Anaptys Announces Second Quarter 2024 Financial Results and Provides Business Update
Anaptys (NASDAQ: ANAB) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Completed enrollment for Phase 2b trial of ANB032 in atopic dermatitis, with top-line data expected in December 2024.
2. Accelerated top-line data for Phase 2b trial of rosnilimab in rheumatoid arthritis to Q1 2025.
3. FDA accepted IND for ANB033, with Phase 1 trial initiation anticipated in Q4 2024.
4. Cash and investments of $393.5 million as of June 30, 2024.
5. Q2 2024 net loss of $46.7 million, or $1.71 per share.
The company remains on track to have four immune cell modulators in clinical development by year-end.
Anaptys (NASDAQ: ANAB) ha annunciato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. Completato il reclutamento per la sperimentazione di Fase 2b di ANB032 nella dermatite atopica, con i dati principali previsti per dicembre 2024.
2. Accelerazione dei dati principali per la sperimentazione di Fase 2b di rosnilimab nell'artrite reumatoide prevista per il primo trimestre 2025.
3. L'FDA ha accettato l'IND per ANB033, con l'inizio della sperimentazione di Fase 1 previsto per il quarto trimestre 2024.
4. Liquidità e investimenti di 393,5 milioni di dollari al 30 giugno 2024.
5. Perdita netta di 46,7 milioni di dollari nel secondo trimestre 2024, equivalente a 1,71 dollari per azione.
La società rimane sulla buona strada per avere quattro modulatori delle cellule immunitarie in sviluppo clinico entro la fine dell'anno.
Anaptys (NASDAQ: ANAB) informó los resultados financieros del segundo trimestre de 2024 y ofreció una actualización empresarial. Los aspectos destacados incluyen:
1. Se completó el reclutamiento para el ensayo de Fase 2b de ANB032 en dermatitis atópica, con datos preliminares esperados para diciembre de 2024.
2. Se anticiparon datos preliminares para el ensayo de Fase 2b de rosnilimab en artritis reumatoide para el primer trimestre de 2025.
3. La FDA aceptó el IND para ANB033, con el inicio del ensayo de Fase 1 previsto para el cuarto trimestre de 2024.
4. Efectivo e inversiones de 393,5 millones de dólares al 30 de junio de 2024.
5. Pérdida neta de 46,7 millones de dólares en el segundo trimestre de 2024, o 1,71 dólares por acción.
La empresa se mantiene en camino de tener cuatro moduladores de células inmunitarias en desarrollo clínico para finales de año.
Anaptys (NASDAQ: ANAB)은 2024년 2분기 재무 결과를 발표하고 비즈니스 업데이트를 제공했습니다. 주요 사항은 다음과 같습니다:
1. 아토피 피부염에서 ANB032의 2b상 시험 참가자 모집을 완료했으며, 주요 데이터는 2024년 12월에 예상됩니다.
2. 류마티스 관절염에서 rosnilimab의 2b상 시험 주요 데이터가 2025년 1분기로 앞당겨졌습니다.
3. FDA가 ANB033의 IND를 수락했으며, 1상 시험 시작이 2024년 4분기로 예상됩니다.
4. 2024년 6월 30일 기준으로 현금 및 투자가 3억 9천 350만 달러입니다.
5. 2024년 2분기에 4,670만 달러의 순손실이 발생했으며, 이는 주당 1.71달러에 해당합니다.
회사는 연말까지 임상 개발 중인 면역세포 조절제가 4개가 될 것으로 예상하고 있습니다.
Anaptys (NASDAQ: ANAB) a publié ses résultats financiers pour le deuxième trimestre de 2024 et a fourni une mise à jour de l'entreprise. Les points clés incluent:
1. Recrutement achevé pour l'essai de phase 2b de l'ANB032 dans la dermatite atopique, avec des données préliminaires attendues en décembre 2024.
2. Accélération des données préliminaires pour l'essai de phase 2b du rosnilimab dans l'arthrite rhumatoïde pour le premier trimestre 2025.
3. La FDA a accepté l'IND pour l'ANB033, le début de l'essai de phase 1 étant anticipé pour le quatrième trimestre 2024.
4. Liquidités et investissements de 393,5 millions de dollars au 30 juin 2024.
5. Perte nette de 46,7 millions de dollars pour le deuxième trimestre 2024, soit 1,71 dollar par action.
L'entreprise est en bonne voie pour avoir quatre modulateurs de cellules immunitaires en développement clinique d'ici la fin de l'année.
Anaptys (NASDAQ: ANAB) hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Wichtige Highlights sind:
1. Die Rekrutierung für die Phase-2b-Studie von ANB032 bei atopischer Dermatitis wurde abgeschlossen, die ersten Daten werden im Dezember 2024 erwartet.
2. Die ersten Daten für die Phase-2b-Studie von Rosnilimab bei rheumatoider Arthritis werden für das erste Quartal 2025 beschleunigt.
3. Die FDA hat den IND für ANB033 akzeptiert, der Start der Phase-1-Studie wird für das vierte Quartal 2024 erwartet.
4. Bargeld und Investitionen in Höhe von 393,5 Millionen Dollar zum 30. Juni 2024.
5. Nettoverlust von 46,7 Millionen Dollar im zweiten Quartal 2024, oder 1,71 Dollar pro Aktie.
Das Unternehmen bleibt auf Kurs, bis Ende des Jahres vier modulatorische Immunzellen in der klinischen Entwicklung zu haben.
- Completed enrollment for Phase 2b trial of ANB032 in atopic dermatitis with 200 patients
- Accelerated top-line data for rosnilimab Phase 2b trial in rheumatoid arthritis to Q1 2025
- FDA accepted IND for ANB033, Phase 1 trial to start in Q4 2024
- Strong cash position of $393.5 million, runway through year-end 2026
- Increased collaboration revenue to $11.0 million in Q2 2024 from $3.5 million in Q2 2023
- Net loss increased to $46.7 million in Q2 2024 from $39.8 million in Q2 2023
- Research and development expenses rose to $42.0 million in Q2 2024 from $32.9 million in Q2 2023
- Cash and investments decreased by $24.4 million since December 31, 2023
Insights
Anaptys' Q2 2024 results reveal a mixed financial picture. While revenue increased to
R&D expenses rose
Anaptys is making significant progress across its immunology pipeline. The completion of enrollment for ANB032's Phase 2b trial in atopic dermatitis, with top-line data expected in December 2024, is a key near-term catalyst. The accelerated timeline for rosnilimab's Phase 2b data in rheumatoid arthritis to Q1 2025 is also positive.
The FDA's acceptance of the IND for ANB033 and the planned initiation of a Phase 1 trial in Q4 2024 further diversifies the company's portfolio. With four immune cell modulators expected to be in clinical development by year-end, Anaptys is building a robust pipeline targeting various inflammatory conditions. However, investors should note that these are still early to mid-stage assets and clinical success remains uncertain.
Anaptys' focus on innovative immunology therapeutics positions it well in a growing market. The global immunology market is projected to reach
However, competition in this space is intense, with established players and other biotechs developing similar therapies. Anaptys' success will depend on demonstrating superior efficacy and safety profiles in upcoming clinical readouts. The potential out-licensing of imsidolimab in 2024 could provide additional non-dilutive funding and validate the company's platform, potentially boosting investor confidence.
- Top-line data expected in December 2024 after having completed enrollment for Phase 2b trial to treat atopic dermatitis (AD) with ANB032, our BTLA agonist
- Top-line data accelerated and now anticipated in Q1 2025 for Phase 2b trial to treat rheumatoid arthritis (RA) with rosnilimab, our PD-1 agonist
- Top-line data now anticipated in Q1 2026 for Phase 2 trial to treat ulcerative colitis (UC) with rosnilimab
- IND accepted by FDA for ANB033, our anti-CD122 antagonist; Phase 1 trial initiation anticipated in Q4 2024
SAN DIEGO, Aug. 05, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the second quarter ended June 30, 2024 and provided a business update.
“We’ve had an exceptional quarter as we approach multiple important value drivers for Anaptys including our first patient data for ANB032, our BTLA agonist. First, enrollment has completed in the Phase 2b trial of ANB032 in AD with strong demand leading to enrollment totaling approximately 200 patients. Importantly, we plan to share top-line Week 14 data in December of 2024,” said Daniel Faga, president and chief executive officer of Anaptys. “Second, strong demand in enrollment for the Phase 2b trial of rosnilimab in RA has accelerated anticipated top-line data from mid-2025 to Q1 2025. And finally, our IND for ANB033 was accepted by FDA in July and we look forward to initiating a Phase 1 trial in healthy volunteers soon. Looking to the end of the year, we still plan to have four immune cell modulators (ICMs) in clinical development.”
Updates on Wholly Owned ICM Pipeline
ANB032 (BTLA agonist antibody)
- Completed enrollment for global Phase 2b trial in moderate-to-severe AD
- Enrolled approximately 200 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI-75 and IGA 0/1
- Enrollment included approximately
15% of patients with Dupixent/anti-IL-13 treatment experience
- Enrollment included approximately
- Top-line Week 14 data expected in December 2024
- Enrolled approximately 200 patients in a placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI-75 and IGA 0/1
- Presented previously reported ANB032 preclinical graft vs. host disease (GvHD) data at the 2024 American Association of Immunology (AAI) Annual Meeting and Society of Investigative Dermatology (SID) Annual Meeting in May 2024 and ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting in June 2024
- Poster presentations are available here
- Poster presentations are available here
Rosnilimab (PD-1 agonist antibody)
- Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA
- 420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
- At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
- Top-line Week 12 data anticipated in Q1 2025
- 420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
- Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
- 132-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
- Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
- Top-line Week 12 data anticipated in Q1 2026
- 132-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
- Presented previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling data at the 2024 Digestive Disease Week (DDW) Annual Meeting in May 2024 and at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting in June 2024
- Poster presentations are available here
ANB033 (anti-CD122 antagonist antibody)
- IND application accepted by FDA in July 2024
- Phase 1 trial initiation in healthy volunteers anticipated in Q4 2024
ANB101 (BDCA2 modulator antibody)
- Plan to submit IND application in Q4 2024
Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
- Comprehensive data from the Phase 3 GEMINI-1 and GEMINI-2 trials to be presented at a medical meeting in H2 2024
- Intend to out-license imsidolimab in 2024
GSK Immuno-Oncology Financial Collaboration
- GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
- GSK and iTEOS announced in June 2024 the initiation of the GALAXIES Lung-301 Phase 3 study, assessing belrestotug and dostarlimab in previously untreated, unresectable locally advanced/metastatic PD-L1 selected NSCLC
- GSK anticipates top-line data in H2 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Cash Runway
- Cash and investments of
$393.5 million as of June 30, 2024 and reiterating cash runway through year-end 2026
Second Quarter Financial Results
- Cash, cash equivalents and investments totaled
$393.5 million as of June 30, 2024, compared to$417.9 million as of December 31, 2023, for a decrease of$24.4 million due primarily to cash used for operating activities offset by$50.0 million received from the Sagard royalty monetization completed in May. - Collaboration revenue was
$11.0 million and$18.2 million for the three and six months ended June 30, 2024, compared to$3.5 million and$4.8 million for the three and six months ended June 30, 2023. The change is due primarily to increased royalties recognized for sales of Jemperli. - Research and development expenses were
$42.0 million and$79.0 million for the three and six months ended June 30, 2024, compared to$32.9 million and$67.9 million for the three and six months ended June 30, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was$3.5 million and$7.0 million for the three and six months ended June 30, 2024, compared to$2.7 million and$5.5 million in the same period in 2023. - General and administrative expenses were
$9.3 million and$21.6 million for the three and six months ended June 30, 2024, compared to$10.7 million and$21.5 million for the three and six months ended June 30, 2023. The G&A non-cash, stock-based compensation expense was$4.0 million and$10.7 million for the three and six months ended June 30, 2024, compared to$5.7 million and$11.8 million in the same period in 2023. - Net loss was
$46.7 million and$90.6 million for the three and six months ended June 30, 2024, or a net loss per share of$1.71 and$3.35 , compared to a net loss of$39.8 million and$84.1 million for the three and six months ended June 30, 2023, or a net loss per share of$1.50 and$3.08 .
About Anaptys
Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators for autoimmune and inflammatory diseases, including two checkpoint agonists: ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis and rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. It also has other immune cell modulator candidates in its portfolio, including ANB033, an anti-CD122 antagonist antibody, entering a Phase 1 trial and ANB101, a BDCA2 modulator antibody, in preclinical development. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, that has completed Phase 3 trials for the treatment of generalized pustular psoriasis, and etokimab, an anti-IL-33 antagonist that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889). To learn more, visit www.AnaptysBio.com or follow us on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials, including ANB032’s Phase 2b clinical trial in atopic dermatitis and rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis and Phase 2 clinical trial in ulcerative colitis; the timing of IND filing for ANB101; the timing of initiation of ANB033’s Phase 1 clinical trial; the timing of a presentation of Phase 3 clinical data at a medical conference; the potential to receive any additional royalties from the GSK collaboration; the Company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction; and the Company’s projected cash runway. Statements including words such as “plan,” “intend,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contact:
Nick Montemarano
Senior Director, Investor Relations and Strategic Communications
858.732.0178
investors@anaptysbio.com
AnaptysBio, Inc. Consolidated Balance Sheets (in thousands, except par value data) (unaudited) | |||||||
June 30, 2024 | December 31, 2023 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 71,821 | $ | 35,965 | |||
Receivables from collaborative partners | 9,007 | 6,851 | |||||
Short-term investments | 278,983 | 354,939 | |||||
Prepaid expenses and other current assets | 7,539 | 9,080 | |||||
Total current assets | 367,350 | 406,835 | |||||
Property and equipment, net | 1,833 | 2,098 | |||||
Operating lease right-of-use assets | 15,291 | 16,174 | |||||
Long-term investments | 42,646 | 27,026 | |||||
Other long-term assets | 256 | 256 | |||||
Total assets | $ | 427,376 | $ | 452,389 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,890 | $ | 4,698 | |||
Accrued expenses | 33,680 | 30,967 | |||||
Current portion of operating lease liability | 1,850 | 1,777 | |||||
Total current liabilities | 40,420 | 37,442 | |||||
Liability related to sale of future royalties | 361,981 | 310,807 | |||||
Operating lease liability, net of current portion | 15,096 | 16,037 | |||||
Stockholders’ equity: | |||||||
Preferred stock, | — | — | |||||
Common stock, | 27 | 27 | |||||
Additional paid in capital | 714,959 | 702,969 | |||||
Accumulated other comprehensive loss | (415 | ) | (797 | ) | |||
Accumulated deficit | (704,692 | ) | (614,096 | ) | |||
Total stockholders’ equity | 9,879 | 88,103 | |||||
Total liabilities and stockholders’ equity | $ | 427,376 | $ | 452,389 |
AnaptysBio, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) (unaudited) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Collaboration revenue | $ | 10,971 | $ | 3,460 | $ | 18,150 | $ | 4,834 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 41,997 | 32,923 | 79,039 | 67,880 | |||||||||||
General and administrative | 9,295 | 10,680 | 21,633 | 21,498 | |||||||||||
Total operating expenses | 51,292 | 43,603 | 100,672 | 89,378 | |||||||||||
Loss from operations | (40,321 | ) | (40,143 | ) | (82,522 | ) | (84,544 | ) | |||||||
Other (expense) income, net: | |||||||||||||||
Interest income | 4,623 | 4,653 | 9,207 | 9,139 | |||||||||||
Non-cash interest expense for the sale of future royalties | (10,953 | ) | (4,358 | ) | (17,270 | ) | (8,694 | ) | |||||||
Other (expense) income, net | — | 3 | (2 | ) | (1 | ) | |||||||||
Total other (expense) income, net | (6,330 | ) | 298 | (8,065 | ) | 444 | |||||||||
Loss before income taxes | (46,651 | ) | (39,845 | ) | (90,587 | ) | (84,100 | ) | |||||||
Provision for income taxes | (9 | ) | — | (9 | ) | — | |||||||||
Net loss | (46,660 | ) | (39,845 | ) | (90,596 | ) | (84,100 | ) | |||||||
Unrealized gain (loss) on available for sale securities | 209 | (344 | ) | 382 | 1,635 | ||||||||||
Comprehensive loss | $ | (46,451 | ) | $ | (40,189 | ) | $ | (90,214 | ) | $ | (82,465 | ) | |||
Net loss per common share: | |||||||||||||||
Basic and diluted | $ | (1.71 | ) | $ | (1.50 | ) | $ | (3.35 | ) | $ | (3.08 | ) | |||
Weighted-average number of shares outstanding: | |||||||||||||||
Basic and diluted | 27,356 | 26,629 | 27,079 | 27,288 |
FAQ
When does Anaptys expect top-line data for ANB032 in atopic dermatitis?
What is the anticipated timeline for rosnilimab's Phase 2b trial results in rheumatoid arthritis?
How much cash and investments did Anaptys (ANAB) report as of June 30, 2024?