Alpine Immune Sciences Provides Corporate Update and Reports Third Quarter 2022 Financial Results
Alpine Immune Sciences (NASDAQ: ALPN) reported Q3 2022 financial results, highlighting a cash position of $277.1 million, sufficient to support operations through 2025. The company successfully raised $113 million to accelerate the development of ALPN-303, showing promising results in clinical trials for autoimmune diseases, including IgA nephropathy. A phase 2 study in systemic lupus erythematosus is planned, along with basket studies in related conditions. However, collaboration revenue slightly declined to $8.4 million, and the company reported a net loss of $13.3 million.
- Successful $113 million follow-on offering extends cash runway through 2025.
- Promising clinical data for ALPN-303 demonstrating dose-dependent effects in autoimmune diseases.
- Plans for a phase 2 study in systemic lupus erythematosus and basket studies in autoimmune conditions.
- Collaboration revenue decreased to $8.4 million from $8.5 million year-over-year.
- Net losses of $13.3 million for Q3 2022, slightly higher than $13.5 million in Q3 2021.
“During our inaugural R&D Day and throughout subsequent scientific meetings this fall, we have shared promising nonclinical and clinical data that supports the best-in-class potential for our lead program ALPN-303 in multiple autoimmune and inflammatory indications. In particular, recent data from healthy volunteers presented at ASN's Kidney Week demonstrated dose-dependent reductions in Gd-IgA1, a key effector molecule and clinical biomarker of disease progress in IgAN, and the first clinical disease-related biomarker data with ALPN-303,” said
Gold continued, “As previously announced, we have voluntarily terminated enrollment in the davoceticept (ALPN-202) clinical studies. We would like to thank the patients and investigators who participated in the NEON studies. We remain focused on using our resources to further advance ALPN-303, as well as acazicolcept (ALPN-101) in SLE in collaboration with AbbVie.”
Third Quarter 2022 and Recent Pipeline and Corporate Updates
- During the September R&D Day, the Company shared updated preliminary data from the phase 1 study (RUBY-1) of ALPN-303 in healthy volunteers and presented a broad development plan, including a proof-of-concept phase 2 study in SLE and basket studies in renal and hematologic autoimmune diseases, with initial clinical data from the basket studies expected in late 2023. (View Release)
-
At the
American Society of Nephrology : Kidney Week Meeting, updated clinical data were presented in a poster titled, “Phase 1 Study in Healthy Adults of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Glomerulonephritides (GN)”. (View Release)- The data demonstrate that ALPN-303 continues to be well tolerated as single intravenous or subcutaneous doses of up to 960 mg and exhibits dose-related pharmacokinetic and on-target pharmacodynamic effects.
- ALPN-303 maintains target coverage of free APRIL for 2-3 and ≥4 weeks with 80 and 240 mg, respectively, corresponding to reductions in serum Ig and antibody-secreting cells (CD38hi plasmablasts/plasma cells).
- ALPN-303 dose-dependently reduces serum galactose-deficient IgA1 (Gd-IgA1), a critical molecule implicated in the pathogenesis of IgA nephropathy (IgAN).
- These data support dose regimens of 80-240 mg SC every 4 weeks in future GN studies.
-
The Company also presented clinical data from the RUBY-1 study of healthy vs at the recent
American College of Rheumatology in a poster titled, “A Randomized Placebo-Controlled Phase 1 Study inHealthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Systemic Lupus Erythematosus and Other Autoantibody-Associated Diseases”. (View Poster) -
Additional updates will be presented at the
American Society of Hematology Conference in December. (View Release)
Corporate
-
The Company ended the third quarter with
$277.1 million $100.0 million $93.5 million -
An additional 1.9 million shares of our common stock were sold pursuant to the underwriters’ partial exercise of their over-allotment option, with net proceeds of
$13.1 million October 4, 2022 . -
The financing brings our pro-forma cash and investments balance to
$290.2 million September 30, 2022 , which should be sufficient to fund our planned operations through 2025. -
On
October 24 , the Company announced that it had voluntarily terminated enrollment in the NEON studies of davoceticept as a monotherapy and in combination with pembrolizumab. (View Release)
Third Quarter 2022 Financial Results
As of
Collaboration revenue for the third quarter ended
Research and development expenses for the third quarter ended
General and administrative expenses for the third quarter ended
About ALPN-303 and the RUBY-1 Study
ALPN-303 is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in the activation and survival of B cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, ALPN-303 exhibits greater potency in preclinical studies versus wild-type TACI-based comparators, as well as other inhibitors of BAFF and/or APRIL alone. ALPN-303 is in development for multiple B cell and/or autoantibody-related diseases, such as systemic lupus erythematosus, glomerulonephritides, and autoimmune cytopenias.
RUBY-1 (NCT05034484) is a phase 1, randomized, placebo-controlled study in healthy adult volunteers designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of intravenously and subcutaneously administered ALPN-303. Initial data show ALPN-303 to be well tolerated up to 960 mg with dose-dependent pharmacokinetics and reductions in circulating immunoglobulins and antibody-secreting cells, supporting the use of a once every four-week dose regimen for subsequent studies.
About
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; and the timing of our public presentations and potential publication of future clinical data. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and prolonged than currently anticipated; as well as the other risks identified in our filings with the
“NEON-1,” “NEON-2,” "Synergy," and the Alpine logo are registered trademarks or trademarks of
ALPN-202, NEON-2 study in collaboration with
|
|
|
|
|
||
Selected Consolidated Balance Sheet Data |
|
|
|
|
||
(In thousands) |
|
|
|
|
||
|
|
|
|
|
||
|
|
(unaudited) |
|
|
||
Cash and cash equivalents |
|
$ |
126,625 |
|
$ |
67,907 |
Short-term investments |
|
|
122,237 |
|
|
94,396 |
Total current assets |
|
|
253,239 |
|
|
192,013 |
Long-term investments |
|
|
28,016 |
|
|
52,866 |
Total assets |
|
|
291,599 |
|
|
255,900 |
Total current liabilities |
|
|
68,459 |
|
|
69,778 |
Total stockholders’ equity |
|
|
182,009 |
|
|
120,903 |
Total liabilities and stockholders’ equity |
|
|
291,599 |
|
|
255,900 |
Consolidated Statement of Operations and Comprehensive Income (Loss) Data |
|
|
|
|
|
|
|||||||||
(In thousands, except share and per share amounts) |
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
(unaudited) |
|
|
|
|
||||||||||
Collaboration revenue |
$ |
8,367 |
|
|
$ |
8,516 |
|
|
$ |
27,288 |
|
|
$ |
18,913 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Research and development |
|
17,589 |
|
|
|
18,309 |
|
|
|
51,487 |
|
|
|
43,380 |
|
General and administrative |
|
4,610 |
|
|
|
3,470 |
|
|
|
13,579 |
|
|
|
10,016 |
|
Total operating expenses |
|
22,199 |
|
|
|
21,779 |
|
|
|
65,066 |
|
|
|
53,396 |
|
Loss from operations |
|
(13,832 |
) |
|
|
(13,263 |
) |
|
|
(37,778 |
) |
|
|
(34,483 |
) |
Other income (expense): |
|
|
|
|
|
|
|
||||||||
Interest expense |
|
(105 |
) |
|
|
(203 |
) |
|
|
(389 |
) |
|
|
(638 |
) |
Interest income |
|
664 |
|
|
|
52 |
|
|
|
1,123 |
|
|
|
166 |
|
Other expense |
|
— |
|
|
|
— |
|
|
|
(72 |
) |
|
|
— |
|
Loss before taxes |
|
(13,273 |
) |
|
|
(13,414 |
) |
|
|
(37,116 |
) |
|
|
(34,955 |
) |
Income tax expense |
|
— |
|
|
|
(80 |
) |
|
|
(1,782 |
) |
|
|
(211 |
) |
Net loss |
$ |
(13,273 |
) |
|
$ |
(13,494 |
) |
|
$ |
(38,898 |
) |
|
$ |
(35,166 |
) |
Comprehensive income (loss): |
|
|
|
|
|
|
|
||||||||
Unrealized loss on investments |
|
(307 |
) |
|
|
(17 |
) |
|
|
(1,385 |
) |
|
|
(1 |
) |
Unrealized gain (loss) on foreign currency translation |
|
7 |
|
|
|
(13 |
) |
|
|
(11 |
) |
|
|
(37 |
) |
Comprehensive loss |
$ |
(13,573 |
) |
|
$ |
(13,524 |
) |
|
$ |
(40,294 |
) |
|
$ |
(35,204 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
|
31,574,358 |
|
|
|
24,724,442 |
|
|
|
31,559,886 |
|
|
|
24,169,993 |
|
Basic and diluted net loss per share |
$ |
(0.42 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.45 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20221114006012/en/
ir@alpineimmunesciences.com
Red House
kelli@redhousecomms.com
Source:
FAQ
What were the financial results for Alpine (ALPN) in Q3 2022?
What is the current cash position of Alpine (ALPN)?
What are the upcoming clinical studies for ALPN-303?
What is the significance of the $113 million follow-on offering for ALPN?
