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Fulcrum Therapeutics Inc

Fulcrum Therapeutics Inc (FULC)

3.50
-0.09
(-2.51%)
Closed July 12 3:00PM
3.53
0.03
(0.86%)
After Hours: 6:34PM

Fulcrum Therapeutics Inc (FULC) Options

Calls

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
1.001.303.903.002.600.000.00 %01-
2.000.252.351.821.300.000.00 %05-
3.000.051.050.640.550.000.00 %0362-
4.000.000.050.130.130.000.00 %0361-
5.000.000.500.000.000.000.00 %00-
6.000.001.500.100.100.000.00 %00-
7.000.001.950.000.000.000.00 %00-
8.000.000.200.420.420.000.00 %010-
9.000.002.000.000.000.000.00 %00-
10.000.001.750.050.050.000.00 %01-
11.000.002.150.000.000.000.00 %00-
12.000.001.450.000.000.000.00 %00-
13.000.002.150.000.000.000.00 %00-

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Puts

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
1.000.002.150.020.020.000.00 %02-
2.000.001.750.030.030.000.00 %03-
3.000.000.050.030.030.000.00 %04,511-
4.000.050.650.400.350.000.00 %031-
5.000.452.401.471.4250.000.00 %01-
6.001.003.400.002.200.000.00 %00-
7.002.604.400.003.500.000.00 %00-
8.003.605.400.004.500.000.00 %00-
9.004.606.400.005.500.000.00 %00-
10.005.107.800.006.450.000.00 %00-
11.005.409.500.007.450.000.00 %00-
12.007.209.600.008.400.000.00 %00-
13.008.6010.300.009.450.000.00 %00-

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FULC Discussion

View Posts
The Canes The Canes 1 month ago
Kiwi you were wise to kiss this goodbye. Here's what I don't understand. They have $330 million in their coffers and a 65 million share float. Their book value is $5.00 and then some. Why is it trading for $3.00?
👍️0
ErnieBilco ErnieBilco 1 month ago
As a bottom feeder I placed my bid this afternoon - if it gets hit anyone in before today will be wiped out or very very close to it.

Good luck if you happen to own it
👍️ 1
Fred Kadiddlehopper Fred Kadiddlehopper 1 month ago
Wow. It looked so promising a short while ago.
👍️0
ErnieBilco ErnieBilco 1 month ago
Rut rowwww - where's the bottom?

On June 1, 2026, Fulcrum Therapeutics, Inc., or the Company, announced the discontinuation of its pociredir program for the treatment of sickle cell disease, or
SCD, and the initiation of a comprehensive review of strategic alternatives intended to maximize stockholder value.
👍️0
EarningsCentral EarningsCentral 2 months ago
👍️0
iHub News iHub News 2 months ago
Fulcrum Therapeutics Shares Climb After Q1 Earnings Outperform ExpectationsApril 27, 2026 11:08 AM
IH Market News
Fulcrum Therapeutics Inc. (NASDAQ:FULC) moved higher in pre-market trading on Monday after reporting first-quarter results that topped analyst expectations.The clinical-stage biopharmaceutical firm posted a loss of $0.25 per share for the quarter, coming in ahead of forecasts calling for a $0.30 per share loss. Net loss totaled $18.9 million for the three months ended March 31, 2026, compared with $17.7 million in the same period a year earlier. Shares gained 2.81% in pre-market activity following the announcement.During the quarter, the company highlighted encouraging clinical findings for pociredir, noting strong induction of fetal hemoglobin along with improvements in key indicators of hemolysis and anemia. Fulcrum said it is targeting the launch of a potential registration-enabling trial in the second half of 2026, subject to feedback from the FDA.“The strength of the clinical data presented in the first quarter further reinforce our conviction in pociredir’s potential to address the underlying biology of sickle cell disease,” said Alex C. Sapir, Fulcrum’s President and Chief Executive Officer. “With a strong balance sheet extending our cash runway into 2029, we are well positioned to advance pociredir through the next phase of clinical development.”Research and development spending rose year over year to $14.1 million from $13.4 million, primarily reflecting higher employee compensation. General and administrative expenses also increased, reaching $8.1 million compared to $7.0 million, driven by higher personnel-related and professional services costs.Fulcrum ended the quarter with $333.3 million in cash, cash equivalents, and marketable securities, down from $352.3 million at the end of 2025. The company expects its existing capital resources to support operations through 2029.Additionally, Fulcrum announced that it has dosed the first participant in an open-label, long-term study designed to assess the safety and durability of pociredir. The company also disclosed that Chief Financial Officer Alan Musso intends to retire later this year and will stay on until a successor is appointed.



More about Fulcrum Therapeutics Inc.



Fulcrum Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing therapies that target the root causes of genetically defined diseases, particularly in areas with significant unmet medical need.Fulcrum Therapeutics stock price

Original: Fulcrum Therapeutics Shares Climb After Q1 Earnings Outperform Expectations
👍️0
ErnieBilco ErnieBilco 5 months ago
Well, I figured a whale got out today just didn't know it was gonna be you.

No, I'm not in but have been watching for an Ernie type entry but it may not happen
👍️0
Whalatane Whalatane 5 months ago
? 7 of 12 patients (58%) reported zero VOCs during the treatment period ?

Good but not great . I needed better data to feel more confident about a large P 3 trial showing stat sig benefit ...sold my position
JMO
Kiwi
👍️0
Whalatane Whalatane 5 months ago
Latest RA Capital position in FULC ...from Gemini

As of February 2026, RA Capital Management holds 6,053,960 shares of Fulcrum Therapeutics (FULC).

This position follows a major sell-off in early December 2025, where the firm reduced its stake by approximately 40.82%.

Key Position Details
Total Shares Owned: 6,053,960
Recent Activity: Sold 4,175,139 shares on December 8, 2025.
Transaction Value: The sale totaled approximately $58.3 million, executed at average prices ranging from $13.33 to $14.98 per share.
Ownership Stake: Prior to this sale, RA Capital held a 19.3% stake (over 10.2 million shares). The current reduced position represents roughly 9.2% of the company.

Despite the substantial reduction, RA Capital remains one of Fulcrum's largest institutional shareholders. The divestment occurred following a period where FULC shares surged over 260% in a single year.


Kiwi
👍️0
Whalatane Whalatane 5 months ago
RA Capital ...big bet on FULC ...FWIW
RA Capital Management, L.P. 10.23M shares Sep 30, 2025 18.90% of outstanding stock

Kiwi
👍️ 1
Whalatane Whalatane 5 months ago
CAMBRIDGE, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, will host a conference call and webcast on Tuesday, February 24, 2026 beginning at 8:00 a.m. ET to present 12-week results from the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease.

So full data 2/24 at 8 am ET

Kiwi
👍️ 2
Fred Kadiddlehopper Fred Kadiddlehopper 5 months ago
Re VERTEX current strruggles (From the Boston Globe 2/5/26)
https://www.bostonglobe.com/2026/02/05/business/vertex-crispr-sickle-cell/

Vertex’s CRISPR treatment for sickle cell disease hits unexpected roadblock
By Jason Mast STAT,Updated February 5, 2026, 2 hours ago

Vertex executives warned that Casgevy, its curative treatment for sickle cell disease, would be slow to reach patients. But few expected it to be this slow.

More than two years after its approval, only about 60 patients across the US, Middle East, and Europe have been treated with the gene-editing therapy. Specialists at four sickle centers told STAT they’ve been surprised by one of the key stumbling blocks to faster rollout: They can’t collect enough cells to create the treatment.

The problem comes at a crucial time for Vertex, which is trying to establish Casgevy even as it fights off rival therapies and braces for a major competitor next year.
To make Casgevy, doctors need to retrieve blood stem cells from patients and send them off to Vertex to be gene edited with CRISPR and then returned for re-infusion. But retrieval, that first, seemingly routine step, has been among the hardest.

Some patients have had to come in for five different hospital stays. A small percentage have given up during the journey or been told by physicians that they are unlikely to ever have enough cells to be treated, devastating news for patients who were hoping to be cured. In some cases, doctors have sent off what they believe to be enough cells, only for Vertex to say the company was able to edit only a small percentage of them.

“I would say if collection wasn’t a problem, you could almost get to double the number of patients,” said John Manis, a Boston Children’s Hospital physician who led a National Institutes of Health working group on cell collection for sickle cell disease.
These hurdles have not changed many patients’ desire for treatment. Casgevy, while not always a cure, offers a potential lifetime free of the excruciating pain crises and other complications of a condition that often kills in mid-life. But the collection changes have lengthened and complicated what was already expected to be an arduous treatment journey — requiring a battery of health exams, insurance approvals, months waiting for the therapy to be manufactured, intensive chemotherapy to clear out unedited cells, and four to six weeks in the hospital to receive the final infusion.

The process can exceed a year. The wait time for a slot at Vertex’s facilities fluctuates with demand but can stretch up to six months, doctors said, and it can take another six months to send back the finished therapy.

Because they can’t predict how long it will take to collect sufficient cells, doctors say they can’t give firm timelines to patients on when they’ll be treated. Christopher McKinney, a hematologist at Children’s Hospital Colorado, described an adolescent with sickle cell who started the process early last year, which should have put him on track to be treated over the summer and not miss school for the hospital stay.

He is instead being treated this week, after he needed five different collections. Each collection can last two to five days, and they have to be spaced weeks apart.

“So, yeah, it’s been quite disruptive,” he said. “And we can’t tell any of the patients how to plan that at this point.”

For Vertex, cell collection difficulties pose both an operational and business challenge. The company manufactures serially, so if a patient requires four collections, it takes up to four different manufacturing slots at the company’s factories, limiting Vertex’s ability to treat more patients.

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The company is also competing with Genetix — formerly known as Bluebird Bio — which had a different gene therapy, Lyfgenia, approved at the same time. Although the pathology of sickle cell disease can make collecting cells from any patient difficult, some doctors say they’ve encountered fewer challenges with Genetix. The company uses a gene-replacement technology that is gentler on cells and thus requires fewer of them.

Alexis Thompson, head of hematology at Children’s Hospital of Philadelphia, said she sometimes asks families who come in wanting Casgevy, because they’ve seen Vertex’s ads or are excited about CRISPR, to consider Lyfgenia.

“We’re at a point now where we’re very concerned about the reliability of timing for the Vertex product,” said Thompson, who helped run trials for Genetix and has consulted for Vertex. “If a family says, I really want and need this to be done by next summer, we say to them, ‘then we can’t honestly recommend this product for you right now.’”

Other doctors cautioned they’ve seen challenges with both. It’s “so bad for both of them,” said Manis.

A Genetix spokesperson declined to share detailed commercial numbers but claimed the company has treated more sickle cell and beta thalassemia patients — for whom these treatments are also approved — in the US than Vertex has treated around the world. He said 70 percent of sickle cell patients were treated after one collection and 89 percent were treated after two. (Beta-thalassemia patients don’t face the same collection challenges for either product.)

In an interview, Vertex Chief Commercial Officer Duncan McKechnie acknowledged the company had collection challenges early on but said its staff has been working to help centers collect better and to improve its manufacturing process.

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McKechnie said the number of collections per patient is now “essentially the same” as it was in trials, when the median patient needed two.

“So I think there’s a lot of learning,” McKechnie said, adding that, despite the complexities of gene therapy, 150 patients have already had their first collection “and 60 or so of them have now, frankly, had their lives transformed.”

A spokesperson added that Vertex tells centers to expect roughly 24 weeks from the first collection to finished product and that, “In the vast majority of cases, this target is hit” and “the turnaround is usually shorter.” But the company declined to share actual data.

For Vertex, time is of the essence. In addition to Genetix, Beam Therapeutics could have a new, potentially more effective and easier to manufacture gene-editing treatment approved next year. If so, Vertex has a limited window to establish Casgevy and recoup the billions it and its partner CRISPR Therapeutics invested in a transformative treatment.

“Will Beam become the leading cell therapy quite quickly just based on this merit alone?” said Eric Schmidt, a biotechnology analyst at Cantor Fitzgerald. “Yes, I think it will be.”

Not designed for sickle cell patients
Hospitals routinely collect stem cells from patients for transplants to treat cancer and certain genetic conditions. But it is uniquely challenging to do in sickle cell patients.

Doctors can safely use only one drug, rather than the typical two, to “mobilize” stem cells out of their niche in the bone marrow and into peripheral blood. These cells are then collected using an apheresis machine, a chaotic bedside console of tubes, knobs, and blood bags that probably “was designed for patients that don’t have sickle cell disease,” said Manis.

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The machine centrifuges blood to separate its component parts, creating a color band from the red of red blood cells to the yellow of plasma. Technicians draw stem cells from the clearish band in the middle. In sickle cell, though, the misshapen blood cells “throws off your color,” said Manis. “So all the visual cues that you ordinarily use aren’t there.”

The gene therapies, meanwhile, require far more stem cells than doctors typically collect from non-sickle cell patients. And Vertex’s process, in particular, is less efficient because it uses CRISPR gene editing, in which cells are opened with a zap of electricity to allow in DNA-cutting enzymes. Both the zaps and the DNA cuts kill some cells, leaving fewer for treatment.

Production became more inefficient when Vertex switched to a commercial manufacturing process that required more cells for quality control tests, McKechnie said.

“It is a small part of the equation,” he said.

These factors amounted to a rude introduction to gene editing for many doctors. They knew that the chemotherapy would make gene therapy a poor fit for most patients — Vertex estimated around 20 percent of the 150,000 sickle cell and beta-thalassemia patients in the US and Europe might be eligible, though some specialists think it’s less — and that manufacturing would take time. Cell collection wasn’t high on the list of concerns.

Sharl Azar, head of the sickle cell clinic at Massachusetts General Hospital, said collection for his first patient, a man in his 30s, took three visits. The last visit stretched for two weeks as the man had a sickle cell pain crisis — possibly related to the collection — and developed an infection.

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Azar was ultimately able to collect enough cells, and Vertex made the drug quickly. The patient has no regrets, Azar said. But another patient, a woman, had to stop after they became convinced they would never get enough cells. It’s harder, he learned, to collect cells from adults over 30.

“She was very devastated by the whole thing,” said Azar. “She ended up having actually a very nasty crisis on the tail end of it, and was in the hospital for six weeks and was super depressed and just absolutely devastated.”

Most confusing for centers has been cases where they’ve sent off what they believe to be enough cells — say 30 million per kilogram — and are told they need to collect more, because Vertex was only able to edit around 10 percent.

“We’ve not been able to get great answers from them on exactly what’s going on that they lose so many cells,” said Thompson.

McKechnie said such cases are “outliers” in a variable manufacturing process and that Vertex has started sharing more information with doctors.

“We’ve become much more transparent,” he said.

Jailbreaking the machine
With the right approach, doctors say they’ve been able to collect more cells. Jeffrey Glassberg, director of the sickle cell center at Mt. Sinai Hospital in Manhattan, said he struggled to collect any cells from the first patient he tried to treat with Lyfgenia. Genetix staff suggested various tips, like trying exchange transfusions — essentially replacing all of a patient’s red blood cells with a donor’s — before collecting.

The first patient still wasn’t able to give enough cells, but transfusions have helped subsequent patients.

“There’s a lot of stuff that is not written in the books,” he said.

Manis, who consulted with both Genetix and Vertex, has been giving advice to hospitals around the country on transfusions, medications, forming coordinated collection teams, and manipulating the machine to work for sickle cell patients. “You have to override the instrument,” he said.

Michele Wang, a hematologist at City of Hope, said the advice helped them collect cells on a third visit from a patient with combined sickle cell-thalassemia who produced barely any cells before.

“We still have more collections,” Wang cautioned. “And we still have more new things to try.”

In a few cases for sickle cell and beta-thalassemia, patients have given cells but the product Vertex or Genetix produced didn’t pass quality control. Such manufacturing failures occurred in five out of 33 patients treated commercially with either product, according to data presented this week from a multi-center consortium. The same study found that nine out of 18 sickle cell patients needed at least three collection cycles.

With more experience, doctors said, the process is likely to get smoother. Azar, the Mass General physician, said he’s been discouraged watching the toll these medicines take on patients and is likely to be conservative. But at Children’s National Hospital, David Jacobsohn said he expects to treat 10 sickle cell and beta-thalassemia patients this year between Vertex and Genetix, after treating 10 patients over the last two years.

Vertex opened a new manufacturing facility in New Hampshire last quarter and is instructing doctors to collect cells from patients for an additional day per hospital visit. McKechnie disputed that Beam Therapeutics, which uses a form of gene editing that is gentler on cells, has better data and noted Vertex is working on other improvements, such as alternatives to chemotherapy, that could expand the number of eligible patients.

For now, Manis and other doctors remain enthusiastic about gene therapies’ ability to transform their patients’ lives for the better — but they understand why many patients decline to pursue them.

“Right now it’s just overwhelming,” he said. If “you’re navigating a job and a family while you’re trying to do this — you’re like forget it, it’s not worth it.”
👍️0
Whalatane Whalatane 6 months ago
Did some more DD on the Nigerian sites
Look like academic / teaching hospitals which is good news
From AI
National Hospital, Abuja (NHA)
Reputation: Recognized as a leading public tertiary hospital in Nigeria and a major referral center for the nation's capital.
Strengths:
Specialized Services: Known for oncology, cardiology, neurosurgery, and IVF. It is noted as the only government hospital with a long-running, subsidized IVF program.
Accreditation: Fully accredited for residency training in several specialties, including internal medicine and obstetrics/gynecology.
Infrastructure: A large 850-bed facility with a well-equipped trauma center.
Challenges: Patients often report long wait times (median encounter of 2.7 hours) and some cite high fees compared to other public facilities.

Barau Dikko Teaching Hospital (BDTH), Kaduna
Reputation: The primary tertiary health institution in Kaduna town, serving as the teaching hospital for Kaduna State University.
Strengths:
Modernization: Recently deployed digital telemedicine services to improve access across the state.
Accreditation: Accredited by the Medical and Dental Council of Nigeria (MDCN) and the West African College of Physicians for postgraduate training in Family Medicine.
Challenges: Faces staffing issues common in state-run facilities; resident doctors have recently issued strike notices over pay disparities compared to federal institutions. There are ongoing plans to convert it to a federal teaching hospital to stabilize funding.

University College Hospital (UCH), Ibadan
Reputation: As the oldest teaching hospital in Nigeria (established 1952), it is widely regarded as one of the best in West Africa.
Strengths:
Academic Excellence: A premier hub for medical education and research with deep expertise in complex medical procedures.
Specialization: It is frequently cited as a "hospital of choice" for advanced tertiary care due to its wide range of medical specialties.
Challenges: Like many large public institutions, it can suffer from overstretched facilities and aging infrastructure despite its high medical standards.


Kiwi
👍️ 1
Whalatane Whalatane 6 months ago
Thx for the DD ...full data maybe late Feb
Kiwi
👍️ 1
The Canes The Canes 6 months ago
Hi Kiwi I was sifting through the data. I recall your biggest concern was the 3 Nigerian sites. You couldn't ascertain if they were included in the readout. The data cut was on Nov 11th. It included 12 patients (1 dropped out day one - no cause for alarm). There are 18 active sites. If you look at that chart you'll see the fonts are in bold letters for 13 of them. Then 5 sites aren't bold. They include the 3 sites in Nigeria or 33% of the study. So I think it's fair to conclude these patients were not included in the readout. I will say the HbF chart looks great as all 12 patients are much improved and 7/12 hit 20%.
👍️0
Fred Kadiddlehopper Fred Kadiddlehopper 6 months ago
Agreed about the political landscape and its effect on the stability of investments in this and other spaces. Good point about the upsizing of the original offering, but the lack of clarity on whether it closed is of concern to me. This is an unnecessary vaguery and could have been avoided by a clearly stated PR that the deal closed and was fully subscribed.
👍️ 1
The Canes The Canes 6 months ago
I remain cautious about the overall situation with bio-techs respect to the leadership at the HHS but let's not go there. Getting back on topic this secondary was over-subscribed to begin with. If you'll recall it went from $150 million to $175 million. Here's an expert from their initial Prospectus press release to illustrate things went famously. I'm pleased. I would like to see the final read out from the Phase One study. Kiwi expressed there could be some potential pitfalls, God forbid. That's worth worrying about.

"Fulcrum Therapeutics, Inc.
Common Stock
We are offering $150.0 million of shares of our common stock pursuant to this prospectus supplement and accompanying prospectus.
Our common stock is traded on The Nasdaq Global Market under the symbol “FULC.” On December 8, 2025, the last reported sale price per share of our common stock was $12.99."
👍️ 1
Fred Kadiddlehopper Fred Kadiddlehopper 6 months ago
I remain cautious due to the evident failure to fully sell the offering, but JPM just initiated coverage with and OUTPERFORM and $20 PT, so there's that FWIW.
👍️0
The Canes The Canes 6 months ago
Hi Fred, management is estimating they'll have $352 million in their coffers end of 2025. However their accounting firm needs to do the company audit to affirm that. Or "completion of the financial closing procedures" you reference. That statement is not related to the secondary and its closing. No correlation, they're totally different subjects. Kiwi suggested they had around $200 million in cash prior to the secondary. That was his estimate. Also the company has spent money in the interim. J.P. Morgan et al got paid several million dollars for running the secondary. This indicates to me they probably didn't succeed in selling the over-subscription but netted around $160 million. Which is great. What matters to me are the statements regarding "potential best in class" and the data itself. Which is hieroglyphics to me. So Kiwi please take a look at the data and let us know what you think. Much appreciated!
👍️ 1
Fred Kadiddlehopper Fred Kadiddlehopper 6 months ago
Today's PR contains some language which might indicate the financing deal hasn't closed yet.
👍️0
Fred Kadiddlehopper Fred Kadiddlehopper 6 months ago
Item 2.02 Results of Operations and Financial Condition.

Fulcrum Therapeutics, Inc., or Fulcrum, expects to report that it had cash, cash equivalents and marketable securities of approximately $352.3 million as of December 31, 2025.

The estimated cash figure is preliminary and unaudited, represents a management estimate as of the date of this Current Report on Form 8-K and is subject to completion of Fulcrum's financial closing procedures. Fulcrum's independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the estimated cash figure.

The information in Item 2.02 of this Current Report on Form 8-K is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
👍️0
Fred Kadiddlehopper Fred Kadiddlehopper 6 months ago
FULC Corporate Slide deck for JPM Conference
https://investorshub.advfn.com/stock-market/NASDAQ/fulcrum-therapeutics-FULC/stock-news/97596828/form-8-k-current-report
👍️0
The Canes The Canes 7 months ago
Thanks for clarifying, don't want another flawed trial like RZLT.
👍️ 1
Whalatane Whalatane 7 months ago
I'm not suggesting they cherry picked the data . I dont think they did .
Its a matter of timing .
The Nigerian sites weren't activated to mid 2025 so it's possible / probable that they make up most of those that had not completed the full 12 wks at the time of the ASH presentation . .
I think they have the full 12 wk data now on all ....then it's the 4 wk followup , then data prep and publish in ...my guess mid February
Kiwi
👍️ 2
The Canes The Canes 7 months ago
So you're suggesting they didn't include the data from Nigeria. It's hard to comprehend they'd cherry pick the data and talk about being best in class. Then to make matters far worse hire J.P. Morgan to market a secondary to their clients. If that plays out then watch out for the ambulance chasers like never before. J.P. may join a class action along with Cantor and Leerink. I'm not buying more but honestly Kiwi it seems rather far fetched.
👍️0
The Canes The Canes 7 months ago
It's quite possible you're correct and the 30 day option for 1.94 million additional shares wasn't gobbled up. Although since it was up-sized immediately from $150m to $175m the demand might already have been there. They didn't hire a schlock group of underwriters to market the secondary. To expect an announcement prior to the 30 day window expiring doesn't make any sense. If they only netted $164 million so be it. That's a very successful outcome.
👍️0
Whalatane Whalatane 7 months ago
Nigerian Participation: The PIONEER trial (NCT05169580) expanded its international presence in 2025 by activating three sites in Nigeria: National Hospital, Abuja; University of Ibadan; and a site in Kaduna.

Verification Method:
The trial utilized Pharmacokinetic (PK) measurements (plasma concentration testing) to verify adherence.
This allowed investigators to correlate biological evidence of the drug in the patient's system with reported pill counts.

Kiwi
👍️ 1
Whalatane Whalatane 7 months ago
The risk near term risk re FULC may be the data from the Nigerian patients in this P 1 data set .
We dont know if any of them were included in the data released so far ...and they are 33% of the trial .
The risk is adhering to the dosing schedule . FULC over came this initial problem with US patients by mandating a face time video with each patient ...each day ... to watch them swallow the med .

AI generated
In the clinical data recently announced for the 20 mg dose cohort of the Phase 1b PIONEER trial, Fulcrum Therapeutics did not specify the inclusion or results of Nigerian patients.
The initial results for this cohort, presented at the American Society of Hematology (ASH) Annual Meeting in December 2025, focused on the following participant characteristics and efficacy metrics for the 12 evaluable patients:
Trial Population: The cohort consisted of 12 adults with severe sickle cell disease (SCD).
General Demographics: While the PIONEER trial is a multicenter, international study, the specific geographic or national origins (such as Nigeria) for the 20 mg cohort members were not highlighted in the primary efficacy data release.
Baseline HbF: The mean baseline fetal hemoglobin (HbF) for the full 20 mg cohort was 7.1%.
Key Results: At Week 6, the cohort showed a mean absolute increase in HbF of 9.9%, with 58% (7 out of 12) of patients achieving absolute HbF levels of 20% or higher.
Fulcrum plans to report updated results for the full 12-week treatment period for all 12 patients in Q1 2026, which may include more detailed demographic information.

Kiwi
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Whalatane Whalatane 7 months ago
Gemini pro's take

Fulcrum Therapeutics priced an upsized underwritten public offering on December 10, 2025, raising approximately $175 million in gross proceeds.
Capital Raise Details
Total Raised: $175 million (gross) before deducting underwriting discounts and expenses.
Securities Offered: 11,851,853 shares of common stock and pre-funded warrants for 1,111,193 additional shares.
Pricing: The common stock was priced at $13.50 per share, with pre-funded warrants at $13.499 each.
Upsizing: The offering was upsized from an original proposal of $150 million.
Closing Date: The offering was expected to close on or about December 11, 2025.
Underwriters' Option: Fulcrum granted underwriters a 30-day option to purchase up to an additional 1,944,456 shares.

My emphasis
Would they exercise the option to pay I assume $13.50 a share , when its trading currently at $11.60 ?
The full P 1 data won't be out to mid/ late February 26 IIRC ...so we need to hope it matches or is better than the P 1 data out so far
JMO
Kiwi
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
The absence of an announcement strongly suggests, at the least, that the underwriters' option was NOT exercised.
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The Canes The Canes 7 months ago
Hi Kiwi, I already averaged down in RZLT. I wish I had been more aggressive but I'm comfortable with my position. As far as KOD goes if I'd heard about it a few months ago I'd have jumped all over it. At these levels I'd be concerned about another going it alone nightmare. Been there done that with VKTX and AMRN. It'll probably eventually be a 4-5 bagger but it's not a risk I'm willing to take. Good luck with it!
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Whalatane Whalatane 7 months ago
Hi Canes ...suggest you and Fred also look at RZLT ...and if so inclined KOD .
Kiwi
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The Canes The Canes 7 months ago
They announced the pricing, amount raised and closing date. I'm sure it's done. I doubt you'll see any more press releases. I've seen this approach several times.
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Whalatane Whalatane 7 months ago
Right ...I also haven't seen that notice .
Kiwi
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
I've noticed that the company hasn't PR whether the latest stock offering has closed and whether the optional amounts were exercised. The deal was to close last week according to the original announcement.
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Whalatane Whalatane 7 months ago
Just some quick notes ...maybe more later .
1) Doubt they increase dose
2) Expect drug effect to plateau at 16-20 wks ( current data is 12 wks ) so pivotal trial will probably be a 6 mth trial
3) Expect full phase 1 data late February 2026 . Dont know if already fast tracked ..will chk ...but that would speed things up .
4) Ceo has emphasized speed to market ...will enroll sickest ( history of hospitalization ) and expand coverage once approved

Fulcrum Therapeutics (FULC) Drug Programs: FDA DesignationsFulcrum Therapeutics (NASDAQ: FULC) is developing small-molecule therapies for genetically defined rare diseases.

Based on publicly available information from FDA announcements, company press releases, and regulatory filings as of December 2025, their key clinical programs have received Fast Track designations from the FDA but no Breakthrough Therapy designations.
Fast Track status expedites development and review for drugs addressing serious unmet needs, while Breakthrough Therapy requires preliminary evidence of substantial improvement over existing therapies (which has not been granted for these programs).



Kiwi
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The Canes The Canes 7 months ago
I was selling my position pre-market because it was up nearly 50%. I was kicking myself when it hit $15. It's impossible to pick the top when these things take off. Anyway I'm back in and think it's a winner. I think pricing the secondary at $13.50 is fantastic. I thought it might be anywhere from $11.50-12.50. You mentioned the effects of their drug plateauing. I surmise that's inevitable and going to be illustrated in the final data set released early next year. I wonder if they'll take a shot at upping the dosage further or is that not worth the risk in your opinion? Can they blend that into a Phase 3 trial? I believe this is already fast tracked. So they should be allowed to jump to Phase 3 correct? I suspect they'd request that right after they release the Phase 1 data. How long does that response "normally" take? Would the Phase 3 be a 12 week study too? Now that they're sitting on $400 million how do you feel about their runway? Thanks for the advice as always!!!
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
The company announced that the new offering is priced at $13.50 per share and a total of 14.9 million shares assuming exercise of the full offering including warrants.
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Whalatane Whalatane 7 months ago
At the November 11, 2025 data cutoff, all 12 patients completed the Week 6 visit and are included in the Week 6 analyses.

Six patients (50%) who enrolled earlier in the cohort reached the Week 12 visit at the time of data cutoff and are included in the Week 12 analyses.

Week 6 results therefore reflect all 12 patients, while Week 12 results reflect the first 6 patients to complete the full treatment period.

So theres 6 patients still to report the full 12 wk data ... due .6 wks from Nov 11th .
That takes us to Dec 23rd ...So hopefully they get that last patient in before Xmas .

The enrollment would have been staggered so I'm guessing they have more 12 wk data now in all but the last 1 or 2 patients .
That might be leaking out and supporting this capital raise ...hey my conspiracy fantasy anyway

Kiwi
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Whalatane Whalatane 7 months ago
Hey congrats . I was buying a little in the after hrs ...basically " revenge " buying. I never sold any on the pop ...and then was mad at myself when it dropped at the close ...so decided to act opposite to my emotions and bt in the after hrs .
Heavy vol and in the green so far today .
Kiwi
PS. I think they know the results of most of those remaining in the P1 trial ...final patient will hit 12 wks in last wk of Dec .
The data they reported so far ....all 12 had completed the initial 6 wks at Nov 11 th . Most will have completed the full 12 wks by now , with the last patient in the last wk of Dec. .
So internally I think they have an idea of what the full 12 wk data set is like
JMO
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The Canes The Canes 7 months ago
I'm in both thanks to you! Don't worry if they don't pan out. I've traded both a couple times, so my net cost is practically zilch. Without your insight I'd be a fish out of water. Although my call on FULC and the secondary was spot on. I put a buy order in at $12.51 a minute before the close and it gapped down after the announcement. They filled it at $12.01. I've never been that lucky before and probably never will be again. I thought it was a typo.
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
Agree it does look rushed.
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Whalatane Whalatane 7 months ago
Latest I see is that the filing is preliminary and pricing will be determined by market conditions .
This may have been rushed by their bankers .
Just my quick take
Kiwi
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
Anyone have any clue about the pricing of this offering? They seem to be unusually cagey about it.
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
Looks like a solid plan and a promising therapeutic. Let's hope they don't trip over their own feet a la UNCY going forward.
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Whalatane Whalatane 7 months ago
I'll throw rotten eggs at their front door ( if they are in the Bay Area ) ...if they raise $ again in 2026 .
They have $200m roughly cash on hand and will raise by your calcs around $175 m now .
Thats enough to run a P 3 trial of very sick sickle cell patients .
My guess is 100 very sick patients for 6 mths on 20 mg of the drug ....if FDA gives them Fast track / Breakthru status and allows them to go straight to a pivotal trial.

In the webcast the Ceo emphasized speed to market ...meaning ...take the sickest , those with a history of hospitalization for sickle cell flares ...run a trial on them as a " unmet need " ...fast track everything .
Then once approved for that population expand to less afflicted thru a long term follow up program they are starting early next yr.

So depends on FDA feedback re fast track , size of trial , if there is an unmet need etc
80,000 people in the US have sickle cell ..over 7 m world wide ( mainly Africa ) .
Of the 80,000 in the US ...20,000 have severe flares

I met someone years ago experiencing a sickle cell flare ...very painful ..in his case not enough to be hospitalized ...but unable to do much other than lie around on pain meds

Kiwi
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
Re, your last paragraph, do you expect another raise after the February event? (Assuming a positive readout.)
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Whalatane Whalatane 7 months ago
Last patient will have 12 wk data in last wk of Dec .
Theres a 4 wk follow up
So into Feb with a clean / chk data , organize to present ...my guess is late February 2026 .
RA Capital sold a large part ( maybe half ) of their stake at the close ...thus the sell off .
I was so pissed at myself for thinking they would delay a capital raise ...I decided to add in the after hrs ie ..act opposite to my emotions ( my preferred style of trading )

Off course this is a set up for RZLT
If they report great data ...sell the news , then buy back when they do the capital raise

Kiwi
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Fred Kadiddlehopper Fred Kadiddlehopper 7 months ago
Haha, CAnes called it, I was just tagging along. LOL!
When is the full P1 data set expected to be completed and made public?
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Whalatane Whalatane 7 months ago
Congrats ...You and Canes called it . I thought they'd wait for full P 1 data set.
Mkt cap was $700m and they are raising up to $172.5 M ...on P 1 data from six patients ( so far ) ..!!!
I'll be impressed if this closes positive tomorrow
Kiwi
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