Delaware |
2836 |
80-0948910 | ||
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
Non-accelerated filer |
☒ |
Smaller reporting company |
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Emerging growth company |
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Title Of Each Class Of Securities To Be Registered |
Amount To Be Registered (1) |
Proposed Maximum Offering Price Per Unit |
Proposed Maximum Aggregate Offering Price (7) |
Amount Of Registration Fee | ||||
Common Stock, par value $0.0001 per share issuable upon exercise of the Public Warrants and Private Placement Warrants |
7,811,322 (2) |
$ 11.50 |
$89,830,203 |
$8,327.26 | ||||
Common Stock, par value $0.0001 per share issuable upon exercise of the Pre-Funded Warrants |
715,224 (3) |
$ 7.99 (5) |
$5,714,639.76 |
$529.75 | ||||
Common stock, par value $0.0001 per share |
12,668,314 (4) |
$ 7.99 (5) |
$101,219,828.86 |
$9,383.08 | ||||
Private Placement Warrants to purchase Common Stock |
3,500,000 |
$— (6) |
— (6) |
— (6) | ||||
Total |
24,694,860 |
$196,764,671.62 |
$18,240.09 | |||||
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|
(1) |
Pursuant to Rule 416(a) under the Securities Act, this Registration Statement shall also cover any additional shares of the Registrant’s common stock that become issuable as a result of any stock dividend, stock split, recapitalization or other similar transaction effected without the receipt of consideration that results in an increase to the number of outstanding shares of the Registrant’s common stock, as applicable. |
(2) |
Consists of (i) 4,311,322 shares of common stock issuable upon the exercise of 8,622,644 Public Warrants (as defined herein); and (ii) 3,500,000 shares of common stock issuable upon the exercise of 3,500,000 Private Placement Warrants (as defined herein). |
(3) |
Consists of up to 715,224 shares of common stock issuable upon the exercise of the Pre-Funded Warrant (as defined herein). |
(4) |
Consists of (i) 2,284,776 outstanding PIPE Shares (as defined herein); (ii) 6,305,061 outstanding Old Renovacor Stockholder Shares (as defined herein); (iii) 1,655,661 outstanding Sponsor Shares (as defined herein); (iv) 1,922,816 Earnout Shares (as defined herein) that may be issued pursuant to the earnout provisions of the Merger Agreement (as defined herein) and (v) 500,000 Sponsor Earnout Shares (as defined herein) that are held in escrow and subject to forfeiture pursuant to certain conditions more fully described in the Sponsor Support Agreement (as defined herein). These shares are being registered for resale on this Registration Statement. |
(5) |
Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c) (and 457(g) in the case of the shares of common stock issuable upon exercise of the Pre-Funded Warrant) under the Securities Act based on the average of the high and low prices of Renovacor, Inc.’s common stock, par value $0.0001 per share, on the New York Stock Exchange on October 8, 2021 (such date being within five business days of the date that this registration statement was filed with the U.S. Securities and Exchange Commission). |
(6) |
In accordance with Rule 457(i), the entire registration fee for the private placement warrants is allocated to the shares of common stock underlying such warrants, and no separate fee is payable for the private placement warrants. |
(7) |
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457 under the Securities Act of 1933. |
• |
up to 4,311,322 shares of Common Stock that are issuable upon the exercise of 8,622,644 warrants originally issued in the initial public offering of Chardan Healthcare Acquisition 2 Corp. (“Chardan”) to the holders thereof (the “Public Warrants”); |
• |
up to 3,500,000 shares of Common Stock that are issuable upon the exercise of 3,500,000 warrants originally issued in a private placement concurrently with the initial public offering of Chardan (the “Private Placement Warrants”); and |
• |
up to 715,224 shares of Common Stock that are issuable upon the exercise of a pre-funded warrant originally issued in the PIPE Investment (as defined below) (the “Pre-Funded Warrant”, and together with the Public Warrants and the Private Placement Warrants, the “Warrants”). |
• |
up to 2,284,776 shares of Common Stock (the “PIPE Shares”) issued in a private placement pursuant to subscription agreements entered into between us and the subscribers on March 22, 2021 (the “PIPE Investment”); |
• |
up to 6,305,061 shares of Common Stock (the “Old Renovacor Stockholder Shares”) issued to certain former stockholders of Old Renovacor (defined below) (the “Old Renovacor Stockholders”) in connection with the Merger (as defined below); |
• |
up to 1,655,661 shares of Common Stock (the “Sponsor Shares”) originally issued in a private placement to Chardan Investments 2, LLC (the “Sponsor”) and certain of its directors and employees; |
• |
up to 1,922,816 shares of Common Stock (the “Earnout Shares”) that may be issued pursuant to the earnout provisions of the Merger Agreement (as defined herein); |
• |
up to 500,000 shares of restricted Common Stock held in escrow and subject to forfeiture pursuant to certain conditions more fully described in the Sponsor Support Agreement (as defined herein) (the “Sponsor Earnout Shares”); and |
• |
up to 3,500,000 Private Placement Warrants. |
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F-1 |
* | The diagram above is representative of the current stage of our development and does not reflect our expectations of the clinical trials needed or an agreed upon pathway with the FDA for commercialization of our product candidates. We acknowledge that the required clinical studies and pathway to commercialization must be agreed upon with the FDA. |
• | Advancing our lead product candidate, REN-001, through IND-enabling activities, clinical trials and regulatory approvalREN-001, and, if approved by the FDA, commercialize REN-001 for the rare disease indication BAG3-associated DCM. We anticipate submission of an IND for REN-001 in mid-2022 and the subsequent commencement of clinical trials. We plan to apply for regulatory designations such as Orphan Drug Designation and Fast Track Designation to facilitate the development of REN-001 to help bring REN-001 to patients in an expedited manner. |
• | Leveraging our deep understanding of BAG3 biology. Our vision is to develop gene therapies for BAG3-associated diseases with high unmet medical need REN-001, is a recombinant AAV9-based gene therapy designed to deliver a fully functional BAG3 gene to augment BAG3 protein levels in cardiomyocytes and slow or halt progression of BAG3 DCM. We also intend to leverage our expertise in BAG3 biology to investigate the utility of BAG3 gene therapy for additional pipeline product opportunities across other potential cardiovascular and CNS indications. Our founder, |
Dr. Arthur M. Feldman, M.D., Ph.D., the Laura H. Carnell Professor of Medicine at the Lewis Katz School of Medicine at Temple University, is a highly regarded cardiovascular scientist and pre-eminent expert on the role of BAG3 in human disease. We intend to leverage Dr. Feldman’s expertise to advance our lead product candidate, REN-001, as well as to develop a research pipeline of additional product candidates. We believe that through our licensed intellectual property, specifically patents for BAG3 gene therapy through multiple routes of administration and in multiple indications, we have developed substantial barriers to entry. |
• | Overcoming challenges of existing gene therapy approaches REN-001, utilizes a local intracoronary vector delivery approach with the intended goal of improved cardiac uptake and methods to maximize dwell time in the cardiac circulation. |
• | Utilizing what we believe is a superior local delivery approach with the potential to reduce total vector burden and manufacturing costs REN-001 for BAG3-associated DCM. This method of local delivery has been shown to be effective at transducing cardiac tissue in preclinical pig models. Specifically, ICr showed improved transduction in the heart relative to other intracoronary delivery methods. ICr delivery is expected to allow for a lower total dose per patient relative to intravenous, or IV, delivery. Advantages of a lower total dose per patient include the potential for decreased risk of adverse events related to total vector exposure and the potential for reduced manufacturing cost. |
• | Leverage and grow our leadership team REN-001 through development. As development of REN-001 and other product candidates progress, we intend to expand our senior management team and clinical, manufacturing, and research and development expertise to support our growth. |
• | We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. |
• | We will require additional funding in order to finance operations and, if we are unable to raise capital when need on acceptable terms, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts. |
• | Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. |
• | We are very early in our research and development efforts. Our business is dependent on our ability to advance our current and future product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them. |
• | Our business is highly dependent on the success of our lead product candidate, REN-001, and our other product candidates. |
• | Preclinical and clinical development involve a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current product candidates or any future product candidates. |
• | There is no guarantee that the toxicology and biodistribution studies in healthy pigs and the efficacy studies in haploinsufficient mice will be successful, or that the FDA will not require further testing in these or other animal models. |
• | As an organization, we have limited experience designing and no experience implementing clinical trials and we have never conducted pivotal clinical trials. Failure to adequately design a trial, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial, or obtain regulatory approval on the basis of the trial results, as well as lead to increased or unexpected costs. |
• | We may not be able to file our IND to commence clinical trials for our lead product candidate, REN-001 or our other product candidates on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed. |
• | REN-001 and our other product candidates may cause adverse events or undesirable side effects that could delay or prevent our regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any. |
• | Changes in regulatory requirements, guidance from the FDA and other regulatory authorities or unanticipated events during our preclinical studies and clinical trials of REN-001 or our other product candidates may result in changes to preclinical studies or clinical trials or additional preclinical or clinical trial requirements, which could result in increased costs to us and could delay our development timeline. |
• | If we are unable to successfully commercialize REN-001 or any of our other product candidates for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed. |
• | We face significant competition, and if our competitors develop product candidates more rapidly than we do or their product candidates are more effective, our ability to develop and successfully commercialize products may be adversely affected. |
• | We rely on licenses of intellectual property from Temple and may license intellectual property from other third parties in the future, and such licenses may not provide adequate rights or may not be available in the future on commercially reasonable terms, if at all, and our licensors may be unable to obtain and maintain patent protection for the technology or products that they license to us. |
• | If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from developing and commercializing similar or identical product candidates would be adversely affected. |
• | Chardan identified a material weakness in its internal control over financial reporting. This material weakness could continue to adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner. |
• | Insiders have substantial influence over us, which could limit your ability to affect the outcome of key transactions, including a change of control. |
• | presenting only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus; |
• | not being required to have our registered independent public accounting firm attest to management’s assessment of our internal control over financial reporting; |
• | presenting reduced disclosure about our executive compensation arrangements; |
• | not being required to hold non-binding advisory votes on executive compensation or golden parachute arrangements; and |
• | extended transition periods for complying with new or revised accounting standards. |
Shares of Common Stock offered by us |
8,526,546 shares of Common Stock, which consists of (i) up to 4,311,322 shares of Common Stock that are issuable upon the exercise of 8,622,644 Public Warrants; (ii) up to 3,500,000 shares of Common Stock that are issuable upon the exercise of 3,500,000 Private Placement Warrants; and (iii) up to 715,224 shares of Common Stock that are issuable upon the exercise of the Pre-Funded Warrant. |
Shares of Common Stock outstanding prior to the exercise of all Warrants |
17,256,042 shares (as of September 30, 2021). |
Shares of Common Stock outstanding assuming exercise of all Warrants |
25,782,588 shares (as of September 30, 2021). |
Exercise price of Warrants |
Each Public Warrant is exercisable for one-half of one share of Common Stock at a price of $11.50 per share, subject to adjustment as described herein. |
Each Private Placement Warrant is exercisable for one share of Common Stock at a price of $11.50 per share, subject to adjustment as described herein. |
The Pre-Funded Warrant is exercisable for shares of Common Stock at an exercise price of $0.01 per share, subject to adjustment as described herein. |
Use of proceeds |
We will receive up to an aggregate of approximately $89.8 million from the exercise of the Warrants, assuming the exercise in full of all of the Warrants for cash. We expect to use the net proceeds from the exercise of the Warrants for general corporate purposes. See “ Use of Proceeds. |
Shares of Common Stock offered by the Selling Securityholders |
12,668,314 shares of Common Stock, consisting of (i) up to 2,284,776 PIPE Shares; (ii) up to 6,305,061 of Old Renovacor Stockholder Shares; (iii) up to 1,655,661 Sponsor Shares; (iv) up to 1,922,816 Earnout Shares; and (v) up to 500,000 Sponsor Earnout Shares. |
Private Placement Warrants offered by the Selling Securityholders |
Up to 3,500,000 Private Placement Warrants. |
Use of proceeds |
We will not receive any proceeds from the sale of shares of Common Stock or the Private Placement Warrants by the Selling Securityholders. |
Transfer restrictions |
Certain of our stockholders are subject to certain restrictions on transfer until the termination of applicable lock-up periods. See “Restrictions on Resales of Our Securities-Lock-up Agreements |
NYSE stock symbols |
Our Common Stock and Public Warrants are listed on the NYSE under the symbols “RCOR” and “RCOR.WS,” respectively. |
• | 4,311,322 shares of our Common Stock issuable upon the exercise of 8,622,644 Public Warrants outstanding as of September 30, 2021, each with an exercise price of $11.50 per share; |
• | 3,500,000 shares of our Common Stock issuable upon the exercise of 3,500,000 Private Placement Warrants outstanding as of September 30, 2021, each with an exercise price of $11.50 per share; |
• | 715,224 shares of our Common Stock issuable upon the exercise of the Pre-Funded Warrant outstanding as of September 30, 2021, with an exercise price of $0.01 per share; |
• | 1,995,362 Earnout Shares reserved for issuance upon triggering events for such Earnout Shares as set forth in the Merger Agreement, including 1,922,816 Earnout Shares being registered pursuant to this Registration Statement and 72,546 Earnout Shares underlying restricted stock unit awards which may be issued in respect of Exchanged Options (as defined below); |
• | 1,111,250 shares of our Common Stock issuable upon the exercise of stock options outstanding as of September 30, 2021 with a weighted average exercise price of $7.39 per share; and |
• | 1,240,537 shares of our Common Stock reserved for future issuance under our 2021 Omnibus Incentive Plan, or the 2021 Incentive Plan, as well as any automatic increases in the number of shares of Common Stock reserved for future issuance under our the 2021 Incentive Plan. |
• | continue to advance our BAG3-based gene therapy products; |
• | continue preclinical development of, and initiate clinical development of REN-001 and our other product candidates; |
• | continue to advance the preclinical and clinical development of our earlier discovery stage programs; |
• | seek to discover and develop additional product candidates; |
• | establish manufacturing processes and arrangements with third parties for the manufacture of initial quantities of our product candidates and component materials and validate clinical- and commercial-scale current good manufacturing practices, or cGMP, facilities; |
• | seek regulatory approvals for any of our product candidates that successfully complete clinical trials; |
• | maintain, expand and protect our intellectual property portfolio; |
• | acquire or in-license other product candidates and technologies; |
• | incur additional legal, accounting or other expenses in operating our business, including the additional costs associated with operating as a public company; and |
• | increase our employee headcount and related expenses to support these activities. |
• | delays or disruptions in preclinical experiments and IND-enabling studies due to restrictions of on-site staff, limited or no access to animal facilities, and unforeseen circumstances at contract research organizations, or CROs, and vendors; |
• | limitations on employee or other resources that would otherwise be focused on the conduct of our preclinical work and any clinical trials we subsequently commence, including because of sickness of |
employees or their families, the desire of employees to avoid travel or contact with large groups of people, an increased reliance on working from home, school closures, or mass transit disruptions; |
• | delays in necessary interactions with regulators, ethics committees, and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and |
• | limitations on maintaining our corporate culture that facilitates the transfer of institutional knowledge within our organization and fosters innovation, teamwork, and a focus on execution. |
• | interruption of key clinical trial activities, such as clinical trial site data monitoring and efficacy, safety and translational data collection, processing and analyses, due to limitations on travel imposed or recommended by federal, state, or local governments, employers and others or interruption of clinical trial subject visits, which may impact the collection and integrity of subject data and clinical study endpoints; |
• | delays or difficulties in initiating or expanding clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff; |
• | delays or difficulties in enrolling and retaining patients in our clinical trials; |
• | increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19 or other health conditions or being forced to quarantine; |
• | interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations, or CMOs, due to staffing shortages, production slowdowns, or stoppages and disruptions in materials and reagents; |
• | 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 or delays in the operations of the FDA and comparable foreign regulatory agencies; |
• | changes in regulations as part of a response to the coronavirus pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue any such clinical trials altogether; |
• | delays in receiving approval from local regulatory authorities to initiate any planned clinical trials; |
• | limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; |
• | refusal of the FDA or comparable regulatory authorities to accept data from clinical trials in affected geographies; and |
• | additional delays, difficulties or interruptions as a result of current or future shutdowns due to the coronavirus pandemic, or other pandemics, in countries where we or our third-party service providers operate. |
• | timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and minimally efficacious dose studies in animals, where applicable; |
• | effective INDs or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; |
• | successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or cGCPs, and current Good Laboratory Practices, or cGLPs; |
• | positive results from our future clinical programs that support a finding of safety and effectiveness and an acceptable risk-benefit profile of our product candidates in the intended populations; |
• | receipt of marketing approvals from applicable regulatory authorities; |
• | establishment of arrangements with CMOs for clinical supply and, where applicable, commercial manufacturing capabilities; |
• | establishment and maintenance of patent and trade secret protection and/or regulatory exclusivity for our product candidates; |
• | commercial launch of our product candidates, if approved, whether alone or in collaboration with others; |
• | acceptance of the benefits and use of our product candidates, including method of administration, if and when approved, by patients, the medical community and third-party payors; |
• | effective competition with other therapies; |
• | establishment and maintenance of healthcare coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket |
• | enforcement and defense of intellectual property rights and claims; and |
• | maintenance of a continued acceptable safety, tolerability and efficacy profile of our product candidates following approval. |
• | developing a manufacturing process to produce our product candidates on a large scale and in a cost-effective manner; |
• | educating medical personnel regarding the potential side-effect profile of our product candidates and, as the clinical program progresses, on any observed side effects with the therapy; |
• | training a sufficient number of medical personnel on how to properly administer our product candidates; |
• | developing a reliable and safe and an effective means of genetically modifying our AAV/BAG3-based gene therapies; |
• | sourcing starting material suitable for clinical and commercial manufacturing; and |
• | establishing sales and marketing capabilities, as well as developing a distribution network to support the commercialization of any approved products. |
• | regulators or institutional review boards, or IRBs, the FDA or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
• | we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
• | clinical trial sites deviating from trial protocol or dropping out of a trial; |
• | clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs; |
• | novel therapies, such as gene therapies with less well-characterized safety profiles, may require slower or more staggered early clinical trial enrollment to adequately assess safety data; |
• | the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; |
• | third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; |
• | we may elect to, or regulators, IRBs, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants in our trials are being exposed to unacceptable health risks; |
• | the cost of clinical trials of any of our product candidates may be greater than we anticipate; |
• | the quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be inadequate to initiate or complete a given clinical trial; |
• | our inability or the inability of third parties to manufacture sufficient quantities of our product candidates for use in clinical trials; |
• | reports from clinical testing of other therapies may raise safety or efficacy concerns about our product candidates; |
• | our failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidate as well as data emerging from other studies or trials in the same class as our product candidate; and |
• | the FDA or applicable foreign regulatory agencies may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial. |
• | regulatory authorities may request that we recall or withdraw the product from the market or may limit the approval of the product through labeling or other means; |
• | regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication or a precaution; |
• | we may be required to change the way the product is distributed or administered, conduct additional clinical trials, or change the labeling of the product; |
• | we may decide to recall or remove the product from the marketplace; |
• | we could be sued and/or held liable for injury caused to individuals exposed to or taking our product candidates; |
• | damage to the public perception of the safety of REN-001 or our other product candidates; and |
• | our reputation may suffer. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, in return for, either the referral of an individual or the purchase, lease, or order, or arranging for or recommending the purchase, lease, or order of any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act; |
• | the federal false claims and civil monetary penalties laws, including the civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
• | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, 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, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations, also impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information; |
• | the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS information related to payments and other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; |
• | the Foreign Corrupt Practices Act, or the FCPA, which prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials for the purpose of obtaining or retaining business or otherwise seeking favorable treatment; and |
• | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by non- governmental third-party payors, including private insurers, or by the patients themselves; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug and biologic manufacturers to file reports relating to pricing and marketing information or which require tracking gifts and other remuneration and items of value provided to physicians, other healthcare providers and entities; state and local laws that require the registration of pharmaceutical sales representatives; state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA; state and foreign governments that have enacted or proposed requirements regarding the collection, distribution, use, security, and storage of personally identifiable information and other data relating to individuals (including the EU General Data Protection Regulation 2016/679, or the GDPR, and the California Consumer Protection Act, or the CCPA), and federal and state consumer protection laws are being applied to enforce regulations related to the online collection, use, and dissemination of data, thus complicating compliance efforts. |
• | an inability to initiate or continue clinical trials of REN-001 or our other product candidates under development; |
• | delay in submitting regulatory applications, or receiving marketing approvals, for our product candidates; |
• | subjecting third-party manufacturing facilities to additional inspections by regulatory authorities; |
• | requirements to cease development or to recall batches of our product candidates; and |
• | in the event of approval to market and commercialize REN-001 or our other product candidates, an inability to meet commercial demands for REN-001 or our other product candidates. |
• | launching commercial sales of our product candidates, whether alone or in collaboration with others; |
• | receiving an approved label with claims that are necessary or desirable for successful marketing, and that does not contain safety or other limitations that would impede our ability to market our product candidates; |
• | creating market demand for our product candidates through marketing, sales and promotion activities; |
• | hiring, training, and deploying a sales force or contracting with third parties to commercialize our product candidates; |
• | manufacturing, either on our own or through third parties, product candidates in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter; |
• | establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; |
• | creating partnerships with, or offering licenses to, third parties to promote and sell product candidates in foreign markets where we receive marketing approval; |
• | maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; |
• | achieving market acceptance of our product candidates by patients, the medical community, and third-party payors; |
• | achieving appropriate reimbursement for our product candidates; |
• | effectively competing with other therapies; and |
• | maintaining an acceptable tolerability profile of our product candidates following launch. |
• | issue a warning letter asserting that we are in violation of the law; |
• | request voluntary product recalls; |
• | seek an injunction or impose administrative, civil or criminal penalties or monetary fines; |
• | suspend or withdraw regulatory approval; |
• | suspend any ongoing clinical trials; |
• | refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto); |
• | restrict the marketing or manufacturing of the product; |
• | seize or detain the product or otherwise require the withdrawal of the product from the market; |
• | refuse to permit the import or export of product candidates; or |
• | refuse to allow us to enter into supply contracts, including government contracts. |
• | the prevalence and severity of any adverse side effects associated with our product candidates; |
• | limitations or warnings contained in the labeling approved for our product candidates by the FDA or comparable foreign regulatory authority, such as a “black box” warning; |
• | availability of alternative treatments, including any competitive therapies in development that could be approved or commercially launched prior to approval of our product candidates; |
• | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
• | the strength of marketing and distribution support and timing of market introduction of competitive products; |
• | pricing; |
• | payor acceptance; |
• | the impact of any future changes to the healthcare system in the United States; |
• | the effectiveness of our sales and marketing strategies; and |
• | the likelihood that the FDA may require development of a REMS, as a condition of approval or post-approval or may not agree with our proposed REMS or may impose additional requirements that limit the promotion, advertising, distribution or sales of our product candidates. |
• | the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; |
• | patent applications may not result in any patents being issued; |
• | patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; |
• | our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block our ability to make, use and sell REN-001 and any of our other product candidates; |
• | there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and |
• | countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing products. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | our right to sublicense patents and other rights to third parties; |
• | our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of REN-001 and any of our other product candidates, and what activities satisfy those diligence obligations; |
• | our right to transfer or assign the license; |
• | the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by us and our licensors; and |
• | the priority of invention of patented technology. |
• | others may be able to develop products that are similar to REN-001 and any of our other product candidates that are not covered by the claims of any issued patents that we own or license; |
• | we or our licensors or predecessors might not have been the first to make the inventions covered by any issued patent or patent application that we own or license; |
• | we or our licensors or predecessors might not have been the first to file patent applications covering certain of our inventions; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights; |
• | it is possible that our pending patent applications will not lead to issued patents; |
• | issued patents that we own or license may be held invalid or unenforceable, including as a result of legal challenges by our competitors; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; |
• | the patents of others may have an adverse effect on our business; and |
• | we may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property. |
• | result in costly litigation that may cause negative publicity; |
• | divert the time and attention of our technical personnel and management; |
• | cause development delays; |
• | prevent us from commercializing REN-001 and any other product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law; |
• | require us to develop non-infringing technology, which may not be possible on a cost-effective basis; |
• | subject us to significant liability to third parties; or |
• | require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology. |
• | identifying, recruiting, integrating, maintaining, and motivating additional employees; |
• | managing our internal development efforts effectively, including the clinical and FDA or other comparable authority review process for REN-001 and our other product candidates, while complying with our contractual obligations to contractors and other third parties; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | decreased demand for our products; |
• | injury to our reputation and significant negative media attention; |
• | withdrawal of clinical trial participants and inability to continue clinical trials; |
• | initiation of investigations by regulators; |
• | costs to defend the related litigation; |
• | a diversion of management’s time and our resources; |
• | substantial monetary awards to trial participants or patients; |
• | product recalls, withdrawals or labeling, marketing or promotional restrictions; |
• | significant negative financial impact; |
• | exhaustion of any available insurance and our capital resources; |
• | the inability to commercialize REN-001 or our other product candidates; and |
• | a decline in our stock price. |
• | actual or anticipated fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to ours; |
• | changes in the market’s expectations about our operating results; |
• | the public’s reaction to our press releases, other public announcements and filings with the SEC; |
• | speculation in the press or investment community; |
• | actual or anticipated developments in our business, competitors’ businesses or the competitive landscape generally; |
• | the commencement, enrollment, or results of our current and future preclinical studies and clinical trials, and the results of trials of our competitors or those of other companies in our market sector; |
• | regulatory approval of our product candidates, or limitations to specific label indications or patient populations for our use, or changes or delays in the regulatory review process; |
• | the success or failure of our efforts to acquire, license, or develop additional product candidates; |
• | innovations or new products developed by us or our competitors; |
• | manufacturing, supply or distribution delays or shortages; |
• | any changes to our relationship with any manufacturers, suppliers, licensors, future collaborators, or other strategic partners; |
• | the operating results failing to meet the expectation of securities analysts or investors in a particular period; |
• | changes in financial estimates and recommendations by securities analysts concerning us or the market in general; |
• | operating and stock price performance of other companies that investors deem comparable to ours; |
• | changes in laws and regulations affecting our business; |
• | commencement of, or involvement in, litigation involving us; |
• | changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; |
• | the volume of our Common Stock available for public sale; |
• | any major change in our board of directors or management; |
• | sales of substantial amounts of our Common Stock by our directors, officers or significant stockholders or the perception that such sales could occur; |
• | general economic and political conditions such as recessions, interest rates, “trade wars,” pandemics (such as COVID-19) and acts of war or terrorism; and |
• | other risk factors and other matters described or referenced under the sections “ Risk Factors Cautionary Note Regarding Forward-Looking Statements. |
• | the timing and cost of, and level of investment in, research, development, regulatory approval and commercialization activities relating to REN-001 and our other product candidates, which may change from time to time; |
• | coverage and reimbursement policies with respect to REN-001 and our other product candidates, if approved, and potential future drugs or biologics that compete with our products; |
• | the cost of manufacturing REN-001 and our other product candidates, which may vary depending on the quantity of production and the terms of our agreements with CMOs; |
• | the timing and amount of the milestone or other payments we must make to the licensors and other third parties from whom we have in-licensed or acquired our product candidates; |
• | the level of demand for any approved products, which may vary significantly; |
• | future accounting pronouncements or changes in our accounting policies; |
• | macroeconomic conditions, both nationally and locally; and |
• | any other change in the competitive landscape of our industry, including consolidation among our competitors or partners. |
• | our board of directors will be divided into three classes, with each class serving staggered three-year terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors; |
• | our board of directors has the exclusive right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of our board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors; |
• | our stockholders may not act by written consent, which forces stockholder action to be taken at an annual or special meeting of stockholders; |
• | a special meeting of stockholders may be called only by the chairperson of our board of directors, our chief executive officer, or a majority of our board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; |
• | our second amended and restated certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; |
• | our board of directors may alter certain provisions of our amended and restated bylaws without obtaining stockholder approval; |
• | the approval of the holders of at least two-thirds of our Common Stock entitled to vote at an election of our board of directors is required to adopt, amend, or repeal our amended and restated bylaws or repeal the provisions of our second amended and restated certificate of incorporation regarding the election and removal of directors; |
• | stockholders must provide advance notice and additional disclosures to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain voting control of our Common Stock; and |
• | our board of directors is authorized to issue shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer. |
• | our ability to maintain the listing of our Common Stock and Warrants on the NYSE, following the Business Combination and operate as a public company; |
• | our ability to recognize the anticipated benefits of the Business Combination; |
• | our ability to raise additional capital to fund our operations and continue the development of our current and future product candidates; |
• | the accuracy of our projections and estimates regarding our expenses, capital requirements, cash utilization, and need for additional financing; |
• | the initiation, progress, success, cost, and timing of our development activities, preclinical studies and future clinical trials; |
• | the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; |
• | the preclinical nature of our business and our ability to successfully advance current and future product candidates through development activities, preclinical studies, and clinical trials; |
• | the timing of our future Investigational New Drug, or IND, applications and the likelihood of, and our ability to obtain and maintain, regulatory clearance of such IND applications for our product candidates; |
• | the novelty of our approach to the treatment of BAG3-associated dilated cardiomyopathy, or DCM, utilizing adeno-associated virus, or AAV, BAG3-based gene therapies to target BAG3 mutations, and the challenges we will face due to the novel nature of such technology; |
• | our dependence on the success of our product candidates, in particular REN-001; |
• | the potential scope and value of our intellectual property and proprietary rights; |
• | our ability, and the ability of our licensors, to obtain, maintain, defend, and enforce intellectual property and proprietary rights protecting our product candidates, and our ability to develop and commercialize our product candidates without infringing, misappropriating, or otherwise violating the intellectual property or proprietary rights of third parties; |
• | the success of competing therapies that are or become available; |
• | regulatory developments and approval pathways in the United States and foreign countries for our product candidates; |
• | the performance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third-party suppliers and manufacturers; |
• | our ability to attract and retain strategic collaborators with development, regulatory, and commercialization expertise; |
• | the extent to which COVID-19 and variants thereof, such as the delta variant, and measures taken to contain its spread ultimately impact our business, including development activities, preclinical studies, and future clinical trials; |
• | the public opinion and scrutiny of AAV/BAG3-based gene therapies for the treatment of heart failure and our potential impact on public perception of our products and product candidates; |
• | our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; |
• | our ability to generate revenue from future product sales and our ability to achieve and maintain profitability; |
• | the size and growth of the potential markets for our product candidates and our ability to serve those markets; |
• | changes in applicable laws or regulations; |
• | our ability to recruit and retain key members of management and other clinical and scientific personnel; |
• | the possibility that we may be adversely impacted by other economic, business, and/or competitive factors; and |
• | other risks and uncertainties indicated in this prospectus, including those under the heading “ Risk Factors |
• | Old Renovacor appointed a voting majority of directors to our board of directors. Subsequent to the Business Combination, our board of directors consisted of seven directors: (i) five directors were designated by Old Renovacor, four of which are independent directors in accordance with the rules of the NYSE and one of which is our Chief Executive Officer and (ii) two directors were designated by the Sponsor; |
• | The executive officers of Old Renovacor became our executive officers; |
• | Old Renovacor represented a significant majority of the assets (excluding cash held in the trust account of Chardan that holds the proceeds from the Chardan IPO, or the Trust Account) and operations of the combined company; and |
• | The intended strategy of the combined company will continue to focus on Old Renovacor’s core product/service offerings related to gene therapy-based treatments for cardiovascular disease. |
Shares and Exchanged Options transferred upon the closing of the Business Combination (1)(2) |
6,500,000 | |||
Value per share (3) |
$ | 10.00 | ||
|
|
|||
Total share consideration (1)(2) |
$ |
65,000,000 |
||
|
|
(1) |
Amount includes (i) 194,926 shares underlying the Exchanged Options and (ii) an aggregate of 13 fractional shares which was cash settled at the Effective Time. |
(2) |
Amount excludes the issuance of 2,000,000 earn-out shares, or the Earnout Shares, to certain stockholders and option holders of Old Renovacor as a result of the combined company satisfying the performance conditions subsequent to Closing. |
(3) |
Share consideration is calculated using a $10.00 reference price. Actual total share consideration will be dependent on the value of the Company’s Common Stock at the Effective Time. |
• | Chardan will issue 600,000 shares of the Earnout Consideration, in the aggregate, if at any time during the period beginning on the Closing Date and ending on December 31, 2023, or the First Earnout Period, the VWAP (as defined in the Merger Agreement) of the Company’s Common Stock over any 20 Trading Days (as defined in the Merger Agreement) (which may or may not be consecutive) within any 30 consecutive Trading Day period is greater than or equal to $17.50 per share of our Common Stock, or the First Milestone. |
• | Chardan will issue an additional 600,000 shares of the Earnout Consideration, in the aggregate, if at any time during the period beginning on the Closing Date and ending on December 31, 2025, or the Second Earnout Period, the VWAP of the Company’s Common Stock over any 20 Trading Days (which may or may not be consecutive) within any 30 consecutive Trading Day period is greater than or equal to $25.00 per share of our Common Stock, or the Second Milestone. |
• | Chardan shall issue an additional 800,000 shares of the Earnout Consideration, in the aggregate, if at any time during the period beginning on the Closing Date and ending on December 31, 2027, or the Third Earnout Period and together with the First Earnout Period and the Second Earnout Period, each, an Earnout Period and collectively, the Earnout Periods, the VWAP of the Company’s Common Stock over any 20 Trading Days (which may or may not be consecutive) within any 30 consecutive Trading Day period is greater than or equal to $35.00 per share of our Common Stock, or the Third Milestone, and together with the First Milestone and the Second Milestone, the Earnout Milestones. |
• | Upon the consummation of any Change in Control during any Earnout Period, any Earnout Milestone with respect to such Earnout Period that has not yet been achieved shall automatically be deemed to have been achieved regardless of the valuation of our Common Stock in such Change in Control transaction and Chardan will take all actions necessary to provide for the issuance of the shares of our Common Stock comprising the applicable Earnout Consideration issuable in respect of such Earnout Milestone(s) prior to the consummation of such Change in Control. |
Expiration |
Target Price |
Earnout Shares Issued |
||||||
December 31, 2023 |
$ | 17.50 | 600,000 | |||||
December 31, 2025 |
$ | 25.00 | 600,000 | |||||
December 31, 2027 |
$ | 35.00 | 800,000 | |||||
|
|
|||||||
2,000,000 |
||||||||
|
|
Expiration |
Target Price |
Earnout Shares Issued |
||||||
December 31, 2023 |
$ | 17.50 | 150,000 | |||||
December 31, 2025 |
$ | 25.00 | 150,000 | |||||
December 31, 2027 |
$ | 35.00 | 200,000 | |||||
|
|
|||||||
500,000 |
||||||||
|
|
• | The consummation of the Business Combination and reclassification of cash held in Trust Account to cash and cash equivalents, net of redemptions (see below); |
• | The consummation of the PIPE Investment; |
• | The accounting for deferred offering costs and transaction costs incurred by both Chardan and Old Renovacor; and |
• | The accounting for the Earnout Consideration and Sponsor Earnout Consideration. |
Number of Shares |
Percentage of Outstanding Shares |
|||||||
Old Renovacor Stockholders |
6,305,061 | 36.1 | % | |||||
Old Renovacor PIPE Investment (1) |
1,750,000 | 10.0 | % | |||||
|
|
|
|
|||||
8,055,061 | 46.1 | % | ||||||
|
|
|
|
|||||
Chardan IPO shares |
6,510,544 | 37.3 | % | |||||
Chardan founder shares (2) |
1,655,661 | 9.5 | % | |||||
Chardan Sponsor PIPE Investment |
250,000 | 1.4 | % | |||||
Chardan Sponsor stockholder PIPE Investment |
1,000,000 | 5.7 | % | |||||
|
|
|
|
|||||
9,416,205 | 53.9 | % | ||||||
|
|
|
|
|||||
Pro forma ownership at June 30, 2021 |
17,471,266 |
100.0 |
% | |||||
|
|
|
|
(1) |
Includes 715,224 shares underlying the Pre-Funded Warrant, which is immediately exercisable following Closing subject to a cap on the beneficial ownership of the holder thereof of 9.99%. |
(2) |
Excludes the Sponsor Earnout Consideration, which are certain Sponsor Shares totaling 500,000 placed into escrow and subject to forfeiture. |
Chardan (Historical) |
Old Renovacor (Historical) |
Transaction Accounting Adjustments |
Pro Forma Combined |
|||||||||||||||
ASSETS |
||||||||||||||||||
Current assets: |
||||||||||||||||||
Cash and cash equivalents |
$ | 304,575 | $ | 448,800 | $ | 86,254,797 | A |
$ | 90,807,359 | |||||||||
30,000,000 | B |
|||||||||||||||||
(4,579,813 | ) | C |
||||||||||||||||
(500,000 | ) | D |
||||||||||||||||
(21,121,000 | ) | J |
||||||||||||||||
Prepaid expenses and other current assets |
— | 545,282 | — | 545,282 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total current assets |
304,575 | 994,082 | 90,053,984 | 91,352,641 | ||||||||||||||
Marketable securities held in Trust Account |
86,254,797 | — | (86,254,797 | ) | A |
— | ||||||||||||
Property |
— | 129 | — | 129 | ||||||||||||||
Deferred merger costs |
— | 2,324,118 | (2,324,118 | ) | C |
— | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total assets |
$ |
86,559,372 |
$ |
3,318,329 |
$ |
1,475,069 |
$ |
91,352,770 |
||||||||||
|
|
|
|
|
|
|
|
|||||||||||
LIABILITIES, TEMPORARY EQUITY AND STOCKHOLDERS’ EQUITY (DEFICIT) |
||||||||||||||||||
Current liabilities: |
||||||||||||||||||
Accounts payable and accrued expenses |
$ | 1,917,910 | $ | 3,228,040 | $ | (2,941,435 | ) | C |
2,204,515 | |||||||||
Promissory note — related party |
500,000 | — | (500,000 | ) | D |
— | ||||||||||||
Warrant liabilities |
3,745,000 | — | — | 3,745,000 | ||||||||||||||
Share earn-out liability |
— | — | 20,801,887 | I |
20,801,887 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total liabilities |
6,162,910 |
3,228,040 |
17,360,452 |
26,751,402 |
||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Temporary equity: |
||||||||||||||||||
Common Stock subject to possible redemption |
86,254,797 | — | (86,254,797 | ) | E |
— | ||||||||||||
Convertible preferred stock |
— | 10,073,820 | (10,073,820 | ) | F |
— | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total temporary equity |
86,254,797 |
10,073,820 |
(96,328,617 |
) |
— |
|||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Stockholders’ equity: |
||||||||||||||||||
Common Stock |
215 | 198 | 228 | B |
1,676 | |||||||||||||
863 | E |
|||||||||||||||||
(198 | ) | F |
||||||||||||||||
631 | F |
|||||||||||||||||
(50 | ) | G |
||||||||||||||||
(211 | ) | J |
||||||||||||||||
Additional paid-in capital |
24,785 | 312,877 | 29,999,772 | B |
77,044,453 | |||||||||||||
(1,814,342 | ) | C |
||||||||||||||||
86,253,934 | E |
|||||||||||||||||
10,074,018 | F |
|||||||||||||||||
(631 | ) | F |
||||||||||||||||
50 | G |
|||||||||||||||||
(5,883,335 | ) | H |
||||||||||||||||
(20,801,887 | ) | I |
||||||||||||||||
(21,120,789 | ) | J |
||||||||||||||||
Accumulated deficit |
(5,883,335 | ) | (10,296,606 | ) | (2,148,154 | ) | C |
(12,444,760 | ) | |||||||||
5,883,335 | H |
|||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total stockholders’ equity (deficit) |
(5,858,335 | ) | (9,983,531 | ) | 80,443,234 | 64,601,368 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total liabilities, temporary equity and stockholders’ equity (deficit) |
$ |
86,559,372 |
$ |
3,318,329 |
$ |
1,475,069 |
$ |
91,352,770 |
Chardan (Historical) |
Old Renovacor (Historical) |
Transaction Accounting Adjustments |
Pro Forma Combined |
|||||||||||||||
Operating expenses: |
||||||||||||||||||
Operating |
$ | 1,932,184 | $ | — | $ | — | $ | 1,932,184 | ||||||||||
Research and development |
— | 4,487,936 | (181,533 | ) | AA |
4,410,700 | ||||||||||||
14,058 | AA |
|||||||||||||||||
90,239 | DD |
|||||||||||||||||
General and administrative |
39,243 | 911,925 | — | 951,168 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss from operations |
(1,971,427 | ) | (5,399,861 | ) | 77,236 | (7,294,052 | ) | |||||||||||
Other income (expense): |
||||||||||||||||||
Interest earned on marketable securities held in Trust Account |
7,166 | — | (7,166 | ) | CC |
— | ||||||||||||
Change in fair value of warrant liability |
280,000 | — | — | 280,000 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (1,684,261 | ) | $ | (5,399,861 | ) | $ | 70,070 | $ | (7,014,052 | ) | |||||||
|
|
|
|
|
|
|
|
|||||||||||
Net Loss per Share (Note 4): |
||||||||||||||||||
Weighted average shares outstanding, basic and diluted |
10,778,305 | 1,955,906 | 17,471,266 | |||||||||||||||
Basic and diluted net loss per common share |
$ | (0.16 | ) | $ | (2.94 | ) | $ | (0.40 | ) |
Chardan (Historical as Revised) |
Old Renovacor (Historical) |
Transaction Accounting Adjustments |
Pro Forma Combined |
|||||||||||||||
Operating expenses: |
||||||||||||||||||
Operating and formation costs |
$ | 801,961 | $ | — | $ | — | $ | 801,961 | ||||||||||
Research and development |
— | 2,424,567 | (2,813 | ) | AA |
2,658,465 | ||||||||||||
56,232 | AA |
|||||||||||||||||
180,479 | DD |
|||||||||||||||||
General and administrative |
— | 805,276 | 2,148,154 | BB |
2,953,430 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss from operations |
(801,961 | ) | (3,229,843 | ) | (2,382,052 | ) | (6,413,856 | ) | ||||||||||
Other income (expense): |
||||||||||||||||||
Interest earned on marketable securities held in Trust Account |
21,191 | — | (21,191 | ) | CC |
— | ||||||||||||
Transaction costs |
(9,357 | ) | — | — | (9,357 | ) | ||||||||||||
Compensation expense on Private Placement Warrants |
(1,680,000 | ) | — | — | (1,680,000 | ) | ||||||||||||
Change in fair value of warrant liability |
(945,000 | ) | — | — | (945,000 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net loss |
$ | (3,415,127 | ) | $ | (3,229,843 | ) | $ | (2,403,243 | ) | $ | (9,048,213 | ) | ||||||
|
|
|
|
|
|
|
|
|||||||||||
Net Loss per Share (Note 4): |
||||||||||||||||||
Weighted average shares outstanding of Common Stock |
3,498,861 | 1,838,075 | 17,471,266 | |||||||||||||||
Basic and diluted net loss per share |
$ | (0.98 | ) | $ | (1.94 | ) | $ | (0.52 | ) |
A. | Reflects the reclassification of marketable securities held in the trust account to cash and cash equivalents. |
B. | Represents cash proceeds of approximately $30,000,000 from the private placement of 2,284,776 shares of our Common Stock at $10.00 per share and the Pre-Funded Warrant entitling the holder thereof to purchase 715,224 shares of the Company’s Common Stock, at an initial purchase price of $9.99 per share underlying the Pre-Funded Warrant pursuant to the concurrent PIPE Investment. The Pre-Funded Warrant is immediately exercisable at an exercise price of $0.01 and will be exercisable indefinitely, provided that the holder of the Pre-Funded Warrant is prohibited from exercising such Pre-Funded Warrant in an amount that would cause such holder’s beneficial ownership of the Company’s Common Stock to exceed 9.9%. |
C. | Represents settlement of preliminary estimated transaction costs of $5,464,893 inclusive of advisory, banking, printing, legal and accounting fees that are expensed as a part of the Business Combination and equity issuance costs that are capitalized into additional paid-in capital. As of June 30, 2021, $2,941,435 was accrued and $2,324,118 was capitalized on the balance sheet of Old Renovacor. Equity issuance costs of $3,316,739 are offset to additional paid-in capital and the remaining balance is expensed through accumulated deficit. The costs expensed through accumulated deficit are included in the unaudited pro forma condensed combined statement of operations for the year ended December 31, 2020 as discussed below (please refer adjustment BB). |
D. | Represents repayment of outstanding notes payable. |
E. | Reflects the reclassification of approximately $86,254,797 of common stock subject to possible redemption to permanent equity. |
F. | Represents the recapitalization of Old Renovacor’s outstanding equity comprised of 2,578,518 shares of convertible preferred stock and 1,987,636 shares of common stock, par value $0.0001 (aggregate value of $10,074,018 reflected as an increase in additional paid-in capital) and the issuance of 6,305,061 shares of our Common Stock (total par value of $631) to Old Renovacor shareholders as consideration for the reverse recapitalization. |
G. | Reflects adjustment for the Sponsor Earnout Shares totaling 500,000 shares which shall be placed into escrow and subject to forfeiture. Chardan has preliminarily determined that the Sponsor Earnout Shares |
are not indexed to Chardan’s own stock and are therefore accounted for as a liability which will be remeasured to fair value at subsequent reporting dates. The change in estimated fair value is noted in adjustment (I). |
H. | Reflects the reclassification of Chardan’s historical accumulated deficit. |
I. | Represents the estimated fair value of the Earnout Consideration for Old Renovacor capital stockholders and Sponsor Earnout Shares. Chardan has preliminarily determined that the Earnout Consideration for Old Renovacor capital stockholders and Sponsor Earnout Shares are not indexed to Chardan’s own stock and is therefore each accounted for as a liability which will be remeasured to fair value at subsequent reporting dates with the change in fair value recognized as a gain or loss in the statement of operations. The pro forma value of the Earnout Consideration for Old Renovacor capital stockholders and Sponsor Earnout Shares was estimated utilizing a Monte Carlo simulation model. The significant assumptions utilized in estimating the fair value of the Earnout Consideration for Old Renovacor capital stockholders and Sponsor Earnout Shares include the following: (1) our Common Stock price of $10.00; (2) the volatility of Chardan’s common stock of 95.0%; and (3) the expected probability of 7.5% and term to a Change in Control of 5-7 years. A 20% increase or decrease in the stock price would change the estimated fair value to $27,050,000 and $18,025,000, respectively. A 20% increase or decrease in the volatility would change the estimated fair value to $21,500,000 and $23,400,000, respectively. Estimates are subject to change as additional information becomes available and additional analyses are performed and such changes could be material once the final valuation is determined at the Effective Time. |
J. | Reflects the redemptions of 2,112,100 shares of Chardan’s common stock, par value $0.0001 per share, that were offered and sold by Chardan in the Chardan IPO and registered pursuant to the IPO registration statement, or the Chardan IPO Shares, for aggregate redemption payments of $21,121,000 allocated to common stock and additional paid-in capital using par value $0.0001 per share and a redemption price of $10.00 per share. |
AA. | Reflects elimination of historical stock-based compensation expense related to canceled Old Renovacor option awards and the recognition of incremental compensation expense related to replacement (modification) of option awards issued. The value of the replacement options was estimated utilizing a Black-Scholes model. The significant assumptions utilized in estimating the fair value of the replacement options include the following: (1) our Common Stock price of $10.00; (2) the strike price ranging from $0.12 to $10.83; (3) volatility of Chardan’s common stock of 95.0%; and (4) the expected term of the award (approximating 5 years). Estimates are subject to change as additional information becomes available and additional analyses are performed and such changes could be material once the final valuation is determined at the Effective Time. |
BB. | Reflects estimated transactions costs of $2,148,154 as if incurred on January 1, 2020, the date the Business Combination occurred for the purposes of the unaudited pro forma condensed combined statement of operations. The amount presented is comprised of transaction costs outlined in adjustment (C) that were not yet recognized and expensed in the historical Chardan and Old Renovacor statement of operations as part of the Business Combination. |
CC. | Reflects elimination of investment income on the Trust Account. |
DD. | Represents the estimated compensation expense related to the Earnout RSU Awards. Chardan has determined that the Earnout RSU Awards contain a market-based vesting condition under ASC 718. Compensation expense in the unaudited pro forma condensed combined statement of operations |
assume the Business Combination occurred on January 1, 2020. The value of the Earnout RSU Awards was estimated utilizing a Monte Carlo simulation model, and the total value of the Earnout RSU Awards was estimated to be $1,173,113, which will be recognized over the implied service period for the award of 6.5 years, and results in incremental compensation expense $90,239 and $180,479 for the six months ended June 30, 2021, and the year ended December, 31, 2020, respectively. The significant assumptions utilized in estimating the fair value of the Earnout RSU awards include the following: (1) our Common Stock price of $10.00; (2) the volatility of Chardan’s common stock of 95.0%; and (3) the expected probability of 7.5% and term to a Change in Control of 5-7 years. A 20% increase or decrease in the stock price would change compensation expense by $(34,700) and $(53,230), respectively, for the six months ended June 30, 2021, and $41,681 and $(32,441), respectively, for the year ended December 31, 2020. A 20% increase or decrease in the volatility would change compensation expense by $(46,095) and $(42,194), respectively, for the six months ended June 30, 2021, and $(3,901) and $11,704, respectively, for the year ended December 31, 2020. The actual fair values of these awards and the related compensation expense are subject to change as additional information becomes available and as additional analyses are performed, such changes could be material once the final valuation is determined at the Effective Time. |
For the Six Months Ended June 30, 2021 |
For the Year Ended December 31, 2021 |
|||||||
Pro forma net loss |
$ | (7,014,052 | ) | $ | (9,048,213 | ) | ||
Weighted average shares outstanding of Common Stock (1) |
17,471,266 | 17,471,266 | ||||||
Net loss per share (basic and diluted) (2) |
$ | (0.40 | ) | $ | (0.52 | ) | ||
Excluded securities: (2) |
||||||||
Earnout Consideration |
1,922,843 | 1,922,843 | ||||||
Sponsor Earnout Consideration |
500,000 | 500,000 | ||||||
Earnout RSU Awards |
77,157 | 77,157 | ||||||
Public Warrants (3) |
4,311,322 | 4,311,322 | ||||||
Private Placement Warrants |
3,500,000 | 3,500,000 | ||||||
Replacement stock options |
194,926 | 194,926 |
(1) |
Includes 715,224 shares underlying the Pre-Funded Warrant, which is immediately exercisable followingthe consummation of the Business Combination, which closed on September 2, 2021, subject to a 9.99% beneficial ownership limitation, which may be increased up to 19.99% at the option of the holder from time to time. The Pre-Funded Warrant is exercisable for nominal consideration and has an indefinite life, and therefore, is included in pro forma weighted average shares outstanding for the periods presented. |
(2) |
The potentially dilutive outstanding securities were excluded from the computation of pro forma net loss per share, basic and diluted, because their effect would have been anti-dilutive or issuance of such shares is contingent upon the satisfaction of certain conditions which were not satisfied by the end of the period. |
(3) |
Each Public Warrant entitles the registered holder to purchase one-half (1/2) of a share of Common Stock, there are currently 8,622,644 Public Warrants issued. |
• | initiate IND-enabling studies for our REN-001 AAV-based gene therapy program; |
• | continue our current research programs and preclinical development of product candidates from our current research programs; |
• | advance additional product candidates into preclinical and clinical development; |
• | advance our clinical-stage product candidate into later stage clinical trials; |
• | seek to discover, validate, and develop additional product candidates, including carrying out activities related to our discovery stage programs; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | scale up our manufacturing processes and capabilities, or arrange for a third party to do so on our behalf, to support our clinical trials of our product candidates and potential commercialization of any of our product candidates for which we may obtain marketing approval; |
• | establish a sales, marketing, and distribution infrastructure or channel to commercialize any product candidate for which we may obtain regulatory approval; |
• | acquire or in-license products, product candidates, or technologies; |
• | maintain, expand, enforce, defend, and protect our intellectual property portfolio; |
• | hire additional clinical, quality control, and scientific personnel; and |
• | add operational, financial, and management information systems and personnel, including personnel to support our product development, planned future commercialization efforts, and our operations as a public company. |
• | employee-related expenses, including salaries, payroll taxes, related benefits and stock-based compensation expense for employees engaged in research and development functions; |
• | expenses incurred in connection with the preclinical development of our product candidates and the development of research programs, including under agreements with third parties, such as consultants, contractors, preclinical laboratories, licensors, CMOs, and CROs; and |
• | laboratory supplies and research materials. |
Six Months Ended June 30, |
||||||||||||
2020 |
2021 |
Change |
||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 976,517 | $ | 4,487,936 | $ | 3,511,419 | ||||||
General and administrative |
399,623 | 911,925 | 512,302 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
$ | (1,376,140 | ) | $ | (5,399,861 | ) | $ | (4,023,721 | ) | |||
|
|
|
|
|
|
|||||||
Net loss |
$ | (1,376,140 | ) | $ | (5,399,861 | ) | $ | (4,023,721 | ) | |||
|
|
|
|
|
|
Year Ended December 31, |
||||||||||||
2019 |
2020 |
Change |
||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 652,709 | $ | 2,424,567 | $ | 1,771,858 | ||||||
General and administrative |
908,548 | 805,276 | (103,272 | ) | ||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
$ | (1,561,257 | ) | $ | (3,229,843 | ) | $ | (1,668,586 | ) | |||
|
|
|
|
|
|
|||||||
Net loss |
$ | (1,561,257 | ) | $ | (3,229,843 | ) | $ | (1,668,586 | ) | |||
|
|
|
|
|
|
Six Months Ended June 30, |
||||||||
2020 |
2021 |
|||||||
Net cash used in operating activities |
$ | (1,441,602 | ) | $ | (4,050,007 | ) | ||
Net cash provided by financing activities |
820,993 | (885,070 | ) | |||||
|
|
|
|
|||||
Net decrease in cash |
$ | (620,609 | ) | $ | (4,935,077 | ) | ||
|
|
|
|
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Net cash used in operating activities |
$ | (1,243,369 | ) | $ | (3,412,046 | ) | ||
Net cash provided by financing activities |
3,336,658 | 6,635,038 | ||||||
|
|
|
|
|||||
Net increase in cash |
$ | 2,093,289 | $ | 3,222,992 | ||||
|
|
|
|
• | the scope, progress, costs, and results of preclinical and clinical development for our other product candidates and development programs; |
• | the number of and development requirements for other product candidates that we pursue; |
• | the costs, timing and outcome of regulatory review of our product candidates; |
• | the cost and timing of completion of commercial-scale manufacturing activities; |
• | our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements; |
• | the payment or receipt of milestones and receipt of other collaboration-based revenues, if any; |
• | our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company upon the closing of the Business Combination, including enhanced internal controls over financial reporting; |
• | the costs and timing of future commercialization activities, including product manufacturing, sales, marketing and distribution, for any of our product candidates for which we receive marketing approval; |
• | the amount and timing of revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; |
• | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property-related claims; and |
• | the extent to which we acquire or in-license other products, product candidates or technologies. |
• | Advancing our lead product candidate, REN-001, through IND-enabling activities, clinical trials and regulatory approvalREN-001, and, if approved by the FDA, commercialize REN-001 for the rare disease indication BAG3-associated DCM. We anticipate submission of an IND for REN-001 in mid-2022 and the subsequent commencement of clinical trials. We plan to apply for regulatory designations such as Orphan Drug Designation and Fast Track Designation to facilitate the development of REN-001 to help bring REN-001 to patients in an expedited manner. |
• | Leveraging our deep understanding of BAG3 biology. |
significant mortality and morbidity. Our lead product candidate, REN-001, is a recombinant AAV9-based gene therapy designed to deliver a fully functional BAG3 gene to augment BAG3 protein levels in cardiomyocytes and slow or halt progression of BAG3 DCM. We also intend to leverage our expertise in BAG3 biology to investigate the utility of BAG3 gene therapy for additional pipeline product opportunities across other potential cardiovascular and CNS indications. Our founder, Dr. Arthur M. Feldman, M.D., Ph.D., the Laura H. Carnell Professor of Medicine at the Lewis Katz School of Medicine at Temple, is a highly regarded cardiovascular scientist and pre-eminent expert on the role of BAG3 in human disease. We intend to leverage Dr. Feldman’s expertise to advance our lead product candidate, REN-001, as well as to develop a research pipeline of additional product candidates. We believe that through our licensed intellectual property, specifically patents for BAG3 gene therapy through multiple routes of administration and in multiple indications, it has developed substantial barriers to entry. |
• | Overcoming challenges of existing gene therapy approaches. REN-001, utilizes a local intracoronary vector delivery approach with the intended goal of improved cardiac uptake and methods to maximize dwell time in the cardiac circulation. |
• | Utilizing what we believe is a superior local delivery approach with the potential to reduce total vector burden and manufacturing costs. REN-001 for BAG3-associated DCM. This method of local delivery has been shown to be effective at transducing cardiac tissue in preclinical pig models. Specifically, ICr showed improved transduction in the heart relative to other intracoronary delivery methods. ICr delivery is expected to allow for a lower total dose per patient relative to intravenous, or IV, delivery. Advantages of a lower total dose per patient include the potential for decreased risk of adverse events related to total vector exposure and the potential for reduced manufacturing cost. |
• | Leverage and grow our leadership team. REN-001 through development. As development of REN-001 and other product candidates progress, we intend to expand our senior management team and clinical, manufacturing, and research and development expertise to support our growth. |
* | The diagram above is representative of the current stage of our development and does not reflect our expectations of the clinical trials needed or an agreed upon pathway with the FDA for commercialization of our product candidates. We acknowledge that the required clinical studies and pathway to commercialization must be agreed upon with the FDA. |
• | We are targeting a monogenic disease with a known genetic cause. |
• | We believe our therapeutic payload is non-immunogenic and is intended for single-dose treatment. |
• | We are utilizing a proven AAV9 capsid. FDA-approved gene therapy product to date. The AAV9 capsid has been shown to transduce cells efficiently, leading to robust expression of the encapsulated gene product. AAV9 has also demonstrated cardiac tropism across multiple species. Recently published results from a third-party phase 1 clinical trial indicates successful transduction of cardiomyocytes with IV dosing of an AAV9-based gene therapy. |
• | We are utilizing intracoronary retrograde infusion, which is intended to reduce total vector burden per patient and potentially lead to a reduction in manufacturing costs. REN-001 for BAG3-associated DCM. This method of local delivery has been shown to be effective at transducing cardiac tissue in preclinical pig models. Specifically, ICr has showed improved transduction in the heart relative to other intracoronary delivery methods. ICr delivery is expected to allow for a lower total dose per patient relative to IV delivery. Advantages of a lower total dose per patient include the potential for decreased risk of adverse events related to total vector exposure and the potential for reduced manufacturing cost. |
Figure 2: |
The entire AAV9-BAG3 vector genome is approximately 6,048 bases in length. Each ITR — derived from the AAV2 genome — is 143 bases, and the CMV and BAG3 |
Figure 3: |
(Left) Biodistribution across muscle tissues in comparison to myocardium. Heart (Ht), diaphragm (Di), quadriceps (Qu), soleus (So), extensor digitorum longus (ED) and tibialis anterior (TA). (Right) Expression biodistribution in non-skeletal muscle. Brain, lung, small intestine (Sm Intest), kidney (Kid) and spleen (Spl). |
Figure 4: |
BAG3 protein levels in cardiac tissue from failing hearts is decreased to 50% of normal levels. |
Figure 5: |
Ejection fraction, or EF, measurements of wild-type BAG3 and GFP transduction into haploinsufficient and control mice (* p=0.04, 0.01, and 0.003 respectively at 2, 4 and 6 weeks for +/-GFP vs. +/-WtBAG3). |
Figure 6: |
EF as measured by echocardiography in wild-type and BAG3-haploinsufficient mice injected with AAV9-GFP or AAV9-63/380BAG3 (* p=0.0006 between healthy control mice injected with AAV9-GFP and BAG3-haploinsufficient mice injected with AAV9-GFP, # p=0.0001 between healthy control mice injected with AAV9-GFP and BAG3-haploinsufficient mice injected with AAV9-63/380BAG3). |
|
Figure 7: |
(Left) Left ventricle ejection fraction, or LVEF, effects of a retro-orbital injection occurring at week 8 post-MI of AAV9-BAG3 to 6-8-week-old |
|
Figure 8: |
(Left) BAG3 protein levels, normalized to Glyceraldehyde 3-phosphate dehydrogenase 7 weeks after a sham procedure or TAC (prior to AAV9 dosing). (Right) Fractional shortening percentage measurementsAAV9-GFP administration. Note: y-axis does not extend to 0% (p=0.001). |
• | completion of nonclinical laboratory tests and animal studies according to GLPs, and applicable requirements for the humane use of laboratory animals or other applicable regulations; |
• | preparation of clinical trial material in accordance with GMPs; |
• | submission to the FDA of an application for an IND application, which must become effective before human clinical trials may begin; |
• | approval by an institutional review board, or IRB, reviewing each clinical site before each clinical trial may be initiated; |
• | performance of adequate and well-controlled human clinical trials according to Good Clinical Practices, or GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity, potency, and efficacy, of the proposed drug or biological product for its intended use; |
• | submission to the FDA of a New Drug Application, or NDA, or Biologics License Application, or BLA, for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; |
• | satisfactory completion of an FDA inspection prior to NDA or BLA approval of the manufacturing facility or facilities where the drug or biological product is produced to assess compliance with GMPs, to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity; |
• | potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the NDA or BLA; |
• | potential FDA Advisory Committee meeting to elicit expert input on critical issues and including a vote by external committee members; |
• | FDA review and approval, or licensure, of the NDA or BLA, and payment of associated user fees, when applicable; and |
• | compliance with any post approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategies, or a REMS, and the potential requirement to conduct post approval studies. |
• | Phase 1 |
• | Phase 2 |
• | Phase 3 |
• | The federal Anti-Kickback Statute makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order, lease of any good, facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. The term “remuneration” has been broadly interpreted to include anything of value; |
• | Federal false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent; |
• | HIPAA created additional federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors or making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, impose obligations on certain types of individuals and entities regarding the electronic exchange of information in common healthcare transactions, as well as standards relating to the privacy and security of individually identifiable health information; |
• | The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and |
• | The Foreign Corrupt Practices Act, or the FCPA, prohibits U.S. businesses and their representatives from offering to pay, paying, promising to pay or authorizing the payment of money or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business. |
Name (1) |
Age |
Position | ||||
Executive officers: |
||||||
Magdalene Cook, M.D. |
47 | President, Chief Executive Officer and Chairperson | ||||
Wendy DiCicco |
53 | Interim Chief Financial Officer | ||||
Marc Semigran, M.D. |
64 | Chief Medical Officer | ||||
Matthew Killeen, Ph.D. |
39 | Chief Scientific Officer | ||||
Non-employee directors: |
||||||
Gbola Amusa, M.D. |
47 | Director | ||||
Edward J. Benz, Jr., M.D. |
75 | Director | ||||
Gregory F. Covino |
56 | Director | ||||
Jonas Grossman, MBA |
47 | Director | ||||
Joan Lau, Ph.D. |
51 | Director | ||||
Thomas Needham, MBA |
57 | Director |
• | Gbola Amusa, M.D. and Jonas Grossman were designated by the Sponsor; |
• | Edward J. Benz, Jr., M.D., Gregory F. Covino, Joan Lau, Ph.D., and Thomas Needham were designated by Old Renovacor; and |
• | Magdalene Cook, M.D., our Chief Executive Officer, was mutually designated by us and the Sponsor. |
• | the Class I directors are Jonas Grossman, Gbola Amusa, and Edward J. Benz, Jr., and their terms will expire at the 2022 annual meeting of stockholders; |
• | the Class II directors are Joan Lau and Thomas Needham, and their terms will expire at the 2023 annual meeting of stockholders; and |
• | the Class III directors are Magdalene Cook and Gregory F. Covino, and their terms will expire at the 2024 annual meeting of stockholders. |
• | select, retain, compensate, evaluate, oversee and, where appropriate, terminate our independent registered public accounting firm; |
• | review and approve the scope and plans for the audits and the audit fees and approve all non-audit and tax services to be performed by the independent auditor; |
• | evaluate the independence and qualifications of our independent registered public accounting firm; |
• | review our financial statements, and discuss with management and our independent registered public accounting firm the results of the annual audit and the quarterly reviews; |
• | review and discuss with management and our independent registered public accounting firm the quality and adequacy of our internal controls and disclosure controls and procedures; |
• | discuss with management our procedures regarding the presentation of financial information, and review earnings press releases and guidance; |
• | oversee the design, implementation and performance of our internal audit function, if any; |
• | set hiring policies with regard to the hiring of employees and former employees of our independent registered public accounting firm and oversee compliance with such policies; |
• | review, approve and monitor and review conflicts of interest of our board of directors and officers and related party transactions; |
• | adopt and oversee procedures to address complaints regarding accounting, internal accounting controls and auditing matters, including confidential, anonymous submissions by our employees of concerns regarding questionable accounting or auditing matters; and |
• | review and discuss with management and our independent registered public accounting firm the adequacy and effectiveness of our legal, regulatory and ethical compliance programs. |
• | review and approve the compensation for our executive officers, including our chief executive officer; |
• | review, approve and administer our employee benefit and equity incentive plans; |
• | establish and review the compensation plans and programs of our employees, and ensure that they are consistent with our general compensation strategy; |
• | monitor compliance with any stock ownership guidelines; and |
• | determine non-employee director compensation. |
• | review and assess and make recommendations to our board of directors regarding desired qualifications, expertise and characteristics sought of board members; |
• | identify, evaluate, select or make recommendations to our board of directors regarding nominees for election to our board of directors; |
• | review our succession planning process for our chief executive officer and any other members of our executive management team; |
• | review and make recommendations to our board of directors regarding the composition, organization and governance of our board of directors and its committees; |
• | review and make recommendations to our board of directors regarding our corporate governance guidelines and corporate governance framework; |
• | oversee director orientation for new directors and continuing education for directors; and |
• | oversee the evaluation of the performance of our board of directors. |
Name and Principal Position |
Year |
Salary ($) (1) |
Nonequity incentive plan compensation ($) (2) |
Total ($) |
||||||||||||
Magdalene Cook, M.D., President and Chief Executive Officer |
2020 | 217,923 | 110,000 | 327,923 | ||||||||||||
2019 | 76,923 | 4,090 | 80,383 |
(1) | Represents salary earned for the year indicated. As discussed below, Dr. Cook commenced receiving salary for her services as Old Renovacor’s Chief Executive Officer effective August 2019 when she first entered into an Employment Agreement with Old Renovacor. Prior to that date, she served as Old Renovacor’s Chief Executive Officer in a non-employee capacity and received no cash or other compensation for such service during 2019. |
(2) | Represents the amount of the annual bonus awarded for performance during the year indicated in accordance with Dr. Cook’s Employment Agreement, as discussed further below under “CEO Employment Agreement and 2020 Compensation Decisions.” For each year, at the time the award was determined (in January following the performance year), Dr. Cook elected to forego the cash award and instead accept an award of shares of restricted stock of equivalent value granted under Old Renovacor’s 2018 Stock Option and Grant Plan. For performance in 2020, Dr. Cook received an award of 34,268 shares of restricted stock in March 2021. Each restricted stock award includes the vesting terms as described below under “Outstanding Equity Awards at Fiscal Year End.” |
• | Salary |
• | Bonus Compensation Summary Compensation Table |
• | Equity Compensation |
• | Vacation; Benefit Plans; Expense Reimbursements |
Stock Awards |
||||||||
Name |
Number of shares or units of stock that have not vested (#) |
Market value of shares or units of stock that have not vested ($) (1) |
||||||
Magdalene Cook, M.D., President and Chief Executive Officer |
10,250 | 32,903 |
(1) | Based on an estimated value as of December 31, 2020 of $3.21 per share. |
Name |
Fees earned or paid in cash ($) (1) |
Option awards ($) (2) |
All other compensation ($) (3) |
Total ($) |
||||||||||||
Edward J Benz, Jr., M.D. |
30,000 | 2,342 | — | 32,342 | ||||||||||||
Arthur Feldman, M.D., Ph.D. |
— | — | 100,000 | 100,000 | ||||||||||||
Campbell Murray (4) |
— | — | — | — | ||||||||||||
Thomas E. Needham, Jr. (5) |
— | — | — | — | ||||||||||||
Anne Prener, M.D. Ph.D. (6) |
30,000 | 3,011 | 5,000 | 38,011 | ||||||||||||
Nandita Shangari (7) |
— | — | — | — |
(1) | Represents cash fees earned for service as a non-employee director for 2020. |
(2) | Represents the grant date fair value of stock options granted under the Renovacor 2018 Stock Option and Grant Plan on January 29, 2020 with respect to the following number of underlying shares of Old Renovacor’s common stock: Dr. Benz, 10,181 shares; and Dr. Prener, 13,090 shares. The grant date fair value was based on a Black-Scholes value using the following assumptions: (i) expected volatility, 69.4%; (ii) risk-free interest rate, 1.46%; (iii) expected dividend yield, N/A; and (iv) expected term (in years), 6.08. All such stock options were outstanding as of December 31, 2020. |
(3) | For Dr. Feldman, represents the fees earned for 2020 under the Feldman Consulting Agreement described above. For. Dr. Prener, represents a cash fee earned for service on Old Renovacor’s Scientific Advisory Board during 2020. |
(4) | Mr. Murray was designated to serve on Old Renovacor’s board of directors by Old Renovacor’s significant investors and he received no compensation for such service. Mr. Murray resigned from the board on September 16, 2020. |
(5) | Mr. Needham was designated to serve on Old Renovacor’s board of directors by Old Renovacor’s significant investors and he received no compensation for such service. |
(6) | Ms. Prener resigned from Old Renovacor’s board of directors on June 1, 2021. |
(7) | Ms. Shangari was designated to serve on Old Renovacor’s board of directors by Old Renovacor’s significant investors and she received no compensation for such service. Ms. Shangari resigned from the board on March 22, 2021. |
• | Salary |
• | Bonus Compensation |
• | Transaction Bonus one-time cash transaction bonus in connection with the consummation of the Business Combination in the amount of $225,000. |
• | True-Up Equity Awardone-time stock option grant on September 3, 2021 to purchase up to 238,793 shares of Common Stock under the 2021 Incentive Plan, to align Dr. Cook with the 50th percentile of CEO equity ownership holdings in our Company’s peer group. These options have an exercise price equal of $7.73 and expire on September 3, 2031. The options will vest and become exercisable 25% on September 3, 2022, with the remaining 75% vesting in thirty-six equal monthly installments thereafter. |
• | Vacation; Benefit Plans; Expense Reimbursements |
• | Salary |
• | Bonus Compensation |
• | Sign-On Bonusone-time cash sign-on bonus in the amount of $200,000. |
• | Initial Option Grant one-time grant of stock options under the 2018 Stock Option and Grant Plan with the grant date of June 2, 2021, for the purchase of 88,991 shares of our Common Stock at an exercise price of $10.83 (with the number of shares and exercise price shown reflecting the adjustments to the award as a result of the Merger). The initial option grant will vest and become exercisable on December 2, 2021 based on Dr. Semigran’s completion of certain performance milestones and expire on June 2, 2031. |
• | True-Up Equity Awardthirty-six equal monthly installments thereafter. |
• | Vacation; Benefit Plans; Expense Reimbursements |
• | any award that is settled in cash rather than by issuance of shares of our Common Stock; |
• | shares of our Common Stock withheld or tendered from previously acquired shares to cover the exercise price of an option or the tax withholding requirements for any award; and |
• | awards granted in assumption of or in substitution for awards previously granted by an acquired company. |
• | Stock Options |
• | Stock Appreciation Rights (SARs) |
• | Restricted Stock, Restricted Stock Units and Other Stock-Based Awards |
specified restrictions, and restricted stock units, which represent the right to receive shares of our Common Stock in the future. These awards may be made subject to repurchase, forfeiture or vesting restrictions at the compensation committee’s discretion. The restrictions may be based on continuous service with our company or the attainment of specified performance goals, as determined by the compensation committee. Restricted stock units may be paid in stock or cash or a combination of stock and cash, as determined by the compensation committee. The compensation committee may also grant other types of equity or equity-based awards subject to the terms of the 2021 Incentive Plan and any other terms and conditions determined by the compensation committee. |
• | Performance Awards |
• | For awards that are not assumed, converted or replaced, the awards will become fully exercisable (as applicable) and vest upon the Change in Control. For performance awards, the amount vesting will be based on the greater of (a) achievement of all performance goals at the “target” level or (b) the actual level of achievement of performance goals as of our fiscal quarter end preceding the Change in Control, and will be prorated based on the portion of the performance period that had been completed through the date of the Change in Control. |
• | For awards that are assumed, converted or replaced by the resulting entity, no automatic vesting will occur upon the Change in Control. Instead, the awards, as adjusted in connection with the transaction, will continue to vest in accordance with their terms. In addition, the awards will become exercisable (as applicable) and vest if the award recipient has a separation from service within two years after the Change in Control by us other than for “cause” or by the award recipient for “good reason” (as defined in the applicable award agreement). For performance awards, the amount vesting will be based on the greater of (a) achievement of all performance goals at the “target” level or (b) the actual level of achievement of performance goals as of our fiscal quarter end preceding the Change in Control, and will be prorated based on the portion of the performance period that had been completed through the date of the separation from service. |
Compensation Elements: Non-Employee Director Compensation Policy |
||||
Annual Board Member Retainers |
||||
Member Annual Retainer |
$ | 35,000 | ||
Chairperson Annual Retainer |
$ | 30,000 | ||
Annual Committee Chair Retainers |
||||
Audit |
$ | 15,000 | ||
Compensation |
$ | 10,000 | ||
Nominating and Corporate Governance |
$ | 8,000 | ||
Annual Committee Member Retainers |
||||
Audit |
$ | 7,500 | ||
Compensation |
$ | 5,000 | ||
Nominating and Corporate Governance |
$ | 4,000 | ||
Equity |
Initial Equity Grant |
Option to purchase 24,000 shares of our Common Stock, made to directors at the commencement of their director service, vesting 25% on the first anniversary of the date of grant and the remainder vesting monthly over a period of 36 months, subject to continued service with the Company | |
Annual Equity Retainer |
Option to purchase 12,000 shares of our Common Stock, subject to continued service with the Company |
• | the amounts involved exceeded or will exceed $120,000; and |
• | any of our directors, executive officers or beneficial holders of more than 5% of any class of our capital stock had or will have a direct or indirect material interest. |
Name |
Number of shares held through PIPE Investment |
|||
Citadel Multi-Strategy Equities Master Fund Ltd. |
200,000 | |||
RTW Master Fund, Ltd. |
513,443 | |||
RTW Innovation Master Fund, Ltd. |
229,213 | |||
RTW Venture Fund Limited |
57,344 | |||
Chardan Healthcare Investments LLC |
250,000 | |||
Renovaholding M S.r.l. |
194,953 | |||
Elysia Capital I SCSp |
85,147 | |||
Francesco Loredan |
12,900 | |||
Longview Healthcare Ventures, LLC |
325,770 | |||
Arthur Feldman |
10,000 | |||
Magdalene Cook |
50,000 | |||
Acorn Bioventures, L.P. |
356,006 | |||
|
|
|||
Total |
2,284,776 |
• | Demand registration rights |
• | Shelf registration rights S-1 and include a “Plan of Distribution” in substantially the form as is attached to the Registration Rights Agreement. No stockholder may be named as an underwriter in the shelf registration statement without the stockholder’s prior written consent. We must use commercially reasonable best efforts to convert or replace the shelf registration statement with a registration statement on Form S-3 promptly following the confirmation that we become eligible to use Form S-3 for registrable securities. We must use commercially reasonable efforts to cause such registration statement to be declared effective as soon as practicable after the initial filing thereof. At any time we have an effective shelf registration statement with respect to stockholders holding a majority of the registrable securities outstanding, such stockholder may make a written request to effect a public offering, including pursuant to an underwritten shelf takedown, provided that such stockholder (a) reasonably expects the aggregate gross proceeds from the sale of the shares of stockholders holding a majority of the registrable securities outstanding to be in excess of $25,000,000 from such underwritten shelf takedown or (b) reasonably expects the offering to be in no event less than $10,000,000 in aggregate gross proceeds. |
• | Piggyback registration rights |
• | Expenses and indemnification |
• | Registrable securities |
• | From and after the closing of the Business Combination until December 31, 2023, or the Sponsor First Earnout Period, 150,000 Sponsor Earn-Out Shares shall vest and be released to the Sponsor if over any 20 Trading Days (as defined in the Merger Agreement) within any 30 Trading Day period the VWAP (as defined in the Merger Agreement) of our Common Stock is greater than or equal to $17.50, or the Sponsor First Milestone. |
• | From and after the closing of the Business Combination until December 31, 2025, or the Sponsor Second Earnout Period, 150,000 Sponsor Earn-Out Shares shall vest and be released to the Sponsor if over any 20 Trading Days within any 30 Trading Day period the VWAP of our Common Stock is greater than or equal to $25.00, or the Sponsor Second Milestone. |
• | From and after the closing of the Business Combination until December 31, 2027, or the Sponsor Third Earnout Period, and together with the First Earnout Period and the Second Earnout Period, the Sponsor Earnout Periods, 200,000 Sponsor Earn-Out Shares shall vest and be released to the Sponsor if over any 20 Trading Days within any 30 Trading Day period the VWAP of our Common Stock is greater than or equal to $35.00, or the Sponsor Third Milestone, and together with the Sponsor First Milestone and the Sponsor Second Milestone, the Sponsor Earnout Milestones. |
• | Upon consummation of any Change in Control (as defined in the Merger Agreement) during any Sponsor Earnout Period, any Sponsor Earnout Milestone with respect to such Sponsor Earnout Period that has not yet been achieved shall automatically be deemed to have been achieved regardless of the valuation of our Common Stock in such Change in Control transaction and the applicable Sponsor Earnout Consideration shall vest and be released to the Sponsor prior to the consummation of such Change in Control. |
• | If any Earnout Milestones are not achieved during the applicable Earnout Period (and a Change in Control does not take place during such Earnout Period), the applicable portion of the Sponsor Earn-Out Shares will be forfeited to the Company for cancellation. |
³ 5% Stockholder |
Series A Preferred Stock |
Total Purchase Price |
||||||
Novartis Bioventures Ltd. |
522,748 | $ | 2,125,003.55 | |||||
New Leaf Biopharma Opportunities II, L.P. |
522,748 | $ | 2,125,003.55 | |||||
Acorn Bioventures |
475,225 | $ | 1,931,819.56 | |||||
Entities affiliated with Innogest Capital (1) |
380,181 | $ | 1,545,459.72 | |||||
Broadview Ventures I LLC |
332,658 | $ | 1,352,275.73 | |||||
BioAdvance |
285,135 | $ | 1,159,091.74 | |||||
Magdalene Cook |
47,523 | $ | 193,183.99 | |||||
Arthur Feldman |
12,300 | $ | 50,000.28 |
(1) | Includes 235,711 shares held by Renovaholding M S.r.l, an affiliate of Innogest Capital formed for purposes of making an investment in Old Renovacor, 19,010 shares held by Francisco Loredan and 125,460 shares initially purchased by Stefan Buono and subsequently transferred to an affiliated investment fund, Elysia Capital. |
• | each person, or group of affiliated persons, known by us to beneficially own more than 5% of our Common Stock; |
• | each of our NEOs; |
• | each of our executive officers and directors; and |
• | all of our executive officers and directors as a group. |
Name and Address of Beneficial Owner (1) |
Number of Shares |
% |
||||||
Five Percent Holders: |
||||||||
Acorn Bioventures, L.P. (2) |
1,658,848 | 9.9 | % | |||||
Arthur Feldman, M.D. (3) |
1,004,433 | 6.0 | % | |||||
Broadview Ventures I LLC (4) |
974,529 | 5.8 | % | |||||
Chardan Investments 2, LLC (5) |
1,605,661 | 9.6 | % | |||||
Innogest Capital (6) |
984,546 | 5.9 | % | |||||
RTW Investments, LP (7) |
2,362,540 | 14.1 | % | |||||
South Ocean Capital Management LLC (8) |
900,000 | 5.4 | % | |||||
Citadel Multi-Strategy Equities Master Fund Ltd. (9) |
1,252,049 | 7.4 | % | |||||
Directors and Executive Officers: |
||||||||
Magdalene Cook, M.D. (10) |
451,448 | 2.7 | % | |||||
Wendy DiCicco |
— | * | ||||||
Matthew Killeen, Ph.D. |
— | * | ||||||
Marc Semigran, M.D. |
— | * | ||||||
Gbola Amusa, M.D. |
— | * | ||||||
Edward J. Benz, Jr., M.D. (11) |
3,963 | * | ||||||
Gregory F. Covino |
— | * | ||||||
Jonas Grossman, MBA (12) |
1,605,661 | 9.6 | % | |||||
Joan Lau, Ph.D. |
— | * | ||||||
Thomas Needham, MBA |
— | * | ||||||
All Directors and Executive Officers as a group (ten individuals) |
2,061,072 | 12.3 | % |
* | Less than 1.0%. |
(1) | Unless otherwise indicated, the business address of each of the directors and officers is c/o Renovacor, Inc., P.O. Box 8142, Greenwich, CT 06836. |
(2) | Includes 1,302,842 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 356,006 shares of our Common Stock issued in the PIPE Investment. Excludes 715,224 shares of the Company’s Common Stock underlying the Pre-Funded Warrant that are not currently exercisable based on the 9.99% beneficial ownership limitation. Isaac Manke, a director of the board of directors of Chardan Healthcare Acquisition 2 Corp. prior to the Business Combination, is a member of the General Partner of the Limited Partnership that directly holds shares by Acorn Bioventures, and as such, may be deemed to share voting and investment power with respect to such shares. Mr. Manke disclaims beneficial ownership with regard to such shares, except to the extent of his proportionate pecuniary interest therein. The address for the reporting persons is 420 Lexington Avenue, Suite 2626, New York, New York 10170. |
(3) | Includes 994,433 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 10,000 shares of our Common Stock issued in the PIPE Investment. |
(4) | Includes 443,823 shares of our Common Stock issued to Broadview Ventures I LLC and 204,936 shares issued to Longview Healthcare Ventures, LLC, an affiliate of Broadview Ventures I LLC, as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 325,770 shares issued in the PIPE Investment to Longview Healthcare Ventures, LLC, an affiliate of Broadview Ventures I LLC. The address for the reporting persons is Goodman’s Bay Corporate Center, West Bay Street, P.O. Box N-3933, Nassau, Bahamas. |
(5) | Excludes 500,000 shares of our Common Stock being held in escrow and subject to vesting or forfeiture based on satisfaction of the Earnout Milestones set forth in that certain Sponsor Support Agreement. The address for the reporting persons is c/o Chardan Healthcare Acquisition 2 Corp., 17 State Street, 21st Floor, New York, NY 10004. |
(6) | Includes shares of our Common Stock held by the following affiliates of Innogest Capital: (i) 437,120 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 194,953 shares of our Common Stock issued in the PIPE Investment to Renovaholding M S.r.l.; (ii) 220,949 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 85,147 shares of our Common Stock issued in the PIPE Investment to Elysia Capital; and (iii) 33,477 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 12,900 shares of our Common Stock issued in the PIPE Investment to Francesco Loredan. The address for the reporting persons is c/o Renovaholding M S.r.l., Via Locatelli 2, 20124 Milan, Italy. |
(7) | Includes shares of our Common Stock held by the following affiliates of RTW Investments, LP: (i) 1,403,121 shares of our Common Stock and 244,710 warrants held by RTW Master Fund, Ltd.; (ii) 626,051 shares of our Common Stock and 94,581 warrants held by RTW Innovation Master Fund, Ltd.; and (iii) 158,368 shares of our Common Stock and 10,709 warrants held by RTW Venture Fund, Ltd. RTW Investments, LP is the manager of RTW Master Fund, Ltd., RTW Venture Fund, Ltd and RTW Innovation Master Fund. Roderick Wong, M.D. is the Managing Partner and Chief Investment Officer of RTW Investments, LP and as such has sole voting and investment control over such shares. Dr. Wong disclaims beneficial ownership of such shares except to the extent of any pecuniary interest therein. The address of RTW Investments, LP and Dr. Wong is 40 10th Avenue, Floor 7, New York, New York, 10014. |
(8) | Information is based on publicly reported holdings as of the date of the most recently filed Schedule 13G, as filed with the SEC on May 5, 2020 by South Ocean Capital Management, LLC. The address for the reporting persons is c/o South Ocean Capital Management, LLC, 255 Via Palacio, Palm Beach Gardens, FL 33418. |
(9) | Includes (i) 200,000 shares of our Common Stock issued in the PIPE Investment; (ii) 902,049 shares of our Common Stock; and (iii) 300,000 Public Warrants. Citadel Advisors LLC is the portfolio manager of the reporting person. Citadel Advisors Holdings LP is the sole member of Citadel Advisors LLC. Citadel GP |
LLC is the general partner of Citadel Advisors Holdings LP. Kenneth Griffin owns a controlling interest in Citadel GP LLC. Mr. Griffin, as the owner of a controlling interest in Citadel GP LLC, may be deemed to have shared power to vote or dispose of the securities held by the reporting person. The address for the reporting person is c/o Citadel Advisors LLC, 601 Lexington Avenue, New York, NY 10022. |
(10) | Includes 401,448 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to Old Renovacor’s Investor Incentive Plan and 50,000 shares of our Common Stock issued in the PIPE Investment. |
(11) | Includes stock options to purchase 3,963 shares of our Common Stock that may be exercised within 60 days of September 30, 2021. |
(12) | Consists of shares of our Common Stock owned by Chardan Investments 2, LLC for which Jonas Grossman is the managing member. The address for the reporting persons is c/o Chardan Healthcare Acquisition 2 Corp., 17 State Street, 21st Floor, New York, NY 10004. |
• | up to 2,284,776 PIPE Shares; |
• | up to 6,305,061 of Old Renovacor Stockholder Shares; |
• | up to 1,655,661 Sponsor Shares; |
• | up to 1,922,816 Earnout Shares; |
• | up to 500,000 Sponsor Earnout Shares; and |
• | up to 3,500,000 Private Placement Warrants. |
Securities Beneficially Owned Prior to This Offering |
Securities to be Sold in This Offering |
Securities Beneficially Owned After This Offering |
||||||||||||||||||||||||||
Shares of Common Stock (1) |
Warrants (2) |
Shares of Common Stock (1) |
Warrants (2) |
Shares of Common Stock (1) |
Warrants (2) |
% |
||||||||||||||||||||||
Magdalene Cook, M.D. (3) |
451,448 | — | 598,531 | — | — | — | — | |||||||||||||||||||||
Acorn Bioventures, L.P. (4) |
1,658,848 | 715,224 | 2,018,665 | — | — | 715,224 | 4.1 | % | ||||||||||||||||||||
Arthur Feldman, M.D. (5) |
1,004,433 | — | 1,395,119 | — | — | — | — | |||||||||||||||||||||
Broadview Ventures I LLC (6) |
974,529 | — | 1,150,225 | — | — | — | — | |||||||||||||||||||||
Chardan Investments 2, LLC (7) |
1,605,661 | 3,500,000 | 2,105,661 | 3,500,000 | — | — | — | |||||||||||||||||||||
Innogest Capital (8) |
984,546 | — | 1,171,096 | — | — | — | — | |||||||||||||||||||||
Robert Driansky Trust Dated 9/11/96 (9) |
296,637 | — | 414,057 | — | — | — | — | |||||||||||||||||||||
Douglas Tilley (10) |
39,551 | — | 55,205 | — | — | — | — | |||||||||||||||||||||
Marianna LaRussa (11) |
19,775 | — | 27,602 | — | — | — | — | |||||||||||||||||||||
Joseph Y. Cheung (12) |
39,551 | — | 55,205 | — | — | — | — | |||||||||||||||||||||
Temple University—Of the Commonwealth System of Higher Education (13) |
95,228 | — | 132,922 | — | — | — | — | |||||||||||||||||||||
BioAdvance (14) |
380,419 | — | 480,862 | — | — | — | — | |||||||||||||||||||||
Novartis Bioventures Ltd. (15) |
697,436 | — | 881,582 | — | — | — | — | |||||||||||||||||||||
New Leaf Ventures Opportunities II, L.P. (16) |
697,436 | — | 881,582 | — | — | — | — | |||||||||||||||||||||
Citadel Multi-Strategy Equities Master Fund Ltd. (17) |
1,102,049 | 150,000 | 200,000 | — | 902,049 | 150,000 | 6.2 | % | ||||||||||||||||||||
RTW Investments, LP (18) |
2,187,540 | 175,000 | 800,000 | — | 1,387,540 | 175,000 | 9.2 | % | ||||||||||||||||||||
Chardan Healthcare Investments LLC (19) |
250,000 | — | 250,000 | — | — | — | — | |||||||||||||||||||||
Michael Rice |
10,000 | — | 10,000 | — | — | — | — | |||||||||||||||||||||
Richard Giroux |
10,000 | — | 10,000 | — | — | — | — | |||||||||||||||||||||
Matthew Rossen |
10,000 | — | 10,000 | — | — | — | — | |||||||||||||||||||||
Isaac Manke |
10,000 | — | 10,000 | — | — | — | — | |||||||||||||||||||||
R.A. Session II |
10,000 | — | 10,000 | — | — | — | — | |||||||||||||||||||||
TOTAL |
12,535,087 | 4,540,224 | 12,668,314 | 3,500,000 | 2,289,589 | 1,040,224 |
(1) | Represents shares of Common Stock, excluding the shares of Common Stock that may be issued upon the exercise of Warrants. |
(2) | Represents the Common Stock underlying the Warrants. |
(3) | Shares to be sold in this offering include (i) 401,448 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, (ii) 147,083 Earnout Shares and (iii) 50,000 shares of our Common Stock issued in the PIPE Investment. The address for the reporting person is c/o Renovacor, Inc., P.O. Box 8142, Greenwich, CT 06836. |
(4) | Shares to be sold in this offering include (i) 1,302,842 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, (ii) 359,817 Earnout Shares; and (iii) 356,006 shares of our Common Stock issued in the PIPE Investment. Isaac Manke, |
a director of the board of directors of Chardan Healthcare Acquisition 2 Corp. prior to the Business Combination, is a member of the General Partner of the Limited Partnership that directly holds shares by Acorn Bioventures, and as such, may be deemed to share voting and investment power with respect to such shares. Mr. Manke disclaims beneficial ownership with regard to such shares, except to the extent of his proportionate pecuniary interest therein. The address for the reporting persons is 420 Lexington Avenue, Suite 2626, New York, NY 10170. |
(5) | Shares to be sold in this offering include (i) 994,433 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, (ii) 390,686 Earnout Shares and (iii) 10,000 shares of our Common Stock issued in the PIPE Investment. The address for the reporting person is 136 Knightsbridge, Wynnewood, PA 19096. |
(6) | Shares to be sold in this offering include (i) 443,823 shares of our Common Stock issued to Broadview Ventures I LLC and 204,936 shares issued to Longview Healthcare Ventures, LLC, an affiliate of Broadview Ventures I LLC, as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, (ii) 117,183 Earnout Shares that may be issued to Broadview Ventures I LLC and 58,513 Earnout Shares that may be issued to Longview Healthcare Ventures, LLC and (iii) 325,770 shares issued in the PIPE Investment to Longview Healthcare Ventures, LLC, an affiliate of Broadview Ventures I LLC. The address for the reporting persons is c/o Broadview Ventures, Inc., 265 Franklin Street, Boston, MA 02110. |
(7) | Shares to be sold in this offering include 500,000 shares of our Common Stock being held in escrow and subject to vesting or forfeiture based on satisfaction of the Earnout Milestones set forth in that certain Sponsor Support Agreement. The address for the reporting persons is c/o Chardan Healthcare Acquisition 2 Corp., 17 State Street, 21st Floor, New York, NY 10004. |
(8) | Shares to be sold in this offering include shares of our Common Stock held by the following affiliates of Innogest Capital: (i) 437,120 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, 118,050 Earnout Shares and 194,953 shares of our Common Stock issued in the PIPE Investment to Renovaholding M S.r.l.; (ii) 220,949 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, 59,487 Earnout Shares and 85,147 shares of our Common Stock issued in the PIPE Investment to Elysia Capital; and (iii) 33,477 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan, 9,013 Earnout Shares and 12,900 shares of our Common Stock issued in the PIPE Investment to Francisco Loredan. The address the reporting persons is c/o Renovaholding M S.r.l., Via Locatelli 2, 20124 Milan, Italy. |
(9) | Shares to be sold in this offering include (i) 296,637 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 117,420 Earnout Shares. |
(10) | Shares to be sold in this offering include (i) 39,551 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 15,654 Earnout Shares. |
(11) | Shares to be sold in this offering include (i) 19,775 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 7,827 Earnout Shares. |
(12) | Shares to be sold in this offering include (i) 39,551 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 15,654 Earnout Shares. |
(13) | Shares to be sold in this offering include (i) 95,228 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 37,694 Earnout Shares. The address for the reporting person is Sullivan Hall, Garden Level, 1330 Polett Walk, Philadelphia, PA 19122. |
(14) | Shares to be sold in this offering include (i) 380,419 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 100,443 Earnout Shares. The address for the reporting person is 170 N. Radnor Chester Road, Suite 350, Radnor, PA 19087. |
(15) | Shares to be sold in this offering include (i) 697,436 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 184,146 Earnout Shares. The address for the reporting person is Lichtstrasse 35, 4056 Basel. |
(16) | Shares to be sold in this offering include (i) 697,436 shares of our Common Stock issued as a portion of the Aggregate Merger Consideration and/or pursuant to the Company’s Investor Incentive Plan and (ii) 184,146 Earnout Shares. The address for the reporting person is 420 Lexington Avenue, New York, NY 10170. |
(17) | Shares to be sold in this offering include 200,000 shares of our Common Stock issued in the PIPE Investment. Citadel Advisors LLC is the portfolio manager of the reporting person. Citadel Advisors Holdings LP is the sole member of Citadel Advisors LLC. Citadel GP LLC is the general partner of Citadel Advisors Holdings LP. Kenneth Griffin owns a controlling interest in Citadel GP LLC. Mr. Griffin, as the owner of a controlling interest in Citadel GP LLC, may be deemed to have shared power to vote or dispose of the securities held by the reporting person. The address for the reporting person is c/o Citadel Advisors LLC, 601 Lexington Avenue, New York, NY 10022. |
(18) | Shares to be sold in this offering include (i) 513,443 shares of our Common Stock issued in the PIPE Investment to RTW Master Fund, Ltd.; (ii) 229,213 shares of our Common Stock issued in the PIPE Investment to RTW Innovation Master Fund, Ltd.; and (iii) 57,344 shares of our Common Stock issued in the PIPE Investment to RTW Venture Fund Limited. RTW Investments, LP is the manager of RTW Master Fund, Ltd., RTW Venture Fund, Ltd and RTW Innovation Master Fund. Roderick Wong, M.D. is the Managing Partner and Chief Investment Officer of RTW Investments, LP and as such has sole voting and investment control over such shares. Dr. Wong disclaims beneficial ownership of such shares except to the extent of any pecuniary interest therein. The address for the reporting persons is RTW Investments, 40 10th Avenue, Floor 7, New York, NY 10014. |
(19) | Shares to be sold in this offering include 250,000 shares of our Common Stock issued in the PIPE Investment. The address for the reporting person is c/o Chardan Capital Markets LLC, 17 State Street, 21st Floor, New York, NY 10004. |
• | in whole and not in part; |
• | at a price of $0.01 per Public Warrant; |
• | at any time during the exercise period; |
• | upon a minimum of 30 days’ prior written notice of redemption; |
• | if, and only if, the last sale price of our Common Stock equals or exceeds $16.00 per share for any ten trading days within a 30-trading day period ending on the third business day prior to the date on which we send the notice of redemption to the warrant holders; and |
• | if, and only if, there is a current registration statement in effect with respect to the shares of Common Stock underlying such Public Warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption. |
• | our sponsor, founders, officers or directors; |
• | financial institutions or financial services entities; |
• | broker-dealers; |
• | governments or agencies or instrumentalities thereof; |
• | regulated investment companies; |
• | S corporations; |
• | real estate investment trusts; |
• | expatriates or former long-term residents of the United States; |
• | persons that actually or constructively own five percent (5%) or more (by vote or value) of our Common Stock; |
• | insurance companies; |
• | dealers or traders subject to a mark-to-market |
• | accrual-method taxpayers who are required under Section 451(b) of the Internal Revenue Code of 1986, as amended, or the Code, to recognize income for U.S. federal income tax purposes no later than when such income is taken into account in applicable financial statements; |
• | persons holding the securities as part of a “straddle,” hedge, integrated transaction or similar transaction; |
• | U.S. holders (as defined below) whose functional currency is not the U.S. dollar; |
• | partnerships or other pass-through entities for U.S. federal income tax purposes and any beneficial owners of such entities; |
• | persons who acquire our securities as compensation; and |
• | tax-exempt entities. |
• | an individual who is a citizen or resident of the United States; |
• | a corporation (or other entity taxable as a corporation) organized in or under the laws of the United States, any state thereof or the District of Columbia; |
• | an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or |
• | a trust if (a) a court within the United States is able to exercise primary supervision over the administration of the trust and one or more United States persons (as defined in the Code) have the authority to control all substantial decisions of the trust, or (b) it has in effect a valid election under Treasury Regulations to be treated as a United States person. |
• | a non-resident alien individual (other than certain former citizens and residents of the United States subject to U.S. tax as expatriates); |
• | a foreign corporation; or |
• | an estate or trust that is not a U.S. holder; |
• | the gain is effectively connected with the conduct by the Non-U.S. holder of a trade or business within the United States (and, under certain income tax treaties, is attributable to a U.S. permanent establishment or fixed base maintained by the Non-U.S. holder); |
• | such Non-U.S. holder is an individual who was present in the United States for 183 days or more in the taxable year of such disposition and certain other requirements are met; or |
• | we are or have been a “United States real property holding corporation” for U.S. federal income tax purposes at any time during the shorter of the five-year period ending on the date of disposition or the period that the Non-U.S. holder held our Common Stock or Private Placement Warrants and, in the case where shares of our Common Stock are regularly traded on an established securities market, the Non-U.S. holder has owned, directly or constructively, more than five percent (5%) of our Common Stock at any time within the shorter of the five-year period preceding the disposition or such Non-U.S. holder’s holding period for the shares of our Common Stock or Private Placement Warrants. There can be no assurance that our Common Stock is or has been treated as regularly traded on an established securities market for this purpose. |
• | 1% of the total number of shares of our Common Stock then outstanding; or |
• | the average weekly reported trading volume of our Common Stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale. |
• | the issuer of the securities that was formerly a shell company has ceased to be a shell company; |
• | the issuer of the securities is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act; |
• | the issuer of the securities has filed all Exchange Act reports and material required to be filed, as applicable, during the preceding 12 months (or such shorter period that the issuer was required to file such reports and materials) other than Form 8-K reports; and |
• | at least one year has elapsed from the time that the issuer filed current Form 10-type information with the SEC reflecting its status as an entity that is not a shell company. |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the SEC; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share; |
• | a combination of any such methods of sale; or |
• | any other method permitted by applicable law. |
Chardan Healthcare Acquisition 2 Corp. Audited Financial Statements |
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F-2 |
||||
Financial Statements: |
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F-3 |
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F-4 |
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F-5 |
||||
F-6 |
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F-7 to F-17 |
||||
Chardan Healthcare Acquisition 2 Corp. Unaudited Condensed Financial Statements |
||||
Financial Statements (unaudited): |
||||
F-18 |
||||
F-19 |
||||
F-20 |
||||
F-21 |
||||
F-22 to F-36 |
||||
Renovacor, Inc. (Old Renovacor) Audited Financial Statements |
||||
F-37 |
||||
Financial Statements: |
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F-38 |
||||
F-39 |
||||
F-40 |
||||
F-41 |
||||
F-42 to F-57 |
||||
Renovacor, Inc. (Old Renovacor) Unaudited Condensed Financial Statements |
||||
Financial Statements (unaudited): |
||||
F-58 |
||||
F-59 |
||||
F-60 |
||||
F-61 |
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F-62 to F-74 |
December 31, |
||||||||
2020 |
2019 |
|||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash |
$ | $ | ||||||
Prepaid expenses and other current asset |
||||||||
|
|
|
|
|||||
Total Current Assets |
||||||||
Marketable securities held in trust account |
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|
|
|
|
|||||
TOTAL ASSETS |
$ |
$ |
||||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities — accounts payable and accrued expenses |
$ | $ | ||||||
Promissory note — related party |
||||||||
|
|
|
|
|||||
TOTAL LIABILITIES |
||||||||
|
|
|
|
|||||
Commitments |
||||||||
Common stock subject to possible redemption |
||||||||
Stockholders’ Equity |
||||||||
Preferred stock, $ |
||||||||
Common stock, $ (1) , respectively |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total Stockholders’ Equity |
||||||||
|
|
|
|
|||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
$ |
||||||
|
|
|
|
(1) | Common stock balance at December 31, 2019, included |
Year Ended December 31, |
||||||||
2020 |
2019 |
|||||||
Operating and formation costs |
$ | $ | ||||||
|
|
|
|
|||||
Loss from operations |
( |
) |
( |
) | ||||
Other income: |
||||||||
Interest earned on marketable securities held in trust account |
||||||||
|
|
|
|
|||||
Net (loss) income |
$ |
( |
) |
$ |
( |
) | ||
|
|
|
|
|||||
Weighted average shares outstanding, basic and diluted (1) |
||||||||
|
|
|
|
|||||
Basic and diluted net loss per common share |
$ |
( |
) |
$ |
( |
) | ||
|
|
|
|
(1) | Excludes an aggregate of |
Common Stock |
Additional Paid in Capital |
Accumulated Deficit |
Total Stockholders’ Equity |
|||||||||||||||||
Shares |
Amount |
|||||||||||||||||||
Balance — January 1, 2019 |
$ |
$ |
$ |
( |
) |
$ |
||||||||||||||
Net loss |
— | ( |
) | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance — December 31, 2019 |
( |
) |
||||||||||||||||||
Cancellation of Founder Shares |
( |
) | ( |
) | ||||||||||||||||
Forfeiture of Founder Shares |
( |
) | ( |
) | ||||||||||||||||
Sales of |
||||||||||||||||||||
Sale of |
— | |||||||||||||||||||
Common stock subject to redemption |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Net income |
— | ( |
) | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance — December 31, 2020 |
$ |
$ |
$ |
( |
) |
$ |
||||||||||||||
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
||||||||
2020 |
2019 |
|||||||
Cash Flows from Operating Activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Interest earned on marketable securities held in trust account |
( |
) | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ( |
) | ||||
Accounts payable and accrued expenses |
||||||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Cash Flows from Investing Activities: |
||||||||
Investment of cash in trust account |
( |
) | ||||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) |
||||||
|
|
|
|
|||||
Cash Flows from Financing Activities: |
||||||||
Proceeds from collection of stock subscription receivable from Sponsor |
||||||||
Proceeds from sale of Units, net of underwriting discounts paid |
||||||||
Proceeds from sale of Private Placement Warrants |
||||||||
Proceeds from promissory note — related party |
||||||||
Repayment of promissory note — related party |
( |
) | ||||||
Payment of offering costs |
( |
) | ||||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
|
|
|
|
|||||
Net Change in Cash |
||||||||
Cash — Beginning of period |
||||||||
|
|
|
|
|||||
Cash — End of period |
$ |
$ |
||||||
|
|
|
|
|||||
Non-Cash investing and financing activities: |
||||||||
Initial classification of common stock subject to possible redemption |
$ | $ |
||||||
|
|
|
|
|||||
Change in value of common stock subject to possible redemption |
$ | ( |
) | $ |
||||
|
|
|
|
• | in whole and not in part; |
• | at a price of $0.01 per warrant; |
• | at any time during the exercise period; |
• | upon a minimum of 30 days’ prior written notice of redemption |
• | if, and only if, the last sale price of the Company’s common stock equals or exceeds $16.00 per share for any 10 trading days within a 30-trading day period ending on the third business day prior to the date on which the Company sends the notice of redemption to the warrant holders; and |
• | if, and only if, there is a current registration statement in effect with respect to the shares of common stock underlying such warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption. |
December 31, 2020 |
December 31, 2019 |
|||||||
Deferred tax assets |
||||||||
Net operating loss carryforward |
$ | $ | ||||||
Total deferred tax assets |
||||||||
Valuation Allowance |
( |
) | ( |
) | ||||
Deferred tax assets, net of allowance |
$ | $ | ||||||
December 31, 2020 |
December 31, 2019 |
|||||||
Federal |
||||||||
Current |
$ | $ | ||||||
Deferred |
( |
) | ( |
) | ||||
State and Local |
||||||||
Current |
||||||||
Deferred |
||||||||
Change in valuation allowance |
||||||||
Income tax provision |
$ | $ | ||||||
December 31, 2020 |
December 31, 2019 |
|||||||
Statutory federal income tax rate |
% | % | ||||||
Valuation allowance |
( |
)% | ( |
)% | ||||
Income tax provision |
% | % | ||||||
Level 1: | Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. |
Level 2: |
Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. | |
Level 3: |
Unobservable inputs based on our assessment of the assumptions that market participants would use in pricing the asset or liability. |
Description |
Level |
December 31, 2020 |
||||||
Assets: |
||||||||
Marketable securities held in Trust Account |
1 | $ |
June 30, 2021 |
December 31, 2020 |
|||||||
(Unaudited) |
(As Revised) |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash |
$ | $ | ||||||
Prepaid expenses |
||||||||
Total current assets |
||||||||
Investments held in Trust Account |
||||||||
Total assets |
$ | $ | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities—accounts payable and accrued expenses |
$ | $ | ||||||
Promissory note—related party |
||||||||
Warrant liabilities |
||||||||
Total liabilities |
||||||||
Commitments |
||||||||
Common stock, $ |
||||||||
Stockholders’ Equity (Deficit): |
||||||||
Preferred stock, $ |
— | |||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ equity (deficit) |
( |
) | ||||||
Total liabilities and stockholders’ equity (deficit) |
$ | $ | ||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Operating costs |
$ | $ | $ | $ | ||||||||||||
Franchise tax expense |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Change in fair value of warrant liabilities |
( |
) | ( |
) | ||||||||||||
Interest earned on marketable securities held in Trust Account |
||||||||||||||||
Fair value in excess of consideration recorded on the issuance of private warrants |
( |
) | ( |
) | ||||||||||||
Transaction costs |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted weighted average shares outstanding, Redeemable Common Stock |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted net earnings per share, Redeemable Common Stock |
$ | $ | $ | $ | ||||||||||||
Basic and diluted weighted average shares outstanding, Non-Redeemable Common Stock |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted net loss per share, Non-Redeemable Common Stock |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||
Shares |
Amount |
|||||||||||||||||||
Balances, December 31, 2020 (Revised) |
$ | $ | $ | ( |
) | $ | ||||||||||||||
Measurement adjustment on redeemable Common Stock |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Net loss |
— | ( |
) | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balances, March 31, 2021 (Unaudited) |
$ |
$ |
$ |
( |
) |
$ |
( |
) | ||||||||||||
Measurement adjustment on redeemable Common Stock |
— | ( |
) | ( |
) | |||||||||||||||
Net loss |
— | ( |
) | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balances, June 30, 2021 (Unaudited) |
$ |
$ |
$ |
( |
) |
$ |
( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|
|
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||
Shares |
Amount |
|||||||||||||||||||
Balances, December 31, 2019 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
Net loss |
— | ( |
) | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balances, March 31, 2020 (Unaudited) |
$ |
$ | $ | ( |
) | $ | ||||||||||||||
Cancellation of Founder Shares |
( |
) | ( |
) | ||||||||||||||||
Forfeiture of Founder Shares |
( |
) | ( |
) | ||||||||||||||||
Sales of |
||||||||||||||||||||
Transaction costs from sale of |
— | |||||||||||||||||||
Common stock subject to redemption |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Net loss |
— | ( |
) | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balances, June 30, 2020 (Unaudited) |
$ |
$ | $ | ( |
) | $ | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
||||||||
2021 |
2020 |
|||||||
Cash Flows from Operating Activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operations: |
||||||||
Transaction costs incurred in connection with IPO |
||||||||
Fair value in excess of consideration recorded on the issuance of private warrants |
||||||||
Change in fair value of warrant liability |
( |
) | ||||||
Interest earned on marketable securities held in Trust Account |
( |
) | ( |
) | ||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses |
( |
) | ||||||
Accrued expenses |
||||||||
Net cash used in operating activities |
( |
) |
( |
) | ||||
Cash Flows from Investing Activities: |
||||||||
Investment of cash in Trust Account |
( |
) | ||||||
Net cash used in investing activities |
( |
) | ||||||
Cash Flows from Financing Activities: |
||||||||
Proceeds from sale of Units, net of underwriting discounts paid |
||||||||
Proceeds from sale of Private Placement Warrants |
||||||||
Proceeds from promissory note—related party |
||||||||
Repayment of promissory note—related party |
( |
) | ||||||
Payment of offering costs |
( |
) | ||||||
Net cash provided by financing activities |
||||||||
Net change in cash |
( |
) | ||||||
Cash at beginning of period |
||||||||
Cash at end of period |
$ |
$ |
||||||
Supplemental disclosure of noncash investing and financing activities: |
||||||||
Initial classification of common stock subject to possible redemption |
$ | $ | ||||||
Initial measurement of warrants issued in connection with the IPO accounted for as liabilities |
$ | $ | ||||||
Change in value of common stock subject to possible redemption |
$ | $ | ( |
) | ||||
Three Months Ended June 30, 2021 |
Three Months Ended June 30, 2020 |
Six Months Ended June 30, 2021 |
Six Months Ended June 30, 2020 |
|||||||||||||
Class A Common Stock subject to possible redemption |
||||||||||||||||
Numerator: Earnings attributable to Class A Common Stock subject to possible redemption |
||||||||||||||||
Franchise tax expense |
$ | ( |
) | $ | — | $ | ( |
) | $ | — | ||||||
|
|
|
|
|
|
|
|
|||||||||
Net earnings attributable to Class A Common Stock subject to possible redemption |
$ | ( |
) | $ | — | $ | ( |
) | $ | — | ||||||
|
|
|
|
|
|
|
|
|||||||||
Denominator: Weighted average Class A Common Stock subject to possible redemption |
||||||||||||||||
Basic and diluted weighted average shares outstanding, Class A Common Stock subject to possible redemption |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted net earnings per share, Class A Common Stock subject to possible redemption |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Non-Redeemable Class A and Class B Common Stock |
||||||||||||||||
Numerator: Non-redeemable net loss - Basic and Diluted |
||||||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Less: Net earnings attributable to Class A Common Stock subject to possible redemption |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Non-redeemable net loss—Basic and Diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
|||||||||
Denominator: Weighted average Non-Redeemable Class A and Class B Common Stock |
||||||||||||||||
Basic and diluted weighted average shares outstanding, Non-Redeemable Class A and Class B Common Stock |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Basic and diluted net loss per share, Non-Redeemable Class A and Class B Common Stock |
$ | $ | ( |
) | $ | $ | ( |
) | ||||||||
|
|
|
|
|
|
|
|
Description |
Amount at Fair Value |
Level 1 |
Level 2 |
Level 3 |
||||||||||||
June 30, 2021 |
||||||||||||||||
Assets |
||||||||||||||||
Investments held in Trust Account: |
||||||||||||||||
Money Market investments |
$ | $ | $ | — | $ | — | ||||||||||
Liabilities |
||||||||||||||||
Warrant liability – Private Placement Warrants |
$ | $ | — | $ | — | $ | ||||||||||
December 31, 2020 |
||||||||||||||||
Assets |
||||||||||||||||
Investments held in Trust Account: |
||||||||||||||||
Money Market investments |
$ | $ | $ | — | $ | — | ||||||||||
Liabilities |
||||||||||||||||
Warrant liability – Private Placement Warrants |
$ | $ | — | $ | — | $ |
As of June 30, 2021 |
As of December 31, 2020 |
|||||||
Stock price |
$ | $ | ||||||
Strike price |
$ | $ | ||||||
Probability of completing a Business Combination |
% | % | ||||||
Dividend yield |
% | % | ||||||
Term (in years) |
||||||||
Volatility |
% | % | ||||||
Risk-free rate |
% | % | ||||||
Fair value of warrants |
$ | $ |
Warrant Liabilities |
||||
Fair value as of December 31, 2020 |
$ | |||
Change in fair value of warrant liabilities |
( |
) | ||
Fair value as of June 30, 2021 |
$ |
December 31, | ||||||||
2019 | 2020 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Prepaids and other current assets |
||||||||
Total current assets |
||||||||
Property and equipment, net |
||||||||
Total assets |
$ | $ | ||||||
Liabilities, Convertible Preferred Stock, and Stockholders’ Deficit |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
Total current liabilities |
||||||||
Total liabilities |
||||||||
Commitments and contingencies (Note 6) |
||||||||
Convertible preferred stock, $ |
||||||||
Stockholders’ deficit: |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ deficit |
( |
) | ( |
) | ||||
Total liabilities, convertible preferred stock, and stockholders’ deficit |
$ | $ | ||||||
December 31, | ||||||||
2019 | 2020 | |||||||
Operating expenses: |
||||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
|
|
|
|
|||||
Loss from operations |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net loss |
( |
) | ( |
) | ||||
Cumulative preferred stock dividends |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net loss attributable to common stockholders |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Net loss per share — basic and diluted |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Weighted average common shares outstanding — basic and diluted |
||||||||
|
|
|
|
Convertible Preferred Stock |
Common Stock |
Additional Paid-in Capital |
Accumulated |
Total Stockholders’ Deficit |
||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Deficit |
||||||||||||||||||||||||
Balance, December 31, 2018 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Vesting of restricted common stock |
— | — | — | — | — | |||||||||||||||||||||||
Issuance of Series A convertible preferred stock, net of issuance costs of $ |
— | — | — | — | — | |||||||||||||||||||||||
Issuance of common stock in exchange for license rights |
— | — | — | |||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance, December 31, 2019 |
( |
) | ( |
) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Vesting of restricted common stock |
— | — | — | — | — | |||||||||||||||||||||||
Issuance of Series A convertible preferred stock, net of issuance costs of $ |
— | — | — | — | — | |||||||||||||||||||||||
Issuance of common stock in exchange for license rights |
— | |||||||||||||||||||||||||||
Issuance of restricted common stock |
— | — | — | — | — | — | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance, December 31, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net l o ss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Stock-based compensation |
||||||||
Shares issued in connection with license agreement |
||||||||
Depreciation expense |
||||||||
Other |
||||||||
Change in assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ( |
) | ||||
Accounts payable |
( |
) | ||||||
Accrued expenses |
||||||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Proceeds from issuance of Series A convertible preferred stock, net of issuance costs |
||||||||
Repayments of long-term debt |
( |
) | ||||||
Net cash provided by financing activities |
||||||||
NET INCREASE IN CASH |
||||||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
||||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD |
$ | $ | ||||||
SUPPLEMENTAL DISCLOSURES OF NONCASH ACTIVITIES: |
||||||||
Conversion of note payable into Series A preferred stock |
$ | $ | ||||||
Vesting of restricted common stock |
$ | $ | ||||||
1. |
Nature of Business and Basis of Presentation |
2. |
Summary of Significant Accounting Policies |
Estimated Useful Life (Years) |
||||
Laboratory equipment |
||||
Furniture and fixtures and office equipment |
||||
Computer equipment and software |
3. |
Prepaid Expenses and Other Current Assets |
December 31, | ||||||||
2019 | 2020 | |||||||
Research and development costs |
$ | $ | ||||||
Insurance |
||||||||
Other |
||||||||
Total prepaid expenses and other current assets |
$ | $ | ||||||
4. |
Property and Equipment, Net |
December 31, | ||||||||
2019 | 2020 | |||||||
Laboratory equipment |
$ | $ | ||||||
Less: accumulated depreciation |
( |
) | ( |
) | ||||
$ | $ | |||||||
5. |
Accrued Expenses |
December 31, | ||||||||
2019 | 2020 | |||||||
Accrued employee compensation and benefits |
$ | $ | ||||||
Accrued external research and development expenses |
||||||||
Shares of restricted common stock subject to repurchase |
||||||||
Accrued professional fees |
||||||||
Total accrued expenses |
$ | $ | ||||||
6. |
Commitments and Contingencies |
7. |
License and Sponsored Research Agreements |
8. |
Convertible Preferred Stock |
Issuance Dates | Shares Issued and Outstanding |
Common Stock Issuable Upon Conversion |
||||||||
Series A |
August 2019 | |||||||||
Series A |
June 2020 | |||||||||
Series A |
November 2020 |
9. |
Common Stock |
Conversion of Series A preferred stock |
||||
Series A preferred stock reserved for 3 rd tranche (see Note 8) |
||||
Stock options available for issuance |
||||
Stock options outstanding |
||||
|
|
|||
Total |
||||
|
|
10. |
Stock-Based Compensation |
Year Ended December 31, 2020 |
||||
Expected volatility |
% | |||
Risk-free interest rate |
% | |||
Expected dividend yield |
||||
Expected term (in years) |
Number of Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (years) |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding — December 31, 2019 |
$ | $ | ||||||||||||||
Granted |
||||||||||||||||
Exercised |
||||||||||||||||
Forfeited |
||||||||||||||||
|
|
|||||||||||||||
Outstanding — December 31, 2020 |
$ | $ | ||||||||||||||
|
|
|||||||||||||||
Options exercisable — December 31, 2020 |
$ | $ | ||||||||||||||
|
|
Number of Shares |
||||
Unvested — January 1, 2019 |
||||
Issued |
||||
Vested |
( |
) | ||
Cancelled |
||||
|
|
|||
Unvested — December 31, 2019 |
||||
Issued |
||||
Vested |
( |
) | ||
Cancelled |
||||
|
|
|||
Unvested — December 31, 2020 |
||||
|
|
Year Ended December 31, |
||||||||
2019 | 2020 | |||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
|
|
|
|
|||||
Total stock-based compensation expense |
$ | $ | ||||||
|
|
|
|
11. |
Income Taxes |
Year Ended December 31, |
||||||||
2019 | 2020 | |||||||
Income tax computed at federal statutory rate |
% | % | ||||||
State tax, net of federal benefit |
||||||||
Other |
||||||||
Change in valuation allowance |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Effective income tax rate |
% | % | ||||||
|
|
|
|
Year Ended December 31, | ||||||||
2019 | 2020 | |||||||
Deferred tax assets |
||||||||
Federal and state net operating losses |
$ | $ | ||||||
Capitalized patent costs |
||||||||
Stock-based compensation |
||||||||
|
|
|
|
|||||
Gross deferred tax assets |
||||||||
Less: valuation allowance |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total deferred tax assets |
$ | $ | ||||||
|
|
|
|
|||||
Deferred tax liabilities |
||||||||
Fixed assets |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Total deferred tax liabilities |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Net deferred tax assets |
$ | $ | ||||||
|
|
|
|
12. |
Net Loss per Share |
For the Years Ended December 31, |
||||||||
2019 | 2020 | |||||||
Convertible Preferred Stock |
||||||||
Stock options to purchase common stock |
||||||||
Restricted shares of common stock subject to repurchase |
13. |
Related Parties |
14. |
Subsequent Events |
December 31, 2020* |
June 30, 2021 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash |
$ | $ | ||||||
Prepaids and other current assets |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Property and equipment, net |
||||||||
Deferred merger costs |
||||||||
|
|
|
|
|||||
Total assets |
$ | $ | ||||||
|
|
|
|
|||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ DEFICIT |
| |||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
|
|
|
|
|||||
Total current liabilities |
||||||||
|
|
|
|
|||||
Total liabilities |
||||||||
Commitments and contingencies (Note 6) |
||||||||
Preferred stock, $ |
||||||||
Stockholders’ deficit: |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total stockholders’ deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total liabilities, convertible preferred stock, and stockholders’ deficit |
$ | $ | ||||||
|
|
|
|
* | The condensed balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. |
Six Months Ended June 30, |
||||||||
2020 |
2021 |
|||||||
Operating expenses: |
||||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
|
|
|
|
|||||
Loss from operations |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net loss |
( |
) | ( |
) | ||||
Cumulative preferred stock dividends |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net loss attributable to common stockholders |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Net loss per share - basic and diluted |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Weighted-average number of common shares used in computing net loss per share applicable to common stockholders - basic and diluted |
||||||||
|
|
|
|
For the Six Months Ended June 30, 2020 |
||||||||||||||||||||||||||||
Additional |
Total |
|||||||||||||||||||||||||||
Convertible Preferred Stock |
Common Stock |
Paid-in |
Accumulated |
Stockholders’ |
||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Capital |
Deficit |
Deficit |
||||||||||||||||||||||
Balance, December 31, 2019 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Series A Preferred Stock, net of issuance costs of $ |
— | — | — | — | — | — | ||||||||||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Issuance of restricted common stock |
— | — | — | — | — | — | ||||||||||||||||||||||
Vesting of restricted common stock |
— | — | — | — | — | |||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance, June 30, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
For the Six Months Ended June 30, 2021 |
||||||||||||||||||||||||||||
Additional |
Total |
|||||||||||||||||||||||||||
Convertible Preferred Stock |
Common Stock |
Paid-in |
Accumulated |
Stockholders’ |
||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Capital |
Deficit |
Deficit |
||||||||||||||||||||||
Balance, December 31, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Issuance of restricted common stock |
— | — | — | |||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance, June 30, 2021 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-Months Ended June 30, |
||||||||
2020 |
2021 |
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Stock-based compensation |
||||||||
Depreciation expense |
||||||||
Change in assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ||||||
Accounts payable |
( |
) | ||||||
Accrued expenses |
||||||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Deferred merger costs |
( |
) | ||||||
Proceeds from issuance of Series A convertible preferred stock, net |
||||||||
Proceeds from issuance of restricted stock |
||||||||
Net cash provided by (used in) financing activities |
( |
) | ||||||
NET DECREASE IN CASH |
( |
) | ( |
) | ||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
||||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD |
$ | $ | ||||||
SUPPLEMENTAL DISCLOSURES OF NONCASH ACTIVITIES: |
||||||||
Deferred merger costs included in accrued expenses and accounts payable |
$ | $ | ||||||
December 31, |
June 30, |
|||||||
2020 |
2021 |
|||||||
Research and development costs |
$ | $ | ||||||
Insurance and other |
||||||||
|
|
|
|
|||||
Total prepaid expenses and other current assets |
$ | $ | ||||||
|
|
|
|
December 31, |
June 30, |
|||||||
2020 |
2021 |
|||||||
Laboratory equipment |
$ | $ | ||||||
Less: accumulated amortization |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Property and equipment, net |
$ | $ | ||||||
|
|
|
|
December 31, |
June 30, |
|||||||
2020 |
2021 |
|||||||
Employee compensation and benefits |
$ | $ | ||||||
External research and development expenses |
||||||||
Deferred merger costs |
||||||||
Professional fees and other |
||||||||
|
|
|
|
|||||
Total accrued expenses |
$ | $ | ||||||
|
|
|
|
Issuance Dates |
Shares Issued and Outstanding |
Common Stock Issuable Upon Conversion |
||||||||||
Series A |
August 2019 | |||||||||||
Series A |
June 2020 | |||||||||||
Series A |
November 2020 |
Conversion of Series A preferred stock |
||||
Series A preferred stock reserved for 3 rd tranche (Note 8) |
||||
Stock options available for issuance |
||||
Stock options outstanding |
||||
|
|
|||
Total |
||||
|
|
Six Months Ended |
||||||||
June 30, |
||||||||
2020 |
2021 |
|||||||
Expected volatility |
% | % | ||||||
Risk-free interest rate |
% | % | ||||||
Expected dividend yield |
||||||||
Expected term (in years) |
Number of Options |
Weighted-Average Exercise Price |
Weighted-Average Remaining Contractual Term (years) |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding - December 31, 2020 |
$ | $ | ||||||||||||||
Granted |
||||||||||||||||
Exercised |
||||||||||||||||
Forfeited |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Outstanding – June 30, 2021 |
$ | $ | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Exercisable – June 30, 2021 |
$ | $ | ||||||||||||||
|
|
|
|
|
|
|
|
Number of Shares |
||||
Unvested - December 31, 2020 |
||||
Issued |
||||
Vested |
( |
) | ||
Cancelled |
||||
Unvested – June 30, 2021 |
||||
Six Months Ended |
||||||||
June 30, |
||||||||
2020 |
2021 |
|||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
Total stock-based compensation expense |
$ | $ | ||||||
2020 |
2021 |
|||||||
Convertible Preferred Stock |
||||||||
Stock options to purchase common stock |
||||||||
Restricted shares of common stock subject to repurchase |
Amount to be Paid |
||||
SEC registration fee |
$ | 18,241 | ||
Legal fees and expenses |
$ | 225,000 | ||
Accounting fees and expenses |
$ | 65,000 | ||
Miscellaneous expenses |
$150,000 | |||
|
|
|||
Total |
$ | 458,241 | ||
|
|
† | Certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish supplementally a copy of all omitted exhibits and schedules to the SEC upon its request. |
* | Filed herewith. |
# | Indicates management contract or compensatory arrangement. |
** | To be filed, if necessary, subsequent to the effectiveness of this registration statement by an amendment to this registration statement or incorporated by reference pursuant to a Current Report on Form 8-K in connection with the offering of securities. |
a. | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
i. | to include any prospectus required by section 10(a)(3) of the Securities Act; |
ii. | to reflect in the prospectus any facts or events arising after the effective date of this registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this registration |
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
iii. | to include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement ; |
b. | That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
c. | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
d. | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
i. | each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
ii. | each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
e. | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use. |
f. | That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary |
offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
i. | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
ii. | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
iii. | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
iv. | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
RENOVACOR, INC. | ||
By: |
/s/ Magdalene Cook, M.D. | |
Magdalene Cook, M.D. President and Chief Executive Officer ( Principal Executive Officer |
Signature |
Title |
Date | ||
/s/ Magdalene Cook, M.D. Magdalene Cook, M.D. |
Chief Executive Officer, President and Chairperson ( Principal Executive Officer |
October 15, 2021 | ||
/s/ Wendy DiCicco Wendy DiCicco |
Interim Chief Financial Officer ( Principal Financial and Accounting Officer |
October 15, 2021 | ||
/s/ Gbola Amusa, M.D. Gbola Amusa, M.D. |
Director | October 15, 2021 | ||
/s/ Edward J. Benz, Jr., M.D. Edward J. Benz, Jr., M.D. |
Director | October 15, 2021 | ||
/s/ Gregory F. Covino Gregory F. Covino |
Director | October 15, 2021 | ||
/s/ Jonas Grossman Jonas Grossman |
Director | October 15, 2021 | ||
/s/ Joan Lau, Ph.D. Joan Lau, Ph.D. |
Director | October 15, 2021 | ||
/s/ Thomas Needham Thomas Needham |
Director | October 15, 2021 |