After Big Pharmas made headlines with earnings beats and misses, biotechs took their turn last week with a flurry of results from companies across the public small- to mid-cap universe.
The heavy earnings day came days after Donald Trump was re-elected president, which BMO Capital Markets analysts predicted would be a net positive for the biopharma industry. The firm sees a higher risk appetite for biotech now that the election is over.
Meanwhile, competition in the cell therapy space is heating up among biotech-partnered Gilead (Arcellx), Bristol Myers Squibb (2seventy bio) and Johnson & Johnson (Legend Biotech), BMO said.
Let’s take a look at some of the highlights from earnings releases that took place this week for clinical-stage biotechs.
Allogene
Revenue: None
Cash position: $403.4 million
Runway: Second half of 2026
Allogene revealed higher response rates and signs of durability for CAR T candidate ALLO-316 at two conferences on Thursday, the same day the company released earnings.
Analysts were pleased with the update for the Phase I TRAVERSE trial in patients with advanced or metastatic renal cell carcinoma who have a CD70+ mutation and have progressed after other treatments. The small study showed a best overall response rate of 50% and a confirmed response rate of 33% in patients who had a high tumor proportion score.
William Blair analysts noted that Allogene will have a “low efficacy bar” in this renal cell carcinoma population, given Merck’s Welireg was approved with just a 22% overall response rate and 5.6 months median progression free survival. These data could also validate the use of Allogene’s allogeneic Dagger technology in future candidates, the firm noted.
Allogene’s lead candidate is cemacabtagene ansegedleucel (cema-cel), which is being tested in a Phase II trial called ALPHA3 for patients with first line large B cell lymphoma. The company is working on site activation and patient screening at the moment. Lymphodepletion is expected to start in mid-2025, with enrollment completed in the first half of 2026. Primary data will come by the end of the year, with a potential regulatory submission in 2027.
“We believe cema-cel has the potential to leapfrog other autologous and allogeneic CD19 CAR-T therapies, remain competitive for longer, and expand the total addressable market,” William Blair wrote.
AnaptysBio
Revenue: $30 million
Cash position: $458 million
Runway: Year-end 2026
It’s a tough world for a small biotech going after a heavyweights like Eli Lilly. Truist Securities thinks the job just got even harder for AnaptysBio after the Big Pharma posted strong data for atopic dermatitis biologic Ebglyss, which was just approved in September.
Lilly presented data at the Fall Clinical Dermatology Conference in late October showing that 57% of patients with atopic dermatitis met the 75% symptom clearance measure at week 16. This raised the bar for Anaptys’ ANB032, which is due to read out in a Phase II trial of the same indication in December.
Executives expressed confidence in Anaptys’ candidates in a third quarter earnings report, touting the best-in-class profile of its programs targeting the BTLA and PD-1 co-inhibitory receptors.
Analysts were not convinced, however. “We don’t think a me-too profile, especially in a competitive space such as [atopic dermatitis] would be enough for AN032,” wrote Truist. “We lack conviction on ANB032.”
It’s not just Lilly, either. The atopic dermatitis market is flooded with options, from biologics to orals to topicals.
“Bottom line, from a small-cap biotech, we’re looking for something transformational, not incremental, for their drugs to have a shot at competing against entrenched incumbents with deep pockets,” Truist said.
Arcellx
Revenue: $26 million
Cash position: $676.7 million
Runway: Into 2027
Arcellx is heading into the fourth quarter on the cusp of a make-or-break milestone. The biotech and partner Gilead reported results earlier this week for CAR T therapy anitocabtagene autoleucel (anito-cel) that showed strong response rates and improved survival outcomes in patients with relapsed or refractory multiple myeloma. The results came from the registrational Phase II iMMagine-1 trial and were a preview of data to come at next month’s American Society of Hematology meeting in San Diego.
Analysts will be watching that presentation for additional details, with William Blair’s team suggesting anito-cel could have best-in-class potential over rivals J&J and Legend, which have Carvykti approved in the indication.
Cassava Sciences
Revenue: None
Cash position: $149 million
Runway: At least 12 months
Embattled Alzheimer’s disease biotech Cassava Sciences hopes the fourth quarter will allow it to set the record straight. In the third quarter, the company settled an SEC lawsuit that alleged data manipulation in studies for its lead drug simufilam.
The last patient visit for the drug’s Phase III trial was announced earlier this month, meaning Cassava is on track to released the late-stage results by the end of the year.
“Given the scrutiny this company has been under, you can expect that we will measure twice and cut once before we report our results,” CEO Rick Barry said on the earnings call Thursday.
Barry promised to report the results as clearly as possible and to report it “whether it is good, bad or ambiguous.”
Barry took over the CEO role in September after the July resignation of long-time leader Remi Barbier.
HilleVax
Revenue: None
Cash position: $189.3 million
Runway: At least 12 months
HilleVax’s earnings report was short and sweet, reflecting a period of soul searching for the Takeda vaccine spinout after lead candidate HIL-214 failed to prevent norovirus complications in infants during a Phase IIb trial. The July readout sent Hillevax’s shares, which had been sitting around $14 apiece, tumbling to below $2 where they sit today.
In the brief third quarter report, Hillevax said it is exploring the development of the norovirus candidate in adults. The company is also considering business development activities and other strategic alternatives.
HilleVax’s cash runway is not crystal clear, but an SEC document suggests it has enough cash to cover the at least the next 12 months. Cash dwindled from $303.5 million at the end of last year to $189.3 million as of September 30. R&D costs were lower than prior quarters but still $20.2 million.
After the mid-stage failure of HIL-214, HilleVax laid off 41 employees, or 40% of its workforce to preserve cash.
Intellia
Revenue: $9.1 million
Cash position: $945 million
Runway: Late 2026
CRISPR gene editing biotech Intellia and partner Regeneron have been cleared for a Phase III trial of NTLA-2001—now known as nexiguran ziclumeran—in ATTR-polyneuropathy, adding another prong to the clinical program for the rare disease gene therapy. Intellia has already shown impressive results for the therapy in ATTR amyloidosis with cardiomyopathy (ATTR-CM), a related disorder.
The companies will now embark on a 50-patient study outside of the U.S. Intellia noted that it has achieved alignment with the FDA on trial design, however. Enrollment is set to get underway by the end of the year.
Meanwhile, enrollment of the Phase III MAGNITUDE trial of nex-z in ATTR-CM is ahead of expectations, but executives were mum on specifics.
The company is also testing NTLA-2002 in hereditary angioedema, revealing in late October that the asset cut monthly swelling attacks by 80% after five weeks. Jefferies analysts called the achievement of a complete response in eight out of 11 patients “unprecedented.”
William Blair sees the ATTR and HAE spaces as becoming increasingly crowded but said Intellia can differentiate itself by offering a one-and-done option for both conditions.
Nkarta
Revenue: None
Cash position: $405.3 million
Runway: Late 2027
Cell therapy company Nkarta is completing its pivot away from oncology with the termination of development of NKX019 in lymphoma. The decision was made after Nkarta got a look at the latest cohort of data and considering the evolving treatment landscape.
But no matter, CEO Paul Hastings said the candidate has shown plenty of promise in autoimmune disease already. The company has dosed an initial patient in the Phase I Ntrust-1 trial for patients with lupus nephritis, while a similar milestone has been reached for the therapy in an investigator-sponsored trial. Enrollment is ongoing for both.
Nkarta is expecting to get enrollment underway for the Phase I Ntrust-2 study by the end of the year. That trial will specifically target patients with systemic sclerosis (scleroderma), idiopathic inflammatory myopathy (myositis) and ANCA-associated vasculitis. The early clinical program is focused on safety with readouts expected in 2025.
The biotech is following emerging science that suggests cell therapy can lead to remission in patients with autoimmune disease. William Blair’s team noted that the lupus space is becoming increasingly crowded as fellow cell therapy biotechs switch from oncology to autoimmune indications. But Nkarta could rise above with a differentiated preconditioning treatment that does not include the chemotherapy fludarabine due to its natural killer (NK) cell approach.
William Blair said the first data on using CAR-NK cells in autoimmune diseaseis expected this month at the American College of Rheumatology conference, which will have read through to Nkarta.
Poseida Therapeutics
Revenue: $71.7 million
Cash position: $230.9 million
Runway: Early 2026
Poseida reported positive cash flow for the first nine months of the year, a feat for a biotech that is still in the clinic without an approved asset. The funds came from milestone and upfront payments received so far this year, totaling $130 million, plus $49 million in R&D reimbursements.
William Blair analysts said more milestone payments are expected from a collaboration with Roche, which could further bolster Poseida’s cash position. The partners expect Phase I data from a clinical trial for P-CD19CD20-ALLO1 in 2025. They have a total of three programs together.
More partnership revenue could be ahead for Poseida, as the company named a second program under its collaboration with Astellas subsidiary Xyphos Biosciences. The two have picked a candidate for a solid tumor CAR T program.
Poseida will host an R&D day for investors on November 14.
Rapport Therapeutics
Revenue: None
Cash position: $320.7 million
Runway: End of 2026
Central nervous system disorder biotech Rapport Therapeutics has been notified that its Phase IIa trial for RAP-219 in diabetic peripheral neuropathic pain has been placed on a clinical hold by the FDA. The agency has requested additional information and amendments to the protocol design before the trial can start. Rapport revealed the news in its third quarter earnings update.
Rapport said that the hold does not apply to an ongoing Phase IIa trial for focal epilepsy or a planned study for bipolar disorder. The company “believes in its ability to resolve the clinical hold,” according to the release. An update will be provided once Rapport is clear on the timing of the trial start.
https://www.biospace.com/business/q3-biotech-earnings-recap-nkarta-intellia-cassava-and-more
