, we are updating our guidance for Adjusted EBITDA to at least $70 million down from previous guidance of $75 million. We continue to expect that we will remain in compliance with our financial covenants for FY 2023.


Management Commentary

Robert Leasure Jr., President and Chief Executive Officer, commented, “We are very pleased with the pace and progress of our integration and site optimization initiatives, the growth we are achieving in new service lines, and the overall positive returns being delivered by the investments we have made in expanding our business over the last 12 to 18 months. We also continue to address the current NHP supply disruption issues in the U.S., which includes establishing procedures aimed at providing additional assurances that future NHP imports are purpose-bred, and pursuing alternative sourcing to meet client demand.”

Mr. Leasure continued, “Our recent investments have expanded our services for the drug discovery and development industry. These new services, including expanded genetic toxicology and safety pharmacology offerings, new biotherapeutics services, and enhanced proteomic technologies, increase our ability to support the development of important new therapeutics including cell and gene therapies, allow us to improve speed to market for our clients, expand our market and client base, and help to reduce our outsourcing expenses. We believe the completion of these growth and consolidation activities will improve our ability to increase sales and enhance margins. I am grateful for the continuing support of the Inotiv team as we collectively address both the challenges and opportunities facing our business and industry while continuing to deliver a high level of client service.”  


Q2 FY 2023 Review

Revenue
(in millions)  

    (unaudited)     (unaudited)              
Segment   Q2 FY
2023
    Q2 FY
2022
    Difference     %
Change
 
DSA   $ 47.0     $ 39.1     $ 7.9       +20.2 %
RMS   $ 104.5     $ 101.2     $ 3.3       +3.3 %
Total   $ 151.5     $ 140.3     $ 11.2       +8.0 %

Higher total revenue was driven by a $7.9 million increase in DSA revenue and a $3.3 million increase in RMS revenue. The increase in the DSA revenue was primarily driven by increasing revenue within the current operating structure. Additionally, we are beginning to see increased revenue from genetic toxicology services in connection with new business at our Rockville facility. The increase in RMS revenue was due primarily to favorable pricing across several products, particularly NHPs, partially offset by the negative impact of lower volumes of NHP sales.
  
 Gross Profit2(in millions)  

    (unaudited)           (unaudited)        
Segment   Q2 FY
2023
    % of
Segment


Revenue
    Q2 FY
2022
    % of

Segment

Revenue
 
DSA   $ 15.1       32.1 %   $ 12.3       31.5 %
RMS   $ 29.8       28.5 %   $ 32.4       32.0 %
Total   $ 44.9       29.6 %   $ 44.7       31.9 %


2

excludes amortization of intangible assets

Higher total gross profit in Q2 FY 2023 was the result of a $2.8 million increase in DSA gross profit from Q2 FY 2022, and a $2.6 million decrease in RMS gross profit from Q2 FY 2022. The increase in DSA gross profit as a percent of DSA revenue was driven primarily by increasing sales within the current operating structure. The decrease in RMS gross profit as a percent of RMS revenue was primarily due to the mix of products sold, inflationary pressure on product expenses, energy and wages and some duplication of expenses as we transfer production to implement our site optimization plans, partially offset by favorable pricing for several different RMS product lines. Additionally, the Company experienced favorable margin impacts from the site closures of our Cumberland and Dublin, VA, facilities, which partially offset the inflationary pressures described above.

Consolidated Net Loss

Consolidated net loss for Q2 FY 2023 was $(9.6) million compared to consolidated net loss of $(6.7) million in Q2 FY 2022. Consolidated net loss for Q2 FY 2023 included $13.0 million of depreciation and amortization expense, an increase of $3.1 million from Q2 FY 2022, and $1.8 million of stock compensation expense, an increase of $0.6 million from Q2 FY 2022. Other increases in operating expenses were driven by increases in general and administrative (“G&A”) and other operating expenses, reflecting the integration of previous acquisitions, increases in start-up costs related to our Rockville facility, higher compensation expense and higher legal and third party fees, among other costs. Net loss for Q2 FY 2023 included $6.7 million in legal and third party fees. Based on current information, we expect legal and third party fees to be lower in the third quarter of fiscal 2023. The Company also incurred $10.5 million of interest expense during Q2 FY 2023 as compared to $7.5 million in Q2 FY 2022.


YTD FY 2023 Review

Revenue
(in millions)  

    (unaudited)     (unaudited)              
Segment   YTD FY
2023
    YTD FY
2022
    Difference     %
Change
 
DSA   $ 88.1     $ 71.9     $ 16.2       +22.5 %
RMS   $ 186.1     $ 152.6     $ 33.5       +22.0 %
Total   $ 274.2     $ 224.5     $ 49.7       +22.1 %

Higher total revenue was driven by a $16.2 million increase in DSA revenue and a $33.5 million increase in RMS revenue. The increase in DSA revenue was primarily driven by additional YTD FY 2023 revenue generated from Integrated Laboratory Systems, LLC (“ILS”), which was acquired on January 10, 2022, plus new services related to genetic toxicicology and organic growth in general toxicology services. The increase in the RMS revenue was due primarily to favorable pricing, particularly NHPs, partially offset by the negative impact of lower volumes of NHP sales. Additionally, the increase in RMS revenue was impacted by the timing of contributions from acquisitions. Envigo was acquired on November 5, 2021, RSI was acquired on December 29, 2021, and OBRC was acquired on January 27, 2022.  
  
 Gross Profit2(in millions)  

    (unaudited)           (unaudited)        
Segment   YTD FY
2023
    % of
Segment


Revenue
    YTD FY
2022
    % of

Segment

Revenue
 
DSA   $ 28.2       32.0 %   $ 24.6       34.2 %
RMS   $ 38.4       20.6 %   $ 39.5       25.9 %
Total   $ 66.6       24.3 %   $ 64.1       28.6 %




excludes amortization of intangible assets

Higher total gross profit in YTD FY 2023 was the result of a $3.6 million increase in DSA gross profit from YTD FY 2022, and a $1.1 million decrease in RMS gross profit from YTD FY 2022. The decrease in DSA gross profit as a percent of DSA revenue was primarily due to laboratory capacity investments and costs associated with the successful recruitment of scientists in YTD FY 2023, to begin adding services and capacity, some of which became available in Q2 FY 2023 and some of which we expect to become available during the remainder of FY 2023. The decrease in RMS gross profit as a percent of RMS revenue was primarily due to significantly reduced margins in the first fiscal quarter of 2023 due to the mix of products sold and inflationary pressure on product expenses, energy and wages and some duplication of expenses as we transfer production to implement our site optimization plans, partially offset by favorable pricing for several different RMS product lines which were effective beginning in Q2 FY 2023, and favorable margin impacts from the site closures of our Cumberland and Dublin, VA, facilities.

Consolidated Net Loss

Consolidated net loss for YTD FY 2023 was $(96.6) million compared to consolidated net loss of $(90.1) million in YTD FY 2022. Consolidated net loss for YTD FY 2023 included: a previously announced $66.4 million non-cash goodwill impairment charge related to our RMS segment; $26.3 million of depreciation and amortization expense, an increase of $10.4 million from YTD FY 2022; and $3.8 million of stock compensation expense, a decrease of $21.2 million from YTD FY 2022. Other increases in operating expenses were driven by higher selling costs, primarily due to increased revenue, higher G&A expenses, reflecting various acquisitions, higher legal, audit and third party fees and higher start-up costs related to our Rockville facility, among other costs. Net loss for YTD FY 2023 included $10.1 million in legal and third party fees. Based on current information, we expect legal and third party fees to be lower in the third quarter of fiscal 2023. Consolidated net loss for YTD FY 2022 also included one-time charges of $56.7 million of fair value remeasurement of the embedded derivative component of the convertible notes issued in September 2021 and $23.0 million of post combination stock compensation expense relating to the adoption of the Envigo Equity Plan. Further, consolidated net loss included $21.0 million of interest expense during YTD FY 2023, up from $12.4 million in YTD FY 2022.


Cash Provided by Operating and Financing Activities and Financial Condition

As of March 31, 2023, the Company had $24.6 million in cash and cash equivalents and no borrowings on its $15.0 million revolving credit facility. Total debt, net of debt issuance costs, as of March 31, 2023, was $374.1 million. We were in compliance with our debt covenants as of March 31, 2023. Cash provided by operating activities was $5.4 million for YTD FY 2023, compared to cash provided by operating activities of $4.0 million for YTD FY 2022. For YTD FY 2023, capital expenditures totaled $16.8 million.


Update on DSA and RMS Activities

  • The Company will be co-locating and further integrating its genetically engineered models and services (“GEMS”) business with its existing Pharmacology, Toxicology, Pharmacokinetic and Laboratory Sciences operations in St. Louis, MO, allowing colleagues with similar skills and expertise to collaborate more closely. We expect the completion of this project to occur in the third fiscal quarter of 2023, and upon completion we will eliminate the need for one of our leased facilities in St Louis. The lease expires in July 2023 and will not be renewed.
  • Within its DSA business segment, the Company’s Rockville, MD, site is now operational with GLP biotherapeutics analytical and genetic toxicology capabilities; the facility expansion in Boulder, CO, has been completed; and the expansion activities at Fort Collins, CO, remain on track and are expected to become operational by the end of FY 2023.
  • Within its RMS business segment, as previously announced during the first fiscal quarter of 2023, the Company completed the shutdown of its Cumberland and Dublin, VA, facilities and initiated a relocation of its operations in Haslett, MI, and Boyertown, PA, to its newly refurbished facility in Denver, PA. The facility closures in Haslett and Boyertown were completed as planned in March 2023, and these facilities have been listed for sale.  
  • In the first fiscal quarter of 2023, the Company initiated the relocation of two RMS facilities in Indianapolis, IN, which are expected to be completed by June 30, 2023.
  • The relocation of the Company’s RMS facility in France to recently updated operations in The Netherlands is now underway, and we expect to have this process completed by the end of June 2023.
  • The Company has completed its consultations with employee representatives to relocate its Blackthorne, U.K., facility to operations in Hillcrest, U.K., and currently expects this relocation to be completed during the third quarter of fiscal 2024.
  • In conjunction with these RMS changes, the Company is reviewing alternatives and route enhancements to our transportation system and has begun to initiate changes, which we expect will result in a reduction in the number of vehicles required, a reduction in energy consumption and its associated greenhouse gas emissions, and ultimately a reduction in transportation expenses while maintaining and improving our service levels.
  • The previously announced sale of the Company’s Israel operations is still in process and is expected to be completed within this fiscal year.


Subsequent Events:

The Company extended by one year the maturity of a $3.7 million unsecured seller payable pursuant to the stock purchase agreement (“SPA”) with Orient Bio, Inc. The unsecured seller payable, which was originally due on July 27, 2023, is now due July 27, 2024. This extension did not affect the rights and remedies of any party to the SPA, nor alter, modify or amend or in any way affect any of the terms and conditions, obligations, covenants or agreements contained in the SPA.

On May 4, 2023, the Company announced the expansion of its safety pharmacology offering with the validation and verification of a cardiopulmonary telemetry study model in cynomolgus macaques. Offered through Inotiv’s DSA business, telemetry allows for the continuous observation of ECG, respiratory rate and volume, blood pressure and other cardiovascular parameters during preclinical safety studies.

Management will host a conference call on Thursday, May 11, 2023, at 4:30 pm ET to discuss second quarter results for fiscal year 2023.

Interested parties may participate in the call by dialing:

  • (877) 407-9753 (Domestic)
  • (201) 493-6739 (International)

The live conference call webcast will be accessible in the Investors section of the Company’s web site and directly via the following link:

https://event.choruscall.com/mediaframe/webcast.html?webcastid=j0NY3Nu6

For those who cannot listen to the live broadcast, an online replay will be available in the Investors section of Inotiv’s web site at: https://www.inotivco.com/investors/investor-information/.

Non-GAAP to GAAP Reconciliation

This press release contains financial measures that are not calculated in accordance with generally accepted accounting principles in the United States (GAAP), including Adjusted EBITDA and Adjusted EBITDA as a percentage of total revenue for the three and six months ended March 31, 2023 and 2022 and selected business segment information for those periods. Adjusted EBITDA as reported herein refers to a financial measure that excludes from consolidated net income (loss) statement of operations line items interest expense and income tax (benefit) expense, as well as non-cash charges for depreciation and amortization, stock compensation expense, acquisition and integration costs, startup costs, restructuring costs incurred in connection with the exit of multiple facilities, unrealized foreign exchange gain/ loss, loss on debt extinguishment, amortization of inventory step up, loss/gain on disposition of assets, loss on fair value remeasurement of convertible notes, other non-recurring third-party costs and goodwill impairment loss. The adjusted business segment information excludes from operating income and unallocated corporate G&A these same expenses.

Adjusted EBITDA and Adjusted EBITDA margin guidance for fiscal year 2023 and periods within the year are provided on a non-GAAP basis. The Company cannot reconcile this guidance to expected net income/loss or expected net income/loss margin without unreasonable effort because certain items that impact net income/loss and net income/loss margin are out of the Company’s control and/or cannot be reasonably predicted at this time, which unavailable information could have a significant impact on the Company’s GAAP financial results. 

The Company believes that these non-GAAP measures provide useful information to investors. Among other things, they may help investors evaluate the Company’s ongoing operations. They can assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Management uses these non-GAAP measures internally to evaluate the performance of the business, including to allocate resources. Investors should consider these non-GAAP measures as supplemental and in addition to, not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP.

Management has chosen to provide this supplemental information to investors, analysts, and other interested parties to enable them to perform additional analyses of our results and to illustrate our results giving effect to the non-GAAP adjustments. Management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.

About the Company

Inotiv, Inc. is a leading contract research organization dedicated to providing nonclinical and analytical drug discovery and development services and research models and related products and services. The Company’s products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of development, all while increasing efficiency, improving data, and reducing the cost of taking new drugs to market. Inotiv is committed to supporting discovery and development objectives as well as helping researchers realize the full potential of their critical R&D projects, all while working together to build a healthier and safer world. Further information about Inotiv can be found here: https://www.inotivco.com/.

This release contains forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to the impact of recent events related to NHP matters on the Company’s business, operations, results, financial condition, cash flows, and assets, the Company’s ability to comply with covenants under its credit agreement, Company’s ability to reduce its legal and third party fees, changes in the market and demand for the Company’s products and services, the development, marketing and sales of products and services, changes in technology, industry and regulatory standards, the timing of acquisitions and the successful closing, integration and business and financial impact thereof, governmental regulations, inspections and investigations, claims, investigations and litigation against or involving the Company, its business and/or its industry, the impact of site closures and consolidations, expansion and related efforts, and various other market and operating risks, including those detailed in the Company’s filings with the U.S. Securities and Exchange Commission.

Company Contact Investor Relations
Inotiv, Inc. The Equity Group Inc.
Beth A. Taylor, Chief Financial Officer Devin Sullivan
(765) 497-8381 (212) 836-9608
[email protected] [email protected]



INOTIV, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)
(Unaudited)
                       
  Three Months Ended   Six Months Ended
  March 31,   March 31,
    2023       2022       2023       2022
 
Service revenue $ 58,752     $ 49,584     $ 108,800     $ 87,760  
Product revenue   92,711       90,729       165,417       136,764  
Total revenue $ 151,463       140,313     $ 274,217     $ 224,524  
Costs and expenses:                      
Cost of services provided (excluding amortization of intangible assets)   38,143       33,305       73,573       57,514  
Cost of products sold (excluding amortization of intangible assets)   68,387       62,282       134,026       102,959  
Selling   4,758       4,647       9,265       7,385  
General and administrative   29,035       21,347       58,004       34,599  
Amortization of intangible assets   8,453       6,414       17,234       9,810  
Other operating expense   4,812       4,450       8,451       38,030  
Goodwill impairment loss               66,367        
Operating income (loss) $ (2,125 )   $ 7,868     $ (92,703 )   $ (25,773 )
Other (expense) income:                      
Interest expense   (10,515 )     (7,547 )     (20,965 )     (12,375 )
Other expense (income)   545       (139 )     (1,333 )     (57,866 )
(Loss) income before income taxes $ (12,095 )   $ 182     $ (115,001 )   $ (96,014 )
Income tax benefit (expense)   2,466       (6,846 )     18,440       5,939  
Consolidated net loss $ (9,629 )   $ (6,664 )   $ (96,561 )   $ (90,075 )
Less: Net income (loss) attributable to noncontrolling interests   365       (577 )     756       (941 )
Net loss attributable to common shareholders $ (9,994 )   $ (6,087 )   $ (97,317 )   $ (89,134 )
                       
Loss per common share                      
Net loss attributable to common shareholders:                      
Basic and diluted $ (0.39 )   $ (0.24 )   $ (3.79 )   $ (3.84 )
                       
Weighted-average number of common shares outstanding:                      
Basic and diluted   25,687       25,315       25,645       23,197  

INOTIV, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)
           
  March 31,


    September 30,
    2023       2022  
  (Unaudited)      
Assets          
Current assets:          
Cash and cash equivalents $ 24,596     $ 18,515  
Restricted cash         465  
Trade receivables and contract assets, net of allowances for credit losses of $7,523 and $6,268, respectively   74,014       100,073  
Inventories, net   64,286       71,441  
Prepaid expenses and other current assets   40,479       42,483  
Assets held for sale   7,270        
Total current assets   210,645       232,977  
           
Property and equipment, net   188,496       186,199  
Operating lease right-of-use assets, net   42,014       32,489  
Goodwill   94,286       157,825  
Other intangible assets, net   326,261       345,886  
Other assets   6,964       7,524  
Total assets $ 868,666     $ 962,900  
           
Liabilities, shareholders’ equity and noncontrolling interest          
Current liabilities:          
Accounts payable $ 30,114     $ 28,695  
Accrued expenses and other liabilities   30,958       35,801  
Revolving credit facility         15,000  
Fees invoiced in advance   55,196       68,642  
Current portion of long-term operating lease   10,061       7,982  
Current portion of long-term debt   4,023       7,979  
Liabilities held for sale   2,101        
Total current liabilities   132,453       164,099  
Long-term operating leases, net   32,730       24,854  
Long-term debt, less current portion, net of debt issuance costs   370,040       330,677  
Other long-term liabilities   6,023       6,477  
Deferred tax liabilities, net   54,785       77,027  
Total liabilities   596,031       603,134  
           
           
           
Shareholders’ equity and noncontrolling interest:          
Common shares, no par value:          
Authorized 74,000,000 shares at March 31, 2023 and at September 30, 2022; 25,759,107 issued and outstanding at March 31, 2023 and 25,598,289 at September 30, 2022   6,491       6,362  
Additional paid-in capital   711,591       707,787  
Accumulated deficit   (444,838 )     (348,277 )
Accumulated other comprehensive income (loss)   702       (5,500 )
Total equity attributable to common shareholders   273,946       360,372  
Noncontrolling interest   (1,311 )     (606 )
Total shareholders’ equity and noncontrolling interest   272,635       359,766  
Total liabilities and shareholders’ equity and noncontrolling interest $ 868,666     $ 962,900  



INOTIV, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)
(Unaudited)
           
  Six Months Ended
  March 31,
    2023       2022  
Operating activities:          
Consolidated net loss $ (96,561 )   $ (90,075 )
Adjustments to reconcile net loss to net cash used in operating activities, net of acquisitions:          
Depreciation and amortization   26,253       15,866  
Employee stock compensation expense   3,827       20,300  
Changes in deferred taxes   (21,303 )     (1,907 )
Provision for doubtful accounts   1,333       381  
Amortization of debt issuance costs and original issue discount   1,512       1,203  
Noncash interest and accretion expense   2,870       2,512  
Loss on fair value remeasurement of embedded derivative         56,714  
Other non-cash operating activities   8       603  
Goodwill impairment loss   66,367        
Loss on debt extinguishment         878  
Non-cash amortization of inventory fair value step-up   427       6,277  
Non-cash restructuring costs   678        
Changes in operating assets and liabilities:          
Trade receivables and contract assets   22,836       (8,926 )
Inventories   7,125       (14,688 )
Prepaid expenses and other current assets   1,862       (10,149 )
Operating lease right-of-use assets and liabilities, net   429       1,457  
Accounts payable   5,018       5,222  
Accrued expenses and other liabilities   (3,474 )     (11,510 )
Fees invoiced in advance   (13,720 )     28,402  
Other asset and liabilities, net   (61 )     1,467  
Net cash provided by operating activities   5,426       4,027  
           
Investing activities:          
Capital expenditures   (16,840 )     (15,202 )
Proceeds from sale of equipment   276       283  
Cash paid in acquisitions         (288,702 )
Net cash used in investing activities   (16,564 )     (303,621 )
           
Financing activities:          
Payments of long-term debt         (37,746 )
Payments of debt issuance costs   (54 )     (9,887 )
Payments on promissory notes   (1,454 )     (763 )
Payments on revolving credit facility   (21,000 )     (10,000 )
Payments on senior term notes and delayed draw term loans   (1,375 )     (601 )
Borrowings on construction loan         1,184  
Borrowings on revolving loan facility   6,000       10,000  
Borrowings on delayed draw term loan   35,000       35,000  
Proceeds from exercise of stock options   107       93  
Proceeds from issuance of senior term notes         205,000  
Payments on capex line of credit         (1,749 )
Net cash provided by financing activities   17,224       190,531  
           
Effect of exchange rate changes on cash and cash equivalents   1,052       (392 )
           
Net increase (decrease) in cash and cash equivalents   7,138       (109,455 )
Less: cash, cash equivalents, and restricted cash held for sale   (1,522 )      
Cash, cash equivalents, and restricted cash at beginning of period   18,980       156,924  
Cash, cash equivalents, and restricted cash at end of period, net of cash, cash equivalents and restricted cash held for sale $ 24,596     $ 47,469  
           
Noncash financing activity:          
Seller financed acquisition $     $ 6,325  
Paid in kind debt issuance costs $ 1,363     $  
           
Supplemental disclosure of cash flow information:          
Cash paid for interest $ 16,374     $ 5,989  
Income taxes paid, net $ 3,952     $ 614  



INOTIV, INC.

RECONCILIATION OF GAAP TO NON-GAAP

SELECT BUSINESS SEGMENT INFORMATION

(In thousands)
(Unaudited)
         
  Three Months Ended     Six Months Ended  
  March 31,     March 31,  
  2023     2022       2023       2022  
DSA                              
Revenue   47,023       39,054       88,116       71,879  
Operating income   1,924       3,752       4,296       9,794  
Operating income as a % of total revenue   1.2 %     2.7 %     1.5 %     4.4 %
Add back:                              
Depreciation and amortization   3,611       3,417       7,591       5,958  
Restructuring costs   97             97        
Startup costs   2,281       1,474       3,786       2,431  
Total non-GAAP adjustments to operating income   5,989       4,891       11,474       8,389  
Non-GAAP operating income   7,913       8,643       15,770       18,183  
Non-GAAP operating income as a % of DSA revenue   16.8 %     22.1 %     17.9 %     25.3 %
Non-GAAP operating income as a % of total revenue   5.2 %     6.2 %     5.8 %     8.1 %
                               
RMS                              
Revenue   104,440       101,259       186,101       152,645  
Operating income/(loss)   12,725       22,562       (58,547 )     22,642  
Operating income/(loss) as a % of total revenue   8.4 %     26.8 %     (21.4 )%     10.1 %
Add back:                              
Depreciation and amortization   9,379       6,425       18,662       9,908  
Restructuring costs   1,643             1,909        
Amortization of inventory step up   183       2,609       427       6,277  
Other non-recurring, third party costs   469       507       1,140       946  
Goodwill impairment loss               66,367        
Total non-GAAP adjustments to operating income/(loss)   11,674       9,541       88,505       17,131  
Non-GAAP operating income   24,399       32,103       29,958       39,773  
Non-GAAP operating income as a % of RMS revenue   23.4 %     31.7 %     16.1 %     26.1 %
Non-GAAP operating income as a % of total revenue   16.1 %     22.9 %     10.9 %     17.7 %

  Three Months Ended     Six Months Ended  
  March 31,     March 31,  
  2023     2022     2023     2022  
Unallocated Corporate G&A   (16,774 )     (18,445 )     (38,452 )     (58,209 )
Unallocated corporate G&A as a % of total revenue   (11.1 )%     (13.1 )%     (14.0 )%     (25.9 )%
Add back:                              
Stock option expense   1,781       1,141       3,827       25,073  
Acquisition and integration costs   105       2,085       1,088       10,893  
Total non-GAAP adjustments to operating income/(loss)   1,886       3,226       4,915       35,966  
Non-GAAP operating loss   (14,888 )     (15,219 )     (33,537 )     (22,243 )
Non-GAAP operating loss as a % of total revenue   (9.8 )%     (10.8 )%     (12.2 )%     (9.9 )%
                               
Total                              
Revenue   151,463       140,313       274,217       224,524  
Operating income/(loss)   (2,125 )     7,869       (92,703 )     (25,773 )
Operating loss as a % of total revenue   (1.4 )%     5.6 %     (33.8 )%     (11.5 )%
Add back:                              
Depreciation and amortization   12,990       9,842       26,253       15,866  
Stock compensation expense   1,781       1,141       3,827       25,073  
Restructuring costs   1,740             2,006        
Acquisition and integration costs   105       2,085       1,088       10,893  
Amortization of inventory step up   183       2,609       427       6,277  
Startup costs   2,281       1,474       3,786       2,431  
Other non-recurring, third party costs   469       507       1,140       946  
Goodwill impairment loss               66,367        
Total non-GAAP adjustments to operating loss   19,549       17,658       104,894       61,486  
Non-GAAP operating income/(loss)   17,424       25,527       12,191       35,713  
Non-GAAP operating income/(loss) as a % of total revenue   11.5 %     18.2 %     4.4 %     15.9 %

  

 INOTIV, INC.
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA
(In thousands)
(Unaudited)
           
  Three Months Ended     Six Months Ended  
  March 31,     March 31,  
    2023     2022     2023     2022  
GAAP Consolidated net loss $ (9,629 )   $ (6,664 )   $ (96,561 )   $ (90,075 )
Adjustments (a):                              
Interest expense   10,515       7,547       20,965       12,375  
Income tax (benefit) expense   (2,466 )     6,846       (18,440 )     (5,939 )
Depreciation and amortization   12,990       9,842       26,253       15,866  
Stock compensation expense (1)   1,781       1,141       3,827       25,073  
Acquisition and integration costs (2)   105       2, 085       1,088       10,893  
Startup costs   2,281       1,474       3,786       2,431  
Restructuring costs (3)   1,740             2,006        
Unrealized foreign exchange (gain)/loss   (739 )     (134 )     511       60  
Loss on debt extinguishment                     877  
Amortization of inventory step up   183       2,609       427       6,277  
Loss (gain) on disposition of assets   (129 )     12       251       (235 )
Loss on fair value remeasurement of convertible notes (4)                     56,714  
Other non-recurring, third party costs   469       507       1,140       946  
Goodwill impairment loss (5)               66,367        
Adjusted EBITDA (b) $ 17,101     $ 25,265     $ 11,620     $ 35,263  
GAAP Consolidated net loss as a percent of total revenue   (6.4 )%     (4.7 )%     (35.2 )%     (40.1 )%
Adjustments as a percent of total revenue   17.6 %     22.8 %     39.5 %     55.8 %
Adjusted EBITDA as a percent of total revenue   11.3 %     18.0 %     4.2 %     15.7 %

(a) Adjustments to certain GAAP reported measures for the three and six months ended March 31, 2023 and 2022 include, but are not limited to, the following:
    (1) For the six months ended March 31, 2022, $23.0 million relates to post combination non-cash stock compensation expense relating to the adoption of the Envigo Equity Plan recognized in connection with the Envigo acquisition.
    (2) For the three and six months ended March 31, 2023 and 2022, represents charges for legal services, accounting services, travel and other related activities in connection with various acquisitions and the related integration of those acquisitions.
    (3) For the three and six months ended March 31, 2023, represents costs incurred in connection with the exit of multiple sites as previously disclosed.
    (4) For the six months ended March 31, 2022, represents loss of $56.7 million resulting from the fair value remeasurement of the embedded derivative component of the convertible notes.
    (5) For the six months ended March 31, 2023, represents a non-cash goodwill impairment charge of $66.4 million related to the RMS segment.
(b) Adjusted EBITDA – Consolidated net (loss) income before interest expense, income tax expense (benefit), depreciation and amortization, stock compensation expense, acquisition and integration costs, startup costs, restructuring costs, unrealized foreign exchange gain/loss, loss on debt extinguishment, amortization of inventory step up, gain/loss on disposition of assets, loss on fair value remeasurement of the embedded derivative component of the convertible notes, other non-recurring third party costs and goodwill impairment loss.

 



eGain Reports Fiscal 2023 Third Quarter Financial Results

Q3 Revenue Within and Non-GAAP Net Income Above Guidance Range

SUNNYVALE, Calif., May 11, 2023 (GLOBE NEWSWIRE) — eGain (Nasdaq: EGAN), a leading knowledge platform for customer engagement, today announced financial results for its fiscal 2023 third quarter ended March 31, 2023.

“Our North America renewal and expansion rates remained strong during the quarter,” said Ashu Roy, eGain’s CEO. “Despite the market slowdown, we signed several new customers near the end of the quarter, and expense controls enabled us to deliver bottom-line results that exceeded our guidance and street consensus.”

Fiscal 2023 Third Quarter Financial Highlights

  • Total revenue was $23.0 million, down 4% year over year (down 1% in constant currency).
  • SaaS revenue was $20.9 million, up 1% year over year (up 3% in constant currency).
  • GAAP net loss was $372,000, or $0.01 per share on a basic and diluted basis, compared to a GAAP net loss of $615,000, or $0.02 per share on a basic and diluted basis, in Q3 2022.
  • Non-GAAP net income was $1.1 million, or $0.03 per share on a basic and diluted basis, compared to non-GAAP net income of $2.4 million, or $0.08 per share on a basic basis and $0.07 per share on a diluted basis, in Q3 2022.
  • Cash provided by operations was $905,000, or an operating cash flow margin of 4%.
  • Total cash and cash equivalents were $81.3 million, compared to $70.5 million in Q3 2022.
  • Total shares purchased through repurchase program was approximately 145,000 at an average cost per share of $7.57, totaling $1.1 million.

Fiscal 2023 First Nine Months Financial Highlights

  • Total revenue was $73.4 million, up 7% year over year (up 11% in constant currency).
  • SaaS revenue was $66.9 million, up 11% year over year (up 14% in constant currency).
  • GAAP net loss was $492,000, or $0.02 per share on a basic and diluted basis, compared to GAAP net loss of $890,000, or $0.03 per share on a basic and diluted basis in Q3 2022.
  • Non-GAAP net income was $4.8 million, or $0.15 per share on a basic and diluted basis, compared to non-GAAP net income of $8.0 million, or $0.26 per share on a basic basis and $0.25 per share on a diluted basis in Q3 2022.
  • Cash provided from operations was $9.1 million, or an operating cash flow margin of 12%.

Fiscal 2023 Fourth Quarter Financial Guidance

For the fourth quarter of fiscal 2023 ending June 30, 2023, eGain expects:

  • Total revenue of between $23.4 million to $24.0 million.
  • Non-GAAP total revenue, adjusted for constant currency, of between $23.4 million to $24.0 million.
  • GAAP net income of $400,000 to $900,000, or $0.01 to $0.03 per share.
    • Includes stock-based compensation expense of approximately $1.5 million.
    • Includes depreciation and amortization of approximately $125,000.
  • Non-GAAP net income of $1.9 million to $2.4 million, or $0.06 to $0.07 per share.

Fiscal 2023 Financial Guidance

For the fiscal 2023 full year ending June 30, 2023, eGain expects:

  • Total revenue of between $96.8 million to $97.4 million.
  • Non-GAAP total revenue, adjusted for constant currency, of between $99.2 million to $99.8 million.
  • GAAP net loss of $300,000 to GAAP net income of $200,000, or $(0.01) to $0.01 per share.
    • Includes stock-based compensation expense of approximately $6.8 million.
    • Includes depreciation and amortization of approximately $600,000.
  • Non-GAAP net income of $6.5 million to $7.0 million, or $0.20 to $0.21 per share.

Guidance Assumption:

  • Weighted average shares outstanding are expected to be approximately 32.5 million for the fourth quarter of fiscal 2023 and 32.8 million for the full fiscal year 2023.

Non-GAAP Financial Measures

This press release includes certain non-GAAP financial measures as supplemental information relating to our operating results, including non-GAAP total revenue that is only adjusted for constant currency to provide better visibility into the underlying business trends and non-GAAP net income. The non-GAAP net income measure is adjusted for stock-based compensation expense. eGain’s management has analyzed the effect of these non-GAAP adjustments on our income tax provision and believes the change in our income tax provision would be minimal due to these non-GAAP adjustments being attributed to the U.S. jurisdiction where it has recorded full valuation allowance against the deferred taxes. Non-GAAP results are presented for supplemental informational purposes only and should not be considered a substitute for financial information presented in accordance with generally accepted accounting principles, or GAAP, and may be different from non-GAAP measures used by other companies. eGain’s management uses these non-GAAP measures to compare our performance to that of prior periods for trend analysis and for budgeting and planning purposes. eGain believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing our financial measures with other software companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in our financial and operational decision-making. Reconciliation tables of the most comparable GAAP financial measures to the non-GAAP financial measures used in this press release are included with the financial tables at the end of this release. eGain urges investors to review the reconciliation and not to rely on any single financial measure to evaluate our business. In addition, this presentation includes eGain’s projected non-GAAP total revenue, a non-GAAP measure used to describe eGain’s expected performance. We have not presented a reconciliation of this non-GAAP measure to eGain’s projected total revenue, the most comparable GAAP financial measure, because the reconciliation could not be prepared without unreasonable effort. The information necessary to prepare the reconciliation is not available on a forward-looking basis and cannot be accurately predicted. The unavailable information could have a significant impact on the calculation of the comparable GAAP financial measure.

Conference Call Information

eGain will discuss its fiscal 2023 third quarter results today via teleconference at 2:00 p.m. Pacific Time. To access the live call, dial 844 481-2704 (U.S. toll free) or +1 412-317-0660 (International) and ask to join the eGain earnings call. A live and archived webcast of the call will also be accessible on the “Investor relations” section of eGain’s website at www.egain.com. In addition, a phone replay of the conference call will be available starting two hours after the call and will remain in effect for one week. To access the phone replay, dial 877-344-7529 (U.S. toll free) or +1 412-317-0088 (International). The replay access code is 1400048.

About eGain

eGain Knowledge Hub automates and orchestrates customer engagement across touch points. Powered by AI and analytics, our secure cloud solution delivers personalized digital-first experiences, quick business value, and easy innovation. Visit www.egain.com for more info.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation: our financial guidance for the fourth quarter of fiscal 2023 and fiscal 2023 full year ending June 30, 2023; and our market opportunity. The achievement or success of the matters covered by such forward-looking statements, including future financial guidance, involves risks, uncertainties, and assumptions, many of which involve factors or circumstances that are beyond our control. If any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from the results expressed or implied by the forward-looking statements we make, including our ability to achieve our targets for the fourth quarter of fiscal 2023 and fiscal 2023 full year ending June 30, 2023. The risks and uncertainties referred to above include, but are not limited to: risks to our business, operating results, financial condition, and prospects from the COVID-19 pandemic and related economic downturns, including but not limited to, its effect on customer demand for our products and services and the impact of potential delays in customer payments; risks associated with new product releases and new services and products features; risks that customer demand may fluctuate or decrease; risks that we are unable to collect unbilled contractual commitments, particularly in the current economic environment; risks that our lengthy sales cycles may negatively affect our operating results; currency risks; our ability to capitalize on customer engagement; risks related to our reliance on a relatively small number of customers for a substantial portion of our revenue; our ability to compete successfully and manage growth; our ability to develop and expand strategic and third party distribution channels; risks related to our international operations; our ability to continue to innovate; our strategy of making investments in sales to drive growth; general political or destabilizing events, including war, intensified international hostilities, conflict or acts of terrorism; the effect of legislative initiatives or proposals, statutory changes, governmental or other applicable regulations and/or changes in industry requirements, including those addressing data privacy, cyber-security and cross-border data transfers; and other risks detailed from time to time in eGain’s public filings, including eGain’s annual report on Form 10-K for the fiscal year ended June 30, 2022 and subsequent reports filed with the Securities and Exchange Commission, which are available on the Securities and Exchange Commission’s website at www.sec.gov. These forward-looking statements are based on current expectations and speak only as of the date hereof. We assume no obligation and do not intend to update these forward-looking statements, except as required by law.

eGain, the eGain logo, and all other eGain product names and slogans are trademarks or registered trademarks of eGain Corporation in the United States and/or other countries. All other company names and products mentioned in this release may be trademarks or registered trademarks of the respective companies.

MKR Investor Relations

Todd Kehrli or Jim Byers
Phone: 323-468-2300
Email: [email protected]

eGain Corporation

Condensed Consolidated Balance Sheets

(in thousands, except par value data)

(unaudited)
             
    March 31,    June 30, 
    2023        2022  
ASSETS            
Current assets:            
Cash and cash equivalents   $ 81,306     $ 72,173  
Restricted cash     7       7  
Accounts receivable, less allowance for doubtful accounts of $169 and $123 as of March 31, 2023 and June 30, 2022, respectively     10,214       26,961  
Costs capitalized to obtain revenue contracts, net     1,359       1,487  
Prepaid expenses     2,614       2,612  
Other current assets     1,083       895  
Total current assets     96,583       104,135  
Property and equipment, net     676       831  
Operating lease right-of-use assets     3,086       3,850  
Costs capitalized to obtain revenue contracts, net of current portion     2,561       3,136  
Goodwill     13,186       13,186  
Other assets, net     1,157       871  
Total assets   $ 117,249     $ 126,009  
             
LIABILITIES AND STOCKHOLDERS’ EQUITY            
Current liabilities:            
Accounts payable   $ 1,495     $ 1,706  
Accrued compensation     7,387       8,708  
Accrued liabilities     5,505       4,926  
Operating lease liabilities     967       1,044  
Deferred revenue     35,106       45,638  
Total current liabilities     50,460       62,022  
Deferred revenue, net of current portion     2,225       3,785  
Operating lease liabilities, net of current portion     1,906       2,537  
Other long-term liabilities     818       808  
Total liabilities     55,409       69,152  
             
Stockholders’ equity:            
Common stock, par value $0.001 – authorized: 60,000 shares; outstanding: 32,022 and 31,930 shares as of March 31, 2023 and June 30, 2022, respectively.     32       32  
Additional paid-in capital     399,548       393,157  
Treasury stock, at cost: 145 and 0 common shares as of March 31, 2023 and June 30, 2022, respectively.     (1,101 )      
Notes receivable from stockholders     (96 )     (95 )
Accumulated other comprehensive loss     (2,501 )     (2,687 )
Accumulated deficit     (334,042 )     (333,550 )
Total stockholders’ equity     61,840       56,857  
Total liabilities and stockholders’ equity   $ 117,249     $ 126,009  

eGain Corporation

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)
                           
    Three Months Ended     Nine Months Ended
    March 31,      March 31, 
    2023        2022       2023        2022  
Revenue:                          
Subscription   $ 20,980     $ 21,728       $ 67,517     $ 63,179  
Professional services     2,033       2,176         5,859       5,268  
Total revenue     23,013       23,904         73,376       68,447  
Cost of revenue:                          
Cost of subscription     5,393       3,803         13,795       10,811  
Cost of professional services     2,202       2,734         6,834       7,125  
Total cost of revenue     7,595       6,537         20,629       17,936  
Gross profit     15,418       17,367         52,747       50,511  
Operating expenses:                          
Research and development     6,687       6,193         20,749       17,988  
Sales and marketing     6,837       8,693         25,191       24,252  
General and administrative     2,406       2,957         7,776       8,687  
Total operating expenses     15,930       17,843         53,716       50,927  
Loss from operations     (512 )     (476 )       (969 )     (416 )
Interest income     818       3         1,633       7  
Other (expense) income, net     (245 )     200         20       182  
Income (Loss) before income tax provision     61       (273 )       684       (227 )
Provision for income taxes     (433 )     (342 )       (1,176 )     (663 )
Net loss   $ (372 )   $ (615 )     $ (492 )   $ (890 )
Per share information:                          
Loss per share:                          
Basic   $ (0.01 )   $ (0.02 )     $ (0.02 )   $ (0.03 )
Diluted   $ (0.01 )   $ (0.02 )     $ (0.02 )   $ (0.03 )
Weighted-average shares used in computation:                          
Basic     32,122       31,647         32,024       31,451  
Diluted     32,122       31,647         32,024       31,451  
                           
Summary of stock-based compensation included in costs and expenses above:                          
Cost of revenue   $ 371     $ 825       $ 1,213     $ 2,349  
Research and development     509       783         1,633       2,310  
Sales and marketing     174       580         997       1,840  
General and administrative     393       820         1,440       2,437  
Total stock-based compensation   $ 1,447     $ 3,008       $ 5,283     $ 8,936  

eGain Corporation

GAAP to Non-GAAP Reconciliation Table

(in thousands, except per share data)

(unaudited)
                         
    Three Months Ended

March 31,
  Nine Months Ended

March 31,
    2023     2022     2023     2022  
Loss from operations   $ (512 )   $ (476 )   $ (969 )   $ (416 )
Add:                        
Stock-based compensation     1,447       3,008       5,283       8,936  
Non-GAAP income from operations   $ 935     $ 2,532     $ 4,314     $ 8,520  
                         
Net loss   $ (372 )   $ (615 )   $ (492 )   $ (890 )
Add:                        
Stock-based compensation     1,447       3,008       5,283       8,936  
Non-GAAP net income   $ 1,075     $ 2,393     $ 4,791     $ 8,046  
Per share information:                        
Non-GAAP earnings per share:                        
Basic   $ 0.03     $ 0.08     $ 0.15     $ 0.26  
Diluted   $ 0.03     $ 0.07     $ 0.15     $ 0.25  
Weighted-average shares used in computation:                        
Basic     32,122       31,647       32,024       31,451  
Diluted     32,968       32,932       32,909       32,827  

eGain Corporation

Other GAAP to Non-GAAP Supplemental Financial Information

(in thousands)

(unaudited)
                         
    Three Months Ended

March 31,
  Growth Rates   Constant Currency
Growth Rates [1]
    2023     2022              
Revenue:                        
SaaS revenue   $ 20,854     $ 20,686       1 %     3 %
Legacy revenue     126       1,042       (88 %)     (87 %)
GAAP subscription     20,980       21,728       (3 %)     (1 %)
GAAP professional services     2,033       2,176       (7 %)     (5 %)
Total GAAP revenue   $ 23,013     $ 23,904       (4 %)     (1 %)
                         
SaaS and professional services revenue:                        
SaaS revenue   $ 20,854     $ 20,686       1 %     3 %
Professional Services     2,033       2,176       (7 %)     (5 %)
Total SaaS and professional services revenue   $ 22,887     $ 22,862       0 %     2 %
                         
Cost of Revenue:                        
GAAP subscription   $ 5,393     $ 3,803              
Non-GAAP subscription   $ 5,393     $ 3,803              
                         
GAAP professional services   $ 2,202     $ 2,734              
Add back:                        
Stock-based compensation     (371 )     (825 )            
Non-GAAP professional services   $ 1,831     $ 1,909              
                         
GAAP total cost of revenue   $ 7,595     $ 6,537              
Add back:                        
Stock-based compensation     (371 )     (825 )            
Non-GAAP total cost of revenue   $ 7,224     $ 5,712       26 %     29 %
                         
Gross Profit:                        
Non-GAAP subscription   $ 15,587     $ 17,925              
Non-GAAP professional services     202       267              
Non-GAAP gross profit   $ 15,789     $ 18,192       (13 %)     (11 %)
                         
Operating expenses:                        
GAAP research and development   $ 6,687     $ 6,193              
Add back:                        
Stock-based compensation expense     (509 )     (783 )            
Non-GAAP research and development   $ 6,178     $ 5,410       14 %     17 %
                         
GAAP sales and marketing   $ 6,837     $ 8,693              
Add back:                        
Stock-based compensation expense     (174 )     (580 )            
Non-GAAP sales and marketing   $ 6,663     $ 8,113       (18 %)     (15 %)
                         
GAAP general and administrative   $ 2,406     $ 2,957              
Add back:                        
Stock-based compensation expense     (393 )     (820 )            
Non-GAAP general and administrative   $ 2,013     $ 2,137       (6 %)     (3 %)
                         
GAAP operating expenses   $ 15,930     $ 17,843              
Add back:                        
Stock-based compensation expense     (1,076 )     (2,183 )            
Non-GAAP operating expenses   $ 14,854     $ 15,660       (5 %)     (2 %)

[1] Constant currency growth rates presented are derived from converting the current period results for entities reporting in currencies other than U.S. Dollars into U.S. Dollars at the exchange rates in effect during the prior period presented rather than the actual exchange rates in effect during the current period.

eGain Corporation

Other GAAP to Non-GAAP Supplemental Financial Information

(in thousands)

(unaudited)
                         
    Nine Months Ended

March 31,
  Growth Rates   Constant Currency
Growth Rates [1]
    2023     2022              
Revenue:                        
SaaS revenue   $ 66,911     $ 60,331       11 %     14 %
Legacy revenue     606       2,848       (79 %)     (74 %)
GAAP subscription     67,517       63,179       7 %     10 %
GAAP professional services     5,859       5,268       11 %     15 %
Total GAAP revenue   $ 73,376     $ 68,447       7 %     11 %
                         
SaaS and professional services revenue:                        
SaaS revenue   $ 66,911     $ 60,331       11 %     14 %
Professional Services     5,859       5,268       11 %     15 %
Total SaaS and professional services revenue   $ 72,770     $ 65,599       11 %     14 %
                         
Cost of Revenue:                        
GAAP subscription   $ 13,795     $ 10,811              
Non-GAAP subscription   $ 13,795     $ 10,811              
                         
GAAP professional services   $ 6,834     $ 7,125              
Add back:                        
Stock-based compensation     (1,213 )     (2,349 )            
Non-GAAP professional services   $ 5,621     $ 4,776              
                         
GAAP total cost of revenue   $ 20,629     $ 17,936              
Add back:                        
Stock-based compensation     (1,213 )     (2,349 )            
Non-GAAP total cost of revenue   $ 19,416     $ 15,587       25 %     28 %
                         
Gross Profit:                        
Non-GAAP subscription   $ 53,722     $ 52,368              
Non-GAAP professional services     238       492              
Non-GAAP gross profit   $ 53,960     $ 52,860       2 %     6 %
                         
Operating expenses:                        
GAAP research and development   $ 20,749     $ 17,988              
Add back:                        
Stock-based compensation expense     (1,633 )     (2,310 )            
Non-GAAP research and development   $ 19,116     $ 15,678       22 %     25 %
                         
GAAP sales and marketing   $ 25,191     $ 24,252              
Add back:                        
Stock-based compensation expense     (997 )     (1,840 )            
Non-GAAP sales and marketing   $ 24,194     $ 22,412       8 %     11 %
                         
GAAP general and administrative   $ 7,776     $ 8,687              
Add back:                        
Stock-based compensation expense     (1,440 )     (2,437 )            
Non-GAAP general and administrative   $ 6,336     $ 6,250       1 %     4 %
                         
GAAP operating expenses   $ 53,716     $ 50,927              
Add back:                        
Stock-based compensation expense     (4,070 )     (6,587 )            
Non-GAAP operating expenses   $ 49,646     $ 44,340       12 %     15 %

[1] Constant currency growth rates presented are derived from converting the current period results for entities reporting in currencies other than U.S. Dollars into U.S. Dollars at the exchange rates in effect during the prior period presented rather than the actual exchange rates in effect during the current period.



Udemy to Present at J.P. Morgan’s 51st Annual Global Technology, Media and Communications Conference

Fireside Chat to be Webcast Live at 1:35 p.m. PT / 4:35 p.m. ET on May 23

SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) — Udemy (Nasdaq: UDMY), a leading destination for learning and teaching online, today announced that Chief Executive Officer Greg Brown will participate in a fireside chat session during J.P. Morgan’s Annual Global Technology, Media and Communications Conference.

On Tuesday, May 23, 2023 at 1:35 p.m. PT / 4:35 p.m. ET, a live webcast of the fireside chat discussion will be available through the “Events & Presentations” section of Udemy’s investor relations website at https://investors.udemy.com/. An archived replay of the webcast will be available for approximately 30 days following the event.

About Udemy

Udemy (Nasdaq: UDMY) improves lives through learning by providing flexible, effective skill development to empower organizations and individuals. The Udemy marketplace platform, with thousands of up-to-date courses in dozens of languages, offers the tools learners, instructors and enterprises need to achieve their goals and reach their full potential. Millions of people learn on the Udemy platform from real-world experts in topics ranging from programming and data science to leadership and team building. Udemy Business enables employers to offer on-demand learning for all employees, immersive learning for tech teams and cohort learning for leaders. Udemy Business customers include Fender®, Glassdoor, On24, The World Bank and Volkswagen. Udemy is headquartered in San Francisco with hubs in Ankara and Istanbul, Türkiye; Austin, Texas; Denver, Colorado; Dublin, Ireland; Melbourne, Australia; and New Delhi, India.

Investor Contact:

Dennis Walsh
Vice President, Investor Relations
[email protected]



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 )