Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Over delivered on Q3 results. Total company revenue was $110.7 million, beating our $103.0 million estimate. With costs in line with expectations, the revenue upside flowed to adj. EBITDA, which substantially exceeded our expectations, of $16.9 million versus our estimate of $4.9 million, as illustrated in Figure #1 Q3 Results. We believe that the results beat Street estimates, with consensus adj. EBITDA of $8.5 million.
Upside variance. The company is seeking ways to make efficient use of its marketing spend, particularly in areas that provide sufficient returns. Sales & Marketing expenses of $52.0 million were lower than our $53.0 million estimate in spite of better than expected revenues. We anticipate Sales & Marketing expenses to accelerate in coming quarters as the company hones in on its marketing strategy and expands into new territories.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Q3 in line. The company reported a Q3 revenue of $807 million, largely in line with our estimate of $814 million. Adj. EBITDA was $36 million, better than our estimate of $24 million. Notably, it appears that there could be tailwinds developing in the company’s Commercial segment.
Positive trends in Commercial. Adj. revenue in the Commercial segment was down 3%, due to lower volumes. However, management indicated that new business signings helped to mitigate the weakness from lost business. Moreover, it appears that momentum from new business signings is beginning to outpace lost business that is rolling off.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q24 Reported With Product Updates. ZyVersa reported a loss of $2.4 million or $(2.43) per share and updated its clinical trial plans for the two products in development. During the quarter, several scientific papers were published showing the role of inflammation in obesity, diabetes, and neurodegeneration. These studies all support previous work by the company and are consistent with the mechanism of action for IC 100.
VAR 200 To Start Phase 2a In Diabetic Kidney Disease. The Cholesterol Efflux Mediator™ VAR 200 has shown reductions in the initial damage that starts a cycle of damage and repair that leads to progressive scarring and loss of kidney function. A Phase 2a trial enrolling patients with diabetic kidney disease (DKD) is expected to begin in 1Q25 with initial data announcement around mid-2025.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Progress Toward Phase 3 With New Phase 2 VERSATILE-002 Data. PDS Biotech Reported 3Q24 loss of $10.7 million or $(0.29) per share, a slightly lower loss than we estimated. Earlier this week, modifications to the IND protocol for the Phase 3 VERSATILE-003 trial were submitted to the FDA. Approval is expected by mid-December, which would allow the trial to begin in early 2025.
New Phase 2 VERSATILE-002 Data Analysis Shows Outcomes Were Maintained Or Improved. As additional patients complete their follow-up periods, further analysis of the data has shown improvements over the previous interim reports. The overall survival has been unchanged at 30.0 months, although the lower limit of the confidence interval has increased to 20 months. This compares with 17.9 months for published Keytruda studies. Overall response rate, complete response rate, and disease control rates have improved as well.
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Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Another Quarter of Y-o-Y Growth. For the 20th consecutive quarter, Lifeway reported y-o-y top line growth. Revenue for the quarter totaled $46.1 million, compared to the prior year’s $40.9 million, We were a little more aggressive in our forecast, projecting revenue of $51.5 million. Gross margin of 25.7% was below the prior year’s 27.2%. Net income was $3.0 million, or $0.19 per diluted share, compared to $3.4 million, or $0.23/sh, and our estimate of $4.2 million or $0.27/sh.
Expanded Distribution. Management noted that the Company expanded its kefir distribution to South Africa in September and recently announced that it is expanding into Dubai and the Emirates market. In South Africa, the products are available on shelves now, while product availability in the Emirates is expected in the fourth quarter. We believe the Company will continue to look for new potential markets to expand its presence in stores while also expanding on its advertising in these new markets to attract the attention of new consumers.
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InPlay Oil is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Third quarter financial results. InPlay Oil generated third quarter net income of C$146 thousand or C$0.00 per share compared to C$9.2 million or C$0.08 per share during the prior year period. We had predicted net income in the amount of C$423 thousand or C$0.00 per share. Average quarterly production declined to 8,206 barrels of oil equivalents per day (boe/d) compared to 9,003 boe/d in the third quarter of 2023 and our estimate of 8,238 boe/d.
Corporate 2024 guidance. While InPlay has maintained its production guidance of 8,700 to 9,000 boe/d, commodity price expectations were lowered, and operating expenses are expected to be in the range of C$13.50 to C$15.50 per boe/d compared to prior guidance of C$13.00 to C$15.25 per boe/d. Capital expenditures are expected to total $63 million compared with prior guidance of C$64 million to C$67 million. Adjusted funds flow is expected to be in the range of C$70 million to C$73 million compared to previous expectations of C$80 million to C$85 million.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Navy Contract. Comtech has been awarded a sole source contract from the U.S. Navy Information Warfare Systems Command for the Company’s U.S sovereign software-defined SLM-5650B satellite communications (“SATCOM”) modems, upgrade kits, firmware options and technical support. The contract is for a four-year period and valued at $50 million with roughly $2 million of funded orders received to date.
Growing Market. Comtech’s new award is indicative of the growing satellite industry, as the satellite ground station market is projected to grow to $6.6 trillion by 2028, representing a 6.89% CAGR beginning in 2024. Various government departments, such as the Department of Defense are needing agile and distributed communications systems for keeping communication open and uninterrupted, producing demand for products such as Comtech’s SATCOM modems. Furthermore, budgets for next year show growth, with an example being the U.S. Space Force from $17 billion in 2022 to a projected $30 billion in 2025. With a growing industry over the next few years and potential growing budgets, we believe that Comtech has the capability of capturing additional contracts.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
BOCA RATON, Fla., and NEW YORK, Nov. 14, 2024 (GLOBE NEWSWIRE) — Noble Capital Markets (Noble), a full-service SEC / FINRA-registered broker-dealer dedicated exclusively to serving public and private middle market companies and their investors, and Stocktwits, the world’s leading social network for investors and traders, today announced a strategic partnership that will launch at NobleCon20, Noble’s 20th annual emerging growth equity conference, and extend into 2025 and beyond. This partnership brings together the unique strengths of both companies to amplify value for clients and subscribers.
As part of this collaboration, Stocktwits joins NobleCon20 as the exclusive social media partner, leveraging its extensive community to elevate the reach of presenting companies. Stocktwits will promote presenting company sessions and Q&As through targeted ads and push notifications, ensuring broader exposure to its 10 million users. This initiative is expected to significantly boost visibility for NobleCon’s presenting companies, connecting them to a larger audience and increasing engagement with potential investors.
“Partnering with Stocktwits aligns perfectly with our mission to provide emerging growth companies with the visibility and resources they deserve,” said Nico Pronk, Noble’s CEO. “With their extensive network and our robust research and capital markets experience, we are positioned to deliver a truly unique conference experience that will benefit both presenters and attendees.”
To further strengthen the event’s reach, select Stocktwits registered users will receive an exclusive discount to attend the in-person conference, featuring an AI-focused keynote panel, 80+ public and select private middle market company presentations, an evening networking hangar party, and a highlight event featuring three of the original “Sharks” from ABC’s Shark Tank. Further details about the event can be found at https://www.nobleconference.com/.
“We’re thrilled to announce our strategic partnership with the Noble team. We’ll begin with collaborating on NobleCon20 and Channelchek, but we’ll continue to partner on informative media that drives awareness for public companies” said Shiv Sharma, Stocktwits President & COO. “Our partnership will enable us to bring exciting and underfollowed growth opportunities directly to our active investor base, delivering content and insights that resonate deeply with our audience.”
Beyond NobleCon20, Stocktwits will also serve as a social media sponsor for Channelchek, Noble’s no-cost investor community. This expanded collaboration will include featuring Noble’s equity research on Stocktwits, which exceeds 200 million monthly page views from the most active investors who are deeply passionate about driving returns. Stocktwits will also refer select companies to be evaluated for Noble’s Company Sponsored Research Program.
As part of the partnership, Noble will feature Stocktwits on Channelchek, introducing companies to Stocktwits’ expanding suite of tools designed to elevate investor visibility, which includes Ads, Sponsored Articles, Featured Posts, Newsletters, Live Earnings Calls, Press Release Optimization, and premium video content, all tailored to increase investor engagement and broaden market reach.
About Noble Capital Markets
Established in 1984, Noble Capital Markets is an SEC / FINRA registered full-service investment bank and advisory firm with an award-winning research team and proprietary investor distribution platform. We deliver middle market expertise to entrepreneurs, corporations, financial sponsors, and investors. Over the past 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports.
About Channelchek
Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to public emerging growth and their industries. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 7,000 public emerging growth companies are listed on the site, and content including equity research, webcasts, and industry articles.
About Stocktwits
Stocktwits is the premier social media platform dedicated to investors and traders. With an active community of over 10 million users, Stocktwits has established itself as a leading voice in the investing world. Driven by the mission to help investors enhance their returns, Stocktwits offers a rich ecosystem of community interaction, data, content, and tools that empower investors to connect, learn, profit, and have fun in the process.
Noble Financial Group and Channelchek are pleased to present the NobleCon20 VIP Giveaway. This contest was open exclusively to registered, verified Channelchek members.
Contest is now closed. The winner will be announced on November 18, 2024. The winner was notified via email on November 15.
Key Points – Pony AI targets a $4.48 billion valuation in its U.S. IPO, offering 15 million ADSs priced between $11 and $13 each. – Revenues surged 85.5% to $39.5 million in the first nine months of 2024, driven by robotaxi and robotruck services. – IPO proceeds will fund market expansion, R&D, and strategic investments, solidifying its position in the autonomous vehicle market.
Pony AI Inc., a trailblazer in autonomous vehicle technology, is preparing for its much-anticipated U.S. IPO with plans to offer 15 million American depositary shares (ADSs). Priced between $11 and $13 per share, the IPO could value the company at $4.48 billion if priced at the upper range, according to recent regulatory filings.
Founded in 2016, Pony AI has rapidly established itself as a key player in the autonomous vehicle sector, offering cutting-edge robotaxi and robotruck services. With unique driverless service licenses in major Chinese cities and strategic partnerships, the company is poised to make a significant impact in the global market.
Pony AI intends to list its ADSs on the Nasdaq under the ticker symbol “PONY.” At the mid-point of its estimated offering price, the IPO is expected to generate net proceeds of $159.8 million, with an additional $153.4 million from private placements. If full over-allotments are exercised, the company could raise as much as $184.9 million. These funds will be allocated to research and development, market expansion, and strategic investments, further bolstering its growth trajectory.
The company’s financial performance underscores its growth potential. Total revenues for the nine months ending September 30, 2024, surged 85.5% to $39.5 million. This growth was driven by a remarkable 422% increase in robotaxi service revenues, which reached $4.7 million due to expanded fare-charging operations in China and engineering projects in South Korea. Meanwhile, robotruck services contributed $27.4 million, reflecting fleet expansion and higher mileage operations through its logistics division, Cyantron.
The IPO comes amid a broader surge in interest in autonomous vehicles, with competitors like WeRide Inc. already capitalizing on market enthusiasm. WeRide, another Chinese autonomous vehicle startup, recently completed its U.S. IPO, raising up to $458.5 million with full over-allotments. The company’s shares, trading under the ticker “WRD,” highlight the growing investor appetite for innovation in autonomous mobility.
As Pony AI gears up for its Nasdaq debut, the company is well-positioned to ride the wave of advancements in autonomous technology. With a robust business model, impressive growth metrics, and strategic plans for expansion, Pony AI’s IPO marks a pivotal moment for the autonomous vehicle sector and the future of transportation innovation.
LIMASSOL, Cyprus, Nov. 14, 2024 (GLOBE NEWSWIRE) — GDEV Inc. (NASDAQ: GDEV), an international gaming and entertainment company (“GDEV” or the “Company”) released its unaudited financial and operational results for the third quarter and first nine months ended September 30, 2024.
GDEV CEO, Andrey Fadeev noted: ”In Q3, despite industry pressure, we delivered sequential revenue growth.
We also kept executing our strategy and moved forward with the transformation of our core products. The updates are rolling across our main franchises to elevate the game experience, adding new modern features to what players already love. We are not after quick wins – it’s about innovating in a way that sets us up for lasting impact.
We are pleased to have established an at-the-market offering (“the ATM”) in September as an important step towards increasing the free float and liquidity of our stock. Under the ATM, the Company may sell up to 1,757,026 ordinary shares of the Company, held in treasury.1. We expect the ATM to be effective until we sell all the treasury shares or for 3 years from the effective date of the Registration Statement whichever is earlier.
I’m also thrilled to share that our former independent director Olga Loskutova has recently joined the management team as our new Chief Operating Officer. However, the board remains within best practices in terms of INED majority directors and one third women. As COO, Olga will be well positioned to enable us to reach our ambitious strategic goals. By staying focused, we’re building momentum for sustainable growth that will shape our future.”
Third quarter 2024 financial highlights:
Revenue of $111 million, growing 5% quarter-over-quarter, while decreased by 9% year-over-year.
Selling and marketing expenses of $52 million, grew by 22% year-over-year and by 10% quarter-on-quarter due to the execution of our strategy to scale the business.
We continue to adhere to our disciplined approach towards costs: game operation cost declined by 6% year-over-year while general and administrative expenses declined by 9% year-over-year.
Profit for the period, net of tax of $15 million in Q3 2024 decreased vs. $24 million in Q3 2023 due to scaling of selling and marketing expenses, among other factors.
Adjusted EBITDA of $16 million in line with the previous quarter.2
European share of bookings increased by 4 p.p. to 30%, driven by effective and more targeted user acquisition campaigns in the region.
Cash position of $153 million, compared to $140 million at the end of Q2 2024, providing broad opportunities for further expansion3.
Third quarter and first nine months 2024 financial performance in comparison
In the third quarter of 2024, our revenue decreased by $11 million (or 9%) year-over-year and amounted to $111 million. While bookings for the third quarter of 2024 decreased by $9 million, the decrease in revenue compared to Q3 2023 was amplified by a decrease in the recognition of deferred revenues associated with bookings recorded in periods prior to Q3 2024: in Q3 2024, $57 million of revenues resulted from the bookings recorded prior to Q3 2024 compared to $65 million of revenues booked in Q3 2023 which resulted from bookings recorded prior to Q3 2023. Revenues reported in Q3 2023, in turn, were impacted by the recognition of record high bookings generated in 2021. The decrease in revenues also reflects the increasing portion of our bookings in Q3 2024 that are required to be recognized as deferred revenue in later periods, as a greater proportion was generated from our PC platform, where players’ lifespan tends to be higher compared with other platforms.
Platform commissions decreased by $4 million (or 13%) in the third quarter of 2024 compared to the same period in 2023, driven by a 9% decrease in revenues generated from in-game purchases, and amplified by growth of revenues derived from PC platforms which are associated with lower commissions.
Game operation cost remained relatively stable at the level of $13 million both in the third quarter of 2024 and 2023.
Selling and marketing expenses in the third quarter of 2024 increased by $9 million, amounting to $52 million. The increase is due to our strategy of scaling our business together with our experiments across various channels, aimed at optimizing future marketing investments.
General and administrative expenses remained relatively stable at $7 million in Q3 2024 compared with $8 million in Q3 2023.
As a result of the factors above together with, among others, a loss resulting from a change in fair value of share warrant obligation of nil in Q3 2024 vs. $0.8 million in Q3 2023 and decrease of finance expenses in Q3 2024 vs Q3 2023 by $3.7 million, we recorded a profit for the period, net of tax, of $15 million compared with $24 million in the same period of 2023. Adjusted EBITDA in Q3 2024 amounted to $16 million, a decrease of $13 million compared with the same period in 2023.
Cash flows generated from operating activities were $12 million in the third quarter of 2024 compared with $8 million in the same period of 2023.
Third quarter 2024 operational performance
Q3 2024
Q3 2023
Change (%)
9M 2024
9M 2023
Change (%)
Bookings ($ million)
93
102
(8%)
310
316
(2%)
Bookings from in-app purchases
87
94
(8%)
288
292
(1%)
Bookings from advertising
7
8
(13%)
22
23
(8%)
Share of advertising
7.1%
7.4%
(0.3 p.p)
7.0%
7.4%
(0.4 p.p.)
MPU (thousand)
314
375
(16%)
359
383
(6%)
ABPPU ($)
92
84
10%
89
85
5%
Bookings declined to reach $93 million in the third quarter 2024 compared with $102 million in the same period of 2023. The decline is primarily due to a decline in monthly paying users by 16% in Q3 2024 vs. the same quarter last year partially offset by an increase in ABPPU.
The share of advertisement sales as a percentage of total bookings decreased in the third quarter of 2024 to reach 7.1% compared to 7.4% in the respective period of 2023. This decline was primarily driven by a global trend of declining CPM rates for advertising in 2024.
Split of bookings by platform
Q3 2024
Q3 2023
9M 2024
9M 2023
Mobile
62%
63%
60%
63%
PC
38%
37%
40%
37%
In the third quarter of 2024, the share of PC versions of our games increased by 1 p.p. compared with the same period of 2023.
Split of bookings by geography
Q3 2024
Q3 2023
9M 2024
9M 2023
US
34%
35%
34%
36%
Asia
22%
23%
22%
24%
Europe
30%
26%
30%
25%
Other
14%
16%
14%
15%
Our split of bookings by geography in the third quarter of 2024 vs. the respective period of 2023 remained broadly similar, with a certain increase in the share of Europe bookings.
Note:
Due to rounding, the numbers presented throughout this release may not precisely add up to the totals. The period-over-period percentage changes are based on the actual numbers and may therefore differ from the percentage changes if those were to be calculated based on the rounded numbers.
The figures in this release are unaudited.
Webcast details
To listen to the audio webcast with supplementary slides please follow the link. Prepared remarks are available on gdev.inc.
About GDEV
GDEV is a gaming and entertainment holding company, focused on development and growth of its franchise portfolio across various genres and platforms. With a diverse range of subsidiaries including Nexters and Cubic Games, among others, GDEV strives to create games that will inspire and engage millions of players for years to come. Its franchises, such as Hero Wars, Island Hoppers, Pixel Gun 3D and others have accumulated over 550 million installs and $2.5 bln of bookings worldwide. For more information, please visit www.gdev.inc
Contacts:
Investor Relations Roman Safiyulin | Chief Corporate Development Officer investor@gdev.inc
Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Such statements are based on current expectations that are subject to risks and uncertainties. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
The forward-looking statements contained in this press release are based on the Company’s current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting the Company will be those that the Company has anticipated. Forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s 2023 Annual Report on Form 20-F, filed by the Company on April 29, 2024, and other documents filed by the Company from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Presentation of Non-IFRS Financial Measures
In addition to the results provided in accordance with IFRS throughout this press release, the Company has provided the non-IFRS financial measure “Adjusted EBITDA” (the “Non-IFRS Financial Measure”). The Company defines Adjusted EBITDA as the profit/loss for the period, net of tax as presented in the Company’s financial statements in accordance with IFRS, adjusted to exclude (i) goodwill and investments in equity accounted associates’ impairment, (ii) loss on disposal of subsidiaries, (iii) income tax expense, (iv) other financial income, finance income and expenses other than foreign exchange gains and losses and bank charges, (v) change in fair value of share warrant obligations and other financial instruments, (vi) share of loss of equity-accounted associates, (vii) depreciation and amortization, (viii) share-based payments expense and (ix) certain non-cash or other special items that we do not consider indicative of our ongoing operating performance. The Company uses this Non-IFRS Financial Measure for business planning purposes and in measuring its performance relative to that of its competitors. The Company believes that this Non-IFRS Financial Measure is a useful financial metric to assess its operating performance from period-to-period by excluding certain items that the Company believes are not representative of its core business. This Non-IFRS Financial Measure is not intended to replace, and should not be considered superior to, the presentation of the Company’s financial results in accordance with IFRS. The use of the Non-IFRS Financial Measure terms may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures.
Reconciliation of the profit for the period, net of tax to the Adjusted EBITDA
US$ million
Q3 2024
Q3 2023
9M 2024
9M 2023
Profit for the period, net of tax
15
24
28
35
Adjust for:
Income tax expense
1
2
3
3
Adjusted finance (income)/expenses5
(2)
0.9
(6)
(2)
Change in fair value of share warrant obligations and other financial instruments
—
0.8
(0.3)
(10)
Share of loss of equity-accounted associates
—
—
—
0.5
Depreciation and amortization
2
2
5
5
Share-based payments
0.7
0.7
1
2
Adjusted EBITDA
16
29
30
33
_______________________________ 1 Pursuant to the Company’s registration statement filed with the SEC on Form F-3 (Registration No. 333-282062) and related prospectus, which was filed with the Securities and Exchange Commission on September 12, 2024. 2 For more information, see section titled “Presentation of Non-IFRS Financial Measures” in the last two pages of this report, including the reconciliation of the profit for the period, net of tax to the Adjusted EBITDA. 3 The amounts include investments in liquid high quality securities. 4 The amounts presented for the three and nine months ended September 30, 2023 may be different to those previously reported for these periods earlier as starting from Q1 2024 the Company reports depreciation and amortization expenses by function as a part of game operation cost, selling and marketing expenses, and general and administrative expenses in accordance with IAS 1. 5 Adjusted finance income/expenses consist of other financial income, finance income and expenses other than foreign exchange gains and losses and bank charges, net.
Conference call and webcast today at 8:30 a.m. Eastern Time
PRINCETON, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a business update and reported financial results for the third quarter of 2024.
“Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. Dr. Bedu-Addo further noted that “based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion.”
With submission of the updated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) this week, the Company expects the FDA clearance decision by mid-December, allowing the Company to initiate site activation in the first quarter of 2025.
“Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated promising clinical activity and a compelling safety profile. Based on continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with favorable toxicity. We are exploring the next steps in the development of Versamune® HPV for cervical cancer,” concluded Dr. Bedu-Addo.
Recent Developments
Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC
Updated trial design to include approximately 350 patients
VERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year, demonstrating durability of the anti-tumor responses
The design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of our agreement with the FDA on registrational design
Design maintains 2:1 randomization and median overall survival as primary endpoint
Design imparts potential for earlier interim readouts and study completion
Design presents potential for reduced execution costs
Amended IND (updated design) submitted November 2024
In September 2024, we provided updated results from our VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of Versamune® HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. Press release here.
In October 2024, we provided updated results from our IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. Press release here.
Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health presented the rationale and design of recurrent prostate cancer trial combining Xtandi® + PDS01ADC vs Xtandi® alone during an oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society, October 2024. Press release here.
Third Quarter 2024 Financial Results Reported net loss was approximately $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024, compared to a net loss of $10.8 million, or $0.35 per basic share and diluted share, for the three months ended September 30, 2023. The decrease was primarily due to lower operating expenses.
Research and development expenses increased to approximately $6.8 million for the three months ended September 30, 2024, from $6.4 million for the three months ended September 30, 2023. The increase of $0.4 million was primarily attributable to higher manufacturing expenses, partially offset by lower clinical costs and personnel expenses.
General and administrative expenses decreased to approximately $3.4 million for the three months ended September 30, 2024, from approximately $4.1 million for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to lower personnel costs and professional fees.
Total operating expenses decreased to approximately $10.2 million for the three months ended September 30, 2024, from $10.5 million for the three months ended September 30, 2023.
Net interest expenses increased to approximately $0.5 million for the three months ended September 30, 2024, from $0.3 million for the three months ended September 30, 2023.
Cash and cash equivalents as of September 30, 2024 totaled approximately $49.8 million.
Conference Details
Date: November 14, 2024 Time: 8:30 a.m. ET Dial-in 1-877-704-4453 or 1-201-389-0920 Webcast Registration: Click Here Call Me™ Registration: Click Here (Available 15 minutes prior to call)
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
Keytruda® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
Xtandi® is a registered trademark of Astellas Pharma Inc.
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