Q1 Earnings Wire

Wednesday May 13, 2026 AM

13 beats. 4 misses. 1 reported.

BEATS

VOR +6.41% .. Vor Bio. Autoimmune cell therapy pivot after the trem-cel oncology shutdown. Platform reset in progress, watch for cash runway disclosure and direction on the new autoimmune CAR-T program.

CMPS +11.76% .. Compass Pathways. NDA rolling submission already underway for COMP360 in TRD with sections submitted. CNPV awarded, which can compress review to 1-2 months. COMP006 26-week Part B data in early Q3 2026. Final NDA submission tracking for Q4 2026. White House EO directs DEA to advance rescheduling review for completed Phase 3 psychedelics. $466M cash, runway into 2028. Over 7,300 treatment centers already in place to deliver multi-hour therapy. The setup is sharp.

VERU +60.00% .. Veru. Fiscal Q2. Enobosarm sarcopenic obesity Phase 2b PLATEAU readout cadence. GLP-1 plus selective androgen receptor combo to preserve lean mass while shedding fat. Small cap, dilution risk, but the readout could matter.

FATE +7.14% .. Fate Therapeutics. iPSC off-the-shelf platform. ASGCT 2026 Boston this week, three presentations: FT819 SLE poster Tuesday, FT836 MICA/B Wednesday, FT839 dual CD19/CD38 conditioning-free oral on Thursday May 14. Q1 print plus ASGCT data is the catalyst stack.

IPSC +35.29% .. Century Therapeutics. Allogeneic iPSC platform. CNTY-813 T1D iPSC-derived islet program on track for IND 4Q 2026 with initial clinical data 2H 2027. Oral presentation at ADA June 8 on Allo-Evasion 5.0 engineered islets. CNTY-308 CD19 CAR-iT into the clinic this year. $217M cash into 1Q 2029 after the $135M oversubscribed January raise. Miami Tier 3. Cell therapy plus T1D plus autoimmune all in one platform.

ABUS +1550% .. Arbutus. Print is noisy on a tiny base. Real story is the Moderna settlement: $950M upfront in July 2026 plus $1.3B contingent on appellate ruling. ABUS receives roughly $178.7M from Genevant in July plus owns 16% of Genevant’s outstanding equity. Q1 revenue $179.1M from the license recognition. $95.2M cash now, cash inflection coming this summer. FDA Fast Track granted to imdusiran for chronic hep B in April. The capital structure changes meaningfully in July.

ALT +28.00% .. Altimmune. Pemvidutide rare liver franchise. BTD in MASH. PERFORMA Phase 3 MASH initiating 2H 2026, 52-week data 2029. EASL Congress May 28, late-breaking oral on 48-week IMPACT data plus three additional readouts including fibrosis regression on quantitative digital pathology. RECLAIM Phase 2 AUD topline Q3 2026 (enrolled ahead of schedule in November 2025). RESTORE Phase 2 ALD enrollment completion Q3 2026. $332M cash 3/31, $535M as of 4/30 after the $225M April offering. Jerry Durso knows the rare liver M&A playbook. Locked thesis, the setup keeps building.

ABEO +21.05% .. Abeona Therapeutics. ZEVASKYN gene therapy commercial launch for recessive dystrophic EB. CHOP activated as a new Qualified Treatment Center May 11. Miami Tier 3. Real revenue ramp into 2H 2026.

PYPD +20.45% .. PolyPid. NDA submission initiated March 30 under rolling review, CMC and nonclinical sections submitted, clinical section coming imminently. Small business PDUFA fee waiver of $4.3M, real capital preservation. EMA Rapporteur meetings in Q2, MAA submission Q3 2026. US commercial partnership discussions in late stages. SHIELD II data at SIS 2026 showed 64% relative risk reduction (p=0.0103) on the ASEPSIS greater than 20 threshold, meaning even patients with wound events saw materially reduced severity. PDUFA target Q1 2027. $10.9M cash, tight but funded into 2H 2026. Miami Tier 3.

UPB +1.32% .. Upstream Bio. Verekitug anti-TSLP long-acting monoclonal. Severe asthma, COPD, CRSwNP Phase 2 programs. Miami Tier 3. TSLP class heat after Tezspire.

AVTX +2.97% .. Avalo Therapeutics. Abdakibart (AVTX-009) IL-1β/IL-1α biparatopic, positive topline in LOTUS Phase 2 hidradenitis suppurativa on May 5, same day priced $375M public offering. Miami Tier 3. Phase 3 funded, differentiated MOA in HS. Cleanest setup in the batch.

HUMA +18.18% .. Humacyte. ATEV/Symvess franchise. Q1 commercial sales of 29 units for $0.5M versus 5 units for $0.1M in Q1 2025. Roughly 6x year over year unit growth. Three new commercial channels opening: Israel MAA accepted on a 180-working-day review, Saudi Arabia $1.475M purchase commitment in March with JV negotiations advancing, FY 2026 DoD Appropriations Act includes dedicated funding for biologic vascular repair for warfighters. Near-term binary: June 11 at SVS VAM Boston, V012 Phase 3 ATEV hemodialysis interim readout on the first 80 of 120 enrolled patients. Positive read sets up sBLA filing 2H 2026 to add hemodialysis. CTEV (coronary) IND submitted, first-in-human CABG study planned 2H 2026. May restructuring removed 45 roles for $14.3M net savings this year against $0.8M severance. $48.9M cash, $2M net cash used in Q1. James Mercadante in as CCO, Dr. Todd Rasmussen as Chief Surgical Officer. Miami Tier 3. June 11 is the binary.

ZBIO +5.19% .. Zenas BioPharma. Obexelimab CD19xFcgRIIb bifunctional for autoimmune (IgG4-RD, SLE, MS). First patient dosed today in Phase 1 of ZB021, novel oral IL-17A/F inhibitor. Pipeline expansion print.

MISSES

TYRA -8.47% .. Tyra Biosciences. Dabogratinib 3x3 strategy intact, the print does not change the thesis. First patient dosed in SURF303 LG-UTUC, potentially registrational, initial results 2027. SURF302 IR NMIBC initial three-month complete response data expected August 2026 with over 20 patients enrolled across two QD dose cohorts. BEACH301 ACH safety sentinel cohort cleared its fourth dose level, initial results Q4 2026 including 6-month average height velocity. New preclinical achondroplasia data at the Fusion FGFR Conference showed prenatal plus postnatal dosing increased foramen magnum area and further delayed synchondrosis fusion versus postnatal alone. $383.5M cash, runway into 2H 2028. Habib Dable joined the board in April, ex-Acceleron CEO who sold to Merck in 2021. Board is being staffed for an outcome. Locked thesis, SURF302 August is the next visible catalyst.

ANRO -53.85% .. Alto Neuroscience. ALTO-207 Phase 2a positive in MDD on May 4, Phase 2b in treatment-resistant depression initiated April 21. Miss is operational R&D spend, not pipeline failure. CNS biomarker-driven precision psych platform.

SPRB -22.13% .. Spruce Biosciences. Tildacerfont CAH commercial buildout. April 20 public offering. New commercial leadership added May 4. Real miss on the print, but commercial team building suggests management sees launch trajectory worth funding.

MIST -242.86% .. Milestone Pharmaceuticals. Percentage is noise on a tiny base. Real story is launch traction: roughly 600 CARDAMYST scripts filled for 560 PSVT patients through April, about 400 unique prescribers writing, over 25% of US commercially insured lives now covered. Express Scripts added the product to its commercial national formularies effective March 27. EMA accepted the MAA (TACHYMIST conditional brand) with EU decision expected H1 2027. Everest Medicines picked up Greater China rights from Corxel in March. Phase 3 AFib-RVR registration trial initiated, first patient H2 2026, sNDA pathway. $184.2M cash into H2 2027. Real launch ramp underneath the print.

REPORTED

INBS reported -$1.80 .. Intelligent Bio Solutions. Fiscal Q3 revenue grew 46% year over year. Rapid drug screening cartridge targeting 70% faster results. FDA 510(k) submission advancing with penetration testing complete. Micro cap commercial ramp.

Takeaways

Cell therapy week is live. FATE at ASGCT, IPSC oral at ADA June 8, ZBIO ZB021 first dose, IMTX yesterday. Saturated conference tape and big pharma scouts are in the room.

Compass is the cleanest regulatory setup on the board. NDA rolling, CNPV awarded, White House EO on rescheduling, $466M cash, 7,300 treatment centers ready. Q4 NDA completion plus 1-2 month review is the path.

Arbutus inflects in July when $178.7M lands from the Moderna settlement plus 16% Genevant equity carry. Capital structure changes materially.

Avalo is the cleanest single-day setup. Positive Phase 2 HS plus a $375M raise eight days ago means funded into Phase 3 with a differentiated IL-1 biparatopic.

Altimmune Q1 plus BTD plus Phase 3 funded plus $535M cash plus rare liver M&A operator CEO. EASL May 28 is the next signal.

TYRA print is noise. SURF302 August is the visible catalyst, SURF303 first patient dosing is the structural one. Habib Dable joining the board fits the pattern.

Humacyte June 11 SVS interim is the binary. Symvess unit growth plus three new commercial channels opening plus disciplined cost structure.

Milestone CARDAMYST early launch traction is real. 600 scripts, 400 prescribers, Express Scripts coverage, AFib-RVR sNDA pathway opening.