☒
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO
|
Delaware
|
20-8969493
|
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
|
|
188 East Blaine Street
|
Suite 200
|
98102
|
Seattle,
|
WA
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
Common Stock, par value $0.001 per share
|
ALPN
|
The Nasdaq Stock Market LLC
|
Large accelerated filer
|
|
☐
|
|
Accelerated filer
|
|
☐
|
|
|
|
|
|
|
|
Non-accelerated filer
|
|
☒
|
|
Smaller reporting company
|
|
☒
|
|
|
|
|
|
|
|
Emerging growth company
|
|
☒
|
|
|
|
|
|
|
Page
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
•
|
our ability to identify, develop and commercialize additional products or product candidates;
|
•
|
our estimates regarding our expenses, revenues, anticipated capital requirements and our needs for additional financing;
|
•
|
our ability to obtain funding for our operations;
|
•
|
the implementation of our business model and strategic plans for our business and technology;
|
•
|
the timing of the commencement, progress and receipt of data from any of our preclinical and clinical trials;
|
•
|
the expected results of any preclinical or clinical trial and the impact on the likelihood or timing of any regulatory approval;
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our technology and product candidates;
|
•
|
the anticipated impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations;
|
•
|
the timing or likelihood of regulatory filings and approvals;
|
•
|
the therapeutic benefits, effectiveness and safety of our product candidates;
|
•
|
the rate and degree of market acceptance and clinical utility of any future products;
|
•
|
our ability to maintain and establish collaborations;
|
•
|
our ability to achieve milestones in our current and any future collaborations;
|
•
|
our expectations regarding market risk, including interest rate changes;
|
•
|
our expectations regarding the sufficiency of our cash and cash equivalents to fund operations for at least the next 12 months;
|
•
|
developments relating to our competitors and our industry; and
|
•
|
our expectations regarding licensing, acquisitions and strategic operations.
|
•
|
We intend to enroll patients in BALANCE, an open-label, dose escalation, and expansion Phase 1b/2 study in patients with active acute GVHD throughout 2020 and into 2021.
|
•
|
We intend to enroll patients in NEON-1, a Phase 1 dose escalation and expansion clinical study in patients with advanced malignancies throughout 2020 and into 2021.
|
•
|
We intend to continue to leverage our existing pipeline and platform to actively explore and evaluate potential value-creating partnering opportunities.
|
•
|
improves survival compared to belatacept in an in vivo animal GVHD model;
|
•
|
reduces disease severity and delays disease onset time relative to control in an in vivo arthritis model with activity superior to abatacept, an FDA-approved drug for rheumatoid, psoriatic, and juvenile idiopathic arthritis;
|
•
|
demonstrates control of colitis in an animal model of inflammatory bowel disease, or IBD;
|
•
|
shows improved disease scores in an animal model of multiple sclerosis, or MS, compared to abatacept; and
|
•
|
demonstrates a lower incidence and severity of sialadenitis, a model of Sjögren’s syndrome, as compared to abatacept or wild-type ICOSL-Fc alone or in combination.
|
•
|
Clinical experience with therapies targeting the CD28 and/or ICOS pathways;
|
•
|
Translational disease tissue expression of CD28 and/or ICOS pathway targets; and
|
•
|
Preclinical disease model efficacy (literature and/or ALPN unpublished)
|
•
|
exhibits three primary mechanisms of action: conditional CD28 costimulation and dual PD-L1/CTLA-4 inhibition;
|
•
|
improves tumor control in a human PD-L1 transduced mouse model of colon cancer compared to the FDA approved anti PD-L1 therapeutic durvalumab;
|
•
|
demonstrates a more robust intra-tumor inflammatory signature in the mouse colon cancer model than durvalumab, potentially indicating superior immune system upregulation to fight cancer; and
|
•
|
has the potential to be used as a monotherapy or in combination with standard of care chemotherapy or checkpoint only inhibition.
|
•
|
an anti-BAFF, anti-ICOSL bispecific antibody being developed by Amgen, Inc (rozibafusp alfa (AMG570/MEDI0700));
|
•
|
an anti-CD28 monoclonal antibody fragment being developed by OSE ImmunoTherapeutics SA (FR104); and
|
•
|
an anti-CD28 peptide being developed by AtoxBio, Inc (reltecimod (AB-103)).
|
•
|
wild-type CD80-Fc being developed by Five Prime Therapeutics, Inc. (FPT155);
|
•
|
bispecific antibodies being developed by Regeneron targeting tumor specific antigens and CD28 (REGN5678 anti-PSMAxCD28);
|
•
|
trispecific antibodies being developed by Sanofi (CD3xCD38xCD28);
|
•
|
bifunctional fusion protein composed of monoclonal antibody against PD-L1 fused to the extracellular domain of human transforming growth factor-ß, or TGF-ß, receptor II being developed by EMD Serono, Inc and GlaxoSmithKline plc (bintrafusp alfa, or M7824);
|
•
|
bifunctional fusion protein composed of PD-1 and OX40L developed by Shattuck Labs, Inc. (SL-279252);
|
•
|
bispecific fusion protein targeting 4-1BB and PD-L1 being developed by Pieris Pharmaceuticals, Inc. (PRS-344);
|
•
|
bispecific monoclonal antibodies being developed by Xencor, Inc. including XmAb20717 targeting CTLA-4 and PD-1, XmAb22841 targeting CTLA-4 and LAG-3, and XmAb23104 targeting PD-1 and ICOS;
|
•
|
bispecific constructs called “DARTs” being developed by Macrogenics Inc., including MGD013 targeting PD-1 and LAG-3 and MGD019 targeting PD-1 and CTLA-4;
|
•
|
bispecific monoclonal antibody being developed by Tesaro, Inc., which was purchased by GlaxoSmithKline plc, targeting PD-1 and LAG-3;
|
•
|
small molecule antagonists being developed by Aurigene Ltd and Curis, Inc., including CA-170 targeting PD-L1 and VISTA and CA-327 targeting PD-L1 and TIM-3;
|
•
|
FS118, a bispecific monoclonal antibody targeting PD-L1 and LAG-3 being developed by F-star Biotechnology, Ltd.;
|
•
|
various combinations of separate anti PD-1/L1 and anti-CTLA-4 monoclonal antibodies; and
|
•
|
various combinations of separate anti PD-1/L1 and costimulatory monoclonal antibodies such as OX-40, 4-1BB, and others.
|
•
|
Amgen, Inc. (BiTE®): fusion proteins consisting of two single-chain variable fragments to link T-cells to tumors;
|
•
|
Macrogenics Inc. (DART®): Dual-Affinity Re-Targeting and Trident technology platforms bind multiple targets with a single molecule;
|
•
|
Xencor Inc. (XmAb Bispecific): Optimized Fc domains for improved potency, half-life and stability;
|
•
|
Zymeworks Inc. (Azymetric™): Proprietary amino acid modifications to facilitate interaction of distinct heavy chains;
|
•
|
Pieris Pharmaceuticals, Inc. (Anticalin®): Engineered proteins derived from natural lipocalins found in blood plasma;
|
•
|
Compass Therapeutics LLC (Targeted Immunomodulation™, StitchMabs™): Antibody discovery targeting the tumor-immune synapse;
|
•
|
Harpoon Therapeutics Inc.: TriTac™ (Tri-specific T cell Activating Construct) contain CD3 binding domain, half-life extension domain and antigen-binding domain;
|
•
|
Shattuck Labs, Inc.: Agonist Redirected Antibody platform claimed to bind tumor-necrosis factor, or TNF, and checkpoint targets;
|
•
|
Ablynx NV (Nanobody®), purchased by Sanofi Pharma, Inc.: Platform technology of single-domain, heavy-chain antibody fragments derived from camelidae (e.g., camels and llamas);
|
•
|
Regeneron, Inc.: VEGF Trap and VelociSuite® antibody technology platforms; and
|
•
|
Five Prime Therapeutics, Inc: Proprietary protein library and rapid protein production and testing platform.
|
•
|
completion of extensive preclinical laboratory tests, preclinical animal studies, and formulation studies all performed in accordance with the FDA’s current good laboratory practice, or cGLP, regulations;
|
•
|
submission to the FDA of an IND application which must become effective before human clinical trials in the U.S. may begin;
|
•
|
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for each proposed indication;
|
•
|
submission to the FDA of a BLA;
|
•
|
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP regulations; and
|
•
|
FDA review and approval of the BLA prior to any commercial marketing, sale, or shipment of the therapeutic product.
|
•
|
Phase 1 clinical trials are initially conducted in a limited population of subjects to test the therapeutic candidate for safety, dose tolerance, absorption, metabolism, distribution, and excretion in healthy humans or, on occasion, in patients with severe problems or life-threatening diseases to gain an early indication of its effectiveness.
|
•
|
Phase 2 clinical trials are generally conducted in a limited patient population to evaluate preliminary efficacy of the therapeutic candidate for specific targeted indications in patients with the disease or condition under study, evaluate dosage tolerance and appropriate dosage, determine a dosage schedule, and identify possible adverse effects and safety risks.
|
•
|
Phase 3 clinical trials are commonly definitive efficacy studies of the experimental medication. Phase 3 trials are typically conducted when Phase 2 clinical trials demonstrate a dose range of the therapeutic candidate is effective and has an acceptable safety profile. Phase 3 clinical trials are generally undertaken with large numbers of patients, such as groups of several hundred to several thousand, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded patient population at multiple, geographically-dispersed clinical trial sites.
|
•
|
Increases pharmaceutical manufacturer rebate liability under the Medicaid Drug Rebate Program due to an increase in the minimum basic Medicaid rebate on most branded prescription drugs, and the application of Medicaid rebate liability to drugs used in risk-based Medicaid managed care plans.
|
•
|
Expands the 340B Drug Pricing Program to require discounts for “covered outpatient drugs” sold to certain children’s hospitals, critical access hospitals, freestanding cancer hospitals, rural referral centers, and sole community hospital.
|
•
|
Requires pharmaceutical companies to offer discounts on brand-name drugs to patients who fall within the Medicare Part D coverage gap, commonly referred to as the “Donut Hole.”
|
•
|
Requires pharmaceutical companies to pay an annual non-tax-deductible fee to the federal government based on each company’s market share of prior year total sales of branded drugs to certain federal healthcare programs, such as Medicare, Medicaid, Department of Veterans Affairs, and Department of Defense.
|
•
|
Establishes the Patient-Centered Outcomes Research Institute to identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. The research conducted by the Patient-Centered Outcomes Research Institute may affect the market for certain pharmaceutical products.
|
•
|
Establishes The Center for Medicare and Medicaid Innovation within the Centers for Medicare and Medicaid Services, or CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration (a term interpreted broadly to include anything of value, including, for example, gifts, discounts, and credits), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order, or recommendation of, an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs;
|
•
|
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other third-party payors that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money owed to the federal government;
|
•
|
provisions of HIPAA, prohibiting knowingly and willfully executing a scheme to defraud any health care benefit program and making false statements relating to health care matters;
|
•
|
provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information;
|
•
|
the federal transparency laws, including the federal Physician Payment Sunshine Act, which was part of the Affordable Care Act, requiring manufacturers of certain drugs and biologics to track and disclose payments and other transfers of value they make to U.S. physicians and teaching hospitals, as well as physician ownership and investment interests in the manufacturer, which information is subsequently made publicly available in a searchable format on a CMS website; and
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state transparency reporting and compliance laws, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
•
|
to obtain the human and financial resources necessary to develop, test, obtain regulatory approval for, manufacture, and market our therapeutic candidates;
|
•
|
to build and maintain a strong intellectual property portfolio and avoid infringing intellectual property of third parties;
|
•
|
to establish and maintain successful licenses, collaborations, and alliances;
|
•
|
to satisfy the requirements of clinical trial protocols, including patient enrollment;
|
•
|
to establish and demonstrate the clinical efficacy and safety of our therapeutic candidates;
|
•
|
to obtain regulatory approvals;
|
•
|
to manage our spending as costs and expenses increase due to preclinical studies, clinical trials, regulatory approvals, manufacturing scale-up, and commercialization;
|
•
|
to obtain additional capital to support and expand our operations; and
|
•
|
to market our products to achieve acceptance and use by the medical community in general.
|
•
|
the timing of our receipt of any marketing and commercialization approvals;
|
•
|
the terms of any approvals and the countries in which approvals are obtained;
|
•
|
the safety and efficacy of our therapeutic products;
|
•
|
the prevalence and severity of any adverse side effects associated with our therapeutic products;
|
•
|
the prevalence and severity of any adverse side effects associated with therapeutics of the same type or class as our therapeutic products;
|
•
|
limitations or warnings contained in any labeling approved by the FDA or other regulatory authority;
|
•
|
relative convenience and ease of administration of our therapeutic products;
|
•
|
the willingness of patients to accept any new methods of administration;
|
•
|
the success of our physician education programs;
|
•
|
the availability of adequate government and third-party payor coverage and reimbursement;
|
•
|
the pricing of our products, particularly as compared to alternative treatments;
|
•
|
our ability to compliantly market and sell our products; and
|
•
|
availability of alternative effective treatments for the disease indications our therapeutic products are intended to treat and the relative risks, benefits, and costs of those treatments.
|
•
|
negative or inconclusive results from our clinical trials, or the clinical trials of others for therapeutic candidates similar to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program;
|
•
|
serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using therapeutics similar to our therapeutic candidates;
|
•
|
serious drug-related side effects experienced in the past by individuals using therapeutics similar to our therapeutic candidates;
|
•
|
delays in submitting Investigational New Drug, or IND, applications or clinical trial applications, or comparable foreign applications, or delays or failure in obtaining the necessary approvals from regulators or IRBs to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;
|
•
|
conditions imposed by the FDA or comparable foreign authorities, such as the European Medicines Agency, or EMA, regarding the scope or design of our clinical trials;
|
•
|
delays in enrolling research subjects in clinical trials;
|
•
|
high drop-out rates of research subjects;
|
•
|
inadequate supply or quality of therapeutic candidate or therapeutic candidate components, or materials or other supplies necessary for the conduct of our clinical trials, including those owned, manufactured, or provided by companies other than ours;
|
•
|
greater than anticipated clinical trial costs, including the cost of any approved drugs used in combination with our therapeutic candidates;
|
•
|
poor effectiveness of our therapeutic candidates during clinical trials;
|
•
|
unfavorable FDA or other regulatory agency inspection and review of a clinical trial site;
|
•
|
failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
|
•
|
delays and changes in regulatory requirements, policies, and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or
|
•
|
varying interpretations of data by the FDA and similar foreign regulatory agencies.
|
•
|
delays or difficulties in enrolling patients in our clinical trials;
|
•
|
delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
|
•
|
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;
|
•
|
interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;
|
•
|
limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
|
•
|
delays in receiving approval from local regulatory authorities and ethics committees to initiate our planned clinical trials;
|
•
|
delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
|
•
|
interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical trials;
|
•
|
changes in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
|
•
|
delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; and
|
•
|
refusal of the FDA to accept data from clinical trials whose conduct has been affected by the COVID-19 outbreak, such as due to missing data.
|
•
|
an inability to initiate or continue preclinical studies or clinical trials of therapeutic candidates under development;
|
•
|
delay in submitting regulatory applications, or receiving regulatory approvals, for therapeutic candidates;
|
•
|
the loss of the cooperation of a collaborator;
|
•
|
subjecting manufacturing facilities of our therapeutic candidates to additional inspections by regulatory authorities;
|
•
|
requirements to cease distribution or to recall batches of our therapeutic candidates; and
|
•
|
in the event of approval to market and commercialize a therapeutic candidate, an inability to meet commercial demands for our products.
|
•
|
exposure to unknown liabilities;
|
•
|
disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired therapeutic candidates, or technologies;
|
•
|
incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs;
|
•
|
higher than expected collaboration, acquisition, or integration costs;
|
•
|
write-downs of assets or goodwill, or incurring impairment charges or increased amortization expenses; and
|
•
|
difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business or impairment of relationships with key suppliers, manufacturers, or customers of any acquired business due to changes in management and ownership and the inability to retain key employees of any acquired business.
|
•
|
an anti-BAFF, anti-ICOSL bispecific antibody being developed by Amgen, Inc. (AMG570/MEDI0700);
|
•
|
an anti-CD28 monoclonal antibody fragment being developed by OSE ImmunoTherapeutics SA (FR104); and
|
•
|
a CD28-modulatory peptide being developed by AtoxBio, Inc. (reltecimod (AB-103));
|
•
|
wild-type CD80-Fc being developed by Five Prime Therapeutics, Inc. (FPT155);
|
•
|
bispecific antibodies being developed by Regeneron targeting tumor specific antigens and CD28 (REGN5678 anti-PSMAxCD28);
|
•
|
trispecific antibodies being developed by Sanofi (CD3xCD38xCD28);
|
•
|
bifunctional fusion protein composed of monoclonal antibody against programmed death ligand 1 (“PD-L1”) fused to the extracellular domain of human transforming growth factor–β (“TGF-β”) receptor II being developed by EMD Serono, Inc and GlaxoSmithKline plc (bintrafusp alfa, or M7824);
|
•
|
bifunctional fusion protein composed of PD-1 and OX40L developed by Shattuck Labs, Inc. (SL-279252);
|
•
|
bispecific fusion protein targeting 4-1BB and PD-L1 being developed by Pieris Pharmaceuticals, Inc. (PRS-344);
|
•
|
bispecific monoclonal antibodies being developed by Xencor, Inc. including XmAb20717 targeting CTLA-4 and PD-1, XmAb22841 targeting CTLA-4 and LAG-3, and XmAb23104 targeting PD-1 and ICOS;
|
•
|
bispecific constructs called “DARTs” being developed by Macrogenics, Inc., including MGD013 targeting PD-1 and LAG-3 and MGD019 targeting PD-1 and CTLA-4;
|
•
|
bispecific monoclonal antibody being developed by Tesaro, Inc., which was purchased by GlaxoSmithKline plc, targeting PD-1 and LAG-3;
|
•
|
small molecule antagonists being developed by Aurigene Ltd and Curis, Inc., including CA-170 targeting PD-L1 and VISTA and CA-327 targeting PD-L1 and TIM-3;
|
•
|
FS118, a bispecific monoclonal antibody targeting PD-L1 and LAG-3 being developed by F-star Biotechnology, Ltd.;
|
•
|
various combinations of separate anti PD-1/L1 and anti-CTLA-4 monoclonal antibodies; and
|
•
|
various combinations of separate anti PD-1/L1 and costimulatory monoclonal antibodies such as OX-40, 4-1BB, and others.
|
•
|
Amgen, Inc. (BiTE®): fusion proteins consisting of two single-chain variable fragments to link T-cells to tumors;
|
•
|
Macrogenics, Inc. (DART®): Dual-Affinity Re-Targeting and Trident technology platforms bind multiple targets with a single molecule;
|
•
|
Xencor, Inc. (XmAb Bispecific): Optimized Fc domains for improved potency, half-life and stability;
|
•
|
Zymeworks, Inc. (Azymetric™): Proprietary amino acid modifications to facilitate interaction of distinct heavy chains;
|
•
|
Pieris Pharmaceuticals, Inc. (Anticalin®): Engineered proteins derived from natural lipocalins found in blood plasma;
|
•
|
Compass Therapeutics, LLC (Targeted Immunomodulation™, StitchMabs™): Antibody discovery targeting the tumor-immune synapse;
|
•
|
Harpoon Therapeutics, Inc.: TriTAC™ (Tri-specific T cell Activating Construct) contain CD3 binding domain, half-life extension domain, and antigen-binding domain;
|
•
|
Shattuck Labs, Inc.: Agonist Redirected Antibody platform claimed to bind tumor-necrosis factor (“TNF”) and checkpoint targets;
|
•
|
Ablynx NV (Nanobody®), purchased by Sanofi Pharma, Inc.: Platform technology of single-domain, heavy-chain antibody fragments derived from camelidae (e.g., camels and llamas);
|
•
|
Regeneron, Inc.: VEGF Trap and VelociSuite® antibody technology platforms; and
|
•
|
Five Prime Therapeutics, Inc.: Proprietary protein library and rapid protein production and testing platform.
|
•
|
intentional failures to comply with FDA or U.S. health care laws and regulations, or applicable laws, regulations, guidance, or codes of conduct set by foreign governmental authorities or self-regulatory industry organizations;
|
•
|
a provision of inaccurate information to any governmental authorities such as FDA;
|
•
|
noncompliance with manufacturing standards we may establish;
|
•
|
noncompliance with federal and state healthcare fraud and abuse laws and regulations; and
|
•
|
a failure to report financial information or data accurately or a failure to disclose unauthorized activities to us.
|
•
|
dispose of assets;
|
•
|
complete mergers or acquisitions;
|
•
|
incur indebtedness;
|
•
|
encumber assets;
|
•
|
pay dividends or make other distributions to holders of our capital stock;
|
•
|
make specified investments;
|
•
|
engage in any new line or business; and
|
•
|
engagement in certain transactions with our affiliates.
|
•
|
others may, or may be able to, make, use, offer to sell, or sell compounds that are the same as or similar to our therapeutic candidates and products but that are not covered by the claims of the patents we own or license;
|
•
|
we or our licensors, collaborators, or any future collaborators may not be the first to file patent applications covering certain aspects of our technology, including therapeutic candidates and products;
|
•
|
others may independently develop similar or alternative technology or duplicate any of our technology without infringing our intellectual property rights;
|
•
|
a third party may challenge our patents and, if challenged, a court may not hold that our patents are valid, enforceable, or that a third party is infringing;
|
•
|
a third party may challenge our patents in various patent offices and, if challenged, we may be compelled to limit the scope of our pending, allowed or granted claims or lose the allowed or granted claims altogether;
|
•
|
any issued patents we own or have licensed may not provide us with any competitive advantages, or may be challenged by third parties;
|
•
|
we may not develop additional proprietary technologies that are patentable;
|
•
|
the patents of others could harm our business; and
|
•
|
our competitors could conduct research and development activities in countries where we do not or will not have enforceable patent rights and then use the information learned from such activities to develop competitive products for sale in major commercial markets where we do not or will not have enforceable patent rights.
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
|
•
|
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a therapeutic candidate is safe and effective for its proposed indication;
|
•
|
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
|
•
|
we may be unable to demonstrate that a therapeutic candidate’s clinical and other benefits outweigh its safety risks;
|
•
|
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials;
|
•
|
the data collected from clinical trials of our therapeutic candidates may not be sufficient to support the submission of a Biologics License Application, or BLA, or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere;
|
•
|
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and
|
•
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
•
|
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, offering, or providing remuneration, directly or indirectly, to induce either the referral of an individual for a healthcare item or service, or the purchasing or ordering of an item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare or Medicaid;
|
•
|
the U.S. federal False Claims Act, which imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, false or fraudulent claims for payment or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. In addition, the government may assert a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
|
•
|
state all-payor fraud laws, which impose criminal and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
|
•
|
HIPAA, HITECH, and their implementing regulations, which impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates performing certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;
|
•
|
the federal Physician Payment Sunshine Act and its implementing regulations, also referred to as “Open Payments,” issued under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or ACA, and any subsequent amending legislation or executive actions, which require manufacturers of pharmaceutical and biological drugs reimbursable under Medicare, Medicaid, and Children’s Health Insurance Programs to report to the Department of Health and Human Services
|
•
|
analogous state laws and regulations, such as, state anti-kickback and false claims laws potentially applicable to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
•
|
adverse regulatory inspection findings;
|
•
|
warning or untitled letters;
|
•
|
voluntary product recalls with public notification or medical product safety alerts to healthcare professionals;
|
•
|
restrictions on, or prohibitions against, marketing our therapeutics;
|
•
|
restrictions on, or prohibitions against, importation or exportation of our therapeutics;
|
•
|
suspension of review or refusal to approve pending applications or supplements to approved applications;
|
•
|
exclusion from participation in government-funded healthcare programs;
|
•
|
exclusion from eligibility for the award of government contracts for our therapeutics;
|
•
|
FDA debarment;
|
•
|
suspension or withdrawal of therapeutic approvals;
|
•
|
seizures or administrative detention of therapeutics;
|
•
|
injunctions; and
|
•
|
restitution, disgorgement of profits, or civil and criminal penalties and fines.
|
•
|
regulatory authorities may withdraw their approval of the product and require us to take the product off the market or seize the product;
|
•
|
we may need to recall the therapeutic or change the way the therapeutic is administered to patients;
|
•
|
additional restrictions may be imposed on the marketing and promotion of the particular therapeutic or the manufacturing processes for the therapeutic or any component thereof;
|
•
|
we may not be able to secure or maintain adequate coverage and reimbursement for our proprietary therapeutic products from government (including U.S. federal health care programs) and private payors;
|
•
|
we may lose or see adverse alterations to compendia listings or treatment protocols specified by accountable care organizations;
|
•
|
we may be subject to fines, restitution, or disgorgement of profits or revenues, injunctions, or the imposition of civil penalties or criminal prosecution;
|
•
|
regulatory authorities may require the addition of labeling statements, such as a “black box” warning, or equivalent, or a contraindication;
|
•
|
regulatory authorities may require us to implement a REMS plan, or to conduct post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product;
|
•
|
we may be required to create a Medication Guide outlining the risks of such side effects for distribution to patients;
|
•
|
we could be sued and held liable for harm caused to patients;
|
•
|
the therapeutic may become less competitive; and
|
•
|
our reputation may suffer.
|
•
|
our ability to obtain regulatory approvals for product candidates, and delays or failures to obtain such approvals;
|
•
|
the failure of any of our product candidates, if approved, to achieve commercial success;
|
•
|
issues in manufacturing our approved products, if any, or product candidates;
|
•
|
the results of current, and any future, preclinical or clinical trials of our product candidates;
|
•
|
the entry into, or termination of, key agreements, including key licensing, collaboration or acquisition agreements;
|
•
|
the initiation or material developments in, or conclusion of, litigation to enforce or defend any of our intellectual property rights or defend against the intellectual property rights of others;
|
•
|
announcements by commercial partners or competitors of new commercial products, clinical progress (or the lack thereof), significant contracts, commercial relationships, or capital commitments;
|
•
|
adverse publicity relating to our markets, including with respect to other products and potential products in such markets;
|
•
|
adverse publicity about our company, employees, therapeutic candidates, and/or therapeutic products in the media or on social media;
|
•
|
the impact of COVID-19 on our company or the economy generally;
|
•
|
the introduction of technological innovations or new therapies competing with our potential products;
|
•
|
the loss of key employees;
|
•
|
changes in estimates or recommendations by securities analysts, if any, who cover our common stock;
|
•
|
general and industry-specific economic conditions potentially affecting our research and development expenditures;
|
•
|
changes in the structure of health care payment systems;
|
•
|
unanticipated serious safety concerns related to the use of any of our product candidates;
|
•
|
failure to meet or exceed financial and development projections we may provide to the public;
|
•
|
failure to meet or exceed the financial and development projections of the investment community;
|
•
|
the perception of the pharmaceutical industry by the public, legislators, regulators, and the investment community;
|
•
|
adverse regulatory decisions;
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;
|
•
|
commencement of, or our involvement in, litigation;
|
•
|
sales of our common stock by us or our stockholders in the future;
|
•
|
trading volume of our common stock;
|
•
|
period-to-period fluctuations in our financial results; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
not be required to comply with the auditor attestation requirements of Section 404(b) of Sarbanes-Oxley;
|
•
|
not be required to hold a nonbinding advisory stockholder vote on executive compensation pursuant to Section 14A of the Securities Exchange Act of 1934, as amended, or the Exchange Act;
|
•
|
not be required to seek stockholder approval of any golden parachute payments not previously approved pursuant to Section 14A of the Exchange Act;
|
•
|
be exempt from any rule adopted by the Public Company Accounting Oversight Board, requiring mandatory audit firm rotation or a supplemental auditor discussion and analysis; and
|
•
|
be subject to reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
|
•
|
stagger the terms of our board of directors and require 66 and 2/3% stockholder voting to remove directors, who may only be removed for cause;
|
•
|
provide that the authorized number of directors may be changed only by resolution of the board of directors;
|
•
|
provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;
|
•
|
authorize our board of directors to issue “blank check” preferred stock and to determine the rights and preferences of those shares, which may be senior to our common stock, without prior stockholder approval;
|
•
|
establish advance notice requirements for nominating directors and proposing matters to be voted on by stockholders at stockholders’ meetings;
|
•
|
prohibit our stockholders from calling a special meeting and prohibit stockholders from acting by written consent;
|
•
|
require 66 and 2/3% stockholder voting to effect certain amendments to our certificate of incorporation and bylaws; and
|
•
|
prohibit cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates.
|
•
|
we will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
|
•
|
we may, in our discretion, indemnify other employees and agents in those circumstances where indemnification is permitted by applicable law.
|
•
|
we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
|
•
|
we will not be obligated pursuant to our amended and restated bylaws to indemnify any director or officer in connection with any proceeding (or part thereof) initiated by such person unless the proceeding was authorized in the specific case by our board of directors or such indemnification is required to be made pursuant to our amended and restated bylaws.
|
•
|
the rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
|
•
|
we may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to our directors or officers.
|
•
|
significant impairment of the liquidity for our common stock, which may substantially decrease the market price of our common stock;
|
•
|
a limited availability of market quotations for our securities;
|
•
|
a determination that our common stock qualifies as a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;
|
•
|
a limited amount of news and analyst coverage for our company; and
|
•
|
a decreased ability to issue additional securities or obtain additional financing in the future.
|
•
|
aggressively move our lead inflammation/autoimmune program ALPN-101 through clinical development for the treatment of inflammatory diseases, such as GVHD;
|
•
|
aggressively move our lead oncology program ALPN-202 through clinical development for the treatment of cancer; and
|
•
|
maximize the value of our pipeline and platform via potential partnering activities.
|
•
|
initiate and complete clinical trials for product candidates, including ALPN-101, a dual ICOS/CD28 antagonist program targeting autoimmune/inflammatory disorders and ALPN-202, a CD80 vIgD-Fc that mediates PD-L1-dependent CD28 costimulation and inhibits the PD-L1 and CTLA-4 checkpoints targeting cancer;
|
•
|
contract to manufacture and perform additional process development for our product candidates;
|
•
|
continue research and development efforts to build our pipeline beyond the current product candidates;
|
•
|
maintain, expand, and protect our intellectual property portfolio;
|
•
|
hire additional clinical, quality control, scientific, and management personnel; and
|
•
|
add operational and financial personnel to support our product development efforts and operational capabilities applicable to operating as a public company.
|
•
|
employee-related expenses, including salaries, benefits, taxes, travel, and stock-based compensation expense for personnel in research and development functions;
|
•
|
expenses related to process development and production of product candidates paid to contract manufacturing organizations;
|
•
|
costs associated with preclinical activities and regulatory operations, including the cost of acquiring, developing, and manufacturing research material;
|
•
|
clinical trials and activities related to regulatory filings for our product candidates; and
|
•
|
allocation of facilities, overhead, depreciation, and amortization of laboratory equipment and other expenses.
|
•
|
the scope, rate of progress, expense, and results of clinical trials;
|
•
|
the scope, rate of progress, and expense of process development and manufacturing;
|
•
|
preclinical and other research activities; and
|
•
|
the timing of regulatory approvals.
|
|
|
Years Ended December 31,
|
|
Increase/
|
||||||||
|
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
Collaboration revenue
|
|
$
|
1,740
|
|
|
$
|
705
|
|
|
$
|
1,035
|
|
Operating expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
35,847
|
|
|
28,970
|
|
|
6,877
|
|
|||
General and administrative
|
|
9,467
|
|
|
8,362
|
|
|
1,105
|
|
|||
Loss on sale of intangible asset
|
|
—
|
|
|
1,203
|
|
|
(1,203
|
)
|
|||
Total operating expenses
|
|
45,314
|
|
|
38,535
|
|
|
6,779
|
|
|||
Loss from operations
|
|
(43,574
|
)
|
|
(37,830
|
)
|
|
(5,744
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
||||||
Interest and other expense
|
|
(338
|
)
|
|
(319
|
)
|
|
(19
|
)
|
|||
Interest income
|
|
1,248
|
|
|
1,296
|
|
|
(48
|
)
|
|||
Other income
|
|
812
|
|
|
—
|
|
|
812
|
|
|||
Loss before taxes
|
|
(41,852
|
)
|
|
(36,853
|
)
|
|
(4,999
|
)
|
|||
Income tax benefit
|
|
—
|
|
|
366
|
|
|
(366
|
)
|
|||
Net loss
|
|
$
|
(41,852
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(5,365
|
)
|
|
|
Years Ended December 31,
|
|
Increase/
|
||||||||
|
|
2018
|
|
2017
|
|
(Decrease)
|
||||||
Collaboration revenue
|
|
$
|
705
|
|
|
$
|
1,731
|
|
|
$
|
(1,026
|
)
|
Operating expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
28,970
|
|
|
10,626
|
|
|
18,344
|
|
|||
General and administrative
|
|
8,362
|
|
|
6,079
|
|
|
2,283
|
|
|||
Loss on sale of intangible asset
|
|
1,203
|
|
|
—
|
|
|
1,203
|
|
|||
Total operating expenses
|
|
38,535
|
|
|
16,705
|
|
|
21,830
|
|
|||
Loss from operations
|
|
(37,830
|
)
|
|
(14,974
|
)
|
|
(22,856
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
||||||
Bargain purchase gain
|
|
—
|
|
|
6,601
|
|
|
(6,601
|
)
|
|||
Interest and other expense
|
|
(319
|
)
|
|
(152
|
)
|
|
(167
|
)
|
|||
Interest income
|
|
1,296
|
|
|
542
|
|
|
754
|
|
|||
Loss before taxes
|
|
(36,853
|
)
|
|
(7,983
|
)
|
|
(28,870
|
)
|
|||
Income tax benefit
|
|
366
|
|
|
200
|
|
|
166
|
|
|||
Net loss
|
|
$
|
(36,487
|
)
|
|
$
|
(7,783
|
)
|
|
$
|
(28,704
|
)
|
•
|
the number and characteristics of the future product candidates we pursue either from our internal research efforts or through acquiring or in-licensing other product candidates or technologies;
|
•
|
the scope, progress, results and costs of independently researching and developing any of our future product candidates, including conducting preclinical research and clinical trials;
|
•
|
whether our existing collaboration generates substantial milestone payments and, ultimately, royalties on future approved products for us;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for any future product candidates we develop independently;
|
•
|
the cost of future commercialization activities, if any;
|
•
|
the cost of manufacturing our future product candidates and products, if any;
|
•
|
our ability to maintain our existing collaboration and to establish new collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
•
|
the costs of preparing, filing, prosecuting, maintaining, defending and enforcing patents, including litigation costs and the outcome of such litigation; and
|
•
|
the timing, receipt and amount of sales of, or royalties on, our current or future collaborators’ product candidates, and our future products, if any.
|
|
|
Years Ended December 31,
|
||||||||||
|
|
2019
|
|
2018
|
|
2017
|
||||||
Net cash used in operating activities
|
|
$
|
(35,346
|
)
|
|
$
|
(28,416
|
)
|
|
$
|
(16,572
|
)
|
Net cash provided by (used in) investing activities
|
|
16,763
|
|
|
32,118
|
|
|
(29,803
|
)
|
|||
Net cash provided by (used in) financing activities
|
|
24,255
|
|
|
(991
|
)
|
|
42,688
|
|
(i)
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
(ii)
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
(iii)
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
|
Name
|
|
Age
|
|
Position
|
|
Executive Officers
|
|
|
|
|
|
Mitchell H. Gold, M.D.
|
|
52
|
|
|
Executive Chairman and Chief Executive Officer
|
Stanford Peng, M.D., Ph.D.
|
|
49
|
|
|
President and Head of Research and Development
|
Paul Rickey
|
|
41
|
|
|
Senior Vice President and Chief Financial Officer
|
Non-Employee Directors
|
|
|
|
|
|
Robert Conway
|
|
66
|
|
|
|
Min Cui, Ph.D.
|
|
51
|
|
|
|
Paul Sekhri
|
|
61
|
|
|
|
Peter Thompson, M.D.
|
|
60
|
|
|
|
James Topper, M.D., Ph.D.
|
|
58
|
|
|
|
Jay Venkatesan, M.D.
|
|
48
|
|
|
|
Christopher Peetz
|
|
41
|
|
|
|
•
|
meeting with our independent auditors, our management team and such other personnel as it deems appropriate to conduct and assist with certain audit committee functions;
|
•
|
overseeing our accounting and financial reporting processes and audits of its financial statements;
|
•
|
deciding whether to appoint, retain or terminate our independent auditors, including the sole authority to approve all audit engagement fees and terms and to pre-approve all audit and permitted non-audit and tax services to be provided by the independent auditors;
|
•
|
reviewing and discussing with management and our independent auditors the financial statements of Alpine Immune Sciences, Inc, including certain disclosures, addressing any issues encountered in the course of the audit work, and evaluating the performance of our independent auditors;
|
•
|
discussing with management our earnings press releases, financial information and any earnings guidance provided to analysts and ratings agencies;
|
•
|
discussing with Alpine Immune Sciences and the internal auditors (if any) our disclosure controls, internal accounting and financial controls and accounting policies and practices;
|
•
|
discussing with management any outsourcing of the internal audit function (if any), including selection of vendor, fees paid and areas to be audited;
|
•
|
establishing procedures for the receipt, retention and treatment of complaints received by us regarding certain accounting or audit matters;
|
•
|
establishing policies governing the hiring by us of any current or former employee of our independent auditors;
|
•
|
reviewing our compliance with applicable laws and regulations and to review and oversee our policies and procedures designed to promote and monitor regulatory compliance;
|
•
|
obtaining assurance from the independent auditors that the audit of the financial statements was conducted in a manner consistent with Section 10A of the Exchange Act;
|
•
|
reviewing, approving and overseeing transactions between us and any related person and any other potential conflict of interest situation;
|
•
|
administering our Whistleblower and Non-Retaliation Policy and responding to and resolving related complaints or concerns;
|
•
|
overseeing portions of our Code of Business Conduct and Ethics as designated by our board of directors;
|
•
|
providing our board of directors with the results of its monitoring and recommendations derived from its responsibilities;
|
•
|
reviewing and approving our investment policy;
|
•
|
providing the independent and internal auditors with access to the board of directors; and
|
•
|
producing the report required to be prepared for inclusion in our annual proxy statement.
|
Name and Principal Position
|
|
Year
|
|
Salary ($)
|
|
|
|
Option
Awards
($)(1)
|
|
|
|
Nonequity
Incentive Plan
Compensation
($)(2)
|
|
All Other
Compensation
($)(3)
|
|
Total ($)
|
|||||
Mitchell H. Gold, M.D.
|
|
2019
|
|
485,000
|
|
|
|
|
852,681
|
|
|
|
|
218,250
|
|
|
—
|
|
|
1,555,931
|
|
Executive Chairman and Chief Executive Officer
|
|
2018
|
|
400,000
|
|
|
|
|
512,630
|
|
|
|
|
130,000
|
|
|
—
|
|
|
1,042,630
|
|
Paul Rickey
|
|
2019
|
|
370,000
|
|
|
|
|
319,757
|
|
|
|
|
119,788
|
|
|
—
|
|
|
809,545
|
|
Senior Vice President and Chief Financial Officer
|
|
2018
|
|
335,000
|
|
|
|
|
329,764
|
|
|
|
|
86,500
|
|
|
—
|
|
|
751,264
|
|
Stanford Peng, M.D., Ph.D.
|
|
2019
|
|
442,708
|
|
|
|
|
319,757
|
|
|
(4)
|
|
208,126
|
|
|
—
|
|
|
970,591
|
|
President and Head of Research and Development
|
|
2018
|
|
400,000
|
|
|
|
|
1,532,873
|
|
|
|
|
103,300
|
|
|
—
|
|
|
2,036,173
|
|
(1)
|
Amounts shown in this column do not reflect dollar amounts actually received by our named executive officers. Instead, these amounts reflect the aggregate grant date fair value of the stock options granted, computed in accordance with the provisions of FASB ASC Topic 718. For additional details regarding the assumptions and methodologies used to calculate the amounts reported, please see the discussion of equity awards contained in Note 13 to our consolidated financial statements contained elsewhere in this Annual Report on Form 10-K.
|
(2)
|
2019 amounts represent cash bonuses earned by the named executive officers pursuant to our Executive Incentive Compensation Plan, or Incentive Plan, for 2019 performance, paid in 2020. In lieu of 100% of such cash bonus amount, Dr. Gold was granted a restricted stock unit, or RSU, award for 67,569 shares of our common stock, representing an aggregate grant date value of $218,250. In lieu of 50% of such cash bonus amounts, Dr. Peng and Mr. Rickey were each granted an RSU award for 32,217 shares of our common stock and 18,543 shares of our common stock, respectively, representing an aggregate grant date value of $104,063 and $59,894, respectively, with the remaining amounts of the cash bonuses earned paid in cash in 2020. 2018 amounts represent cash bonuses earned under our 2018 performance bonus plan, paid in 2019.
|
(3)
|
Perquisites and personal benefits are excluded as the total value of all perquisites and personal benefits for each named executive officer is less than $10,000.
|
(4)
|
Reflects the probable value of $0 for Dr. Peng’s April 22, 2019 performance-based option award. The maximum value of such award is $231,160.
|
•
|
A lump-sum payment totaling 100% (or, in case of Dr. Gold, 150%) of the Eligible Employee’s applicable annual base salary.
|
•
|
A lump-sum payment equal to (1) 100% of the Eligible Employee’s applicable target annual bonus plus (2) a payment equal to the Eligible Employee’s pro-rated applicable target annual bonus.
|
•
|
100% of the Eligible Employee’s then-outstanding and unvested time-based equity awards will become vested and exercisable.
|
•
|
Payment or reimbursement of continued health coverage for the Eligible Employee and the Eligible Employee’s dependents under COBRA for a period of up to 12 months (or, in Dr. Gold’s case, 18 months).
|
•
|
Continued payments totaling 75% (or, in Dr. Gold’s case, 100%) of the Eligible Employee’s applicable annual base salary over a period of 9 months (or in Dr. Gold’s case, 12 months).
|
•
|
100% of the Eligible Employee’s then-outstanding and unvested time-based equity awards granted prior to the closing of the merger by and between Alpine Immune Sciences, Inc. and Nivalis Therapeutics, Inc. that would have otherwise vested during the 12-month period following the date of the Eligible Employee’s termination, and 0% in all other cases.
|
•
|
Payment or reimbursement of continued health coverage for the Eligible Employee and the Eligible Employee’s dependents under COBRA for a period of up to 9 months (or, in Dr. Gold’s case, 12 months).
|
|
|
|
|
|
|
Option Awards
|
||||||||||||||
Name
|
|
Vesting
Commencement
Date
|
|
Grant
Date
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
|
Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)
|
|
|
|
Option
Exercise
Price ($)
|
|
Option
Expiration
Date
|
||||
Mitchell H. Gold
|
|
01/16/2015
|
|
12/16/2015
|
|
51,242
|
|
|
—
|
|
|
—
|
|
|
|
|
0.45
|
|
|
12/15/2025
|
|
|
01/20/2017
|
|
03/14/2017
|
|
219,209
|
|
|
81,415
|
|
|
—
|
|
|
(1)
|
|
0.65
|
|
|
03/13/2027
|
|
|
01/20/2017
|
|
04/12/2017
|
|
152,340
|
|
|
56,576
|
|
|
—
|
|
|
(1)
|
|
5.02
|
|
|
04/11/2027
|
|
|
01/02/2018
|
|
01/02/2018
|
|
33,541
|
|
|
36,459
|
|
|
—
|
|
|
(1)
|
|
11.31
|
|
|
01/01/2028
|
|
|
02/06/2019
|
|
02/06/2019
|
|
—
|
|
|
200,000
|
|
|
—
|
|
|
(1)
|
|
6.51
|
|
|
02/05/2029
|
Paul Rickey
|
|
04/01/2017
|
|
04/12/2017
|
|
49,693
|
|
|
24,842
|
|
|
—
|
|
|
(1)
|
|
5.02
|
|
|
04/11/2027
|
|
|
01/02/2018
|
|
01/02/2018
|
|
21,562
|
|
|
23,438
|
|
|
—
|
|
|
(1)
|
|
11.31
|
|
|
01/01/2028
|
|
|
02/06/2019
|
|
02/06/2019
|
|
—
|
|
|
75,000
|
|
|
—
|
|
|
(1)
|
|
6.51
|
|
|
02/05/2029
|
Stanford Peng
|
|
09/06/2016
|
|
09/22/2016
|
|
131,216
|
|
|
30,276
|
|
|
—
|
|
|
(1)
|
|
0.65
|
|
|
09/21/2026
|
|
|
09/06/2016
|
|
03/14/2017
|
|
30,283
|
|
|
6,984
|
|
|
—
|
|
|
(1)
|
|
0.65
|
|
|
03/13/2027
|
|
|
01/02/2018
|
|
01/02/2018
|
|
31,145
|
|
|
33,855
|
|
|
—
|
|
|
(1)
|
|
11.31
|
|
|
01/01/2028
|
|
|
09/28/2018
|
|
09/28/2018
|
|
—
|
|
|
250,000
|
|
|
—
|
|
|
(2)
|
|
6.33
|
|
|
09/27/2028
|
|
|
02/06/2019
|
|
02/06/2019
|
|
—
|
|
|
75,000
|
|
|
—
|
|
|
(1)
|
|
6.51
|
|
|
02/05/2029
|
|
|
04/22/2019
|
|
04/22/2019
|
|
—
|
|
|
—
|
|
|
50,000
|
|
|
(3)
|
|
7.20
|
|
|
04/21/2029
|
(1)
|
1/4th of the shares will vest on the one-year anniversary of the vesting commencement date, and 1/36th of the remaining shares shall vest on each monthly anniversary thereafter, such that 100% of the shares shall be vested and exercisable as of the four-year anniversary of the vesting commencement date.
|
(2)
|
1/2 of the shares subject to the option become vested and exercisable on October 1, 2020 and the balance of the shares subject to the option become vested and exercisable on October 1, 2022, subject to continued service through each such date.
|
(3)
|
100% of the shares underlying the option will vest upon the achievement of specified performance goals that are achieved on or prior to April 16, 2023, as determined by the board of directors or the compensation committee of the board of directors.
|
|
|
||
Annual retainer for board membership
|
$
|
40,000
|
|
Annual retainer for board chairperson
|
25,000
|
|
|
Annual retainer for audit committee chairperson
|
15,000
|
|
|
Annual retainer for audit committee member
|
7,500
|
|
|
Annual retainer for compensation committee chairperson
|
10,000
|
|
|
Annual retainer for compensation committee member
|
5,000
|
|
|
Annual retainer for nominating and corporate governance committee chairperson
|
7,500
|
|
|
Annual retainer for nominating and corporate governance committee member
|
3,750
|
|
Name
|
|
Fees Earned
or paid in
Cash ($)
|
|
Option Awards ($)(1)
|
|
Total ($)
|
||||||
Robert Conway(2)
|
|
$
|
58,750
|
|
|
$
|
19,259
|
|
|
$
|
78,009
|
|
Min Cui, Ph.D.(3)
|
|
40,986
|
|
|
28,217
|
|
|
69,203
|
|
|||
Peter Thompson, M.D.(4)
|
|
52,500
|
|
|
19,259
|
|
|
71,759
|
|
|||
James N. Topper, M.D., Ph.D.(5)
|
|
50,000
|
|
|
19,259
|
|
|
69,259
|
|
|||
Paul Sekhri(6)
|
|
53,385
|
|
|
19,259
|
|
|
72,644
|
|
|||
Christopher Peetz(7)
|
|
47,500
|
|
|
19,259
|
|
|
66,759
|
|
|||
Jay Venkatesan, M.D.(8)
|
|
40,000
|
|
|
19,259
|
|
|
59,259
|
|
(1)
|
Amounts shown in this column do not reflect dollar amounts actually received by our non-employee directors. Instead, these amounts reflect the aggregate grant date fair value of the stock options granted, computed in accordance with the provisions of FASB ASC Topic 718.
|
(2)
|
As of December 31, 2019, Mr. Conway held outstanding options to purchase 23,155 shares of common stock.
|
(3)
|
As of December 31, 2019, Dr. Cui held outstanding options to purchase 7,650 shares of common stock.
|
(4)
|
As of December 31, 2019, Dr. Thompson held outstanding options to purchase 15,300 shares of common stock.
|
(5)
|
As of December 31, 2019, Dr. Topper held outstanding options to purchase 15,300 shares of common stock.
|
(6)
|
As of December 31, 2019, Mr. Sekhri held outstanding options to purchase 21,243 shares of commons stock.
|
(7)
|
As of December 31, 2019, Mr. Peetz held outstanding options to purchase 15,300 shares of common stock.
|
(8)
|
As of December 31, 2019, Dr. Venkatesan held outstanding options to purchase 122,713 shares of common stock.
|
|
|
A
|
|
B
|
|
C
|
||||
Plan Category
|
|
Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options and
Rights
|
|
Weighted-
Average
Exercise
Price of
Outstanding
Options and
Rights
|
|
Number of
Securities
Remaining
Available for
Future
Issuance Under
Equity
Compensation
Plans
(Excluding
Securities
Reflected in
Column A) (1)
|
||||
Equity compensation plans approved by security holders
|
|
|
|
|
|
|
||||
Amended and Restated 2015 Stock Plan, as amended, or the 2015 Stock Plan
|
|
1,369,752
|
|
|
$
|
3.49
|
|
|
—
|
|
2015 Equity Incentive Plan
|
|
495,548
|
|
|
$
|
11.30
|
|
|
—
|
|
2018 Equity Incentive Plan
|
|
1,399,266
|
|
|
$
|
6.35
|
|
|
269,959
|
|
Employee Stock Purchase Plan
|
|
—
|
|
|
N/A
|
|
|
45,211
|
|
|
Total
|
|
3,264,566
|
|
|
$
|
5.90
|
|
|
315,170
|
|
(1)
|
Represents the number of securities remaining available for future issuance under the 2015 Equity Incentive Plan, the 2015 Stock Plan, the 2018 Equity Incentive Plan and the Employee Stock Purchase Plan. The number of shares available for issuance under the 2018 Equity Incentive Plan is subject to an annual increase on the first day of each year equal to the lesser of (a) 1,500,000 shares or (b) 5% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year or (c) a lesser number of shares of common stock approved by the board of directors prior to January 1 of a given year.
|
•
|
each person who we know beneficially owns more than 5% of our common stock;
|
•
|
each of our directors;
|
•
|
each of our named executive officers; and
|
•
|
all of our directors and executive officers as a group.
|
|
|
Common Stock
Beneficially Owned
|
||||
Name of Beneficial Owner
|
|
Shares
|
|
Percentage
|
||
5% Stockholders:
|
|
|
|
|
||
Alpine Immunosciences, L.P.(1)
|
|
4,069,222
|
|
|
21.8
|
%
|
OrbiMed Private Investments VI, LP(2)
|
|
3,816,206
|
|
|
20.4
|
%
|
Decheng Capital China Life Sciences USD Fund III, L.P.(3)
|
|
4,400,371
|
|
|
22.2
|
%
|
Frazier Life Sciences VIII, L.P.(4)
|
|
2,716,701
|
|
|
14.5
|
%
|
Entities affiliated with BVF Partners L.P.(5)
|
|
1,137,764
|
|
|
6.1
|
%
|
Directors and Executive Officers:
|
|
|
|
|
||
Mitchell H. Gold(6)
|
|
4,633,474
|
|
|
24.1
|
%
|
Paul Rickey(7)
|
|
113,092
|
|
|
*
|
|
Stanford Peng(8)
|
|
236,496
|
|
|
1.3%
|
|
Jay Venkatesan(9)
|
|
4,241,914
|
|
|
22.6
|
%
|
Peter Thompson(10)
|
|
3,833,418
|
|
|
20.4
|
%
|
James N. Topper(11)
|
|
2,733,913
|
|
|
14.6
|
%
|
Robert Conway(12)
|
|
40,067
|
|
|
*
|
|
Paul Sekhri(13)
|
|
23,155
|
|
|
*
|
|
Christopher Peetz (14)
|
|
14,662
|
|
|
*
|
|
Min Cui(15)
|
|
4,405,470
|
|
|
22.2
|
%
|
All current directors and executive officers as a group
(10 persons)(16)
|
|
16,206,439
|
|
|
76.1
|
%
|
(*)
|
Less than one percent.
|
(1)
|
According to a Schedule 13D filed on January 23, 2019 with the Securities and Exchange Commission, Alpine BioVentures, GP, LLC, Mitchell H. Gold and Jay Venkatesan may be deemed to beneficially own 4,069,222 shares which are held by Alpine Immunosciences, L.P., including 74,441 shares issuable upon the exercise of warrants, which are exercisable within 60 days of February 29, 2020. Alpine BioVentures GP, LLC is the general partner of Alpine Immunosciences, L.P. Dr. Gold and Dr. Venkatesan are the Managing Partners of Alpine BioVentures GP, LLC. Dr. Gold and Dr. Venkatesan are also limited partners of Alpine Immunosciences, L.P. By virtue of such relationships, Dr. Gold and Dr. Venkatesan may be deemed to have voting and investment power with respect to the shares held by Alpine Immunosciences, L.P. and as a result may be deemed to have beneficial ownership of such shares. Each of Dr. Gold and Dr. Venkatesan disclaims beneficial ownership of the shares held by Alpine Immunosciences, L.P., except to the extent of his pecuniary interest therein, if any. The address for Alpine Immunosciences, L.P. is 600 Stewart Street, Suite 1503, Seattle Washington 98101.
|
(2)
|
According to a Schedule 13D filed on January 23, 2019 with the Securities and Exchange Commission, OrbiMed Advisors LLC and OrbiMed Capital GP VI LLC may be deemed to beneficially own 3,816,206 shares which are held by OrbiMed Private Investments VI, LP, including 145,251 shares issuable upon the exercise of warrants, which are exercisable within 60 days of February 29, 2020. OrbiMed Capital GP VI LLC (“GP VI”) is the general partner of OrbiMed Private Investments VI, LP. OrbiMed Advisors LLC (“OrbiMed Advisors”) is the managing member of GP VI. Carl L. Gordon, Sven H. Borho and Jonathan T. Silverstein share voting and investment power over the shares held by OrbiMed Private Investments VI, LP and as a result may be deemed to have beneficial ownership of such shares. Dr. Thompson, an employee of OrbiMed Advisors, may be deemed to have beneficial ownership of such shares. Each of GP VI, OrbiMed Advisors, Carl L. Gordon, Sven H. Borho, Jonathan T. Silverstein and Dr. Thompson disclaims beneficial ownership of the shares held by OrbiMed Private Investments VI, LP, except to the extent of its or his pecuniary interest therein, if any. The address for OrbiMed Private Investments VI, LP is 601 Lexington Avenue, 54th Floor, New York, New York 10022.
|
(3)
|
Decheng Capital Management III (Cayman), LLC (“Decheng Capital Management”) and Min Cui may be deemed to beneficially own 4,400,371 shares which are held by Decheng Capital China Life Sciences USD Fund III, L.P. (“Decheng”), including 1,234,636 shares issuable upon the exercise of warrants that are exercisable within 60 days of February 29, 2020. Decheng Capital Management is the general partner of Decheng. Dr. Cui is the sole manager of Decheng Capital Management and may be deemed to have voting and investment power with respect to the shares held
|
(4)
|
According to a Schedule 13D filed on January 23, 2019 with the Securities and Exchange Commission, FHM Life Sciences VIII, L.P., FHM Life Sciences VIII, L.L.C., James Topper and Patrick J. Heron may be deemed to beneficially own 2,716,701 shares which are held by Frazier Life Sciences VIII, L.P., including 145,251 shares issuable upon the exercise of warrants that are exercisable within 60 days of February 29, 2020. FHM Life Sciences VIII, LP is the general partner of Frazier Life Sciences VIII, L.P. and FHM Life Sciences VIII, LLC is the general partner of FHM Life Sciences VIII, LP. Dr. Topper and Patrick J. Heron are the sole members of FHM Life Sciences VIII, LLC and therefore share voting and investment power over the shares held by Frazier Life Sciences VIII, L.P. Dr. Topper and Mr. Heron disclaim beneficial ownership of the shares held by Frazier Life Sciences VIII, L.P. except to the extent of their pecuniary interests in such shares, if any. The address for Frazier Life Sciences VIII, L.P. is 601 Union Street, Suite 3200, Seattle, Washington 98101.
|
(5)
|
According to a Schedule 13G filed on February 14, 2020 with the Securities and Exchange Commission, (i) Biotechnology Value Fund, L.P. (“BVF”) may be deemed to beneficially own 571,646 shares, (ii) Biotechnology Value Fund II, L.P. (“BVF2”) may be deemed to beneficially own 460,853 shares, and (iii) Biotechnology Value Trading Fund OS LP (“Trading Fund OS”) may be deemed to beneficially own 83,002 shares. BVF Partners OS Ltd. (“Partners OS”), as the general partner of Trading Fund OS, may be deemed to beneficially own the 83,002 shares held by Trading Fund OS. BVF Partners L.P. (“BVF Partners”), as the general partner of BVF, BVF2, the investment manager of Trading Fund OS, and the sole member of Partners OS, may be deemed to beneficially own the 1,137,764 shares beneficially owned in the aggregate by BVF, BVF2, Trading Fund OS, and a certain BVF Partners managed account (“Partners Managed Account”), including 22,263 shares held in the Partners Managed Account. BVF Inc., as the general partner of BVF Partners, may be deemed to beneficially own the 1,137,764 shares beneficially owned by BVF Partners. Mr. Mark N. Lampert, as a director and officer of BVF Inc., may be deemed to beneficially own the 1,137,764 shares beneficially owned by BVF Inc. These shares include an aggregate of 217,875 shares subject to warrants held by BVF, BVF2 and Trading Fund OS that are exercisable within 60 days of February 29, 2020. The warrants are only exercisable to the extent that the holder, together with its affiliates and any other person or entity acting as a group, would not beneficially own more than 4.99% of the outstanding shares of common stock after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the warrants (the “Beneficial Ownership Limitation”). As a result, the table above excludes the 217,875 shares subject to warrants exercisable within 60 days of February 29, 2020 due to the Beneficial Ownership Limitation, based on the number of shares outstanding as February 29, 2020. The address of each of BVF Inc., Partners, BVF, BVF2, Trading Fund OS, Partners OS and Mr. Lampert is 44 Montgomery Street, 40th Floor, San Francisco, California 94104.
|
(6)
|
Consists of (i) 1,292 shares of our common stock held directly by Dr. Gold, (ii) 562,960 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020, (iii) 3,994,781 shares of our common stock held directly by Alpine Immunosciences, L.P and (iv) 74,441 shares of our common stock issuable upon the exercise of warrants held by Alpine Immunosciences, L.P. which are exercisable within 60 days of February 29, 2020. Please see footnote 1 regarding Dr. Gold’s voting and investment power over the shares held by Alpine Immunosciences, L.P.
|
(7)
|
Consists of (i) 10,000 shares of our common stock held directly by Mr. Rickey and (ii) 103,092 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020.
|
(8)
|
Consist of 236,496 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020.
|
(9)
|
Consists of (i) 21,739 shares of our common stock held directly by Dr. Venkatesan, (ii) 37,266 shares of our common stock held in trust for the benefit of Dr. Venkatesan’s children, (iii) 113,687 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020, (iv) 3,994,781 shares of our common stock held directly by Alpine Immunosciences, L.P., and (v) 74,441 shares of our common stock issuable upon the exercise of warrants held by Alpine Immunosciences, L.P. which are exercisable within 60 days of February 29, 2020. Please see footnote 1 regarding Dr. Venkatesan’s voting and investment power over the shares held by Alpine Immunosciences, L.P.
|
(10)
|
Consists of (i) 17,212 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020, (ii) 3,670,955 shares of our common stock held directly by OrbiMed Private Investments VI, LP and (iii) 145,251 shares of our common stock issuable upon the exercise of warrants held by OrbiMed Private Investments VI, LP which are exercisable within 60 days of February 29, 2020. Please see footnote 2 regarding Dr. Thompson’s voting and investment power over the shares held by OrbiMed Private Investments VI, LP.
|
(13)
|
Consist of 23,155 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020.
|
(14)
|
Consist of 14,662 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020.
|
(15)
|
Consists of (i) 5,099 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020, (ii) 3,165,735 shares of our common stock held directly by Decheng Capital China Life Sciences USD Fund III, L.P. and (iii) 1,234,636 shares of our common stock issuable upon the exercise of warrants held by Decheng Capital China Life Sciences USD Fund III, L.P. which are exercisable within 60 days of February 29, 2020. Please see footnote 3 regarding Dr. Cui’s voting and investment power over the shares held by Decheng Capital China Life Sciences USD Fund III, L.P.
|
(16)
|
Includes only current directors and executive officers serving in such capacity as of February 29, 2020. Includes 1,118,642 shares of our common stock issuable upon the exercise of options within 60 days of February 29, 2020 and 1,599,579 shares of our common stock issuable upon the exercise of warrants within 60 days of February 29, 2020.
|
Name of Purchaser
|
|
Number of Shares of Common Stock Purchased
|
|
Number of Shares of Common Stock Subject to Warrants
|
|
Aggregate Purchase Price
|
||||
Alpine Immunosciences, L.P.
|
|
190,875
|
|
|
74,441
|
|
|
$
|
1,024,998.75
|
|
OrbiMed Private Investments VI, LP
|
|
372,439
|
|
|
145,251
|
|
|
$
|
1,999,997.43
|
|
Frazier Life Sciences VIII, L.P.
|
|
372,439
|
|
|
145,251
|
|
|
$
|
1,999,997.43
|
|
|
|
Year Ended December 31,
|
||||||
Fee Category
|
|
2019
|
|
2018
|
||||
Audit fees(1)
|
|
$
|
393,778
|
|
|
$
|
490,171
|
|
Audit-related fees(2)
|
|
—
|
|
|
—
|
|
||
Tax fees(3)
|
|
—
|
|
|
—
|
|
||
All other fees(4)
|
|
—
|
|
|
—
|
|
||
Total fees
|
|
$
|
393,778
|
|
|
$
|
490,171
|
|
(1)
|
Audit fees consist of fees for professional services provided in connection with the audit of our annual consolidated financial statements, review of our quarterly consolidated financial statements, procedures for comfort letters, consents and assistance with and review of documents filed with the SEC.
|
(2)
|
Audit-related fees consist of assurance and related services that are reasonably related to the performance of the audit or review of our financial statements and are not reported under “Audit Fees”.
|
(3)
|
Tax fees consist of fees associated with tax compliance, tax advice and tax planning fees.
|
(4)
|
All other fees include any fees billed that are not audit fees, audit-related fees or tax fees.
|
(a)
|
The financial statements, schedules and exhibits filed as a part of this Annual Report on Form 10-K are as follows:
|
(a)
|
Financial statements – The financial statements included in Item 8 are filed as part of this Annual Report on Form 10-K.
|
(b)
|
Financial Statement Schedules – All schedules have been omitted because they are not applicable or required, or the information required to be set forth therein is included in the consolidated financial statements or notes thereto included in Item 8 of this Annual Report on Form 10-K.
|
(c)
|
Exhibits – The exhibits required to be filed as part of this report are listed in the Exhibit List attached hereto and are incorporated herein by reference.
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit Number
|
|
Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
2.1†
|
|
|
8-K
|
|
001-37449
|
|
2.1
|
|
April 18, 2017
|
|
3.1
|
|
|
10-K
|
|
001-37449
|
|
3.1
|
|
March 28, 2018
|
|
3.2
|
|
|
S-1
|
|
333-204127
|
|
3.4
|
|
May 13, 2015
|
|
4.1
|
|
|
10-K
|
|
001-37449
|
|
4.1
|
|
March 28, 2018
|
|
4.2
|
|
|
S-1
|
|
333-204127
|
|
4.2
|
|
May 13, 2015
|
|
4.3
|
|
|
S-1
|
|
333-204127
|
|
4.3
|
|
May 13, 2015
|
|
4.4
|
|
|
10-K
|
|
001-37449
|
|
4.5
|
|
March 28, 2018
|
|
4.5
|
|
|
10-K
|
|
001-37449
|
|
4.6
|
|
March 28, 2018
|
|
4.6
|
|
|
8-K
|
|
001-37449
|
|
10.3
|
|
January 16, 2019
|
|
4.7
|
|
|
8-K
|
|
001-37449
|
|
4.1
|
|
August 28, 2019
|
|
4.8+
|
|
|
|
|
|
|
|
|
|
|
10.1*
|
|
|
S-8
|
|
333-205220
|
|
4.4
|
|
June 25, 2015
|
|
10.2*
|
|
|
S-8
|
|
333-205220
|
|
4.5
|
|
June 25, 2015
|
|
10.3*
|
|
|
S-8
|
|
333-205220
|
|
4.6
|
|
June 25, 2015
|
|
10.4*
|
|
|
S-8
|
|
333-205220
|
|
4.7
|
|
June 25, 2015
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit Number
|
|
Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
10.5*
|
|
|
S-1
|
|
333-204127
|
|
10.18
|
|
May 13, 2015
|
|
10.6*
|
|
|
8-K
|
|
001-37449
|
|
10.2
|
|
April 1, 2019
|
|
10.7*
|
|
|
8-K
|
|
001-37449
|
|
10.1
|
|
December 11, 2017
|
|
10.8*
|
|
|
10-K
|
|
001-37449
|
|
10.33
|
|
March 28, 2018
|
|
10.9*
|
|
|
10-K
|
|
001-37449
|
|
10.35
|
|
March 28, 2018
|
|
10.10*
|
|
|
10-K
|
|
001-37449
|
|
10.37
|
|
March 28, 2018
|
|
10.11*
|
|
|
S-8 POS
|
|
333-218134
|
|
4.1
|
|
September 11, 2017
|
|
10.12*
|
|
|
S-8 POS
|
|
333-218134
|
|
4.2
|
|
September 11, 2017
|
|
10.13
|
|
|
8-K
|
|
001-37449
|
|
1.1
|
|
June 11, 2018
|
|
10.14*
|
|
|
8-K
|
|
001-37449
|
|
10.1
|
|
June 14, 2018
|
|
10.15*
|
|
|
8-K
|
|
001-37449
|
|
10.2
|
|
June 14, 2018
|
|
10.16*
|
|
|
8-K
|
|
001-37449
|
|
10.1
|
|
January 27, 2020
|
|
10.17
|
|
|
8-K
|
|
001-37449
|
|
10.1
|
|
January 16, 2019
|
|
10.18
|
|
|
8-K
|
|
001-37449
|
|
10.2
|
|
January 16, 2019
|
|
10.19*
|
|
|
8-K
|
|
001-37449
|
|
10.1
|
|
April 1, 2019
|
|
10.20
|
|
|
10-Q
|
|
001-37449
|
|
10.6
|
|
May 9, 2019
|
|
10.21*
|
|
|
10-Q
|
|
001-37449
|
|
10.1
|
|
August 13, 2019
|
|
10.22
|
|
|
8-K
|
|
001-37449
|
|
10.1
|
|
August 28, 2019
|
|
21.1
|
|
|
10-K
|
|
001-37449
|
|
21.1
|
|
March 28, 2018
|
|
23.1+
|
|
|
|
|
|
|
|
|
|
|
24.1+
|
|
|
|
|
|
|
|
|
|
|
31.1+
|
|
|
|
|
|
|
|
|
|
|
31.2+
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference
|
||||||
Exhibit Number
|
|
Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
32.1+
|
|
|
|
|
|
|
|
|
|
|
32.2+
|
|
|
|
|
|
|
|
|
|
|
101.INS+
|
|
Inline XBRL Instance Document
|
|
|
|
|
|
|
|
|
101.SCH+
|
|
Inline XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
101.CAL+
|
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
101.LAB+
|
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
101.PRE+
|
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
101.DEF+
|
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
104
|
|
Cover page formatted as Inline XBRL and contained in Exhibit 101
|
|
|
|
|
|
|
|
|
*
|
Indicates a management contract or a compensatory plan, contract or arrangement.
|
†
|
All schedules and exhibits to the Merger Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the Securities and Exchange Commission upon request.
|
+
|
Filed herewith.
|
#
|
Portions of this exhibit have been omitted pursuant to a request for confidential treatment and the omitted portions have been filed separately with the Securities and Exchange Commission.
|
|
|
ALPINE IMMUNE SCIENCES, INC.
|
|
|
|
|
|
Date: March 30, 2020
|
|
By:
|
/s/ Mitchell H. Gold, M.D.
|
|
|
Name:
|
Mitchell H. Gold, M.D.
|
|
|
Title
|
Executive Chairman and Chief Executive Officer
|
|
|
|
|
|
|
ALPINE IMMUNE SCIENCES, INC.
|
|
|
|
|
|
Date: March 30, 2020
|
|
By:
|
/s/ Paul Rickey
|
|
|
Name:
|
Paul Rickey
|
|
|
Title:
|
Senior Vice President and Chief Financial Officer
|
Name
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Mitchell H. Gold, M.D.
|
|
Chief Executive Officer and Executive Chairman of the Board of Directors (Principal Executive Officer)
|
|
March 30, 2020
|
Mitchell H. Gold, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ Paul Rickey
|
|
Senior Vice President and Chief Financial Officer (Principal Accounting and Financial Officer)
|
|
March 30, 2020
|
Paul Rickey
|
|
|
|
|
|
|
|
|
|
/s/ Peter Thomson, M.D.
|
|
Director
|
|
March 30, 2020
|
Peter Thompson, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ James N. Topper, M.D., Ph.D.
|
|
Director
|
|
March 30, 2020
|
James N. Topper, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ Jay Venkatesan, M.D.
|
|
Director
|
|
March 30, 2020
|
Jay Venkatesan, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ Robert Conway
|
|
Director
|
|
March 30, 2020
|
Robert Conway
|
|
|
|
|
|
|
|
|
|
/s/ Paul Sekhri
|
|
Director
|
|
March 30, 2020
|
Paul Sekhri
|
|
|
|
|
|
|
|
|
|
/s/ Christopher Peetz
|
|
Director
|
|
March 30, 2020
|
Christopher Peetz
|
|
|
|
|
|
|
|
|
|
/s/ Min Cui, Ph.D.
|
|
Director
|
|
March 30, 2020
|
Min Cui, Ph.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Assets
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
16,123
|
|
|
$
|
10,711
|
|
Short-term investments
|
|
24,397
|
|
|
41,592
|
|
||
Restricted cash, current
|
|
132
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
|
1,650
|
|
|
1,242
|
|
||
Total current assets
|
|
42,302
|
|
|
53,545
|
|
||
Restricted cash, noncurrent
|
|
254
|
|
|
132
|
|
||
Property and equipment, net
|
|
1,552
|
|
|
1,196
|
|
||
Operating lease, right-of-use asset
|
|
9,985
|
|
|
—
|
|
||
Total assets
|
|
$
|
54,093
|
|
|
$
|
54,873
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
||||
Accounts payable
|
|
$
|
1,543
|
|
|
$
|
1,716
|
|
Accrued liabilities
|
|
5,285
|
|
|
4,363
|
|
||
Deferred revenue
|
|
1,435
|
|
|
—
|
|
||
Current portion of long-term debt
|
|
418
|
|
|
2,048
|
|
||
Total current liabilities
|
|
8,681
|
|
|
8,127
|
|
||
Operating lease liability, noncurrent
|
|
11,429
|
|
|
—
|
|
||
Long-term debt
|
|
4,509
|
|
|
2,155
|
|
||
Total liabilities
|
|
24,619
|
|
|
10,282
|
|
||
Commitments and contingencies
|
|
|
|
|
|
|
||
Convertible preferred stock, $0.001 par value per share; 10,000,000 shares authorized at December 31, 2019 and 2018; zero shares issued and outstanding at December 31, 2019 and 2018
|
|
—
|
|
|
—
|
|
||
Stockholders’ equity:
|
|
|
|
|
||||
Common stock, $0.001 par value per share; 200,000,000 shares authorized at December 31, 2019 and 2018; 18,638,359 shares issued and 18,587,892 shares outstanding at December 31, 2019; 13,904,672 shares issued and 13,854,205 shares outstanding at December 31, 2018
|
|
19
|
|
|
14
|
|
||
Treasury stock, at cost; 50,467 shares at December 31, 2019 and 2018
|
|
—
|
|
|
—
|
|
||
Additional paid-in capital
|
|
117,371
|
|
|
90,664
|
|
||
Accumulated other comprehensive gain (loss)
|
|
10
|
|
|
(13
|
)
|
||
Accumulated deficit
|
|
(87,926
|
)
|
|
(46,074
|
)
|
||
Total stockholders’ equity
|
|
29,474
|
|
|
44,591
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
54,093
|
|
|
$
|
54,873
|
|
|
Years Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Collaboration revenue
|
$
|
1,740
|
|
|
$
|
705
|
|
|
$
|
1,731
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
35,847
|
|
|
28,970
|
|
|
10,626
|
|
|||
General and administrative
|
9,467
|
|
|
8,362
|
|
|
6,079
|
|
|||
Loss on sale of intangible asset
|
—
|
|
|
1,203
|
|
|
—
|
|
|||
Total operating expenses
|
45,314
|
|
|
38,535
|
|
|
16,705
|
|
|||
Loss from operations
|
(43,574
|
)
|
|
(37,830
|
)
|
|
(14,974
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Bargain purchase gain
|
—
|
|
|
—
|
|
|
6,601
|
|
|||
Interest and other expense
|
(338
|
)
|
|
(319
|
)
|
|
(152
|
)
|
|||
Interest income
|
1,248
|
|
|
1,296
|
|
|
542
|
|
|||
Other income
|
812
|
|
|
—
|
|
|
—
|
|
|||
Loss before taxes
|
(41,852
|
)
|
|
(36,853
|
)
|
|
(7,983
|
)
|
|||
Income tax benefit
|
—
|
|
|
366
|
|
|
200
|
|
|||
Net loss
|
$
|
(41,852
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(7,783
|
)
|
Comprehensive income (loss):
|
|
|
|
|
|
||||||
Unrealized gain (loss) on investments
|
29
|
|
|
46
|
|
|
(59
|
)
|
|||
Unrealized loss on foreign currency translation
|
(6
|
)
|
|
—
|
|
|
—
|
|
|||
Comprehensive loss
|
$
|
(41,829
|
)
|
|
$
|
(36,441
|
)
|
|
$
|
(7,842
|
)
|
Weighted-average shares used to compute basic and diluted net loss per share
|
18,358,864
|
|
|
13,849,470
|
|
|
6,481,665
|
|
|||
Basic and diluted net loss per share
|
$
|
(2.28
|
)
|
|
$
|
(2.63
|
)
|
|
$
|
(1.20
|
)
|
|
Convertible
Preferred Stock
|
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-in Capital
|
|
Accumulated
Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total
Stockholders’ Equity
|
|||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||||||||
Balance, December 31, 2016
|
4,311,770
|
|
|
$
|
11,535
|
|
|
|
608,701
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
144
|
|
|
$
|
—
|
|
|
$
|
(1,601
|
)
|
|
$
|
(1,457
|
)
|
Issuance of Series A-1 convertible preferred stock
|
4,989,663
|
|
|
37,666
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Conversion of convertible preferred stock to common stock
|
(9,301,433
|
)
|
|
(49,201
|
)
|
|
|
9,301,433
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
49,200
|
|
|
—
|
|
|
—
|
|
|
49,201
|
|
|||||||
Common stock acquired in business combination
|
—
|
|
|
—
|
|
|
|
3,914,058
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
38,103
|
|
|
—
|
|
|
—
|
|
|
38,103
|
|
|||||||
Adjustment of par value from $0.0001 per share to $0.001 per share
|
—
|
|
|
—
|
|
|
|
—
|
|
|
13
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Conversion of warrant liability to equity
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
52
|
|
|
—
|
|
|
—
|
|
|
52
|
|
|||||||
Exercise of stock options and common stock
warrants
|
—
|
|
|
—
|
|
|
|
57,453
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|||||||
Repurchase of common stock
|
—
|
|
|
—
|
|
|
|
(50,467
|
)
|
|
—
|
|
|
50,467
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
838
|
|
|
—
|
|
|
—
|
|
|
838
|
|
|||||||
Unrealized loss on investments
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(59
|
)
|
|
—
|
|
|
(59
|
)
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,783
|
)
|
|
(7,783
|
)
|
|||||||
Balance, December 31, 2017
|
—
|
|
|
—
|
|
|
|
13,831,178
|
|
|
14
|
|
|
50,467
|
|
|
—
|
|
|
88,346
|
|
|
(59
|
)
|
|
(9,384
|
)
|
|
78,917
|
|
|||||||
Cumulative effect of changes related to adoption of new revenue standard
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(203
|
)
|
|
(203
|
)
|
|||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
|
23,027
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
9
|
|
|||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,309
|
|
|
—
|
|
|
—
|
|
|
2,309
|
|
|||||||
Unrealized gain on investments
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
46
|
|
|
—
|
|
|
46
|
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,487
|
)
|
|
(36,487
|
)
|
|||||||
Balance, December 31, 2018
|
—
|
|
|
—
|
|
|
|
13,854,205
|
|
|
14
|
|
|
50,467
|
|
|
—
|
|
|
90,664
|
|
|
(13
|
)
|
|
(46,074
|
)
|
|
44,591
|
|
|||||||
Issuance of Units in Private Placement, net of offering costs
|
—
|
|
|
—
|
|
|
|
4,706,700
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|
23,593
|
|
|
—
|
|
|
—
|
|
|
23,598
|
|
|||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
|
26,987
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|
—
|
|
|
—
|
|
|
13
|
|
|||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,041
|
|
|
—
|
|
|
—
|
|
|
3,041
|
|
|||||||
Issuance of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60
|
|
|
|
|
|
|
60
|
|
|||||||||||||||
Unrealized gain on investments
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29
|
|
|
—
|
|
|
29
|
|
|||||||
Unrealized loss on foreign currency translation
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
—
|
|
|
(6
|
)
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41,852
|
)
|
|
(41,852
|
)
|
|||||||
Balance, December 31, 2019
|
—
|
|
|
$
|
—
|
|
|
|
18,587,892
|
|
|
$
|
19
|
|
|
50,467
|
|
|
$
|
—
|
|
|
$
|
117,371
|
|
|
$
|
10
|
|
|
$
|
(87,926
|
)
|
|
$
|
29,474
|
|
|
Years Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(41,852
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(7,783
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Loss on sale of property and equipment
|
16
|
|
|
—
|
|
|
—
|
|
|||
Loss on sale of intangible asset
|
—
|
|
|
1,203
|
|
|
—
|
|
|||
Bargain purchase gain
|
—
|
|
|
—
|
|
|
(6,601
|
)
|
|||
Depreciation expense
|
468
|
|
|
388
|
|
|
241
|
|
|||
Amortization of premium/discount on investments
|
(360
|
)
|
|
(669
|
)
|
|
—
|
|
|||
Non-cash interest expense
|
140
|
|
|
169
|
|
|
87
|
|
|||
Deferred income tax
|
—
|
|
|
(305
|
)
|
|
(204
|
)
|
|||
Stock-based compensation expense
|
3,041
|
|
|
2,309
|
|
|
838
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Prepaid expenses and other current assets
|
(408
|
)
|
|
66
|
|
|
(1,193
|
)
|
|||
Right-of-use asset
|
1,553
|
|
|
—
|
|
|
—
|
|
|||
Accounts payable and accrued liabilities
|
816
|
|
|
5,390
|
|
|
(226
|
)
|
|||
Deferred revenue
|
1,435
|
|
|
(480
|
)
|
|
(1,731
|
)
|
|||
Lease liabilities
|
(195
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash used in operating activities
|
(35,346
|
)
|
|
(28,416
|
)
|
|
(16,572
|
)
|
|||
Investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(821
|
)
|
|
(495
|
)
|
|
(586
|
)
|
|||
Proceeds from sale of intangible asset
|
—
|
|
|
250
|
|
|
—
|
|
|||
Purchase of short-term investments
|
(59,382
|
)
|
|
(72,863
|
)
|
|
(88,307
|
)
|
|||
Maturities of short-term investments
|
75,575
|
|
|
105,226
|
|
|
—
|
|
|||
Proceeds from the sale of short-term investments
|
1,391
|
|
|
—
|
|
|
27,960
|
|
|||
Cash and cash equivalents acquired in connection with merger
|
—
|
|
|
—
|
|
|
31,130
|
|
|||
Net cash provided by (used in) investing activities
|
16,763
|
|
|
32,118
|
|
|
(29,803
|
)
|
|||
Financing activities
|
|
|
|
|
|
||||||
Proceeds from sale of preferred stock
|
—
|
|
|
—
|
|
|
37,666
|
|
|||
Proceeds from sale of common stock, net of offering costs
|
23,598
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from borrowings, net of issuance costs
|
1,977
|
|
|
—
|
|
|
5,000
|
|
|||
Repayment of debt
|
(1,333
|
)
|
|
(1,000
|
)
|
|
—
|
|
|||
Proceeds from exercise of stock options
|
13
|
|
|
9
|
|
|
22
|
|
|||
Net cash provided by (used in) financing activities
|
24,255
|
|
|
(991
|
)
|
|
42,688
|
|
|||
Effect of exchange rate on cash, cash equivalents and restricted cash
|
(6
|
)
|
|
—
|
|
|
—
|
|
|||
Net increase (decrease) in cash and cash equivalents and restricted cash
|
5,666
|
|
|
2,711
|
|
|
(3,687
|
)
|
|||
Cash and cash equivalents and restricted cash, beginning of period
|
10,843
|
|
|
8,132
|
|
|
11,819
|
|
|||
Cash and cash equivalents and restricted cash, end of period
|
$
|
16,509
|
|
|
$
|
10,843
|
|
|
$
|
8,132
|
|
Supplemental Information
|
|
|
|
|
|
||||||
Recognition of right-of-use asset
|
$
|
11,173
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cash paid for interest
|
$
|
170
|
|
|
$
|
149
|
|
|
$
|
53
|
|
Convertible preferred stock exchanged for common stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
49,201
|
|
Discount in connection with issuance of debt
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
428
|
|
Cash paid for income taxes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
76
|
|
Outstanding Nivalis common stock
|
3,914,058
|
|
|
Per share fair value of Nivalis common stock
|
$
|
9.60
|
|
Outstanding Nivalis stock options
|
421,992
|
|
|
Weighted average per share fair value of Nivalis stock options
|
$
|
1.25
|
|
Total fair value of consideration (in 000’s)
|
$
|
38,103
|
|
Assets:
|
Fair Value
|
||
Cash and cash equivalents
|
$
|
31,130
|
|
Marketable securities
|
12,952
|
|
|
Other receivables
|
79
|
|
|
IPR&D
|
1,453
|
|
|
Total assets acquired
|
45,614
|
|
|
Liabilities:
|
|
|
|
Accrued liabilities
|
(401
|
)
|
|
Deferred tax liability
|
(509
|
)
|
|
Total liabilities assumed
|
(910
|
)
|
|
Bargain purchase gain
|
(6,601
|
)
|
|
Total
|
$
|
38,103
|
|
|
Year Ended December 31,
|
||
|
2017
|
||
Pro forma revenues
|
$
|
1,731
|
|
Pro forma net loss
|
$
|
(18,327
|
)
|
Pro forma basic and diluted net loss per share
|
$
|
(1.32
|
)
|
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Warrants to purchase common stock
|
1,877,094
|
|
|
24,123
|
|
|
24,123
|
|
Options to purchase common stock
|
3,252,144
|
|
|
2,509,850
|
|
|
1,611,996
|
|
Total
|
5,129,238
|
|
|
2,533,973
|
|
|
1,636,119
|
|
|
December 31, 2019
|
||||||||||||||
|
Amortized
Cost |
|
Gross
unrealized gains |
|
Gross
unrealized losses |
|
Fair market
value |
||||||||
Money market funds
|
$
|
9,995
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
9,995
|
|
U.S. treasury bills
|
5,019
|
|
|
2
|
|
|
—
|
|
|
5,021
|
|
||||
Corporate debt securities and commercial paper
|
21,862
|
|
|
14
|
|
|
—
|
|
|
21,876
|
|
||||
Total
|
$
|
36,876
|
|
|
$
|
16
|
|
|
$
|
—
|
|
|
$
|
36,892
|
|
|
December 31, 2018
|
||||||||||||||
|
Amortized
Cost
|
|
Gross
unrealized
gains
|
|
Gross
unrealized
losses
|
|
Fair market
value
|
||||||||
Money market funds
|
$
|
6,405
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,405
|
|
U.S. treasury bills
|
13,966
|
|
|
—
|
|
|
(2
|
)
|
|
13,964
|
|
||||
Corporate debt securities and commercial paper
|
31,331
|
|
|
—
|
|
|
(11
|
)
|
|
31,320
|
|
||||
Total
|
$
|
51,702
|
|
|
$
|
—
|
|
|
$
|
(13
|
)
|
|
$
|
51,689
|
|
Assets:
|
December 31, 2019
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Money market funds
|
$
|
9,995
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
9,995
|
|
U.S. treasury bills
|
5,021
|
|
|
—
|
|
|
—
|
|
|
5,021
|
|
||||
Corporate debt securities and commercial paper
|
—
|
|
|
21,876
|
|
|
—
|
|
|
21,876
|
|
||||
Total
|
$
|
15,016
|
|
|
$
|
21,876
|
|
|
$
|
—
|
|
|
$
|
36,892
|
|
Assets:
|
December 31, 2018
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Money market funds
|
$
|
6,405
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,405
|
|
U.S. treasury bills
|
13,964
|
|
|
—
|
|
|
—
|
|
|
13,964
|
|
||||
Corporate debt securities and commercial paper
|
—
|
|
|
31,320
|
|
|
—
|
|
|
31,320
|
|
||||
Total
|
$
|
20,369
|
|
|
$
|
31,320
|
|
|
$
|
—
|
|
|
$
|
51,689
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Laboratory equipment
|
$
|
1,838
|
|
|
$
|
1,506
|
|
General equipment and furniture
|
486
|
|
|
158
|
|
||
Computer equipment and software
|
169
|
|
|
103
|
|
||
Leasehold improvements
|
85
|
|
|
128
|
|
||
Property and equipment, at cost
|
2,578
|
|
|
1,895
|
|
||
Less accumulated depreciation and amortization
|
(1,026
|
)
|
|
(699
|
)
|
||
Property and equipment, net
|
$
|
1,552
|
|
|
$
|
1,196
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Tennant improvement allowance receivable
|
$
|
586
|
|
|
$
|
—
|
|
Prepaid research and development
|
574
|
|
|
83
|
|
||
Prepaid insurance
|
301
|
|
|
300
|
|
||
Deferred financing costs
|
15
|
|
|
477
|
|
||
Prepaid other
|
74
|
|
|
145
|
|
||
Other receivables
|
100
|
|
|
237
|
|
||
Prepaid expenses and other current assets
|
$
|
1,650
|
|
|
$
|
1,242
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Research and development services
|
$
|
2,543
|
|
|
$
|
2,457
|
|
Employee compensation
|
1,761
|
|
|
1,009
|
|
||
Legal and professional fees
|
515
|
|
|
646
|
|
||
Accrued other
|
466
|
|
|
251
|
|
||
Total
|
$
|
5,285
|
|
|
$
|
4,363
|
|
Year Ending December 31,
|
|
Total
|
||
2020
|
|
$
|
441
|
|
2021
|
|
1,765
|
|
|
2022
|
|
1,765
|
|
|
2023
|
|
1,029
|
|
|
2024
|
|
—
|
|
|
Total future principal payments
|
|
$
|
5,000
|
|
|
Twelve months ended December 31, 2019
|
||
Operating lease cost
|
$
|
1,905
|
|
Variable lease cost
|
370
|
|
|
Total lease cost
|
$
|
2,275
|
|
Cash paid for amounts included in the measurement of lease liabilities
|
$
|
837
|
|
Right-of-use assets exchanged for new operating lease liabilities
|
$
|
11,173
|
|
|
Minimum Lease Payments
|
||
2020
|
$
|
216
|
|
2021
|
1,961
|
|
|
2022
|
2,012
|
|
|
2023
|
2,065
|
|
|
2024
|
2,119
|
|
|
Thereafter
|
11,870
|
|
|
Total future minimum lease payments
|
20,243
|
|
|
Less: imputed interest
|
(8,814
|
)
|
|
Operating lease liabilities
|
$
|
11,429
|
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||
Shares to be issued upon exercise of outstanding stock options
|
3,252,144
|
|
|
2,509,850
|
|
Shares to be issued upon conversion of common stock warrants
|
1,877,094
|
|
|
24,123
|
|
Shares available for future stock grants
|
269,959
|
|
|
496,530
|
|
Shares to be issued under employee stock purchase plan
|
45,211
|
|
|
45,211
|
|
Shares of common stock reserved for future issuance
|
5,444,408
|
|
|
3,075,714
|
|
|
Warrants
Outstanding
|
|
Weighted-
average
Exercise
Price
|
|
Weighted-
average
Remaining
Contract
Term
(in years)
|
|||
Outstanding at December 31, 2018
|
24,123
|
|
|
$
|
24.86
|
|
|
5.62
|
Granted
|
1,852,971
|
|
|
$
|
12.66
|
|
|
4.10
|
Outstanding at December 31, 2019
|
1,877,094
|
|
|
$
|
12.82
|
|
|
4.11
|
Exercisable at December 31, 2019
|
1,873,225
|
|
|
$
|
12.83
|
|
|
4.11
|
|
Options
Outstanding
|
|
Weighted-
average
Exercise
Price
|
|
Weighted-
average
Remaining
Contract
Term
(in years)
|
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||
Outstanding at December 31, 2018
|
2,509,850
|
|
|
$
|
5.82
|
|
|
|
|
|
|
|
Granted
|
1,156,350
|
|
|
$
|
6.36
|
|
|
|
|
|
||
Exercised
|
(26,987
|
)
|
|
$
|
0.48
|
|
|
|
|
|
||
Forfeited/Expired
|
(387,069
|
)
|
|
$
|
7.06
|
|
|
|
|
|
||
Outstanding at December 31, 2019
|
3,252,144
|
|
|
$
|
5.91
|
|
|
7.67
|
|
$
|
2,569
|
|
Vested and expected to vest after December 31, 2019
|
3,202,144
|
|
|
$
|
5.89
|
|
|
7.64
|
|
$
|
2,569
|
|
Exercisable at December 31, 2019
|
1,469,574
|
|
|
$
|
5.09
|
|
|
6.50
|
|
$
|
2,121
|
|
|
Years Ended December 31,
|
||||
|
2019
|
|
2018
|
|
2017
|
Weighted-average estimated fair value at grant
|
$4.14
|
|
$5.43
|
|
$4.69
|
Risk-free interest rate (1)
|
1.42% - 2.63%
|
|
2.27% - 3.07%
|
|
1.90% - 2.26%
|
Expected term of options (in years) (2)
|
5.27 – 6.08
|
|
5.50 – 7.00
|
|
5.69 – 6.32
|
Expected stock price volatility (3)
|
70% - 77%
|
|
70% - 77%
|
|
72% - 83%
|
Expected dividend yield (4)
|
—%
|
|
—%
|
|
—%
|
(1)
|
The risk-free interest rate assumption was based on zero-coupon U.S. Treasury instruments that had terms consistent with the expected term of our stock option grants.
|
(2)
|
We used the “simplified method” for options to determine the expected term of stock options granted to employees, since we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited time our shares have been publicly traded. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option.
|
(3)
|
Volatility is a measure of the amount by which a financial variable, such as share price, has fluctuated or is expected to fluctuate during a period. We analyzed the stock price volatility of companies at a similar stage of development to estimate expected volatility of our stock price.
|
(4)
|
We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future.
|
|
Years Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Employee:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
$
|
1,608
|
|
|
$
|
890
|
|
|
$
|
183
|
|
General and administrative
|
1,359
|
|
|
1,385
|
|
|
588
|
|
|||
Non-Employee:
|
|
|
|
|
|
|
|
||||
Research and development
|
68
|
|
|
16
|
|
|
52
|
|
|||
General and administrative
|
6
|
|
|
18
|
|
|
15
|
|
|||
Total stock-based compensation expense
|
$
|
3,041
|
|
|
$
|
2,309
|
|
|
$
|
838
|
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Domestic
|
$
|
(38,234
|
)
|
|
$
|
(36,853
|
)
|
Foreign
|
(3,618
|
)
|
|
—
|
|
||
Total
|
$
|
(41,852
|
)
|
|
$
|
(36,853
|
)
|
|
Years Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Current:
|
|
|
|
|
|
||
U.S. - Federal
|
$
|
—
|
|
|
$
|
—
|
|
U.S. - State
|
—
|
|
|
(61
|
)
|
||
Total current
|
—
|
|
|
(61
|
)
|
||
Deferred:
|
|
|
|
|
|
||
U.S. - Federal
|
—
|
|
|
(305
|
)
|
||
U.S. - State
|
—
|
|
|
—
|
|
||
Total deferred
|
—
|
|
|
(305
|
)
|
||
Total income tax benefit
|
$
|
—
|
|
|
$
|
(366
|
)
|
|
Years Ended December 31,
|
||||
|
2019
|
|
2018
|
||
U.S. Statutory rate
|
21.0
|
%
|
|
21.0
|
%
|
Effect of:
|
|
|
|
|
|
State taxes (net of federal benefit)
|
—
|
%
|
|
3.8
|
%
|
Permanent differences
|
(0.1
|
)%
|
|
—
|
%
|
Federal research and development credit
|
1.1
|
%
|
|
4.2
|
%
|
Change in valuation allowance
|
(19.8
|
)%
|
|
(27.3
|
)%
|
Benefit of a lower tax rate
|
—
|
%
|
|
(0.1
|
)%
|
Stock-based compensation
|
(0.5
|
)%
|
|
(0.6
|
)%
|
Foreign rate differential
|
0.6
|
%
|
|
—
|
%
|
Other
|
(2.3
|
)%
|
|
—
|
%
|
Effective income tax rate
|
—
|
%
|
|
1.0
|
%
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Net operating loss
|
$
|
17,193
|
|
|
$
|
10,546
|
|
Research and development credits
|
3,182
|
|
|
1,958
|
|
||
Intangible asset basis
|
35
|
|
|
54
|
|
||
Lease liability
|
2,400
|
|
|
—
|
|
||
Deferred rent
|
—
|
|
|
21
|
|
||
Stock based compensation
|
1,586
|
|
|
1,382
|
|
||
Other
|
1
|
|
|
3
|
|
||
Gross deferred tax assets
|
24,397
|
|
|
13,964
|
|
||
Valuation allowance
|
(22,040
|
)
|
|
(13,774
|
)
|
||
Total deferred tax assets, net of valuation allowance
|
2,357
|
|
|
190
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
||
Prepaid expenses
|
(75
|
)
|
|
(91
|
)
|
||
Fixed asset basis
|
(185
|
)
|
|
(99
|
)
|
||
Right-of-use asset basis
|
(2,097
|
)
|
|
—
|
|
||
Total deferred tax liability
|
(2,357
|
)
|
|
(190
|
)
|
||
Net deferred tax assets and liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Federal (before January 1, 2018)
|
$
|
11,094
|
|
|
$
|
11,094
|
|
Federal (after January 1, 2018)
|
$
|
67,500
|
|
|
$
|
33,417
|
|
State
|
$
|
6,433
|
|
|
$
|
16,756
|
|
Foreign
|
$
|
787
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Federal
|
$
|
3,986
|
|
|
$
|
2,456
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Unrecognized benefits – beginning of year
|
$
|
469
|
|
|
$
|
114
|
|
Gross increases (decreases) – prior year tax positions
|
—
|
|
|
59
|
|
||
Gross increases – current year tax positions
|
306
|
|
|
296
|
|
||
Unrecognized benefit – end of year
|
$
|
775
|
|
|
$
|
469
|
|
•
|
the title and stated value;
|
•
|
the number of shares we are offering;
|
•
|
the liquidation preference per share;
|
•
|
the purchase price;
|
•
|
the dividend rate, period and payment date and method of calculation for dividends;
|
•
|
whether dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate;
|
•
|
the procedures for any auction and remarketing, if any;
|
•
|
the provisions for a sinking fund, if any;
|
•
|
the provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights;
|
•
|
any listing of the preferred stock on any securities exchange or market;
|
•
|
whether the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be calculated, and the conversion period;
|
•
|
whether the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price, or how it will be calculated, and the exchange period;
|
•
|
voting rights, if any, of the preferred stock;
|
•
|
preemptive rights, if any;
|
•
|
restrictions on transfer, sale or other assignment, if any;
|
•
|
whether interests in the preferred stock will be represented by depositary shares;
|
•
|
a discussion of any material U.S. federal income tax considerations applicable to the preferred stock;
|
•
|
the relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs;
|
•
|
any limitations on the issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and
|
•
|
any other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock.
|
•
|
any merger or consolidation with, disposition of assets to, or issuance or redemption of stock to or from, the acquiring person;
|
•
|
any termination of 5% or more of the employees of the target corporation as a result of the acquiring person’s acquisition of 10% or more of the shares; and
|
•
|
allowing the acquiring person to receive any disproportionate benefit as a stockholder.
|
•
|
any breach of the director’s duty of loyalty to the corporation or its stockholders;
|
•
|
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
|
•
|
unlawful payments of dividends or unlawful stock repurchases or redemptions; or
|
•
|
any transaction from which the director derived an improper personal benefit.
|
|
(1)
|
Registration Statement (Form S-8 No. 333-205220) pertaining to the 2012 Stock Incentive Plan of N30 Pharmaceuticals, Inc., 2015 Equity Incentive Plan of Nivalis Therapeutics, Inc. and Employee Stock Purchase Plan of Nivalis Therapeutics, Inc.,
|
|
(2)
|
Registration Statement (Form S-8 No. 333-211197) pertaining to the Employment Inducement Awards of Nivalis Therapeutics, Inc.,
|
|
(3)
|
Registration Statement (Post-Effective Amendment No. 1 on Form S-8 to Form S-4 No. 333-218134) pertaining to the Amended and Restated 2015 Stock Plan of Alpine Immune Sciences, Inc.,
|
|
(4)
|
Registration Statement (Form S-8 No. 333-223965) pertaining to the Amended and Restated 2015 Stock Plan, as amended, and the 2015 Equity Incentive Plan of Alpine Immune Sciences, Inc.,
|
|
(5)
|
Registration Statement (Form S-8 No. 333-225792) pertaining to the 2018 Equity Incentive Plan of Alpine Immune Sciences, Inc.,
|
|
(6)
|
Registration Statement (Form S-1 No. 333-230365) and related Prospectus of Alpine Immune Sciences, Inc. for the registration of 6,542,310 shares of its common stock,
|
|
(7)
|
Registration Statement (Form S-8 No. 333-230369) pertaining to the 2018 Equity Incentive Plan of Alpine Immune Sciences, Inc., and
|
|
(8)
|
Registration Statement (Form S-8 No. 333-230372) pertaining to the Stand-Alone Inducement Stock Option Grant of Alpine Immune Sciences, Inc.,
|
1.
|
I have reviewed this Annual Report on Form 10-K of Alpine Immune Sciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Mitchell H. Gold, M.D.
|
Mitchell H. Gold, M.D.
|
Executive Chairman and Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Annual Report on Form 10-K of Alpine Immune Sciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Paul Rickey
|
Paul Rickey
|
Senior Vice President and Chief Financial Officer
(Principal Accounting Officer and Principal Financial Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Mitchell H. Gold, M.D.
|
Mitchell H. Gold, M.D.
|
Executive Chairman and Chief Executive Officer
(Principal Executive Officer)
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Paul Rickey
|
Paul Rickey
|
Senior Vice President and Chief Financial Officer
(Principal Accounting Officer and Principal Financial Officer)
|