r/Plus_Therapeutics

So tempted to buy more!

What has me especially tempted is what we still haven’t heard from the symposium.
We know they brought in 3 individuals to speak, and I have a hard time believing Cerenome would include them if what they had to say wasn’t meaningful to the story being presented.
Then there are another 5 people involved beyond those 3. Who are they? Could some be patients or survivors? I honestly don’t know, and I’m not claiming they are. But considering we already know there are long term survivors in both the LM and GBM programs, it certainly has me wondering.
Add that to everything else happening with CNSide, LM, GBM and manufacturing, and I keep coming back to the same conclusion.
There is still risk here, but from where I’m sitting, there seem to be an awful lot of pieces lining up in a positive direction.
And yes, I’m seriously tempted to buy more. Possibly another 3K

reddit.com
u/Freedom5567 — 1 day ago

Could Dr. Michael Youssef be 1 of the 8 interviewed?

Expanding upon MH-J3R great find yesterday and posting it on reddit. Based on the post from filmmaker Nami Assir on LinkedIn where he said he filmed Cerenome interviewing 8 individuals that were a mix of physicians and patients. In Nami's LinkedIn post he attached three photos. One is of Nami setting up and the other two photos look like they're interviewing individuals. One of the photos is too blurry to make out, but the other one is much more clear and based on my personal opinion it looks like they're interviewing Dr. Michael Youssef who was one of the independent experts that spoke at the Cerenome sponsored event at the SNO/ASCO CNS conference that Freedom5567 mentioned a couple weeks ago.

Here's the link to the LinkedIn post from Nami Assir.

https://www.linkedin.com/posts/namiassir_last-week-with-cerenome-gabby-contacted-activity-7495465182307962880-l_D7

I am attaching the photos from the post and a zoomed in photo so you all can compare and whom I believe is Dr. Michael Youssef.

I am not confirming anything or know what was discussed in the interviews. I'm just saying that based on what I am seeing, I believe that one of the individuals that they interviewed was Dr. Michael Youssef.

What are your thoughts?

u/Unusual-Page8312 — 1 day ago

Something Interesting About Cerenome and the Upcoming ABTA Conference

Something interesting about the upcoming ABTA Annual Conference on September 18 to 20.
Cerenome has the ABTA conference listed on its own Events and Media calendar, yet there doesn’t appear to be any Cerenome presentation or participation publicly listed by ABTA yet.
What makes that interesting is the relationship already there.
ABTA has featured patient stories from BOTH REYOBIQ programs.
Jim Stockand is a recurrent GBM survivor who participated in ReSPECT GBM.
Dr. Marlyn Cabrera is an LM survivor who participated in ReSPECT LM.
These aren’t random stories either. The ABTA material was sponsored by Plus Therapeutics, now Cerenome.
So we have ABTA publicly highlighting a survivor from each of Cerenome’s 2 major REYOBIQ programs, and Cerenome now specifically listing the September ABTA conference on its corporate calendar.
Does that mean these patients will be involved in September? We don’t know, and I wouldn’t claim that. But I find the connection very interesting, especially since we still don’t know exactly what Cerenome’s participation at ABTA will involve.
Maybe it’s simply patient outreach and awareness. Maybe there’s more planned. Either way, I think it’s worth keeping an eye on.
I’m also expecting we could see the transcript tomorrow from last week’s SNO/ASCO CNS Metastases Symposium. I’m especially interested in the LM discussion and hearing exactly what the 3 independent guest speakers had to say. We have seen some of the information presented, but hearing the full discussion and perspectives from those 3 experts could provide a lot more context.
A few interesting pieces still waiting to fall into place.

reddit.com
u/Freedom5567 — 4 days ago

Considered view of Q2 Financials

My read on management after the Phase 2 update and today’s earnings is that they are trying to position the company for the next stage rather than simply manage quarter to quarter. The LM study is still enrolling, but they appear to believe they can establish the optimal dose and dosing interval with a relatively small number of additional patients and still hit that milestone before year-end.

The cash position is obviously tight, and management knows it. What caught my attention is the continued reference to partnering/licensing efforts, together with the Houston office expansion. I would not take either as confirmation that a deal is coming, but taken together they suggest management is planning for a larger operating footprint and exploring ways to fund that growth without relying entirely on equity. If they believe the recent LM data has improved the value of REYOBIQ, this would be a logical time to pursue a partnership, licensing transaction or other non-dilutive capital.

CNSide also appears to be part of that broader buildout. They have exceeded the 150 million covered-lives target, billing is starting through XiFin, there is a backlog of tests to submit, and Medicare reimbursement remains a 2026 objective. Expanding the Houston presence also makes sense if they expect CNSide volumes, clinical activity and the therapeutic programs to increase over the next year.
So I think the next few months come down to execution and financing. Establish the LM dosing regimen, keep GBM moving, convert CNSide coverage into actual revenue, build out the infrastructure in Houston, and find the best way to fund the company through the next major clinical milestones.

There is obviously no guarantee that a partnership or other non-dilutive solution materializes, and an equity offering that meaningfully erodes existing shareholders is still very much on the table. I just think that is the nuclear option rather than the preferred outcome, particularly if management believes the clinical and commercial assets are worth materially more than where the market is valuing them today.

reddit.com
u/MH-J3R — 6 days ago

Average price and skin in the game, where is everyone sitting?

Out of curiosity, what does everyone’s actual position look like here?

How many shares are you holding, what’s your average price, and roughly how significant is the position for you.

Also curious whether you’ve been averaging down over the last few months or are still sitting on your original entry.

reddit.com
u/Ecstatic_Range_7868 — 7 days ago

Is the ATM killing every rally?

Is management itself suppressing the share price with the ATM?

I’m genuinely curious what other shareholders think about this, because the more I look at the Q2 numbers, the more uncomfortable I am with the way the ATM is being used.

The company established the new ATM in June and then, in June alone, sold 436,448 new shares for roughly $1.85M.

That is almost half a million new shares dumped into this tiny and extremely illiquid stock in a single month. It increased the share count by roughly 6% from the pre ATM level in June alone.

I have no problem with dilution itself. This is a clinical stage biotech and obviously they need capital to continue development. What I question is why they needed to do it this aggressively and this quickly.

They were not in a situation where that $1.85M was desperately needed immediately. They could have started raising in June more slowly and preserved some flexibility for later catalysts and potentially better prices.

At the beginning of June the stock was trading above $5. By June 30 it closed at $4.37.

I am not claiming the ATM caused that decline because we do not have daily ATM sales data. But when you put 436k newly issued shares into a stock with this little liquidity, it is hard not to wonder how much buying demand was simply being absorbed by the company itself.

And this is where July worries me even more.

We only know the share count through June 30. The price action in July has looked very similar. The broader market has been strong, money keeps flowing into equities, the company has announced positive developments, yet CNSY repeatedly struggles to sustain even modest upward moves.

So my real question is: how many additional shares are already out there since June 30?

If they continued selling at anything close to the June pace, the actual dilution today could already be meaningfully higher than the 6% we currently know about.

And then there is the IR side.

The company just presented new ReSPECT LM data at a scientific conference. Investors have been waiting for the poster, the company previously said the posters would be available following the presentation, and it still has not been published.

That is what I struggle to understand.

If you know you need to raise millions from shareholders, why aggressively sell equity at depressed prices while doing such a poor job of supporting investor interest?

Publishing a poster obviously does not guarantee the stock goes up. But if you are going to use the market as your primary source of capital, surely you should want as much visibility, liquidity and investor interest as possible so you can raise the same amount of money with fewer shares.

I’m not asking management to pump the stock. I’m asking whether this is actually a sensible way to manage shareholder capital.

What does everyone else think? Am I being too harsh on the ATM strategy, or are you also concerned about how many shares may already have been issued since the end of June?

reddit.com
u/Ecstatic_Range_7868 — 6 days ago

At times like this, remember these wise words of the GOAT:

Best time to sell is when people are fearful. Then buy back in when it hits an all-time high.

u/Ok_Hand5810 — 6 days ago

Cerenome Reports Seconda Quarter 2026

Cerenome Reports Second Quarter 2026 Financial Results and Business Update August 14, 2026 PDF Version HOUSTON, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence, today announced financial results for the second quarter ended June 30, 2026, and provided an overview of recent and upcoming business highlights.

"Our team made substantial progress this quarter in advancing our integrated CNS oncology platform including a full repositioning and rebranding of the Company," said Marc H. Hedrick, M.D., M.B.A., Cerenome President and Chief Executive Officer. "For the remainder of the year, I expect the progress to accelerate across all verticals, highlighted by our buildout of the diagnostic commercial organization."

Q2 2026 AND RECENT HIGHLIGHTS

Corporate

Rebranded from Plus Therapeutics, Inc. to Cerenome, Inc., effective August 3, 2026, with the Company’s common stock trading on the Nasdaq Capital Market under the ticker symbol “CNSY” REYOBIQ™ Development

Continued enrollment in the ReSPECT-LM multiple-dose clinical trial. As of June 30, 2026, approximately one-third of patients had been enrolled, with no dose-limiting toxicities observed to date, supporting the development of a recommended Phase 2 dose/dosing regimen by year-end Continued enrollment in the ReSPECT-GBM Phase 2 trial. Current enrollment rates indicate full enrollment in 2026 followed by a data readout and a subsequent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) Initial site activation of the ReSPECT-PBC pediatric brain cancer Phase 1 trial at Lurie Children’s Hospital. First dosing expected in the third quarter of 2026. Continued commercial-level manufacturing scale-up and supply chain enhancement for REYOBIQ drug supply CNSide® CSF Assay Platform

Performed 232 CNSide cerebrospinal fluid tests during the first half of 2026 and continued to grow the number of ordering providers and institutions Achieved the 2026 corporate objective for contracted commercial payer coverage of 150 million covered lives by mid-year Received Medicare Provider Transaction Access Number and dedicated American Medical Association billing identifier for CNSide Partnered with Genomic Testing Cooperative to integrate next-generation sequencing into the CNSide platform Achieved College of American Pathology or CAP accreditation, the gold standard in laboratory quality assurance, for Cerenome’s CLIA laboratory in Houston, TX Partnered with Xifin, Inc., the market leader in artificial intelligence enabled revenue cycle management for diagnostic providers, to serve as our billing and clearinghouse partner Data & Artificial Intelligence

Partnered with Ephemeral Technologies to develop native artificial intelligence, a corporate operating system and data infrastructure designed to integrate therapeutic, diagnostic and bioinformatic data sets and to facilitate advanced data analytics and machine learning across Cerenome’s CNS oncology platform SECOND QUARTER 2026 FINANCIAL RESULTS

Cash, cash equivalents and investments were $8.6 million as of June 30, 2026 and December 31, 2025 Recognized $0.4 million in grant revenue from CPRIT for the advancement of REYOBIQ in LM in the second quarter of 2026, compared with $1.4 million in grant revenue from CPRIT for the same program in the second quarter of 2025 Operating loss for the second quarter of 2026 was $9.1 million, compared with an operating loss of $1.5 million for the second quarter of 2025. The change primarily reflects expansion of CNSide commercial operations and continued funding of the REYOBIQ Phase 2 trial Net loss for the second quarter of 2026 was $9.0 million, or $1.31 per basic share, compared with net income of $5.2 million, or $0.62 per basic share, for the second quarter of 2025, which included a $6.5 million change in fair value of derivative instruments AFFIRMED ANTICIPATED MILESTONES AND OUTLOOK FOR 2026

The Company is affirming the milestone framework and outlook it provided when reporting full-year 2026 financial results, as follows:

REYOBIQ Clinical Program

Define the optimal dose/dosing interval for REYOBIQ in Leptomeningeal Metastases Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma; data is expected in Q1 2027, followed by an End-of-Phase 2 meeting with the FDA Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial Complete commercial manufacturing scale-up for REYOBIQ CNSide Commercial Rollout

Expand U.S. commercial payer coverage beyond 150 million covered lives Secure Medicare coverage and reimbursement Achieve an annualized run-rate of test orders exceeding 1,250 Expand the CNSide assay platform to include a comprehensive portfolio of clinically relevant tests for patients at risk for CNS cancers

About Leptomeningeal metastases (LM) Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ™ (rhenium Re186 obisbemeda) REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.

About CNSide Diagnostics, LLC CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.

About Cerenome Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company’s CNSide Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing. Its lead therapeutic platform, REYOBIQ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data and artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value.

Forward-Looking Statements This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate," "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company's ability to maintain the listing of its common stock on Nasdaq; the success of the new rebrand; expectations pertaining to 2026 milestones, its platform and its data strategy; the results of the Company's research and development activities, including uncertainties relating to the continued clinical trials of its product candidates and therapies, and the timing and outcome of the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-PBC trials; the Company's liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company's partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions and product performance; challenges associated with radiotherapeutic manufacturing, production, and distribution capabilities necessary to support the Company's clinical trials and any commercial level product demand; and the continued success of CNSide CSF Assay, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay, and expectations as to the Company's future performance, including the next steps in developing the Company's product candidates. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Cerenome discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, Quarterly Report on Form 10-Q for the three months ended March 31, 2026, and Current Reports on Form 8-K. These filings are available for review through the SEC's website at www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations, and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact CORE IR investor@cerenome.com

(Financial Tables follow)

CERENOME, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (in thousands, except share and par value data) June 30, 2026 December 31, 2025 Assets Current assets: Cash and cash equivalents $ 2,366 $ 4,256 Restricted cash and cash equivalents — 4,502 Investments 6,221 4,356 Grant receivable 1,761 322 Other current assets 1,423 1,734 Total current assets 11,771 15,170 Property and equipment, net 1,409 257 Operating lease right-of-use assets 43 70 Goodwill 372 372 Intangible assets, net 265 333 Other assets 170 123 Total assets $ 14,030 $ 16,325 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable and accrued expenses $ 7,550 $ 5,920 Investor liability pursuant to Letter Agreement — 4,502 Operating lease liability 44 56 Deferred grant liability 927 927 Line of credit — 750 Other liabilities 46 159 Total current liabilities 8,567 12,314 Noncurrent operating lease liability — 15 Total liabilities 8,567 12,329 Commitments and contingencies (Note 8) Stockholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively — — Common stock, $0.001 par value; 2,000,000,000 shares authorized; 7,320,345 and 5,557,371 shares issued as of June 30, 2026 and December 31, 2025, respectively; 7,310,008 and 5,547,034 shares outstanding as of June 30, 2026 and December 31, 2025, respectively 7 6 Treasury stock (at cost), 10,337 shares as of June 30, 2026 and December 31, 2025, respectively (500 ) (500 ) Additional paid-in capital 537,773 520,355 Accumulated deficit (531,817 ) (515,865 ) Total stockholders’ equity 5,463 3,996 Total liabilities and stockholders’ equity $ 14,030 $ 16,325

CERENOME, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Grant revenue $ 411 $ 1,390 $ 1,439 $ 2,449 Operating expenses: Research and development 4,265 1,246 7,130 3,002 General and administrative 5,203 1,682 10,485 4,521 Total operating expenses 9,468 2,928 17,615 7,523 Operating loss (9,057 ) (1,538 ) (16,176 ) (5,074 ) Other income (expense): Interest income 56 27 246 28 Interest expense (5 ) — (22 ) (548 ) Financing expenses — 150 — (3,061 ) Warrant issuance costs — — — (964 ) Change in fair value of derivative instruments — 6,512 — (2,631 ) Total other income (expense) 51 6,689 224 (7,176 ) Net income (loss) $ (9,006 ) $ 5,151 $ (15,952 ) $ (12,250 ) Per share information Net income (loss) per share of common stock – basic $ (1.31 ) $ 0.62 $ (2.36 ) $ (12.54 ) Weighted average number of shares of common stock outstanding – basic 6,898,804 1,935,554 6,773,125 976,885 Net income (loss) per share of common stock – diluted $ (1.31 ) $ (0.16 ) $ (2.36 ) $ (12.54 ) Weighted average number of shares of common stock outstanding – diluted 6,898,804 8,366,199 6,773,125 976,885

CERENOME, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) Six Months Ended June 30, 2026 2025 Cash flows from operating activities: Net loss $ (15,952 ) $ (12,250 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 233 223 Stock-based compensation expense 1,852 300 Noncash financing expenses — 3,061 Noncash interest expense 22 — Change in fair value of derivative instruments — 2,631 Accretion of discount on short-term investments (15 ) (22 ) Operating lease right-of-use asset amortization 27 44 Gain on sale of assets — (16 ) Increases (decreases) in cash caused by changes in operating assets and liabilities: Grant receivable (1,439 ) (450 ) Other assets 264 (265 ) Accounts payable and accrued expenses 1,778 (5,181 ) Change in operating lease liabilities (27 ) (45 ) Other liabilities (113 ) — Net cash used in operating activities (13,370 ) (11,970 ) Cash flows from investing activities: Purchases of property and equipment (1,317 ) (10 ) Proceeds from sale of property and equipment — 30 Purchase of short-term investments (14,049 ) (7,756 ) Sales of short-term investments 7,765 — Redemption of short-term investments 4,434 6,662 Net cash used in investing activities (3,167 ) (1,074 ) Cash flows from financing activities: Proceeds from credit facility 1,000 — Repayment of credit facility (1,772 ) (3,292 ) Proceeds from issuance of notes payable and warrants — 3,738 Repayment of notes payable — (3,703 ) Proceeds from sale of common stock, pre-funded warrants and warrants — 15,001 Proceeds from exercise of warrants — 882 Proceeds from sale of common stock under Lincoln Park Purchase Agreement — 2,795 Proceeds from underwritten public offering 15,000 — Proceeds from Distribution Agreement 1,853 — Payments for commissions and offering costs from Distribution Agreement (71 ) — Payment to investors pursuant to Letter Agreement (4,502 ) — Offering costs for sale of common stock (1,363 ) (220 ) Net cash provided by financing activities 10,145 15,201 Net change in cash and cash equivalents (6,392 ) 2,157 Cash, restricted cash and cash equivalents at beginning of period 8,758 76 Cash, restricted cash and cash equivalents at end of period $ 2,366 $ 2,233 Supplemental disclosure of cash flows information: Cash paid during period for: Interest $ — $ 539 Supplemental schedule of non-cash investing and financing activities: Exchange of warrants for notes payable $ — $ 3,694 Redemption of notes by issuance of common stock, pre-funded warrants and warrants $ — $ 3,512 Unpaid offering cost $ 104 $ 252

reddit.com
u/Zestyclose_Yak3051 — 6 days ago

How's everybody feeling?

Not seeing allot of posts these days. So we're all just waiting patiently right? Anybody care to offer any updates on price movement? When Cam I expect my losses to shrink?

reddit.com
u/Positive_Use_1308 — 8 days ago

Future Timeline for REYOBIQ???

I know that there is a lot of uncertainty and frustration out there in regards to Cerenome and REYOBIQ. So I have been doing some research to trying to find a drug that went through a similar process.

Obviously I couldn't find an exact match but I was looking for a drug that had similar market characteristics, qualities, and metrics. I was looking for a drug that treated a fatal or life shortening disease, received Orphan Drug Designation, had fast track approval, similar market value size, and little to no competitors.

Now I know that there are multiple drugs out there that meet these specifications, but the one drug that caught my attention that was very similar as I researched it was Trikafta by Vertex Pharmaceuticals. Trikafta treats cystic fibrosis.

Trikafta Timeline:

Jan/Feb 2018 - Vertex released its initial Phase 2 results for Trikafta.

Feb 2018 - Fast Track Designation

Apr 2018 - Vertex announces Trikafta Phase 3 initiation and Vertex releases more Phase 2 data.

May 2018 - Breakthrough Therapy Designation based on strong early clinical data.

Aug 2018 - Orphan Drug Designation for treatment of cystic fibrosis.

Mid 2018 - Trikafta in Phase 3

Jul 2019 - NDA Submission

Aug 2019 - NDA acceptance + Priority Review

Oct 2019 - FDA Approval Received

Again this is just to give you an idea of what could happen, because the FDA has processes and procedures that they follow, so we can look at drugs in the past and see what they went through, and how long it took to get an idea of what we might be looking at time wise in the future.

Now IF we were to assume a similar timeline for REYOBIQ based on what Trikafta went through here is what I am seeing as a Possible Timeline.

REYOBIQ Possible Timeline:

Aug 2026 and Nov 2026 - Cerenome releases initial Phase 2 data on REYOBIQ for LM and GBM

Dec 2026 - Fast Track Designation for REYOBIQ

Jan 2027 - FDA meeting

Feb 2027 - Cerenome announces Phase 3 initiation

May 2027 - REYOBIQ in Phase 3

Jul 2028 - NDA Submission

Aug 2028 - NDA acceptance + Priority Review

Oct 2028 - FDA Approval Received

Trikafta currently generates $10-12 billion in revenue for Vertex Pharmaceuticals and controls about 85% of the cystic fibrosis market nearly 7 years after FDA approval.

I see Cerenome and REYOBIQ doing something very similar but what do you all think?

reddit.com
u/Unusual-Page8312 — 12 days ago