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CytomX Therapeutics (ticker: NASDAQ:), a biopharmaceutical firm, offered an in depth replace on their proprietary Probody therapeutic platform and its product candidates throughout their Fourth Quarter 2023 Monetary Outcomes Convention Name.
The corporate highlighted developments of their pipeline, together with CX-904 and CX-2051, and their collaboration with trade giants resembling Bristol-Myers Squibb (NYSE:) and Amgen (NASDAQ:). CytomX reported a strong monetary place with $175 million in money, money equivalents, and investments as of the top of 2023, and expects to fund operations into the second half of 2025, thanks partly to elevated income from strategic partnerships.
Key Takeaways
- CytomX mentioned their Probody therapeutic platform, specializing in CX-904, a T-cell engager, and different product candidates.
- Partnerships with Amgen, Bristol-Myers Squibb, Regeneron (NASDAQ:), and Moderna (NASDAQ:) have been highlighted as important contributors to the corporate’s progress.
- CytomX reported a powerful monetary place with $175 million in money, anticipated to maintain the corporate till the latter half of 2025.
- Income has elevated as a result of productive collaborations, contributing to environment friendly capital allocation and offering non-dilutive capital.
- CEO Sean McCarthy emphasised the potential of masked antibodies to enhance tolerability by lowering systemic goal engagement.
- Knowledge on the CX-904 molecule is anticipated to be introduced within the second half of 2024.
Firm Outlook
- The money stability is projected to fund operations properly into the second half of 2025.
- CytomX plans to current knowledge on the CX-904 molecule within the latter a part of 2024, which can embrace security profile and antitumor exercise.
Bearish Highlights
- No particular bearish data was offered throughout the name.
Bullish Highlights
- CytomX’s strategic alliances and partnerships are seen as a supply of power and non-dilutive capital.
- Developments within the Probody therapeutic platform point out a promising future for the corporate’s drug improvement efforts.
Misses
- The corporate has not but shared a lot knowledge on the CX-904 molecule, however plans to take action sooner or later.
Q&A Highlights
- CEO Sean McCarthy highlighted the vast majority of circulating Probody therapeutic is in a masked kind, which is a key characteristic of their platform.
- The corporate’s deal with lowering systemic goal engagement and bettering tolerability was mentioned as an necessary facet of their analysis.
In abstract, CytomX Therapeutics has offered an optimistic replace on its Probody therapeutic platform and monetary standing, with a powerful emphasis on its collaborative efforts and the potential of its product candidates. The corporate’s monetary well being seems stable, with enough money to assist its operations for the subsequent couple of years. Because the biopharmaceutical trade continues to evolve, CytomX’s progressive method to drug improvement and its strategic partnerships place it as an organization to observe within the coming years.
InvestingPro Insights
CytomX Therapeutics has been making headlines with its progressive Probody therapeutic platform and strategic collaborations. Wanting on the knowledge from InvestingPro, we are able to glean further insights into the corporate’s monetary well being and inventory efficiency.
InvestingPro Knowledge metrics present a market capitalization of $168.14 million, indicating a comparatively small however doubtlessly nimble participant within the biopharmaceutical house. Regardless of this, the corporate’s P/E ratio stands at -17.19, reflecting investor skepticism about its earnings potential within the close to time period. Moreover, the income development has been spectacular, with a staggering improve of 361.96% over the past twelve months as of Q1 2023.
InvestingPro Ideas for CytomX Therapeutics point out a mixture of warning and optimism. Analysts have revised their earnings upwards for the upcoming interval, suggesting a optimistic outlook on the corporate’s monetary efficiency. Nonetheless, it is also famous that the corporate is rapidly burning by way of money, which is a vital level for buyers to think about as they assess the corporate’s long-term sustainability.
An necessary metric to think about is the inventory’s latest efficiency. CytomX has skilled a powerful return over the past three months, with a worth whole return of 78.01%. This may very well be an indication of rising investor confidence within the firm’s prospects. But, it is necessary to notice that the inventory has taken a big hit over the past week, with a worth whole return of -7.72%, which could replicate short-term volatility or market reactions to latest occasions.
For these excited about deeper evaluation and extra InvestingPro Ideas, resembling the corporate’s money place relative to debt and the shortage of dividend payouts to shareholders, go to https://www.investing.com/professional/CTMX. There are 11 further ideas listed on InvestingPro that may present additional perception into CytomX’s monetary nuances and inventory efficiency. Bear in mind to make use of the coupon code PRONEWS24 to get a further 10% off a yearly or biyearly Professional and Professional+ subscription, providing a extra complete understanding of the corporate’s potential and dangers.
Full transcript – CytomX Therapeutics Inc (CTMX) This fall 2023:
Operator: Good day, and thanks for standing by. Welcome to the CytomX Therapeutics Fourth Quarter 2023 Monetary Outcomes Convention Name. Presently, all individuals are in a hear only-mode. After the speaker’s presentation there will likely be a question-and-answer session. [Operator Instructions] Please be suggested that, at this time’s convention is being recorded. I might now like to show the convention over to your speaker at this time, Chris Ogden, Senior Vice President, Finance and Accounting. Please go forward.
Chris Ogden: Thanks. Good afternoon and thanks for becoming a member of us. Earlier than we start, I want to remind everybody that, throughout this name, we will likely be making forward-looking statements. As a result of forward-looking statements relate to the longer term, they’re topic to inherent uncertainties and dangers which are troublesome to foretell and lots of of that are outdoors of our management. Necessary dangers and uncertainties are set forth in our most up-to-date public filings with the SEC at sec.gov. We undertake no obligation to replace any forward-looking statements, whether or not on account of new data, future developments or in any other case. Earlier this afternoon, we issued a press launch that features a abstract of our 2023 full 12 months monetary outcomes and highlights latest progress at CytomX. We encourage everybody to learn at this time’s press launch within the related supplies, which have been filed with the SEC. Moreover, the press launch, a recording of this name and our SEC filings might be discovered underneath the Traders and Information part of our web site. With me on the decision at this time is Dr. Sean McCarthy, CytomX’s Chief Government Officer and Chairman. Sean will present introductory feedback on CytomX’s progress and key milestones earlier than we cowl our pipeline progress and financials for the fourth quarter and expectations for the 12 months forward. With that, I’ll now flip the decision over to Sean.
Sean McCarthy: Thanks, Chris and good afternoon, everybody. Thanks for becoming a member of us for an replace on CytomX continued progress. The promise of masking and conditional activation methods to enhance the therapeutic window for potent biologics like ADCs, T-cell engagers and cytokines continues to be an necessary and thrilling frontier in most cancers R&D and our management on this subject at CytomX derives from greater than a decade of innovation with the Probody therapeutic platform. Our foundational scientific work with the Probody platform has achieved many firsts in demonstrating how advertising methods may very well be efficient in most cancers sufferers, and we’ve opened a broad subject through which progress continues to speed up. The CytomX staff is very targeted on delivering on the promise of conditional activation for the good thing about sufferers. We’re presently advancing a era of product candidates that span a number of modalities, leveraging validated oncology targets, potent efficient mechanisms and tailor-made masking methods. Every of our candidates is designed to deal with massive business markets and main unmet medical want in most cancers. We have had a extremely productive begin to 2024. We stay on observe for preliminary CX-904 Part 1a dose escalation knowledge within the second half of this 12 months, and we’re busy launching Part 1 scientific trials for our latest therapeutic candidates CX-2051 and CX-801 with preliminary Part 1a knowledge anticipated in 2025. Let me now present further context and element for our lead packages. I will begin with our — with CX-904, our Probody T-cell engager concentrating on EGFR and CD3. T-cell partaking bispecific antibodies have huge potential for the therapy of most cancers and first demonstrated significant scientific profit in hematologic malignancies. Wanting throughout the T-cell engager panorama for stable tumors is taken time to see significant scientific outcomes, however we’re now beginning to see necessary breakthroughs producing nice pleasure. Successes embrace Immunocore Tebentafusp in Uveal Melanoma, the primary authorised T-cell engager for stable tumors, and extra lately Amgen’s Tarlatamab concentrating on DLL3, which has demonstrated spectacular leads to small cell lung most cancers. The event of those and different packages has not solely offered lengthy awaited proof-of-concept, however this necessary work has additionally helped to more and more outline a roadmap and key issues for easy methods to optimally develop this rising class of potent therapies together with optimization of dosing paradigms. Nonetheless, for this modality to completely breakthrough in stable tumors, there are nonetheless important challenges to beat. T-cell engages deliver very excessive efficiency, and this efficiency can result in toxicities in regular tissues the place the tumor oxygen of curiosity might also be current. Actually, that is fairly often the case, a traditional tissue goal expression is broadly acknowledged to be a limitation on the event of T-cell engages for stable tumors. Moreover, one other properly acknowledged limitation for T-cell engages is cytokine launch syndrome ensuing from systemic binding to CD3 on T-cells. At CytomX, we’ve a broad-based program targeted on masking T-cell engagers to lower tumor antigen binding in regular tissues and CD3 binding within the periphery, thereby bettering therapeutic index. We’re working with companions Amgen, Astellas, Regeneron, and Bristol-Myers Squibb on this thrilling house. Our lead program is CX-904 that targets the tumor antigen EGFR and CD3 on T-cell. CX-904 is designed to deal with the principal challenges of growing an EGFR CD3 T-cell engager with the aim of delivering anti-tumor exercise at tolerable systemic doses. This program is partnered with Amgen and a world co-development collaboration. The market alternative for CX-904 is broad. There are lots of of 1000’s of EGFR optimistic sufferers with metastatic tumors throughout a variety of most cancers sorts that would doubtlessly be addressed by this remedy. CytomX is presently conducting an ongoing Part 1a research in late-stage unselected sufferers with superior stable tumors usually identified to have EGFR expression. Our principal aim for this Part 1a research is to guage security and to determine doses and schedules for detailed analysis in particular EGFR optimistic most cancers sorts in Part 1b. Extra particularly on security, we’re seeking to preserve CRS and the everyday EGFR mediated toxicities at manageable ranges in an effort to obtain doses within the predicted therapeutically energetic vary. The choice of Part 1b tumor sorts will likely be pushed by a mixture of things together with observations from Part 1a, unmet medical want and business potential, together with match with our companions’ strategic pursuits. We’re making regular progress within the clinic, having now superior by way of a number of dose cohorts at above dose ranges that will be anticipated to be tolerated with an unmasked EGFR T-cell engager. In late 2023, we additionally started to backfill sure dose ranges to extra totally discover the profile of this drug candidate. We count on to share preliminary Part 1a dose escalation knowledge within the second half of 2024 with our associate Amgen, and likewise to current these knowledge in an acceptable setting externally. These knowledge will inform a possible choice to provoke Part 1b in 2025. Transferring now to our continued work within the antibody drug conjugate house. There was large progress in ADCs prior to now few years and the influence for sufferers has pushed important strategic curiosity on this subject. CX-2025 is our first-in-class EpCAM-directed Probody ADC. Our IND utility for CX-2051 was cleared by the FDA in January, scientific research start-up actions are in progress and we count on to provoke Part 1 dose escalation in stable tumors usually identified to have EpCAM expression together with colorectal most cancers within the near-term. EpCAM is a excessive potential oncology goal as a result of its excessive cell floor expression in lots of most cancers sorts. Certainly, EpCAM was one of many first tumor actions to be characterised greater than three many years in the past and it has since been implicated in lots of roles in most cancers development. Anti-EpCAM therapeutic methods have proven potent anticancer exercise in pre-clinical fashions and this has been translated into scientific exercise, however to-date, scientific success has been restricted to native administration as a result of EpCAM is current in so many regular epithelial tissues. Efforts to generate systemically administered anti-EpCAM therapeutics haven’t been profitable to-date as a result of toxicities in epithelial tissues, together with the GI tract. Our progressive drug candidate, CX-2051, and is tailor-made to optimize the therapeutic index for EpCAM-expressing epithelial cancers by marking the antibody to scale back binding in regular tissues however to permit activation in tumor tissue. Now we have armed the antibody with a cytotoxic payload based mostly on camptothecin, a topoisomerase I inhibitor, a category of drug that has proven potent scientific anticancer exercise within the ADC context for a number of targets, resulting in dramatic advances for sufferers. CX-2051 has demonstrated a large predicted therapeutic index and robust preclinical exercise and tolerability in a number of preclinical fashions, together with colorectal most cancers. Like EGFR I mentioned beforehand, CX-2051 might additionally doubtlessly tackle a big affected person inhabitants as EpCAM is very expressed throughout many indications, together with colorectal, gastric, endometrial and ovarian cancers. Our Part I trial will observe an adaptive design and is meant to display fast scientific proof of idea to tell a possible choice to maneuver into dose growth research in 2025. We’re actually excited to see what this distinctive and first-in-class ADC can do for sufferers. Turning now to CX-801, our duly masked conditionally activated interferon alpha-2b, which we imagine has the potential to change into a cornerstone of mixture immunotherapy for a variety of tumor sorts. The IND for CX-801 was cleared by the FDA in January, and we count on to provoke Part I dose escalation in stable tumors, together with melanoma, renal most cancers and head and neck squamous cell carcinoma within the first half of 2024. Interferon alpha is a robust cytokine with the flexibility to potently drive tumor antigen presentation and activate antitumor immunity. It has demonstrated scientific exercise and gained regulatory approval a few years in the past in a number of most cancers sorts, together with melanoma, renal most cancers and bladder most cancers. Nonetheless, interferon remedy is well-known to be related to important systemic unintended effects and its use has been outmoded by checkpoint inhibitors and different therapeutic approaches. It is also been proven that interferon might potentiate the scientific results of PD-1 in metastatic melanoma. However once more, this method has been restricted by systemic toxicities. Interferon remedy has lately returned to focus with Ferring Prescription drugs’ approval in 2022 of Adstiladrin, an interferon alpha-2b encoding gene remedy indicated for the therapy of localized BCG nonresponsive non-muscle invasive bladder most cancers, reaffirming that this potent cytokine might certainly obtain sturdy antitumor responses in sufferers. Based mostly on the preclinical profile of CX-801 in addition to prior scientific expertise with interferon therapies, we see 801 as a possible new centerpiece of mixture most cancers immunotherapy. Our preclinical knowledge most lately introduced at 60, 2023 demonstrates synergy for our masked interferon alpha with PD-1 inhibition, each when it comes to antitumor exercise, and in activation of the tumor inflammatory microenvironment. Furthermore, we have additionally proven that systemic exercise of our masked interferon is considerably decreased and total tolerability is markedly improved in comparison with the unmasked cytokine in animal fashions. We anticipate that the chance for CX-801 will likely be together with checkpoint inhibition, the place it might function a potent immune modulator to each improve the frequency and sturdiness of responses in IO delicate tumors doubtlessly to determine or restore efficacy in IO resistant or chilly tumors. Our Part I dose escalation trial being initiated within the first half 2024 will make the most of an adaptive design to guage security and indicators of scientific exercise for 801 monotherapy and advance quickly to mixture with checkpoint inhibition. Earlier than shifting to financials, I would like to offer updates on our partnerships, and beginning with an replace on our long-standing collaboration with Bristol-Myers Squibb. We have been knowledgeable on March 6 of BMS’s intention to discontinue BMS-986288, the CTLA-4 program. This surprising choice adopted a broad inside portfolio evaluation at BMS. We proceed to work with BMS to achieve extra visibility on the information from this program and the components that led to this choice. Transferring ahead, the BMS collaboration continues to be very energetic and can now focus primarily within the subject of T-cell engagers, the place, collectively, we’ve initiated a number of new packages over the past 2 years. Notably, this shift in focus inside the BMS alliance now means that almost all of our associate packages at the moment are targeted on T-cell engagers, reflecting sturdy strategic curiosity on this space and displaying that this modality is rising as a key utility of masking and conditional activation. Persevering with the T-cell engager theme, given our ongoing progress with enrollment of the CX-904 Part 1a research, I would like to stipulate among the key phrases of our strategic alliance with Amgen. Below the phrases of our settlement, CytomX and Amgen are co-developing CX-904. CytomX is answerable for early-stage improvement and Amgen will likely be answerable for late-stage improvement, with the transition occurring after completion of Part 1b by CytomX. Inside the CX-904 settlement, CytomX has an choice to take part financially within the international co-development of CX-904 with Amgen. If we train our co-development choice, we choose in to a big U.S. revenue share and we’re eligible for as much as $460 million in improvement, regulatory and business milestone funds and ex U.S. royalties within the low double-digit to mid-teen proportion. We see this collaboration as having substantial potential to construct long-term worth for CytomX, and we look ahead to making further progress with our associate on this program. Transferring now to our different drug discovery stage partnerships. We proceed to make progress in our alliances, together with with our latest companions, Regeneron and Moderna. Throughout our alliances, we’ve greater than a dozen energetic discovery packages. CytomX holds important business rights on quite a few these belongings, and we’ve a number of near- and long-term milestones that we’re working in direction of. Chris will evaluation in a couple of moments the monetary advantages that proceed to accrue to us from our partnerships as we run the corporate in a really capital environment friendly means. With that, I will hand over to Chris to offer a monetary replace.
Chris Ogden: Thanks, Sean. I am happy to have the ability to share an replace on our 2023 monetary outcomes with everybody at this time. CytomX entered 2024 with a powerful stability sheet, with $175 million in money, money equivalents and investments as of December 31, 2023, in comparison with $194 million on the finish of 2022. We count on our money stability will fund the operations of the corporate properly into the second half of 2025. This money steering doesn’t assume any further milestones from present collaborations or any new enterprise improvement, each of which CytomX has a powerful observe file of acquiring. Our money place displays our deal with controlling prices and environment friendly capital allocation, in addition to our constant observe file of funding the corporate by way of a mixture of each strategic enterprise improvement and fairness financing over time. Our partnerships have constantly been a strategic pathway for worth creation and financing alternatives that permit us to generate non-dilutive capital whereas growing the attain of our platform. Our partnerships proceed to advance and have generated greater than $500 million of incoming money to this point, and we see near-term alternatives for added milestone funds in 2024 and 2025. Regardless of a difficult macro atmosphere in 2023, we maintained a powerful stability sheet place and executed effectively to place the corporate to create doubtlessly important worth inflections that will likely be realized over the subsequent 12 to 18 months. Now shifting to income and working bills for the 12 months. Complete income was $101.2 million for 2023, in comparison with $53.2 million for the corresponding interval in 2022. We noticed a rise in income as a result of the next proportion of completion for analysis packages within the Bristol-Myers Squibb collaboration and the latest collaborations with Regeneron and Moderna. Working expense for This fall 2023 was $27.2 million, in comparison with $29.6 million within the fourth quarter of 2022. R&D bills decreased by $34.3 million from final 12 months to $77.3 million, in comparison with $111.6 million in 2022. Common and administrative bills decreased by $13.1 million for the 12 months ended December 31, 2023 to $29.8 million, in comparison with $42.8 million for the corresponding interval in 2022. Total, our prudent monetary administration of the corporate and targeted capital allocation priorities has resulted in continued stability sheet power as we progressed our pipeline. Now, I will hand the decision again to Sean for closing remarks.
Sean McCarthy: Thanks, Chris, and thanks, everybody, to your time this afternoon and to your curiosity in CytomX. 2024 guarantees to be an thrilling 12 months for us and the longer-term outlook for 2025 and past can also be very compelling as we make progress throughout our multimodality pipeline. The sphere of antibody masking and conditional activation is continuous to speed up, and we stay very properly positioned to construct on the depth of our expertise as a number one innovator on this space. We’re leveraging our multimodality Probody therapeutic platform to find and develop new most cancers therapies based mostly on T-cell engagers, ADCs and cytokines, every of which represents a extremely related and well timed space of strategic curiosity throughout the trade. The CytomX staff is extremely targeted on delivering an progressive pipeline for the good thing about individuals dwelling with most cancers. And I would like to shut by thanking everybody concerned for his or her dedication to our imaginative and prescient. With that, operator, let’s go forward and we are able to open up the decision for Q&A.
Operator: [Operator Instructions] Our first query at this time will likely be coming from Peter Lawson of Barclays.
Chris Ogden: Operator, possibly we might put Peter again within the queue and go to the subsequent query.
Operator: Sure. Thanks. Our subsequent query will likely be coming from Joe Catanzaro of Piper Sandler.
Joe Catanzaro: Hey, everyone. Hopefully, you’ll be able to hear me okay. Thanks for taking the questions and the replace right here. So I do know we noticed latest knowledge from a aggressive masking program, and so they confirmed appear to be close to zero detectable unmasked antibody in circulation. Simply possibly are you able to remind us what you’ve got traditionally seen with Probody packages round this metric, whether or not you are monitoring it for 904 and what your expectations could be? After which possibly my follow-up query is on the protection facet. So in preclinical tox work for 904, I do know you’ve got reported some knowledge round CRS. However in GLP work, was it CD3-mediated tox or EGFR-mediated tox that confirmed up first and which was dose-limiting?
Sean McCarthy: Joe, thanks for the questions. Sure. So we’re monitoring, clearly, all improvements within the subject and all progress. I feel we are able to conclude from a number of latest knowledge units from a number of corporations that, to start with, one thing that I feel we have proven fairly a while in the past, is that masking works. Masking antibodies and different modalities is clearly having — displaying the flexibility to lower systemic goal engagement, and relying upon goal and format, to additionally enhance tolerability. So we’re excited to see this progress throughout the sector. What we have proven through the years fairly constantly with a number of packages, whether or not it was our PD-L1 Probody or 2009 [indiscernible] a few of our earlier packages from which we have discovered a lot, we have proven that the overwhelming majority of the circulating entity, the Probody therapeutic, is in masked kind. And that, once more, has translated into what we interpret as a profitable lowering of goal engagement. So the sector has come a great distance, and we’re excited to see now within the palms of others a majority of these method can also be starting to achieve some traction. By way of our work on EGFR-CD3 and 904, we’ve introduced — fairly actually, we’ve not introduced quite a lot of knowledge on this program for numerous aggressive causes, however we did share an early iteration of our EGFR-CD3 program with fairly in depth characterization in syngeneic animal fashions and in Sino. And we targeted largely on the cytokine induction in these monkey research displaying a dramatic shift with the masking, dramatic shift when it comes to the flexibility to induce cytokines. However we’ve not shared a complete lot of knowledge on the precise CX-904 molecule but. That can come sooner or later.
Operator: Our subsequent query will likely be coming from Anupam Rama of JPMorgan.
Malcolm Kuno: That is truly Malcolm Kuno on for Anupam. So what’s the dimension and scope of the Part 1 dose escalation knowledge that we ought to be excited about in 2H ’24 for CX-904? And on that, when ought to we get a greater sense of a extra granular time line?
Sean McCarthy: Sure. Thanks for the query. So we stay on observe with 904 to share knowledge within the second half, as I discussed in my ready remarks. Our principal goal at this second in time is to construct the information set to share with our associate, Amgen, within the second half of the 12 months. After which that will end in presentation externally in an acceptable setting. We’re not guiding to any specifics at this cut-off date. Clearly, what we’re on the lookout for although in Part 1a is to display the — and actually totally discover the protection profile of 904 when it comes to CRS, when it comes to EGFR-mediated toxicities, clearly, search for any early proof of antitumor exercise. I might count on the replace within the second half. It will be a significant variety of sufferers, however that is actually all that we’re able to say at this second in time.
Operator: [Operator Instructions] There are not any extra questions within the queue. Thanks a lot for becoming a member of the convention name at this time. Everybody could disconnect.
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