The 2015 Enterprise Management Incentive Share Option Plan of Replimune UK (the
"2015 Plan") provided for Replimune UK to grant incentive stock options,
non-statutory stock options, stock awards, stock units, stock appreciation
rights and other stock-based awards. Incentive stock options were granted under
the 2015 Plan only to the Company's employees, including officers and directors
who were also employees. Non-statutory stock options were granted under the 2015
Plan to employees, members of the board of directors, outside advisors and
consultants of the Company.

2017 Equity Compensation Plan



In July 2017, in conjunction with reorganization by Replimune Limited, pursuant
to which each shareholder thereof exchanged their outstanding shares in
Replimune Limited for shares in Replimune Group, Inc., on a one-for-one basis
(the "Reorganization"), the 2015 Plan was terminated, and all awards were
cancelled with replacement awards issued under the 2017 Equity Compensation Plan
(the "2017 Plan"). Subsequent to the Reorganization, no additional grants have
been or will be made under the 2015 Plan and any outstanding awards under the
2015 Plan have continued, and will continue with their original terms. The
Company concluded that the cancellation of the 2015 Plan and issuance of
replacement awards under the 2017 Plan was a modification with no change in the
material rights and preferences and therefore no recorded change in the fair
value of each respective award.

The Company's 2017 Plan provides for the Company to grant incentive stock
options or non-statutory stock options, stock awards, stock units, stock
appreciation rights and other stock-based awards. Incentive stock options were
granted under the 2017 Plan only to the Company's employees, including officers
and directors who were also employees. Restricted stock awards and non-statutory
stock options were granted under the 2017 Plan to employees, officers, members
of the board of directors, advisors and consultants of the Company. The maximum
number of common shares that may be issued under the 2017 Plan was 2,659,885, of
which none remained available for future grants as of June 30, 2022. Shares with
respect to which awards have expired, terminated, surrendered or cancelled under
the 2017 Plan without having been fully exercised will be available for future
awards under the 2018 Plan referenced below. In addition, shares of common stock
that are tendered to the Company by a participant to exercise an award are added
to the number of shares of common stock available for the grant of awards.

2018 Omnibus Incentive Compensation Plan



On July 9, 2018, the Company's board of directors adopted, and the Company's
stockholders approved the 2018 Omnibus Incentive Compensation Plan (the "2018
Plan"), which became effective immediately prior to the effectiveness of the
registration statement filed in connection with the Company's initial public
offering. The 2018 Plan provides for the issuance of incentive stock options,
non-qualified stock options, stock awards, stock units, stock appreciation
rights and other stock-based
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awards. The number of shares of common stock initially reserved for issuance
under the 2018 Plan is 3,617,968 shares. If any options or stock appreciation
rights, including outstanding options and stock appreciation rights granted
under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or are
canceled, forfeited, exchanged, or surrendered without having been exercised, or
if any stock awards, stock units or other stock-based awards, including
outstanding awards granted under the 2017 Plan, are forfeited, terminated, or
otherwise not paid in full in shares of common stock, the shares of the
Company's common stock subject to such grants will be available for purposes of
the 2018 Plan. The number of shares reserved for issuance under the 2018 Plan
will increase automatically on the first day of each April equal to 4.0% of the
total number of shares of Company stock outstanding on the last trading day in
the immediately preceding fiscal year, which includes for these purposes, the
5,284,238 shares issuable upon exercise of those pre-funded warrants described
in Note 7 to these consolidated financial statements, or such lesser amount as
determined by the Board. On April 1, 2022, the number of shares reserved for
issuance under the 2018 Plan automatically increased by 2,104,915 shares
pursuant to the terms of the 2018 Plan and based on total number of shares of
Company stock outstanding on March 31, 2022. On April 1, 2021, the number of
shares reserved for issuance under the 2018 Plan automatically increased by
2,074,028 shares pursuant to the terms of the 2018 Plan. As of June 30, 2022,
2,337,711 shares remained available for future grants under the 2018 Plan.

The 2015 Plan, the 2017 Plan and the 2018 Plan are administered by the board of
directors or, at the discretion of the board of directors, by a committee of the
board of directors. However, the board of directors shall administer and approve
all grants made to non-employee directors. The exercise prices, vesting and
other restrictions are determined at the discretion of the board of directors,
except that the exercise price per share of incentive stock options may not be
less than 100% of the fair market value of the common stock on the date of grant
(or 110% of fair value in the case of an award granted to employees who hold
more than 10% of the total combined voting power of all classes of stock at the
time of grant) and the term of stock options may not be greater than five years
for an incentive stock option granted to a 10% stockholder and greater than ten
years for all other options granted. Stock options awarded under both plans
expire ten years after the grant date, unless the board of directors sets a
shorter term. Vesting periods for the plans are determined at the discretion of
the board of directors. Incentive stock options granted to employees and
non-statutory options granted to employees, officers, members of the board of
directors, advisors, and consultants of the Company typically vest over four
years. In 2021 the board of directors initiated the award of restricted stock
units ("RSUs"), under the 2018 Plan in addition to stock option awards available
as part of the Company's equity incentive for employees, officers, advisors and
consultants of the Company. The RSUs typically vest over four approximately
equal annual installments with the first such installment occurring on a
designated vesting date that is approximately on the one year anniversary of the
date of grant and the subsequent installments occurring on the subsequent three
annual anniversaries of the designated vesting date.

Employee Stock Purchase Plan



On July 9, 2018, the Company's board of directors adopted and the Company's
stockholders approved the Employee Stock Purchase Plan (the "ESPP"), which
became effective immediately prior to the effectiveness of the registration
statement that was filed in connection with the Company's IPO. The total shares
of common stock initially reserved for issuance under the ESPP is 348,612
shares. In addition, as of the first trading day of each fiscal year during the
term of the ESPP (excluding any extensions), an additional number of shares of
the Company's common stock equal to 1% of the total number of shares outstanding
on the last trading day in the immediately preceding fiscal year, which includes
for these purposes, the 5,284,238 shares issuable upon exercise of those
pre-funded warrants described in Note 7 to these consolidated financial
statements, or 697,224 shares, whichever is less (or such lesser amount as
determined by the Company's board of directors) will be added to the number of
shares authorized under the ESPP. In accordance with the terms of the ESPP, on
April 1, 2022 and 2021, the number of shares reserved for issuance under the
ESPP automatically increased by 526,228 and 518,507 shares respectively, for a
total of 2,076,603 shares reserved for the ESPP. If the total number of shares
of common stock to be purchased pursuant to outstanding purchase rights on any
particular date exceed the number of shares then available for issuance under
the ESPP, then the plan administrator will allocate the available shares
pro-rata and refund any excess payroll deductions or other contributions to
participants. The Company's ESPP is not currently active.

Out-of-Plan Inducement Grant



In May 2021, the Company granted an equity award to a newly hired executive as a
material inducement to enter into employment with the Company. The grant
constitutes an "employment inducement grant" in accordance with Rule 5635(c)(4)
of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of
the other stock incentive plans described above. The inducement grant included a
nonqualified stock option to purchase up to 125,000 shares of the Company's
common stock, as well as a restricted stock unit grant representing 88,333
shares of the Company's common stock. These stock option and restricted stock
unit inducement grants have terms and conditions consistent with those set forth
under the 2018 Plan and vest under the same respective vesting schedules as
stock option and restricted stock unit awards granted under the 2018 Plan. The
inducement grant is included in the stock option and RSU award tables below.
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Stock option valuation



The fair value of stock option grants is estimated using the Black-Scholes
option-pricing model. As the Company has limited company-specific historical and
implied volatility information, the expected stock volatility is based on a
combination of Replimune volatility and the historical volatility of a publicly
traded set of peer companies. For options with service-based vesting conditions,
the expected term of the Company's stock options has been determined utilizing
the "simplified" method for awards that qualify as "plain-vanilla" options. The
expected term of stock options granted to non-employees is equal to the
contractual term of the option award. The risk-free interest rate is determined
by reference to the U.S. Treasury yield curve in effect at the time of grant of
the award for time periods approximately equal to the expected term of the
award. Expected dividend yield is based on the fact that the Company has never
paid cash dividends and does not expect to pay any cash dividends in the
foreseeable future.

The following table presents, on a weighted-average basis, the assumptions that
the Company used to determine the grant-date fair value of stock options granted
to employees and directors:

                                 Three Months Ended
                                      June 30,
                                  2022              2021
Risk-free interest rate                2.59  %     1.12  %
Expected term (in years)                   6.0         6.0
Expected volatility                    75.6  %     80.2  %
Expected dividend yield                   0  %        0  %


Stock options

The following table summarizes the Company's stock option activity:



                                                                      Weighted               Weighted
                                                                       Average               Average               Aggregate
                                               Number of              Exercise             Contractual             Intrinsic
                                                 Shares                 Price              Term (Years)              Value
Outstanding as of March 31, 2022               6,514,334            $    16.78                        7.26       $   30,358
Granted                                        1,265,509            $    18.08
Exercised                                       (124,028)           $    12.60
Cancelled                                       (144,256)           $    19.82
Outstanding as of June 30, 2022                7,511,559            $    17.01                        7.47       $   31,884
Options exercisable as of March 31, 2022       3,645,749            $    10.85                        6.31       $   24,875
Options exercisable as of June 30, 2022        4,144,044            $    13.15                        6.36       $   26,859


As of June 30, 2022, there was $46.3 million of unrecognized compensation cost
related to unvested common stock options, which is expected to be recognized
over a weighted average period of 2.7 years.

The weighted average grant-date fair value of stock options granted during the
three months ended June 30, 2022 and 2021 was $12.15 and $22.29, respectively.
The aggregate intrinsic value of stock options exercised during the three months
ended June 30, 2022 was $0.5 million.

Restricted stock units


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A summary of the changes in the Company's RSUs during the three months ended
June 30, 2022 is as follows:

                                                                                                            Weighted
                                                                                                             Average
                                                                 Number of Restricted Shares          Grant Date Fair Value
Outstanding as of March 31, 2022                                           826,213                             31.38
Granted                                                                    616,902                             18.01
Vested                                                                    (149,341)                            32.92
Cancelled                                                                  (37,651)                            27.79
Outstanding as of June 30, 2022                                          1,256,123                             24.74


As of June 30, 2022, there was $29.0 million of unrecognized compensation cost
related to unvested restricted stock units, which is expected to be recognized
over a weighted average period of 3.4 years. As of June 30, 2021, there was
$20.9 million unrecognized compensation cost related to unvested restricted
stock units.

9. Net loss per share



Basic and diluted net loss per share attributable to common stockholders was
calculated as follows:

                                                                       Three Months Ended June 30,
                                                                       2022                   2021
Numerator:
Net loss                                                         $      (42,253)         $    (27,311)
Denominator:
Weighted average common shares outstanding, basic and diluted        54,211,446            51,910,331
Net loss per share, basic and diluted                            $        

(0.78) $ (0.53)




The November 2019 Pre-Funded Warrants, the June 2020 Pre-Funded Warrants and the
October 2020 Pre-Funded Warrants are included as outstanding common stock in the
calculation of basic and diluted net loss per share.

The Company's potentially dilutive securities, which include stock options and
warrants to purchase common stock have been excluded from the computation of
diluted net loss per share as the effect would be to reduce the net loss per
share. Therefore, the weighted average number of common shares outstanding used
to calculate both basic and diluted net loss per share is the same. The Company
excluded the following potential common shares, presented based on amounts
outstanding at each period end, from the computation of diluted net loss per
share for the periods indicated because including them would have had an
anti-dilutive effect:

                                            Three Months Ended June 30,
                                         2022                        2021
Options to purchase common stock     7,511,559                   7,411,680
Warrants to purchase common stock      497,344                     497,344
                                     8,008,903                   7,909,024



10. Significant agreements

Agreement with Bristol-Myers Squibb Company

In February 2018, the Company entered into an agreement with Bristol-Myers Squibb Company ("BMS"). Pursuant to the agreement, BMS will provide to the Company, at no cost, a compound for use in the Company's ongoing clinical trial of RP1. Under the agreement, the Company will sponsor, fund and conduct the clinical trial in accordance with an agreed-upon


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protocol. BMS granted the Company a non-exclusive, non-transferrable,
royalty-free license (with a right to sublicense) under its intellectual
property to its compound in the clinical trial and agreed to supply its
compound, at no cost to the Company, for use in the clinical trial. In January
2020, this agreement was expanded to cover an additional cohort of 125 patients
with anti-PD-1 failed melanoma.

Unless earlier terminated, the agreement will remain in effect until (i) the
completion of the clinical trial, (ii) all related clinical trial data have been
delivered to both parties and (iii) the completion of any statistical analyses
and bioanalyses contemplated by the clinical trial protocol or any analysis
otherwise agreed upon by the parties. The agreement may be terminated by either
party (x) in the event of an uncured material breach by the other party, (y) in
the event the other party is insolvent or in bankruptcy proceedings or (z) for
safety reasons. Upon termination, the licenses granted to the Company to use
BMS's compound in the clinical trial will terminate.

In April 2019, the Company entered into a separate agreement with BMS on terms
similar to the terms set forth in the agreement described above, pursuant to
which BMS will provide to the Company, at no cost, nivolumab for use in the
Company's Phase 1 clinical trial of RP2 in combination with nivolumab.

Agreement with Regeneron Pharmaceuticals, Inc.



In May 2018, the Company entered into an agreement with Regeneron
Pharmaceuticals, Inc. ("Regeneron"). The Company and Regeneron are each
independently developing compounds for the treatment of certain tumor types.
Pursuant to the agreement, the Company and Regeneron will undertake one or more
clinical trials using a combination of the compounds being developed by each
entity. Under the agreement, each study will be conducted under terms set out in
a separately agreed upon study plan that will identify the name of the sponsor
and which party will manage the particular clinical trial, and include the
protocol, the budget and a schedule of clinical obligations. In June 2018, under
the terms of the agreement between the Company and Regeneron, the parties agreed
to the first study plan. The Company and Regeneron have agreed to the protocol,
budget, sample testing and clinical obligations schedule under the study plan.
Development and supply costs associated with the first study plan will be split
equally between the Company and Regeneron.

Pursuant to the terms of the agreement, each party granted the other party a
non-exclusive license under its respective intellectual property and agreed to
contribute the necessary resources needed to fulfill its respective obligations,
in each case, under the terms of the agreed-upon or to-be agreed upon study
plans. Development costs of a particular clinical trial will be split equally
between the Company and Regeneron in accordance with the agreed upon study plan.

The agreement may be terminated by either party if (i) there is no active study
plan for which a final study report has not been completed and the parties have
not entered into a study plan for an additional clinical trial within a period
of time after the delivery of the most recent final study report or (ii) in the
event of a material breach.

The agreement with Regeneron is accounted for under ASC 808, Collaborative
Arrangements ("ASC 808"), as both parties are active participants and each party
pays its own compound costs and shares equally in development costs in
accordance with and up to the amount in the agreed upon first study plan. The
Company will account for costs incurred as part of the study, including costs to
supply compounds for use in the study, as research and development expenses
within the consolidated statement of operations. The Company will recognize any
amounts received from Regeneron in connection with this agreement as an offset
to research and development expense within the consolidated statement of
operations.

Under the terms of the agreement, on a quarterly basis the Company and Regeneron
true-up costs of the study and make corresponding payments to the party that
incurred the majority of the costs up to the amount in the study plan or
modified version thereof agreed by the Joint Development Committee established
to govern the collaboration. In July 2022, Regeneron informed the Company that
the costs of the study have reached the initial budget for the initial study
plan of June 2018 and that Regeneron's reimbursement of CERPASS study costs to
the Company have completed in the period ending June 30, 2022 in relation to the
initial study budget. The Company and Regeneron are in communication regarding
receiving Regeneron's acknowledgement of the sharing of the study costs
according to the current budget that superseded that of the initial study plan
and initial budget. The true-up cost in discussion for the period ending June
30, 2022 is $1.4 million to the Company, which have not been recorded in prepaid
expenses and other current assets in the consolidated balance sheet or as an
offset to research and development expense within the consolidated statement of
operations. During the three months ended June 30, 2022 and 2021, the Company
did not make any payments to Regeneron under the terms of the agreement. During
the three months ended June 30, 2022 and 2021, the Company received payments
under the terms of the agreement from Regeneron of $2.0 million and $1.3
million, respectively. As of June 30, 2022 and March 31, 2022, the Company
recorded $1.1 million and $2.0 million of receivables from Regeneron in
connection with this agreement in prepaid expenses and other current assets in
the consolidated balance sheet, respectively.
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11. Commitments and contingencies

Leases

The table below presents the lease-related assets and liabilities recorded on the consolidated balance sheet as of June 30, 2022:



                                              Three Months Ended June 30,
                                                   2022                   2021
Lease cost
Finance lease costs:
Amortization of right-to-use asset     $          607                   $   

607


Interest on lease liabilities                     552                       558
Operating lease costs                             259                       242
Total lease cost                       $        1,418                   $ 1,407


The following table summarizes the classification of lease costs in the
consolidated statement of operations for the three months ended June 30, 2022
and 2021 as follows:

                                                 Three Months Ended June 30,
                                                      2022                   2021
Finance Lease Costs
  Research and development                $          518                   $   518
  Selling, general and administrative                 89                        89
Other income (expense)                               552                       558
Operating Lease Costs
Research and development                             110                        94
  Selling, general and administrative                149                       148
Total lease cost                          $        1,418                   $ 1,407


The following table summarizes the maturity of the Company's lease liabilities
on an undiscounted cash flow basis and a reconciliation to the operating and
financing lease liabilities recognized on its balance sheet as of June 30, 2022:

                                                      June 30, 2022
                                  Operating leases       Financing lease        Total
2023 (remaining nine months)     $             777      $          1,932      $  2,709
2024                                         1,044                 2,639         3,683
2025                                         1,053                 2,718         3,771
2026                                         1,062                 2,799         3,861
2027                                         1,030                 2,883         3,913
Thereafter                                   2,868                38,022        40,890
Total lease payments                         7,834                50,993        58,827
Less: interest                               2,257                24,102        26,359
Total lease liabilities          $           5,577      $         26,891      $ 32,468

The following table provides lease disclosure as of June 30, 2022 and March 31, 2022:


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                                            June 30, 2022       March 31, 2022
Leases

Right-to-use operating lease asset $ 5,269 $ 5,552 Right-to-use finance lease asset

                   41,487               

42,094


Total lease assets                         $       46,756      $        

47,646

Operating lease liabilities, current $ 1,036 $ 1,070 Finance lease liabilities, current

                  2,581                

2,562


Operating lease liabilities, non-current            4,541                

4,801


Finance lease liabilities, non-current             24,310               24,406
Total lease liabilities                    $       32,468      $        32,839

The following table provides lease disclosure for the three months ended June 30, 2022 and 2021:

Three Months Ended June 30,


                                                                    2022                                  2021
Other information
Cash paid for amounts included in the measurement of
lease liabilities:
Operating cash flows from operating leases           $        261                             $     242
Operating cash flows from finance leases             $        552                             $     558
Financing cash flows from finance leases             $         77                             $      53
Weighted-average remaining lease term - operating
leases                                                             7.6            years                8.6            years
Weighted-average remaining lease term - financing
leases                                                            17.3            years               18.1            years
Weighted-average discount rate - operating leases            10.0    %                              9.9  %
Weighted-average discount rate - financing leases             8.3    %                              8.3  %


The variable lease costs and short-term lease costs were insignificant for three months ended June 30, 2022 and 2021.

Manufacturing commitments

The Company has entered into an agreement with a contract manufacturing organization to provide clinical trial products. As of June 30, 2022 and March 31, 2022, the Company had committed to minimum payments under these arrangements totaling $1,631 and $1,951, respectively, through June 30, 2022.

Indemnification agreements



In the ordinary course of business, the Company may provide indemnification of
varying scope and terms to vendors, lessors, business partners and other parties
with respect to certain matters including, but not limited to, losses arising
out of breach of such agreements or from intellectual property infringement
claims made by third parties. In addition, the Company has entered into
indemnification agreements with members of its executive management team and its
board of directors that will require the Company, among other things, to
indemnify them against certain liabilities that may arise by reason of their
status or service as directors or officers. The maximum potential amount of
future payments the Company could be required to make under these
indemnification agreements is, in many cases, unlimited. To date, the Company
has not incurred any material costs as a result of such indemnifications. The
Company is not aware of any claims under indemnification arrangements, and
therefore it has not accrued any liabilities related to such obligations in its
consolidated financial statements as of June 30, 2022 or March 31, 2022.

Legal proceedings

The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities.


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12. Geographic information

The Company operates in two geographic regions: the United States (Massachusetts) and the United Kingdom (Oxfordshire). Information about the Company's long-lived assets held in different geographic regions is presented in the tables below:



                   June 30, 2022       March 31, 2022
United States     $        6,601      $        6,318
United Kingdom             1,666               1,615
                  $        8,267      $        7,933



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Item 2. Management's discussion and analysis of financial condition and results of operations.



You should read the following discussion and analysis of our financial condition
and results of operations together with our unaudited consolidated financial
statements and related notes appearing in Part I, Item 1 of this Quarterly
Report on Form 10-Q, or this Quarterly Report, and with our audited consolidated
financial statements and notes thereto for the year ended March 31, 2022,
included in our Annual Report on Form 10-K for the fiscal year ended March 31,
2022.

In addition to historical information, some of the statements contained in this
discussion and analysis or set forth elsewhere in this Quarterly Report,
including information with respect to our plans and strategy for our business,
constitute forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, or the Exchange Act. We have based these
forward-looking statements on our current expectations and projections about
future events. The following information and any forward-looking statements
should be considered in light of factors discussed elsewhere in this Quarterly
Report, particularly including those risks identified in Part II, Item 1A "Risk
Factors" and our other filings with the Securities Exchange Commission, or SEC.

We caution you that forward-looking statements are not guarantees of future
performance and that our actual results of operations, financial condition and
liquidity, and the development of the industry in which we operate may differ
materially from the forward-looking statements contained in this Quarterly
Report. Statements made herein are as of the date of the filing of this
Quarterly Report with the SEC and should not be relied upon as of any subsequent
date. Even if our results of operations, financial condition and liquidity, and
the development of the industry in which we operate are consistent with the
forward-looking statements contained in this Quarterly Report, they may not be
predictive of results or developments in future periods. We disclaim any
obligation, except as specifically required by law and the rules of the SEC, to
publicly update or revise any such statements to reflect any change in our
expectations or in events, conditions or circumstances on which any such
statements may be based or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements.

Overview

General



We are a clinical-stage biotechnology company committed to applying our leading
expertise in the field of oncolytic immunotherapy to transform the lives of
cancer patients through our novel tumor-directed oncolytic immunotherapies. Our
proprietary tumor-directed oncolytic immunotherapy product candidates are
designed and intended to maximally activate the immune system against cancer.

Oncolytic immunotherapy is an emerging drug class, which we intend to establish
as the second cornerstone of immune-based cancer treatments, alongside
checkpoint blockade. Oncolytic immunotherapy exploits the ability of certain
viruses to selectively replicate in and directly kill tumors, as well as induce
a potent, patient-specific, anti-tumor immune response. Our product candidates
incorporate multiple mechanisms of action into a practical "off-the-shelf"
approach that is intended to maximize the immune response against a patient's
cancer and to offer significant advantages over other approaches to inducing
anti-tumor immunity, including personalized vaccine approaches. We believe that
the bundling of multiple approaches for the treatment of cancer into single
therapies will increase clinical efficacy and simplify the development path of
our product candidates, while also improving patient outcomes at a lower cost to
the healthcare system than the use of multiple different drugs.

Our proprietary RPx platform is based on a proprietary, engineered strain of
herpes simplex virus 1, or HSV-1, backbone with payloads added to maximize
immunogenic cell death and the induction of a systemic anti-tumor immune
response. The RPx platform has a dual local and systemic mechanism of action, or
MOA, consisting of direct selective virus-mediated killing of the tumor
resulting in the release of tumor-derived antigens and altering of the tumor
microenvironment to ignite a strong and durable systemic response. This MOA is
expected to be synergistic with most established and experimental cancer
treatment modalities, and, with an attractive safety profile the RPx platform is
expected to have the versatility to be developed alone or combined with a
variety of other treatment options. We currently have three RPx product
candidates in our development pipeline, RP1 (vusolimogene oderparepvec), our
lead product candidate, RP2 and RP3. Although our fiscal year runs from April
1st - March 31st, our programs and program updates are reported on a calendar
year basis.

We are conducting a number of clinical trials of RP1, both as a monotherapy and
in combination with anti-PD-1 therapy, with a focus on immune-responsive tumors.
We are actively enrolling patients in a randomized, controlled Phase-2 clinical
trial of RP1 with cutaneous squamous cell carcinoma, or CSCC, RP1's lead
indication, which is referred to herein as CERPASS or the CERPASS trial, under
an agreement with our partner Regeneron Pharmaceuticals, Inc., or Regeneron.
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CERPASS is a registration directed clinical trial evaluating RP1 in combination
with cemiplimab, an anti-PD-1 therapy developed by Regeneron, versus cemiplimab
alone. CERPASS is enrolling approximately 180 evaluable patients with locally
advanced or metastatic CSCC who are naïve to anti-PD1 therapy. The CERPASS trial
will evaluate complete response, or CR rate, and overall response rate, or ORR,
as its two primary efficacy endpoints as assessed by independent review, as well
as duration of response, progression-free survival, or PFS, and overall
survival, or OS, as secondary endpoints. Regeneron has granted to us a
non-exclusive royalty-free license to cemiplimab for use in this trial, is
funding one-half of the clinical trial costs up to the amount agreed in the
first study plan, and is supplying cemiplimab at no cost. We are currently in
communication with Regeneron regarding receiving Regeneron's acknowledgement of
the sharing of the study costs according to the current budget that superseded
that of the initial study plan and initial budget. If the CERPASS trial
generates compelling clinical data demonstrating the benefits of the combined
treatment, we believe the data could support a filing with regulatory
authorities seeking marketing approval. We have enrolled the pre-specified
target of 180 patients in the CERPASS trial and additional patients screened in
August will also be enrolled with the last patient expected to initiate dosing
this quarter. Topline primary analysis data from the CERPASS trial is expected
in the first half of 2023.

We continue our collaboration with Bristol Myers Squibb Company, or BMS, under
which BMS has granted us a non-exclusive, royalty-free license to, and is
supplying at no cost, its anti-PD-1 therapy, nivolumab, for use in combination
with RP1 in a multi-cohort Phase 1/2 clinical trial which is referred to herein
as IGNYTE, or the IGNYTE trial. There are four tumor specific cohorts currently
enrolling in the IGNYTE trial including a registration directed Phase 2
expansion cohort enrolling 125 patients with anti-PD-1 failed cutaneous melanoma
who are being treated with RP1 in combination with nivolumab. The additional
three cohorts are in non-melanoma skin cancers, or NMSC, which includes patients
with both naïve and anti-PD-1 failed disease, in anti-PD-1 failed microsatellite
instability high, or MSI-H/dMMR tumors (which we recently changed by protocol
amendment from anti-PD1 naïve disease), and in anti-PD(L)-1 failed non-small
cell lung cancer, or NSCLC.

We initiated the registration directed Phase 2 expansion cohort in the IGNYTE
trial enrolling 125 patients with anti-PD-1 failed cutaneous melanoma after
completing enrollment in a prior Phase 2 cohort in the same clinical trial of
approximately 30 patients with melanoma, which demonstrated the tolerability and
clinical activity of the combination of RP1 and nivolumab in patients with
melanoma, including those who had failed prior anti-PD-1 when given alone or in
combination with CTLA-4 blockade. In March 2021, we held a Type B meeting with
the FDA to discuss the design of the 125 patient expansion cohort in the IGNYTE
trial. In this meeting, the FDA expressed that while a randomized controlled
clinical trial would always be preferred for registration purpose, that in this
patient population with no clear standard of care, if the clinical data is
sufficiently compelling then the data could be considered for submission by the
FDA under the accelerated approval pathway. The FDA also indicated that a
randomized confirmatory trial would also be needed as is required under the
accelerated approval pathway. The design of the confirmatory trial is intended
to be discussed with the FDA prior to a BLA submission. In March 2022, we
released updated data showing that RP1 combined with nivolumab continues to
demonstrate deep and durable responses in patients with melanoma, including a
37.5% overall response rate in anti-PD-1 failed disease. We have completed
enrollment of the first 75 patients in this cohort of the IGNYTE trial and
expect to release a data snapshot from these patients with six months follow-up
in late 2022. The data snapshot from these first 75 patients will be
investigator assessed as compared to the primary endpoint of ORR for all
patients in this cohort which is to be assessed by central review. In order to
document sufficient durability of response, an important secondary endpoint of
the study, the primary analysis upon which a filing is intended to be made, is
expected to be triggered 12 months following the last patient being enrolled.

We continue to enroll patients in our three additional IGNYTE Phase-2 cohorts
under our collaboration with BMS in which we are evaluating RP1 in combination
with nivolumab. In NMSC, enrollment in the anti-PD-1 naïve NMSC cohort has
completed, included patients with cutaneous squamous cell carcinoma, or CSCC,
basal cell carcinoma, or BCC, merkel cell carcinoma, or MCC, and angiosarcoma.
Updated data from the CSCC patients in the anti-PD-1 naïve NMSC cohort,
presented in March 2022, continued to show nearly half of the patients achieving
a complete response and nearly 65% achieving a complete or partial response. We
are currently enrolling 30 patients in an extension of the NMSC cohort of RP1 in
combination with nivolumab in NMSC patients who have failed prior treatment with
anti-PD(L)-1. In March 2022, we reported initial data from this extension cohort
where responses had been observed in anti-PD(L)-1 failed CSCC, MCC and
angiosarcoma tumors. We believe the activity of RP1 combined with nivolumab in
this anti-PD(L)-1 failed cohort represents a new potential therapeutic option
for these patients and supports the broad potential for RP1 in anti-PD(L)-1
failed disease beyond melanoma. Recruitment remains ongoing into the cohorts of
patients with anti-PD1 failed NMSC, including CSCC, anti-PD1 failed NSCLC, and
anti-PD1 failed MSI-H/dMMR cancers, with a data update expected in the first
half of 2023.

We also have open for enrollment a Phase 1b/2 clinical trial of single agent RP1
in solid organ transplant recipients with skin cancers, including CSCC, which is
referred to herein as ARTACUS or the ARTACUS trial, which we believe to be
potentially registrational (in its own right or, subject to discussion with
regulatory authorities, following enrollment of additional patients, including
as a potential label expansion after an initial approval of RP1 in a different
indication). We are currently enrolling up to 65 patients in the ARTACUS trial
to assess the safety and efficacy of RP1 in liver and kidney transplant
recipients with skin cancers. Enrollment in this clinical trial has been
impacted by COVID-19, as the patient population is severely immune-compromised
and considered very high risk. Even though the patient numbers are currently
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small, as reported in March 2022, we have observed responses in these patients
with RP1as monotherapy with a similar safety profile to that observed in our
other RP1 clinical trials in patients who are not immune suppressed. Enrollment
continues in the ARTACUS trial and we expect to provide a data update in the
first half of 2023.

In addition to these ongoing trials with RP1, we are developing a protocol for
testing RP1 along and combined with an anti-PD1 therapy for the neoadjuvant
treatment of CSCC. We expect to initiate this clinical trial in the first half
of 2023.

We are also developing additional product candidates, RP2 and RP3, that have
been further engineered to enhance anti-tumor immune responses and are intended
to address additional tumor types, including traditionally less immune
responsive tumor types. In addition to the expression of GALV-GP R(-) and human
GM-CSF as in RP1, RP2 has been engineered to express an antibody-like molecule
intended to block the activity of CTLA-4, a protein that inhibits the full
activation of an immune response, including to tumors. RP3 has been engineered
with the intent to further stimulate an anti-tumor immune response through
activation of immune co-stimulatory pathways through the additional expression
of the ligands for CD40 and 4-1BBL, as well as anti-CTLA-4 and GALV-GP R(-), but
without the expression of GM-CSF.

We initiated a Phase-1 clinical trial of RP2 alone and in combination with
nivolumab in the second half of 2019. This clinical trial is also being
conducted as part of our collaboration with BMS, under which BMS has granted us
a non-exclusive, royalty-free license to, and will supply at no cost, nivolumab,
for use in combination with RP2. In November 2020, we and BMS agreed to increase
the number of patients in the combination part of the clinical trial from 12 to
30 patients. We have presented data from the single agent RP2 portion of this
clinical trial that showed deep and durable responses, including demonstration
of tumor response in uninjected lesions and in patients with difficult to treat
advanced cancers. We believe that this data supports the hypothesis that
anti-CTLA-4 delivered intra-tumorally through oncolytic virus replication, with
accompanying antigen release and presentation, can provide potent anti-tumor
effects. We have also presented combination data from both the clinical trial
that showed compelling activity in patients with immune insensitive tumors and
with anti-PD-1 failed disease. In the second half of 2021, we reported full
enrollment in the initial 30 patient combination with nivolumab part of the
Phase 1 clinical trial following which a protocol amendment was made to expand
this clinical trial to enroll additional patients who are required to have
specific tumor types of interest, including gastro-intestinal cancers, breast
cancer, lung cancer, head and neck cancer and uveal melanoma, rather than any
type of tumor as were eligible for the initial 30 patient group. Initial data
from this expanded cohort of RP2 Phase 1 patients is expected toward the end of
2022.

We have obtained clearance from the Medicines and Healthcare products Regulatory
Agency in the United Kingdom to enter clinical development with RP3 and in
December 2020 we initiated dosing in this clinical trial. This Phase 1 clinical
trial is designed to evaluate RP3 alone and combined with anti-PD-1 therapy in
advanced solid tumor patients. In March 2022, we reported initial data from the
single agent monotherapy cohort of RP3 in superficial and deep tumors exploring
two dose levels of RP3, including injections into deep tumors. The higher dose
level has been confirmed as the recommended Phase 2 dose and no new safety
signals have been observed as compared to RP1 or RP2. Enrollment of the
combination part of this study has begun, combining RP3 with nivolumab under a
collaboration and supply agreement with BMS. This cohort is focusing on
enrolling patients with gastro-intestinal cancers, breast cancer, lung cancer
and head and neck cancer. Additional monotherapy patients will also be enrolled.
Initial data from this expanded cohort of RP3 Phase 1 patients is expected
toward the end of 2022.

We intend to initiate a Phase 2 development plan for RP2 and/or RP3 to target a
range of tumor types with un-met need, including where liver tumors are common
and in patients with early disease where the objective of treatment would be to
increase the proportion of patients achieving cure. This includes the
development of RP2 and/or RP3 in combination with the current standard of care,
including immunotherapy, chemotherapy and radiation, and in settings following
the current standard of care. We are planning for initial signal finding single
arm Phase 2 clinical trials in the following tumor types: squamous cell
carcinoma of the head and neck, or SCCHN, locally advanced and
recurrent/metastatic; hepatocellular carcinoma, or HCC, both first and second
line; and colorectal cancer, or CRC, third line; with additional signal finding
studies intended to follow. We expect to initiate this Phase 2 development work
in the first quarter of 2023.

RP1, RP2 and RP3 are administered by direct injection into solid tumors, guided
either visually or by ultrasound, computerized tomography, or CT, or other
imaging methods. We believe that direct injection maximizes virus-mediated tumor
cell death, provides the most efficient delivery of virus-encoded immune
activating proteins into the tumor with the goal of activating systemic
immunity, and limits the systemic toxicities that could be associated with
intravenous administration. Activation of systemic immunity through local
administration is intended to lead to the induction of anti-tumor immune
responses leading to clinical response of tumors that have not themselves been
injected.

Financial

Since our inception, we have devoted substantially all of our resources to developing our proprietary RPx platform, building our intellectual property portfolio, conducting research and development of our product candidates, business planning,


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raising capital and providing general and administrative support for our
operations. To date, we have incurred significant operating losses and we have
financed our operations primarily with proceeds from the sale of equity
securities and to a lesser extent, the proceeds from the issuance of debt
securities. Our ability to generate product revenue sufficient to achieve
profitability will depend on the successful development and eventual
commercialization of one or more of our product candidates. We do not have any
products approved for sale and have not generated any revenue from product
sales.

Since our initial public offering, or IPO, on July 20, 2018, we have raised an
aggregate of approximately $600.0 million in net proceeds to fund our
operations, of which $101.2 million was from our IPO, $463.4 million was from
three separate follow-on offerings, or the Public Offerings, that we closed in
November 2019, June 2020 and October 2020, respectively, and $35.4 million was
from at-the-market offerings. We sold 7,407,936 shares of common stock in our
IPO, an aggregate of 13,619,822 shares of our common stock and pre-funded
warrants to purchase 5,284,238 shares of common stock in the Public Offerings,
and 1,973,997 shares of common stock through our at-the-market facility.

Our net losses were $42.3 million and $27.3 million for the three months ended
June 30, 2022 and 2021, respectively. As of June 30, 2022, we had an accumulated
deficit of $353.5 million. These losses have resulted primarily from costs
incurred in connection with research and development activities and general and
administrative costs associated with our operations. We expect to continue to
incur significant expenses and increasing operating losses for at least the next
several years.

We anticipate that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our product candidates, and if and as we:

•conduct our current and future clinical trials with RP1, RP2 and RP3;

•further preclinical development of our platform;

•operate our own in-house manufacturing facility;

•seek to identify and develop additional product candidates;

•seek marketing approvals for any of our product candidates that successfully complete clinical trials, if any;

•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

•until our manufacturing facility is fully validated, continued limited manufacturing by third parties for clinical development;

•maintain, expand and protect our intellectual property portfolio;

•hire and retain additional clinical, quality control, scientific and general and administration personnel;

•acquire or in-license other drugs and technologies; and



•add operational, financial and management information systems and personnel,
including personnel to support our research and development programs, any future
commercialization efforts and operations as a public company.

Because of the numerous risks and uncertainties associated with pharmaceutical
product development, we are unable to accurately predict the timing or amount of
increased expenses or when, or if, we will be able to achieve or maintain
profitability. Even if we are able to generate product sales, we may not become
profitable. If we fail to become profitable or are unable to sustain
profitability on a continuing basis, then we may be unable to continue our
operations at planned levels and be forced to reduce or terminate our
operations.

As of June 30, 2022, we had cash and cash equivalents and short-term investments
of $395.1 million. We believe that our existing cash and cash equivalents and
short-term investments will enable us to fund our operating expenses and capital
expenditure requirements through at least 12 months from the issuance of the
consolidated financial statements included in this Quarterly Report.

See "-Liquidity and capital resources" and "Risk factors-Risks related to our financial position and need for additional capital."


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The COVID-19 pandemic



We are continuing to monitor the global outbreak and spread of COVID-19, and,
throughout the pandemic, have implemented measures designed to comply with
applicable federal, state and local guidelines, as well as care for our
employee's health and well-being. We will continue to examine our protocols as
the pandemic and health guidance evolves. The COVID-19 pandemic We continues to
affect the United States and global economies and has affected and may continue
to affect our operations and those of third parties on which we rely, including
by causing disruptions in our raw material and anti-PD-1 supply, the
manufacturing of our product candidates and our commercialization processes. In
addition, timing of patient enrollment and treatment in certain of our ongoing
clinical studies has been impacted by the pandemic. However, the extent of these
delays is currently unknown and has and will likely continue to vary by clinical
study. In addition, we may incur unforeseen costs as a result of disruptions in
raw material supplies, clinical product supplies, and preclinical studies or
clinical trial delays. The full extent to which the COVID-19 pandemic will
directly or indirectly impact our business, results of operations and financial
condition will depend on future developments that are highly uncertain and
cannot be accurately predicted, including new information that may emerge
concerning COVID-19, the actions taken in an effort to contain it or to
potentially treat or continue to vaccinate against COVID-19 and the economic
impact on local, regional, national and international markets. We continue to
actively monitor this situation and the possible effects on our financial
condition, liquidity, operations, suppliers, supplies, industry and workforce.
For additional information, see "Risk Factors-Our financial condition and
results of operations could be adversely affected by the coronavirus
disease-2019, or COVID-19, outbreak." in Part II, Item 1A of this Quarterly
Report.

Components of our results of operations

Revenue



To date, we have not generated any revenue from product sales as we do not have
any approved products and do not expect to generate any revenue from the sale of
products in the near future. If our development efforts for RP1 or any other
product candidates that we may develop in the future are successful and result
in regulatory approval, or if we enter into collaboration or license agreements
with third parties, we may generate revenue in the future from a combination of
product sales or payments from those collaborations or license agreements.

Operating expenses

Our expenses since inception have consisted solely of research and development costs and general and administrative costs.

Research and development expenses



Research and development expenses consist primarily of costs incurred for our
research activities, including our discovery efforts and the development of our
product candidates, and include:

•expenses incurred under agreements with third parties, including clinical
research organizations, or CROs, that conduct research, preclinical activities
and clinical trials on our behalf as well as contract manufacturing
organizations, or CMOs, that manufacture our product candidates for use in our
preclinical and clinical trials;

•salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

•costs of outside consultants engaged in research and development functions, including their fees, stock-based compensation and related travel expenses;

•the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials;

•costs related to compliance with regulatory requirements in connection with the development of our product candidates; and

•facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.


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These costs may be partially offset by cost-sharing arrangements under collaboration agreements from time to time.

We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued research and development expenses.



Our direct external research and development expenses are tracked on a
program-by-program basis and consist of costs, such as fees paid to consultants,
contractors, CMOs, and CROs in connection with our preclinical and clinical
development activities. We do not allocate personnel costs, costs associated
with our discovery efforts, laboratory supplies, and facilities, including
depreciation or other indirect costs, to specific product development programs
because these costs are deployed across multiple product development programs
and, as such, are not separately classified. All non-employee costs associated
with our manufacturing facility have been fully burdened to our RP1 program.

Research and development activities are central to our business model. Product
candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials.
We expect that our research and development expenses will continue to increase
for the foreseeable future as we continue enrollment and initiate additional
clinical trials and continue to discover and develop additional product
candidates. The successful development and commercialization of our product
candidates is highly uncertain. This is due to the numerous risks and
uncertainties associated with product development and commercialization,
including the following:

•the scope, rate of progress, expense and results of our ongoing clinical trials, as well as future clinical trials or other product candidates and other research and development activities that we may conduct;

•the number and scope of preclinical and clinical programs we decide to pursue;

•our ability to maintain our current research and development programs and to establish new ones;

•uncertainties in clinical trial design;

•the rate of enrollment in clinical trials;



•the successful completion of clinical trials with safety, tolerability, and
efficacy profiles that are satisfactory to the FDA or any comparable foreign
regulatory authority;

•the receipt of regulatory approvals from applicable regulatory authorities;

•our success in operating our manufacturing facility, or securing manufacturing supply through relationships with third parties;

•our ability to obtain and maintain patents, trade secret protection, and regulatory exclusivity, both in the United States and internationally;

•our ability to maintain, expand and protect our rights in our intellectual property portfolio;

•the commercialization of our product candidates, if and when approved;

•the acceptance of our product candidates, if approved, by patients, the medical community, and third-party payors;

•our ability to successfully develop our product candidates for use in combination with third-party products or product candidates;

•negative developments in the field of immuno-oncology;

•competition with other products; and

•significant and changing government regulation and regulatory guidance.


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A change in the outcome of any of these variables with respect to the
development of a product candidate could mean a significant change in the costs
and timing associated with the development of that product candidate. For
example, if the FDA or another regulatory authority were to require us to
conduct clinical trials beyond those that we anticipate will be required for the
completion of clinical development of a product candidate, or if we experience
significant trial delays due to patient enrollment or other reasons, we could be
required to expend significant additional financial resources and time on the
completion of clinical development. We may never succeed in obtaining regulatory
approval for any of our product candidates.

Selling, general and administrative expenses



Selling, general and administrative expenses consist primarily of salaries and
other related costs, including stock-based compensation, for personnel in our
executive, finance, corporate, commercial and business development and
administrative functions. Selling, general and administrative expenses also
include professional fees for legal, patent, accounting, auditing, tax and
consulting services, pre-commercial planning, travel expenses, and
facility-related expenses, which include direct depreciation costs and allocated
expenses for rent and maintenance of facilities and other operating costs.

We expect that our selling, general and administrative expenses will continue to
increase in the future as we increase our selling, general and administrative
headcount to support our continued research and development and pre-launch
activities to prepare for potential commercialization of our product candidates.
We also expect to continue to incur increased expenses, including accounting,
audit, legal, regulatory and tax-related services associated with maintaining
compliance with exchange listing and SEC requirements; director and officer
insurance costs; and investor and public relations costs.

Other income (expense), net

Research and development incentives



Research and development incentives consists of reimbursements of research and
development expenditures. We participate, through our subsidiary in the United
Kingdom, in the research and development program provided by the United Kingdom
tax relief program, such that a percentage of up to 14.5% of our qualifying
research and development expenditures are reimbursed by the United Kingdom
government, and such incentives are reflected as other income.

Investment income

Investment income consists of income earned on our cash and cash equivalents and short-term investments.

Interest expense on finance lease liability

Interest expense on finance lease liability consists of amortization of finance charges under our financing lease.

Other income (expense), net

Other income (expense), net consists primarily of realized and unrealized foreign currency transaction gains and losses.

Income taxes



Since our inception and through June 30, 2022, we have not recorded any income
tax benefits for the net losses we incurred in each jurisdiction in which we
operate, as we believe, based upon the weight of available evidence, that it is
more likely than not that all of our net operating loss carryforwards will not
be realized.

Results of operations

Comparison of the three months ended June 30, 2022 and 2021

The following chart summarizes our results of operations for the three months ended June 30, 2022 and 2021:


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                                                         Three Months Ended
                                                              June 30,
                                                 2022           2021          Change
                                                       (Amounts in thousands)
Operating expenses:
Research and development                      $  29,478      $  18,554      $  10,924
General and administrative                       11,398          8,827          2,571
Total operating expenses                         40,876         27,381         13,495
Loss from operations                            (40,876)       (27,381)       (13,495)
Other income (expense):
Research and development incentives                 851            788      

63


Investment income                                   343             92      

251

Interest expense on finance lease liability (552) (558)

6


Other (expense) income                           (2,019)          (252)     

(1,767)


Total other income (expense), net                (1,377)            70         (1,447)
Net loss                                      $ (42,253)     $ (27,311)     $ (14,942)

Research and development expenses



Research and development expenses for the three months ended June 30, 2022 were
$29.5 million, compared to $18.6 million for the three months ended June 30,
2021. The following table summarizes our research and development expenses for
the three months ended June 30, 2022 and 2021:

                                                                       Three Months Ended
                                                                            June 30,
                                                           2022               2021              Change

Direct research and development expenses by program:

RP1                                                     5,962              3,702              2,260
 RP2                                                       1,868              3,079             (1,211)
 RP3                                                       5,008                238              4,770
Unallocated research and development expenses:                                                       -
   Personnel related (including stock-based
compensation)                                             12,505              9,254              3,251
  Other                                                    4,135              2,281              1,854
Total research and development expenses                $  29,478          $ 

18,554 $ 10,924




The change in our direct research and development expenses between our product
candidates is associated with technology transfer, process development,
qualification and comparability of our in-house manufactured materials compared
to our third-party manufactured materials in readiness for utilizing our product
candidates made at our in-house manufacturing facility in our clinical
development programs and preparation for potential commercial manufacture, if
approved.

The increase in RP1 is primarily the result of an increase in our number of
clinical trial sites and patient enrollment as compared to the prior year, and
reduction of costs sharing in the CERPASS trial from Regeneron during the
current period as discussed in Note 10 to the consolidated financial statements
appearing elsewhere in this Quarterly Report. During the three months ended June
30, 2022, manufacturing specifically focused on the technology transfers and
process development from RP2 to RP3, which is the driver of the change in RP2
and RP3 program costs year over year.

The increase of $5.1 million in our unallocated expenses was due primarily to a
$3.3 million increase in personnel-related costs, including a $3.1 million
increase in payroll and fringe benefits and a stock-based compensation increase
of $0.2 million. The increase in personnel-related costs largely reflected the
hiring of additional personnel in our research and development functions as we
continue to expand the development plan in multiple indications. Personnel
related costs for the three months ended June 30, 2022 and 2021 included
stock-based compensation expense of $2.6 million and $2.5 million, respectively.
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Selling, general and administrative expenses



Selling, general and administrative expenses were $11.4 million for the three
months ended June 30, 2022, compared to $8.8 million for the three months ended
June 30, 2021. The increase of $2.6 million is primarily the result of an
increase of $1.4 million in personnel related costs, including a stock-based
compensation increase of $0.8 million, and an increase of $0.6 million in
payroll and fringe benefits. The increase in personnel related costs was driven
by the continued hiring of additional personnel in our general and
administrative functions, including the addition of commercial personnel
associated with pre-launch commercial planning and initial build of the
Company's commercial infrastructure, which accounts for approximately
$0.2 million of the increase. In addition, there is an increase of approximately
$0.6 million related to outside services and external expenses related to
commercial planning and initial commercial activities compared to prior year, as
we expand our operations.

Total other (expense) income, net



Other (expense) income was $(1.4) million for the three months ended June 30,
2022, compared to $0.1 million for the three months ended June 30, 2021. The net
change of $1.4 million is primarily attributable to an increase in expense of
$1.8 million in the current year compared to the prior year due to exchange rate
fluctuations related to the changes in foreign exchange rates of the Great
British Pound to the United States Dollar, specifically on intercompany and
other non-functional currency transactions. This increased expense is somewhat
offset by an increase in investment income of approximately $0.3 million.

Liquidity and capital resources



Since our inception, we have not generated any revenue from product sales and
have incurred significant operating losses and negative cash flows from our
operations. We have not yet commercialized any of our product candidates, which
are in various phases of preclinical and clinical development, and we do not
expect to generate revenue from sales of any products for the foreseeable
future, if at all.

Sources of liquidity



To date, we have financed our operations primarily with proceeds from the sale
of equity securities and, to a lesser extent, proceeds from borrowing under a
secured loan facility. Through June 30, 2022, we had received net proceeds of
$686.8 million through the sale of shares of common stock in public offerings
and at-the-market offerings. As of June 30, 2022, we had cash and cash
equivalents and short-term investments of $395.1 million.

On June 23, 2022, in connection with our entry into a new sales agreement with
the SVB Securities LLC, or the Agent, we and the Agent mutually agreed to
terminate a previous sales agreement. Under the new sales agreement, we may
sell, from time to time, at our option, up to an aggregate of $100 million of
shares of our common stock by methods deemed to be an "at the market offering"
as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as
amended, or if authorized by us, in negotiated transactions or block trade, in
each case, pursuant to a registration statement on Form S-3 filed by us with the
Securities and Exchange Commission on June 23, 2022.

Cash flows



The following table summarizes our cash flows for each of the periods presented:

                                                                  Three Months Ended June 30, 2022
                                                                      2022                2021
                                                                       (Amounts in thousands)
Net cash used in operating activities                             $  (33,455)         $ (18,314)
Net cash provided by (used in) investing activities                    5,315             26,992
Net cash provided by financing activities                             32,522              1,120

Effect of exchange rate changes on cash and cash equivalents 1,915

                212
Net decrease in cash and cash equivalents                         $    6,297          $  10,010


Operating activities
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During the three months ended June 30, 2022, net cash used in operating
activities was $33.5 million, primarily resulting from our net loss of $42.3
million, partially offset by non-cash charges of $8.1 million, primarily
consisting of stock-based compensation expense of $7.2 million, and an increase
in cash of $0.7 million related to changes in our operating assets and
liabilities. Changes in our operating assets and liabilities for the three
months ended June 30, 2022 consisted primarily of a $1.1 million decrease in
accrued expenses and other current liabilities, a $0.9 million increase in
accounts payable, a $0.9 million decrease in research and development incentives
receivable from the United Kingdom government due to the timing and amount of
our qualifying expenditures, a net $0.6 million change in operating and
financing right-of-use assets and lease liabilities, and as well as a $1.2
million increase in prepaid expenses and other current assets.

During the three months ended June 30, 2021, net cash used in operating
activities was $18.3 million, primarily resulting from our net loss of $27.3
million, partially offset by non-cash charges of $7.4 million, primarily
consisting of an increase in stock-based compensation expense of $3.8 million,
and an increase in cash of $1.6 million related to changes in our operating
assets and liabilities. Net cash used by our changes in our operating assets and
liabilities for the three months ended June 30, 2021 consisted primarily of a
$1.2 million increase in prepaid expenses and other current assets, a $0.8
million decrease in research and development incentives receivable from the
United Kingdom government due to the timing and amount of our qualifying
expenditures, a net $0.6 million increase in cash related to changes in
operating and financing right-of-use assets and lease liabilities and a $0.5
million increase in accrued expenses and other current liabilities.

Investing activities



During the three months ended June 30, 2022, net cash provided by investing
activities was $5.3 million, consisting of $67.0 million in proceeds from sales
and maturities of short-term investments, partially offset by $60.6 million in
purchases of available for sale securities and $1.1 million in purchases of
property, plant and equipment.

During the three months ended June 30, 2021, net cash used in investing
activities was $27.0 million, consisting of $59.5 million in proceeds from sales
and maturities of short-term investments, partially offset by $32.2 million in
purchases of available for sale securities and $0.3 million in purchases of
property, plant and equipment.

Financing Activities

During the three months ended June 30, 2022, net cash provided by financing activities was $32.5 million, consisting primarily of $31.0 million from the issuance of common stock through ATM sales, as well as approximately $1.6 million in proceeds from the exercise of stock options.

During the three months ended June 30, 2021, net cash provided by financing activities was $1.1 million, consisting of primarily $1.2 million in proceeds from the exercise of stock options.

Funding requirements



Our plan of operation is to continue implementing our business strategy,
continue research and development of RP1 and our other product candidates and
continue to expand our research pipeline and our internal research and
development capabilities. We expect our expenses to increase substantially in
connection with our ongoing activities, particularly as we advance the
preclinical activities and clinical trials of our product candidates and if and
as we:

•conduct our current and future clinical trials with RP1, RP2 and RP3;

•further preclinical development of our RPx platform;

•operate, qualify and maintain our own in-house manufacturing facility;

•seek to identify and develop additional product candidates;

•seek marketing approvals for any of our product candidates that successfully complete clinical trials, if any;

•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;

•until our planned manufacturing facility is fully validated, continued limited manufacturing by third parties for clinical development.


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•maintain, expand and protect our intellectual property portfolio;

•hire and retain additional clinical, quality control, scientific and general and administration personnel;

•acquire or in-license other drugs and technologies; and



•add operational, financial and management information systems and personnel,
including personnel to support our research and development programs, any future
commercialization efforts and operations as a public company.

As of June 30, 2022, we had cash and cash equivalents and short-term investments
of $395.1 million. We believe that our existing cash, cash equivalents and
short-term investments as of June 30, 2022, will enable us to fund our
operations into the second half of calendar 2024, excluding any confirmatory
trial required by the FDA or other regulatory body. We have based these
estimates on assumptions that may prove to be wrong, and we could utilize our
available capital resources sooner than we expect.

Because of the numerous risks and uncertainties associated with the development
of RP1 and other product candidates and programs, and because the extent to
which we may enter into collaborations with third parties for development of our
product candidates is unknown, we are unable to estimate the timing and amounts
of increased capital outlays and operating expenses associated with completing
the research and development of our product candidates. Our future capital
requirements will depend on many factors, including those described in this
section and above under "-Operating expenses-Research and development expenses."

Developing novel biopharmaceutical products, including conducting preclinical
studies and clinical trials, is a time-consuming, expensive and uncertain
process that takes years to complete, and we may never generate the necessary
data or results required to obtain marketing approval for any product candidates
or generate revenue from the sale of any products for which we may obtain
marketing approval. In addition, our product candidates, if approved, may not
achieve commercial success. Our commercial revenues, if any, will be derived
from sales of therapies that we do not expect to be commercially available for
many years, if ever. Accordingly, we will need to obtain substantial additional
funds to achieve our business objectives.

Adequate additional funds may not be available to us on acceptable terms, or at
all. We do not currently have any committed external source of funds. To the
extent that we raise additional capital through the sale of our equity or
convertible debt securities, our shareholders' interest may be diluted, and the
terms of these securities may include liquidation or other preferences and
anti-dilution protections that could adversely affect the rights of our common
stockholder. Additional debt or preferred equity financing, if available, may
involve agreements that include restrictive covenants that may limit our ability
to take specific actions, such as incurring debt adversely impact our ability to
conduct our business, and may require the issuance of warrants, which could
potentially dilute your ownership interest.

If we raise additional funds through collaborations, strategic alliances or
licensing arrangements with third parties, we may have to relinquish valuable
rights to our technology, future revenue streams, research programs, or product
candidates or grant licenses on terms that may not be favorable to us. If we are
unable to raise additional funds through equity or debt financings or
collaborations, strategic alliances or licensing arrangements with third parties
when needed, we may be required to delay, limit, reduce and/or terminate our
product development programs or any future commercialization efforts or grant
rights to develop and market product candidates that we would otherwise prefer
to develop and market ourselves.

Contractual obligations and commitments



During the three months ended June 30, 2022, there were no material changes to
our contractual obligations and commitments from those described under the
heading "Management's Discussion and Analysis of Financial Condition and Results
of Operations-Contractual Obligations and Commitments" in our Annual Report on
Form 10-K for the year ended March 31, 2022, which was filed with the SEC on
May 20, 2021.

Collaborations

BMS

In February 2018, we entered into a Clinical Trial Collaboration and Supply
Agreement with Bristol-Myers Squibb Company, or BMS. Pursuant to the agreement,
BMS is providing to us, at no cost, nivolumab, its anti-PD-1 therapy, for use in
combination with RP1 in our ongoing Phase 1/2 clinical trial. Under the
agreement, we will sponsor, fund and conduct the
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clinical trial in accordance with an agreed-upon protocol. BMS granted us a
non-exclusive, non-transferrable, royalty-free license (with a right to
sublicense) under its intellectual property to use nivolumab in the clinical
trial and has agreed to supply nivolumab, at no cost to us, for use in the
clinical trial. Both parties will own the study data produced in the clinical
trial, other than study data related solely to nivolumab, which will belong
solely to BMS, or study data related solely to RP1, which will belong solely to
us. In January 2020, this agreement was expanded to cover an additional cohort
of 125 patients with anti-PD-1 failed melanoma.

Unless earlier terminated, the agreement will remain in effect until (i) the
completion of the clinical trial, (ii) all related clinical trial data have been
delivered to both parties and (iii) the completion of any statistical analyses
and bioanalyses contemplated by the clinical trial protocol or any analysis
otherwise agreed upon by the parties. The agreement may be terminated by either
party (x) in the event of an uncured material breach by the other party, (y) in
the event the other party is insolvent or in bankruptcy proceedings or (z) for
safety reasons. Upon termination, the licenses granted to us to use nivolumab in
the clinical trial will terminate. The agreement contains representations,
warranties, undertakings and indemnities customary for a transaction of this
nature.

In April 2019, we entered into a separate agreement with BMS on terms similar to
the terms set forth in the agreement described above, pursuant to which BMS will
provide, at no cost to us, nivolumab for use in our Phase 1 clinical trial of
RP2 in combination with nivolumab.

Regeneron



In May 2018, we entered into a Master Clinical Trial Collaboration and Supply
Agreement with Regeneron Pharmaceuticals, Inc., or Regeneron. Pursuant to the
agreement we agreed to undertake one or more clinical trials with Regeneron for
the administration of our product candidates in combination with cemiplimab, an
anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types, the
first of which, agreed in June 2018, is our ongoing Phase 2 clinical trial
testing RP1 in combination with cemiplimab versus cemiplimab alone in patients
with CSCC. Each clinical trial will be conducted pursuant to an agreed study
plan which, among other things, will identify the name of the sponsor and which
party will manage the particular study, and include the protocol, the budget and
a schedule of clinical obligations. The first study plan related to the Phase 2
clinical trial in CSCC has been agreed.

Pursuant to the terms of the agreement, each party granted the other party a
non-exclusive license of their respective intellectual property and agreed to
contribute the necessary resources needed to fulfill their respective
obligations, in each case, under the terms of agreed study plans. Development
costs of an agreed study plan will be split equally. In July 2022, Regeneron
informed the Company that the costs of the study have reached the initial budget
for the initial study plan of June 2018 and that Regeneron's reimbursement of
CERPASS study costs to the Company have completed in the period ending June 30,
2022 in relation to the initial study budget. The Company and Regeneron are in
communication regarding receiving Regeneron's acknowledgement of the sharing of
the study costs according to the current budget that superseded that of the
initial study plan and initial budget. The agreement contains representations,
warranties, undertakings and indemnities customary for a transaction of this
nature. The agreement also contains certain time-based covenants that restrict
us from entering into a third-party arrangement with respect to the use of our
product candidates in combination with an anti-PD-1 therapy and that restrict
Regeneron from entering into a third-party arrangement with respect to the use
of cemiplimab in combination with an HSV-1 virus, in each case, for the
treatment of a tumor type that is the subject of a clinical trial to which the
covenants apply. Unless otherwise mutually agreed in a future study plan, these
covenants are only applicable to our ongoing Phase 2 clinical trial in CSCC.

The agreement may be terminated by either party if (i) there is no active study
plan for which a final study report has not been completed and the parties have
not entered into a study plan for an additional clinical trial within a period
of time after the delivery of the most recent final study report or (ii) in the
event of a material breach.

Critical accounting policies and estimates



Our management's discussion and analysis of financial condition and results of
operations is based on our consolidated financial statements, which have been
prepared in accordance with generally accepted accounting principles in the
United States. The preparation of our consolidated financial statements and
related disclosures requires us to make estimates and assumptions that affect
the reported amounts of assets and liabilities, costs and expenses and the
disclosure of contingent assets and liabilities in our consolidated financial
statements. We base our estimates on historical experience, known trends and
events and various other factors that we believe are reasonable under the
circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from
other sources. We evaluate our
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estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.



While our significant accounting policies are described in greater detail in
Note 2 to our consolidated financial statements appearing elsewhere in this
Quarterly Report, we believe that the following accounting policies are those
most critical to the judgments and estimates used in the preparation of our
consolidated financial statements.

Accrued research and development expenses



As part of the process of preparing our consolidated financial statements, we
are required to estimate our accrued research and development expenses. This
process involves reviewing open contracts and purchase orders, communicating
with our personnel to identify services that have been performed on our behalf
and estimating the level of service performed and the associated cost incurred
for the service when we have not yet been invoiced or otherwise notified of
actual costs. The majority of our service providers invoice us in arrears for
services performed, on a pre-determined schedule or when contractual milestones
are met; however, some require advanced payments. We make estimates of our
accrued expenses as of each balance sheet date in the consolidated financial
statements based on facts and circumstances known to us at that time. Examples
of estimated accrued research and development expenses include fees paid to:

•CROs in connection with performing research activities and conducting preclinical studies and clinical trials on our behalf;

•CMOs in connection with the production of preclinical and clinical trial materials;

•investigative sites or other service providers in connection with clinical trials;

•vendors in connection with preclinical and clinical development activities; and

•vendors related to product manufacturing and development and distribution of preclinical and clinical supplies.



We base our expenses related to preclinical studies and clinical trials on our
estimates of the services received and efforts expended pursuant to quotes and
contracts with multiple CMOs and CROs that supply, conduct and manage
preclinical studies and clinical trials on our behalf. The financial terms of
these agreements are subject to negotiation, vary from contract to contract and
may result in uneven payment flows. There may be instances in which payments
made to our vendors will exceed the level of services provided and result in a
prepayment of the expense. Payments under some of these contracts depend on
factors such as the successful enrollment of patients and the completion of
clinical trial milestones. In accruing service fees, we estimate the time period
over which services will be performed and the level of effort to be expended in
each period. If the actual timing of the performance of services or the level of
effort varies from the estimate, we adjust the accrual or the amount of prepaid
expenses accordingly. Although we do not expect our estimates to be materially
different from amounts actually incurred, our understanding of the status and
timing of services performed relative to the actual status and timing of
services performed may vary and may result in reporting amounts that are too
high or too low in any particular period. To date, there have not been any
material adjustments to our prior estimates of accrued research and development
expenses.

Stock-based compensation

We issue stock-based awards to employees, directors, consultants and
non-employees in the form of stock options and restricted stock units. We
measure such stock-based awards in accordance with ASC 718, Compensation - Stock
Compensation, which requires all stock-based awards to be recognized in the
consolidated statements of operations and comprehensive loss based on their fair
value on the date of the grant and the related compensation expense for those
awards is recognized over the requisite service period, which is generally the
vesting period of the respective award. We have, to date, only issued
stock-based awards with service-based vesting conditions and record the expense
for these awards using the straight-line method. The fair value of each stock
option grant is estimated on the date of grant using the Black-Scholes
option-pricing model, which requires inputs based on certain subjective
assumptions, including the expected stock price volatility, the expected term of
the option, the risk-free interest rate for a period that approximates the
expected term of the option, and our expected dividend yield. See Note 9 to our
consolidated financial statements appearing elsewhere in this Quarterly Report
for more information. Forfeitures are accounted for as they occur. The fair
value of each stock-based award is estimated on the date of grant based on the
fair value of our common stock on that same date.

We classify stock-based compensation expense in our consolidated statements of
operations in the same manner in which the award recipient's payroll costs are
classified or in which the award recipient's service payments are classified.
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Recently issued accounting pronouncements



A description of recently issued accounting pronouncements that may potentially
impact our financial position and results of operations is disclosed in Note 2
to our consolidated financial statements appearing elsewhere in this Quarterly
Report.

Emerging growth company status



As an "emerging growth company," the Jumpstart Our Business Startups Act of 2012
permits us to take advantage of an extended transition period to comply with new
or revised accounting standards applicable to public companies until those
standards would otherwise apply to private companies. We have irrevocably
elected to "opt out" of this provision and, as a result, we will comply with new
or revised accounting standards when they are required to be adopted by public
companies that are not emerging growth companies.

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