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CytomX Therapeutics (ticker: NASDAQ:), a biopharmaceutical firm, supplied 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 sturdy monetary place with $175 million in money, money equivalents, and investments as of the tip of 2023, and expects to fund operations into the second half of 2025, thanks partially 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 vital contributors to the corporate’s progress.
- CytomX reported a robust monetary place with $175 million in money, anticipated to maintain the corporate till the latter half of 2025.
- Income has elevated on account 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 offered within the second half of 2024.
Firm Outlook
- The money stability is projected to fund operations effectively 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 supplied in the course of 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 growth 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 function of their platform.
- The corporate’s concentrate on lowering systemic goal engagement and enhancing tolerability was mentioned as an essential side of their analysis.
In abstract, CytomX Therapeutics has supplied an optimistic replace on its Probody therapeutic platform and monetary standing, with a robust emphasis on its collaborative efforts and the potential of its product candidates. The corporate’s monetary well being seems stable, with ample money to assist its operations for the subsequent couple of years. Because the biopharmaceutical trade continues to evolve, CytomX’s modern method to drug growth and its strategic partnerships place it as an organization to look at within the coming years.
InvestingPro Insights
CytomX Therapeutics has been making headlines with its modern Probody therapeutic platform and strategic collaborations. Wanting on the knowledge from InvestingPro, we will glean extra 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 enhance of 361.96% during the last 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 constructive outlook on the corporate’s monetary efficiency. Nonetheless, it is also famous that the corporate is shortly burning by means of money, which is a essential level for traders to contemplate as they assess the corporate’s long-term sustainability.
An essential metric to contemplate is the inventory’s current efficiency. CytomX has skilled a robust return during the last three months, with a value complete return of 78.01%. This could possibly be an indication of rising investor confidence within the firm’s prospects. But, it is essential to notice that the inventory has taken a big hit during the last week, with a value complete return of -7.72%, which could mirror short-term volatility or market reactions to current occasions.
For these taken with deeper evaluation and extra InvestingPro Ideas, resembling the corporate’s money place relative to debt and the dearth of dividend payouts to shareholders, go to https://www.investing.com/professional/CTMX. There are 11 extra 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 autumn 2023:
Operator: Good day, and thanks for standing by. Welcome to the CytomX Therapeutics Fourth Quarter 2023 Monetary Outcomes Convention Name. Presently, all contributors are in a hear only-mode. After the speaker’s presentation there can be a question-and-answer session. [Operator Instructions] Please be suggested that, at this time’s convention is being recorded. I’d 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 wish to remind everybody that, throughout this name, we can 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 can be tough to foretell and plenty of of that are exterior 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 yr monetary outcomes and highlights current 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 could be discovered underneath the Buyers and Information part of our web site. With me on the decision at this time is Dr. Sean McCarthy, CytomX’s Chief Govt 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 yr 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 essential 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 could possibly be efficient in most cancers sufferers, and now we have opened a broad subject by which progress continues to speed up. The CytomX crew is very targeted on delivering on the promise of conditional activation for the good thing about sufferers. We’re at present 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 monitor for preliminary CX-904 Section 1a dose escalation knowledge within the second half of this yr, and we’re busy launching Section 1 scientific trials for our latest therapeutic candidates CX-2051 and CX-801 with preliminary Section 1a knowledge anticipated in 2025. Let me now present extra context and element for our lead packages. I am going to begin with our — with CX-904, our Probody T-cell engager focusing on EGFR and CD3. T-cell participating bispecific antibodies have huge potential for the remedy 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 essential breakthroughs producing nice pleasure. Successes embrace Immunocore Tebentafusp in Uveal Melanoma, the primary accepted T-cell engager for stable tumors, and extra not too long ago Amgen’s Tarlatamab focusing on DLL3, which has demonstrated spectacular ends in small cell lung most cancers. The event of those and different packages has not solely supplied lengthy awaited proof-of-concept, however this essential work has additionally helped to more and more outline a roadmap and key concerns for optimally develop this rising class of potent therapies together with optimization of dosing paradigms. Nonetheless, for this modality to totally breakthrough in stable tumors, there are nonetheless vital challenges to beat. T-cell engages carry very excessive efficiency, and this efficiency can result in toxicities in regular tissues the place the tumor oxygen of curiosity may additionally be current. In reality, that is fairly often the case, a traditional tissue goal expression is extensively acknowledged to be a limitation on the event of T-cell engages for stable tumors. Moreover, one other effectively acknowledged limitation for T-cell engages is cytokine launch syndrome ensuing from systemic binding to CD3 on T-cells. At CytomX, now we have 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 enhancing 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 creating 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 worldwide co-development collaboration. The market alternative for CX-904 is broad. There are tons of of hundreds of EGFR constructive sufferers with metastatic tumors throughout a variety of most cancers varieties that might doubtlessly be addressed by this remedy. CytomX is at present conducting an ongoing Section 1a examine in late-stage unselected sufferers with superior stable tumors usually identified to have EGFR expression. Our principal aim for this Section 1a examine is to guage security and to establish doses and schedules for detailed analysis in particular EGFR constructive most cancers varieties in Section 1b. Extra particularly on security, we’re seeking to maintain CRS and the standard EGFR mediated toxicities at manageable ranges in an effort to obtain doses within the predicted therapeutically energetic vary. The collection of Section 1b tumor varieties can be pushed by a mix of things together with observations from Section 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 means of a number of dose cohorts at above dose ranges that might 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 absolutely discover the profile of this drug candidate. We count on to share preliminary Section 1a dose escalation knowledge within the second half of 2024 with our companion Amgen, and in addition to current these knowledge in an acceptable setting externally. These knowledge will inform a possible resolution to provoke Section 1b in 2025. Transferring now to our continued work within the antibody drug conjugate house. There was super progress in ADCs prior to now few years and the affect for sufferers has pushed vital 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 examine start-up actions are in progress and we count on to provoke Section 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 on account of its excessive cell floor expression in lots of most cancers varieties. Certainly, EpCAM was one of many first tumor actions to be characterised greater than three a long time 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 on account of toxicities in epithelial tissues, together with the GI tract. Our modern 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. We’ve got 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 may additionally doubtlessly handle a big affected person inhabitants as EpCAM is very expressed throughout many indications, together with colorectal, gastric, endometrial and ovarian cancers. Our Section I trial will observe an adaptive design and is meant to show speedy scientific proof of idea to tell a possible resolution 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 develop into a cornerstone of mixture immunotherapy for a variety of tumor varieties. The IND for CX-801 was cleared by the FDA in January, and we count on to provoke Section 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 power 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 varieties, together with melanoma, renal most cancers and bladder most cancers. Nonetheless, interferon remedy is well-known to be related to vital systemic unintended effects and its use has been outdated by checkpoint inhibitors and different therapeutic approaches. It is also been proven that interferon may potentiate the scientific results of PD-1 in metastatic melanoma. However once more, this method has been restricted by systemic toxicities. Interferon remedy has not too long ago returned to focus with Ferring Prescribed drugs’ approval in 2022 of Adstiladrin, an interferon alpha-2b encoding gene remedy indicated for the remedy of localized BCG nonresponsive non-muscle invasive bladder most cancers, reaffirming that this potent cytokine may 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 not too long ago offered 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 diminished and general tolerability is markedly improved in comparison with the unmasked cytokine in animal fashions. We anticipate that the chance for CX-801 can be together with checkpoint inhibition, the place it may function a potent immune modulator to each enhance the frequency and sturdiness of responses in IO delicate tumors doubtlessly to ascertain or restore efficacy in IO resistant or chilly tumors. Our Section 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 might 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 sudden resolution adopted a broad inner portfolio overview at BMS. We proceed to work with BMS to achieve extra visibility on the info from this program and the elements that led to this resolution. 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, now we have initiated a number of new packages during the last 2 years. Notably, this shift in focus throughout the BMS alliance now means that almost all of our companion packages are actually targeted on T-cell engagers, reflecting robust 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 Section 1a examine, I might like to stipulate a number of the key phrases of our strategic alliance with Amgen. Beneath the phrases of our settlement, CytomX and Amgen are co-developing CX-904. CytomX is accountable for early-stage growth and Amgen can be accountable for late-stage growth, with the transition occurring after completion of Section 1b by CytomX. Throughout the CX-904 settlement, CytomX has an choice to take part financially within the world co-development of CX-904 with Amgen. If we train our co-development possibility, we choose in to a big U.S. revenue share and we’re eligible for as much as $460 million in growth, regulatory and business milestone funds and ex U.S. royalties within the low double-digit to mid-teen share. We see this collaboration as having substantial potential to construct long-term worth for CytomX, and we stay up for making extra progress with our companion 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, now we have greater than a dozen energetic discovery packages. CytomX holds vital business rights on various these property, and now we have a number of near- and long-term milestones that we’re working in direction of. Chris will overview in just a few moments the monetary advantages that proceed to accrue to us from our partnerships as we run the corporate in a really capital environment friendly method. With that, I am going to 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 robust 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 effectively into the second half of 2025. This money steering doesn’t assume any extra milestones from current collaborations or any new enterprise growth, each of which CytomX has a robust monitor report of acquiring. Our money place displays our concentrate on controlling prices and environment friendly capital allocation, in addition to our constant monitor report of funding the corporate by means of a mixture of each strategic enterprise growth 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 rising the attain of our platform. Our partnerships proceed to advance and have generated greater than $500 million of incoming money thus far, and we see near-term alternatives for extra milestone funds in 2024 and 2025. Regardless of a difficult macro atmosphere in 2023, we maintained a robust stability sheet place and executed effectively to place the corporate to create doubtlessly vital worth inflections that can be realized over the subsequent 12 to 18 months. Now shifting to income and working bills for the yr. 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 on account of a better share of completion for analysis packages within the Bristol-Myers Squibb collaboration and the current collaborations with Regeneron and Moderna. Working expense for This autumn 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 yr to $77.3 million, in comparison with $111.6 million in 2022. Basic and administrative bills decreased by $13.1 million for the yr 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 am going to hand the decision again to Sean for closing remarks.
Sean McCarthy: Thanks, Chris, and thanks, everybody, in your time this afternoon and in your curiosity in CytomX. 2024 guarantees to be an thrilling yr 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 effectively 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 crew is extremely targeted on delivering an modern pipeline for the good thing about folks residing with most cancers. And I might 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 will open up the decision for Q&A.
Operator: [Operator Instructions] Our first query at this time can be coming from Peter Lawson of Barclays.
Chris Ogden: Operator, perhaps we may put Peter again within the queue and go to the subsequent query.
Operator: Sure. Thanks. Our subsequent query can be coming from Joe Catanzaro of Piper Sandler.
Joe Catanzaro: Hey, all people. Hopefully, you possibly can hear me okay. Thanks for taking the questions and the replace right here. So I do know we noticed current knowledge from a aggressive masking program, and so they confirmed appear like close to zero detectable unmasked antibody in circulation. Simply perhaps 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 perhaps my follow-up query is on the security 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 will conclude from a number of current knowledge units from a number of corporations that, to begin 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 power 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 reducing of goal engagement. So the sector has come a good distance, and we’re excited to see now within the arms of others these kind of method can also be starting to achieve some traction. By way of our work on EGFR-CD3 and 904, now we have offered — fairly actually, we’ve not offered loads of knowledge on this program for varied 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 power to induce cytokines. However we’ve not shared an entire lot of knowledge on the precise CX-904 molecule but. That may come sooner or later.
Operator: Our subsequent query can be coming from Anupam Rama of JPMorgan.
Malcolm Kuno: That is really Malcolm Kuno on for Anupam. So what’s the dimension and scope of the Section 1 dose escalation knowledge that we needs to be serious 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 monitor 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 info set to share with our companion, Amgen, within the second half of the yr. After which that might 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 Section 1a is to show the — and actually absolutely discover the security 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’d count on the replace within the second half. It might 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 might disconnect.
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